Local Coverage Determination Clarification Act of 2016

Issues related to physician owned distributors of devices Issues related to deficit reduction and Medicare Issues related to Medicare program integrity , including changes to the Stark laws and Anti-Kickback Statute Issues relating to payment reform, ACOs and Bundling Issues related to the CMS program for durable medical equipment Issues related to the development of Medicare payments for telehealth and remote monitoring services Issues related to applying the unique device identifier to Medicare claims forms S. 1253 Patient Access to Disposable Medical Technology Act of 2015 S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act H.R. 4714 the Removing Barriers to Clinical Research Act of 2016 S. 2736 Patient Access to Durable Medical Equipment Act H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act H.R. 5721, S. 3392 Local Coverage Determination Clarification Act of 2016

Client expense: $650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act Implementation; Medicare; Medicare Physician Fee Schedule; H.R.5721 - Local Coverage Determination Clarification Act of 2016 Medicare Clinical Laboratory Fee Schedule; Clinical Laboratory Improvement Amendments of 1988; Medical Devices (Diagnostic); Protecting Access to Medicare Act (PAMA); Medicare Access and CHIP Reauthorization Act; Electronic Health Records; Health Information Technology Reform Act; Physician Quality Reporting System; Stark Self-Referral Reform; Medicare Sustainable Growth Rate; Laboratory Developed Tests; Physician Shortages and Graduate Medical Education; Health Care Personnel Shortages and Allied Health Education; Appropriations for Federal Agencies; Global Health Initiatives; Non-Communicable Disease

Client expense: $63,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Labor Statistics (BLS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA), White House Office

S.2425-Patient Access and Medicare Protection Act (PAMPA) implementation. Support for legislation to ensure patient safety and preserve the integrity of the Medicare program by ending abuses of the physician self-referral law for radiation therapy services; Protecting Integrity in Medicare Act (H.R. 5088) Support for structural changes that lead to delivering high-quality care for patients while increasing efficiencies and promoting Medicare sustainability; oppose radiation oncology benefit managers. Support for ensuring radiation oncologists participation in the Medicare electronic health record incentive program. Support for reforming the way Medicare pays for radiation oncology services by tying payments to quality and value. Implementation of H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 Support the elimination of abuse to the Medicare program by closing the in-office ancillary services exception to the Stark Law for radiation oncology services. S. 1549, To amend title XVIII of the Social Security Act to provide for advanced illness care coordination services for Medicare beneficiaries, and for other purposes. Helping Hospitals Improve Patient Care (H.R. 5273) H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $169,918 · Firm income: Not reported

Support for a national reporting database of medical errors related to the delivery of radiation therapy. Support for the development of an appropriate medical event definition. Support to ensure that patient care advances in biomedical research impacting patient care are not compromised by any policies imposed on the medical use and research applications of cesium chloride. FDA review process of medical devices; The Medical Device Guardians Act of 2016 (H.R. 5404) Support for NRC Commissioner nominee to have medical background. Support patient choice in treatment options by closing the in-office ancillary services exception to the Stark Law for radiation oncology services; Protecting Integrity in Medicare Act (H.R. 5088) Oppose Non-Burning Sunshine Report Language Oppose HR 2698, Tanning Tax Repeal Act of 2015 Support HR 239, To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes Radiation Oncology reimbursement Radiation Oncology safety Cancer Moonshot Initiative H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $169,918 · Firm income: Not reported

HR 5721 Local Coverage Determination Clarification Act S 3392 Local Coverage Determination Clarification Act of 2016 HR 3712 / S 2173 Improving Access to Mental Health Act

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

Monitor federal issues and legislation related to healthcare policy. Monitor federal issues and legislation related to Medicare reimbursement. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Extend Section 3111, P.L. 111-148. Monitor the implementation of Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act, 2017, and Zika Response and Preparedness Act (P.L. 114-223). H.R. 6, House 21st Century Cures Act. H.R. 270, Flexibility in Health IT Reporting (Flex-IT) Act of 2015. H.R.775, Medicare Access to Rehabilitation Services Act of 2015. H.R. 1600, Patients' Access to Treatments Act of 2015. H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. H.R. 1859, Ensuring Children's Access to Specialty Care Act of 2015. H.R. 2256, Veterans Information Modernization Act. H.R. 2464, Demanding Accountability for Veterans Act of 2015. H.R. 3020, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015. H.R. 3309, Flex-IT 2 Act H.R. 4227, Medicare Advantage Bill of Rights. H.R. 4848, HIP Act H.R. 4909, National Defense Authorization Act for Fiscal Year 2017 H.R. 5001, Flexibility in Electronic Health Record Reporting Act. H.R. 5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. H.R. 5293, Department of Defense Appropriations, FY 2017. H.R.5721, Local Coverage Determination Clarification Act S. 480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015. S.539, Medicare Access to Rehabilitation Services Act of 2015. S. 2392, Medicare Advantage Bill of Rights. S. 2511, Improving Health Information Technology Act. S. 2822, Flexibility in Electronic Health Record Reporting Act S. 2943, National Defense Authorization Act for Fiscal Year 2017 S. 2978, The Protect Continuing Physician Education and Patient Care Act. S. 3000, Department of Defense Appropriations, FY 2017. S. 3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017. S.3173, EHR Regulatory Relief Act. Senate 21st Century Cures Act counterpart package, including S. 2700, S.185, S.2713, S.2745, S.2742, S.1878, S.1077, S.1101, S.2055, S.1767, S.1597, S.2512, S.2030, S.1622, S.2014, S.800, S.849, S.2503, and S.2511. Funding for NIH, CDC, DOD, related to arthritis and rheumatic disease research and education. Funding for Pediatric Subspecialty Loan Repayment Program. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY 2017.

HR 3229/S. 2196 To amend title XVIII of the Social Security Act to provide for the non-application of Medicare competitive acquisition rates to complex rehabilitative wheelchairs and accessories. Spoke with Rep. Jared Polis district staff member regarding casework for a United Spinal member. H.R. 1516/S. 1013 Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology (CRT) items designed or individually configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, or functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) or instrumental ADLs. A proposal in the Presidents FY2017 Budget expands the competitive bidding program to additional categories, including ostomy and urological supplies. This decision will limit access to prosthetic supplies which need to be clinically prescribed, selected, and/or adjusted and fitted for individuals by specially trained health care professionals based on the unique medical and physical needs of each person in relation to their disease or condition. The incorrect catheters or ostomy supplies can put individuals at risk of severe skin damage, infection, hospitalization and possibly death. Since ostomy and urological medical supplies restore the lost functions of waste storage and elimination, they are defined in the Social Security Act as prosthetics. United Spinal signed onto a letter, led by the Center for Medicare Advocacy, to the Centers for Medicare and Medicaid Services highlighting the problems with access to durable medical equipment (such as wheelchairs and other assistive technology and medical equipment that can be used in the home) when individuals are dual-eligibles - that is, on Medicare and Medicaid. There continues to be a misalignment of payment procedures in Medicare and Medicaid resulting in denials, delays, and higher than appropriate health care costs for essential DME among dually eligible beneficiaries. United Spinal supports the recommended solution which requires state Medicaid agencies, as is the law in Connecticut, to process prior authorization requests for DME for Medicaid beneficiaries whether or not they also are on Medicare. United Spinal signed onto a letter to the House in support of H.R. 5721, the Local Coverage Determination Clarification Act. This important legislation would help ensure basic procedural fairness in Local Coverage Determinations (LCDs), and thereby provide an important Medicare beneficiary protection that is often lacking in local coverage decisions. Competitive Bidding Letter United Spinal signed on to a letter to the Centers for Medicare and Medicaid Services (CMS) supporting competitive bidding reforms including the requirement of DME provider state licensure; the letter states its opposition to the competitive bidding programs limits on choice, access and quality of durable medical equipment. Negative Pressure Wound Therapy United Spinal signed onto this CMS letter which focused on the proposal to implement the newly created statutory benefit to pay home health agencies separately for disposable negative pressure wound therapy. In general, the letter supports the Centers for Medicare and Medicaid Services (CMS) proposal implementing the new statutory benefit to ensure patient access to this important therapy. United Spinal signed onto and helped draft a letter to the Centers for Medicare and Medicaid Services opposing charging people with mobility impairments an extra payment for physician time. PAC VBP United Spinal signed onto this written statement on the Medicare Post-Acute Care Value-Based Purchasing Act of 2015 (H.R. 3298) regarding Medicare Spending per Beneficiary (MSPB) measure. MSPB is an economic measure to assess Medicare utilization and is used to ascertain the productivity of a provider within a given setting, or a type of provider compared to another type of provider. The letter states that the PAC-VBP program should not measure MSPB without simultaneously measuring quality, function, and quality of life outcomes so that the Medicare program knows what it is getting for its payments to providers. ICD-10 United Spinal Association, and other stakeholders, requested an in-person meeting to discuss the unintended consequences of ICD-10 conversion on access to inpatient rehabilitation hospitals and units (IRFs) for Medicare beneficiaries with brain injuries and select orthopedic conditions, and to explore possible remedies to this problem. MPFS 2017 and OPPS 2017 United Spinal signed onto a couple of letters to the Centers for Medicare and Medicaid Services on related to various health IT provisions ensuring better protections of chronic care management services and streamlining tools for advanced imaging services.

Support for a national reporting database of medical errors related to the delivery of radiation therapy. Support for the development of an appropriate medical event definition. Support to ensure that patient care advances in biomedical research impacting patient care are not compromised by any policies imposed on the medical use and research applications of cesium chloride. FDA review process of medical devices; The Medical Device Guardians Act of 2016 (H.R. 5404) Support for NRC Commissioner nominee to have medical background. Support patient choice in treatment options by closing the in-office ancillary services exception to the Stark Law for radiation oncology services; Protecting Integrity in Medicare Act (H.R. 5088) Oppose HR 2698, Tanning Tax Repeal Act of 2015 Support HR 239, To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes Radiation Oncology reimbursement Radiation Oncology safety Cancer Moonshot Initiative H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $124,957 · Firm income: Not reported

S.2425-Patient Access and Medicare Protection Act (PAMPA) implementation. Support for legislation to ensure patient safety and preserve the integrity of the Medicare program by ending abuses of the physician self-referral law for radiation therapy services; Protecting Integrity in Medicare Act (H.R. 5088) Support for structural changes that lead to delivering high-quality care for patients while increasing efficiencies and promoting Medicare sustainability; oppose radiation oncology benefit managers. Support for ensuring radiation oncologists participation in the Medicare electronic health record incentive program. Support for reforming the way Medicare pays for radiation oncology services by tying payments to quality and value. Implementation of H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 Support the elimination of abuse to the Medicare program by closing the in-office ancillary services exception to the Stark Law for radiation oncology services. S. 1549, To amend title XVIII of the Social Security Act to provide for advanced illness care coordination services for Medicare beneficiaries, and for other purposes. Helping Hospitals Improve Patient Care (H.R. 5273) H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $124,957 · Firm income: Not reported

Issues related to physician owned distributors of devices Issues related to deficit reduction and Medicare Issues related to Medicare program integrity Issues relating to payment reform, ACOs and Bundling Issues related to the CMS program for durable medical equipment Issues related to the development of Medicare payments for telehealth and remote monitoring services Issues related to applying the unique device identifier to Medicare claims forms S. 1253 Patient Access to Disposable Medical Technology Act of 2015 S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act H.R. 4714 the Removing Barriers to Clinical Research Act of 2016 S. 2736 Patient Access to Durable Medical Equipment Act H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act H.R. 5721, S. 3392 Local Coverage Determination Clarification Act of 2016

Client expense: $700,000 · Firm income: Not reported

Medicare and Medicaid issues, Medigap issues, Medicare Advantage HR 5721 a bill to amend Medicare and revise the process by which Medicare Administrative Contractors (MACs) issue and reconsider local coverage determinations.

Client expense: $297,932 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 5721 Local Coverage Determination Clarification Act S 3392 Local Coverage Determination Clarification Act of 2016 HR 3712 / S 2173 Improving Access to Mental Health Act

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Preservation of Medicaid as an entitlement program and avoiding cuts, including per capita caps and block grants. Importing Medicare Affordability, Enrollment, Notification (S. 3371, H.R. 6109, H.R. 5772) Independence at Home Act (S. 3130) Improving Medicaid care coordination for medically complex children (H.R. 546, S. 298) Local Coverage Determination Act (H.R. 5721) Implementation of and improving the Achieving a Better Life Experience Act, P.L. 113-295 Implementation of the Affordable Care Act, P.L. 111-148 and P.L. 111-192 HCBS Settings Rule S. 1604 Transition to Independence Medicaid Buy-In Option. H.R. 5903 ABLE Age Adjustment Act, S. 2704 and H.R. 4813 ABLE Financial Planning Act, S. 2703 and H.R. 4794 ABLE to Work Act, S. 2702 and H.R. 4795 Money Follows the Person Program Extension

Client expense: $40,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, White House Office

HR. 5721 and S. 3392 - Medicare Adminstrative Contractors/Local Coverage Determinations

Client expense: $227,455 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act Implementation; Medicare; Medicare Physician Fee Schedule; H.R.5721 - Local Coverage Determination Clarification Act of 2016 Medicare Clinical Laboratory Fee Schedule; Clinical Laboratory Improvement Amendments of 1988; Protecting Access to Medicare Act (PAMA); Medicare Access and CHIP Reauthorization Act; Electronic Health Records; Health Information Technology Reform Act; Physician Quality Reporting System; Stark Self-Referral Reform; Medicare Sustainable Growth Rate; Laboratory Developed Tests; Physician Shortages and Graduate Medical Education; Health Care Personnel Shortages and Allied Health Education; Appropriations for Federal Agencies; Global Health Initiatives; Non-Communicable Disease

Client expense: $60,750 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Labor Statistics (BLS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA), White House Office