MEGAN MARCINKO

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries. Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place. Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures. Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care. Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program. Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models. Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year. Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP). Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

H.R. 1215, the Protecting Access to Care Act; all provisions.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products. For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products. Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General. H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General. H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

H.R. 1215, the "Protecting Access to Care Act," all provisions. H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries. Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place. Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures. Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care. Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program. Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models. Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year. Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP). Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General. H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General. H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). Support for legislation and/or regulation requiring all non-grandfathered private health insurance plans to cover preventative services given an "A" or "B" rating by the U.S. Preventative Services Task Force (USPSTF), especially provisions relating to comprehensive benefits for tobacco cessation services. Opposition to H.R. 1136, the "FDA Deeming Authority Clarification Act of 2017," all provisions. Comments to the Department of Housing and Urban Development re: Reducing Regulatory Burden; Enforcing the Regulatory Reform Agenda Under Executive Order 13777; Docket No. FR-6030-N-01. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Comments re: Docket No. USTR-2017-0006; provisions relating to public health measures to protect citizens from the death and disease caused by tobacco products. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Comments in support of Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, Docket No. FDA-2016-N-2527. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). Support for legislation and/or regulation requiring all non-grandfathered private health insurance plans to cover preventative services given an "A" or "B" rating by the U.S. Preventative Services Task Force (USPSTF), especially provisions relating to comprehensive benefits for tobacco cessation services. Opposition to H.R. 1136,the "FDA Deeming Authority Clarification Act of 2017," all provisions.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). Support for legislation and/or regulation requiring all non-grandfathered private health insurance plans to cover preventative services given an "A" or "B" rating by the U.S. Preventative Services Task Force (USPSTF), especially provisions relating to comprehensive benefits for tobacco cessation services. Opposition to H.R. 1136, the "FDA Deeming Authority Clarification Act of 2017," all provisions. Comments to the Department of Housing and Urban Development re: Reducing Regulatory Burden; Enforcing the Regulatory Reform Agenda Under Executive Order 13777; Docket No. FR-6030-N-01. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Comments re: Docket No. USTR-2017-0006; provisions relating to public health measures to protect citizens from the death and disease caused by tobacco products. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products. For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products. Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). Support for legislation and/or regulation requiring all non-grandfathered private health insurance plans to cover preventative services given an "A" or "B" rating by the U.S. Preventative Services Task Force (USPSTF), especially provisions relating to comprehensive benefits for tobacco cessation services. Opposition to H.R. 1136, the "FDA Deeming Authority Clarification Act of 2017," all provisions. Comments to the Department of Housing and Urban Development re: Reducing Regulatory Burden; Enforcing the Regulatory Reform Agenda Under Executive Order 13777; Docket No. FR-6030-N-01. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Comments re: Docket No. USTR-2017-0006; provisions relating to public health measures to protect citizens from the death and disease caused by tobacco products. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Comments in support of Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, Docket No. FDA-2016-N-2527. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products. For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products. Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries. Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place. Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures. Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care. Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program. Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models. Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year. Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP). Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries. Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place. Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures. Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care. Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program. Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models. Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year. Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP). Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries. Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place. Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures. Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care. Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program. Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models. Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year. Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP). Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general. Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI). Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule. H.R. 2276, the "Audiology Patient Choice Act," all provisions. Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate. Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System. Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements. Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices. Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS). Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes. Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017. Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC). Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed rule. Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products. Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products. For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products. Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA). H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017. Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill. Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General. H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200. Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products. H.R.1628 - American Health Care Act of 2017; in general. The "Better Care Reconciliation Act"; in general. Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General.

Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications. Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids. Federal "Truth-in-Advertising" legislation; in general. Issues pertaining to scope of practice; in general. Repeal of the Affordable Care Act; in general. Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids. Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200.

Medicare physician payment reform and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general. Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019. Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter). H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions. H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions. Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs. Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program. Issues pertaining to scope of practice; in general.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. Opposition to the provision in the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2017 to collect all data for all 10- and 90-day global services from all practitioners who perform these services, rather than from a representative sample of practitioners, which was required by The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Comments in support of the Centers for Medicare and Medicaid Services (CMS) restoring the Refinement Panel to serve as the relative value appeals process that was appropriately in place prior to 2011. Comments re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P. Comments expressing concern about the quasi-qualified entity provisions of the final rule, Medicare Program: Expanding Uses of Medicare Data by Qualified Entities."

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. Opposition to the provision in the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2017 to collect all data for all 10- and 90-day global services from all practitioners who perform these services, rather than from a representative sample of practitioners, which was required by The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Comments in support of the Centers for Medicare and Medicaid Services (CMS) restoring the Refinement Panel to serve as the relative value appeals process that was appropriately in place prior to 2011. Comments re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P. Comments expressing concern about the quasi-qualified entity provisions of the final rule, Medicare Program: Expanding Uses of Medicare Data by Qualified Entities." Comments/concerns regarding efforts to require Qualified Clinical Data Registries (QCDRs) to consolidate one or more of their proposed non-PQRS quality measures with (a) existing, traditional PQRS quality measures, (b) other non-PQRS measures proposed by other QCDRs, or (c) non-PQRS measures proposed by the QCDR. Comments re: CMS-5517-FC - Medicare Program: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models for use of QCDRs and certified electronic health record technology (CEHRT) for reporting measures under the Quality performance category. Comments re: "Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models," published in the Federal Register on November 4, 2016. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-FC and IFC, published in the Federal Register as a final notice on November 14, 2016, addressing: 1.) Additional Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Procedures Assigned to New Technology APC Groups for CY 2017; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act for 2014 (PAMA). Repeal of the Independent Payment Advisory Board (IPAB); in general.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the Medicare Audiology Services Enhancement Act of 2015, all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the Audiology Patient Choice Act of 2015, all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY17. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request for 2017. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request for 2017. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

H.R. 1344/S. 2424, the Early Hearing Detection and Intervention Act of 2015, all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request for 2017. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments. Support for provisions in the "21st Century Cures" bill relating to the exchange of clinical outcomes data between electronic health record (EHR) technologies and clinician-led clinical data registries, including provisions to promote and facilitate interoperability of clinical data and to prevent EHR vendors from blocking the transmission of such data to third parties, including clinician-led clinical data registries. Comments re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the Truth in Healthcare Marketing Act of 2015, all provisions.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments. Support for provisions in the "21st Century Cures" bill relating to the exchange of clinical outcomes data between electronic health record (EHR) technologies and clinician-led clinical data registries, including provisions to promote and facilitate interoperability of clinical data and to prevent EHR vendors from blocking the transmission of such data to third parties, including clinician-led clinical data registries. Comments re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities.

Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States. Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding. H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions. H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions. S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the Medicare Audiology Services Enhancement Act of 2015, all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the Audiology Patient Choice Act of 2015, all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. Opposition to the provision in the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2017 to collect all data for all 10- and 90-day global services from all practitioners who perform these services, rather than from a representative sample of practitioners, which was required by The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Comments in support of the Centers for Medicare and Medicaid Services (CMS) restoring the Refinement Panel to serve as the relative value appeals process that was appropriately in place prior to 2011. Comments re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P. Comments expressing concern about the quasi-qualified entity provisions of the final rule, Medicare Program: Expanding Uses of Medicare Data by Qualified Entities." Comments/concerns regarding efforts to require Qualified Clinical Data Registries (QCDRs) to consolidate one or more of their proposed non-PQRS quality measures with (a) existing, traditional PQRS quality measures, (b) other non-PQRS measures proposed by other QCDRs, or (c) non-PQRS measures proposed by the QCDR. Comments re: CMS-5517-FC - Medicare Program: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models for use of QCDRs and certified electronic health record technology (CEHRT) for reporting measures under the Quality performance category. Comments re: "Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models," published in the Federal Register on November 4, 2016. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-FC and IFC, published in the Federal Register as a final notice on November 14, 2016, addressing: 1.) Additional Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Procedures Assigned to New Technology APC Groups for CY 2017; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act for 2014 (PAMA). Repeal of the Independent Payment Advisory Board (IPAB); in general.

Medicare physician payment reform, in general. Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015. Audiology-related legislation, in general. H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions. Flexibility of the Meaningful Use Program, in general. Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC). H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions. Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies. Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved. Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries. Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. Opposition to the provision in the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2017 to collect all data for all 10- and 90-day global services from all practitioners who perform these services, rather than from a representative sample of practitioners, which was required by The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Comments in support of the Centers for Medicare and Medicaid Services (CMS) restoring the Refinement Panel to serve as the relative value appeals process that was appropriately in place prior to 2011. Comments re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017. Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P. Comments expressing concern about the quasi-qualified entity provisions of the final rule, Medicare Program: Expanding Uses of Medicare Data by Qualified Entities."

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Premarket review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the Child Nicotine Poisoning Prevention Act of 2015, all provisions.

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products. Opposition to the $110 million funding cut in the House FY 2017 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH). Comments to the FDA re: requirement that all non-grandfathered private health insurance plans cover preventive services given an A or B rating by the U.S. Preventive Services Task Force (USPSTF), including the availability of comprehensive benefits for tobacco cessation services.

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products. Opposition to the $110 million funding cut in the House FY 2017 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products. Opposition to the $110 million funding cut in the House FY 2017 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Premarket review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the Child Nicotine Poisoning Prevention Act of 2015, all provisions.

Food and Drug Administration oversight of tobacco products, in general. Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general. Pre-market review provisions of the Tobacco Control Act, in general. Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Implementation of a smoke-free policy in all public housing. H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions. Support for finalization of deeming regulations re: all tobacco products. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products. Opposition to the $110 million funding cut in the House FY 2017 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH). Comments to the FDA re: requirement that all non-grandfathered private health insurance plans cover preventive services given an A or B rating by the U.S. Preventive Services Task Force (USPSTF), including the availability of comprehensive benefits for tobacco cessation services.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions. H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions. H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services. Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016), the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.

S. 2175, the Department of Veterans Affairs (VA) Provider Equity Act.

H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY17. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.

H.R. 1344/S. 2424, the Early Hearing Detection and Intervention Act of 2015, all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request for 2017. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US.

H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions. Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs. Agency for Healthcare Research and Quality (AHRQ) funding request for 2017. Funding for Graduate Medical Education, in general. Funding for NIH and medical research, in general. Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services. Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA). Funding for the Pediatric Device Consortia for 2017. Funding for Human Temporal Bone Laboratories in the US. Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.