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Closing Loopholes for Orphan Drugs Act
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vs 6,526 other HR bills in the 114th — cohort avg 56d
Closing Loopholes for Orphan Drugs Act This bill amends the Public Health Service Act to revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program.
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Filing registrants (6)
2016 · third_quarter · Health Issues
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule; Support S. 3173 EHR Regulatory Relief Act, a bill to amend title XVIII of the Social Security Act to provide for a 90-day EHR reporting period for the determination of whether an eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use; Support for H.R. 5713, The Sustaining Healthcare Integrity and Fair Treatment Act of 2016, a bill that would extend 25% rule relief and provide targeted relief to certain LTCHs struggling to meet the new criteria standards; Support for H.R. 6174, the Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.
Client expense: $4,050,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250 - DXM Abuse Prevention Act of 2015 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $492,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule; Support S. 3173 EHR Regulatory Relief Act, a bill to amend title XVIII of the Social Security Act to provide for a 90-day EHR reporting period for the determination of whether an eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use; Support for H.R. 5713, The Sustaining Healthcare Integrity and Fair Treatment Act of 2016, a bill that would extend 25% rule relief and provide targeted relief to certain LTCHs struggling to meet the new criteria standards; Support for H.R. 6174, the Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.
Client expense: $4,970,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · fourth_quarter · Health Issues
Issues pertaining to implementation of the Affordable Care Act, particularly Medicaid expansion and state marketplaces Medical Tort Reform The Implementation of the Affordable Care Act 340B Drug pricing program Development of legislation to create partnership opportunities for essential hospitals Graduate medical education/physician residency slots/ indirect Medical Education Funding Increase awareness and work around eliminating health care disparities HR6 21st Century Cures Act Issues related to Telehealth and Telemedicine Issues around Medicare payment for end-of-life care planning Mental Health Reform Legislation S. 1945 Mental Health Reform Act of 2015 HR 2646 Helping Families in Mental Health Crisis Act of 2015 Hospital Trauma Care H.R. 4365 Protecting Patient Access to Emergency Medications Act S. 2873/H.R. 5395 Expanding Capacity for Health Outcomes Act H.R. 546/S. 298 ACE Kids Act H.R. 6174 Closing Loopholes for Orphan Drugs Act
Client expense: $280,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
2016 · third_quarter · Health Issues
Support S 258 and HR 169, Critical Access Hospital Relief Act, a bill that would remove the 96-hour physician certification requirement as a condition of payment for critical access hospitals (CAHs); Support HR 293, a bill to exempt certain journals and text books used in continuing medical education (CME) from manufacturer transparency reporting requirements; Participated in the Hearing, Examining the 340B Drug Pricing Program and submitted testimony about the 340B program, a federal drug discount program to Subcommittee members who will review the functionality of the program to ensure it is meeting its intended goals; HR 6, 21st Century Cures, a bill that accelerates the discovery and development of cures, and also includes provisions addressing interoperability of health IT and would provide additional money to NIH and the FDA; Two midnight discussion with several members of Congress; Support, Advancing Telehealth Opportunities in Medicare Telehealth, submitted a letter outlining the benefits of telehealth and showcases successful hospital and health system efforts. It also outlines barriers to greater use of telehealth; Submitted letter pertaining to interoperabilty within the hospital communities; Support S. 599, Improving Access to Emergency Psychiatric Care Act of 2015, legislation easing the shortage of psychiatric beds and extend and expand the CMS emergency psychiatric demonstration project; Comments on H.R.1458, BACPAC Act of 2015, a bill to amend title XVIII of the Social Security Act to provide bundled payments for post-acute care services under parts A and B of Medicare, and submitted a statement for a hearing on HR 1458 (re bundled payments for post-acute and other post-hospital services); Discussed Equity of Care Issues with Members of Congress; Advocate for funding by working with the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Hospital Preparedness Program staff on ensuring adequate Ebola hospital funding; Working with the Centers for Disease Control and Prevention (CDC) on ongoing Ebola-related issues and guidance; Working with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to ensure that hospitals continue to be able to use blood glucose monitoring systems (BGMS) on hospitalized patients;Discussion of draft guidance on drug compounding and repackaging; Working with ASPR and CDC staff to define the impact of the Hospital Preparedness Program and Public Health Emergency Preparedness Program on improving health care system preparedness; Support efforts to advocate on Ebola within a discussion with FDA regarding impact on access to chest tubes regarding the Atrium Medical Corp and Maquet consent decree ; Advocate for regulatory approach in a discussion with White House staff regarding new initiative promoting bystander involvement in stopping hemorrhage in injured civilians; Attended a roundtable discussion on Opioid-related dependence, overdose, and death at HHS; Advocate for changes to The Care Planning Act, a bill that would provide for advanced illness care coordination services for Medicare beneficiaries; Support HR 2878 and S 1461,a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Support S.799/HR 1462, Protecting Our Infants Act of 2015, a bill to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome; Discussed S.1349, a bill that amends title XVIII (Medicare) of the Social Security Act to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning treatment; Supported expansions to Medicare reimbursement for telehealth along with changes to the Health Care Connect Fund; Comments on S.1648, Rural Emergency Acute Care Hospital Act of 2015, a bill to amend title XVIII of the Social Security Act to create a sustainable future for rural healthcare. Urged that HHS refrain from finalizing a stage 3 meaningful use rule; Advocate for Appropriate Surveyor Guidance on Calculated Hospitals in discussion about member concerns regarding remarks of CMS official that were confusing during a health lawyers association webinar; Discussion with CMS staff regarding proposed rule on establishing market-based payments for clinical laboratory tests; Discussion to rescind the proposed 2 percent cut to CY 2016 outpatient PPS conversion factor; Support H.R.2948, Medicare Telehealth Parity Act of 2015, a bill to amend title XVIII (Medicare) of the Social Security Act to expand telehealth coverage in three phases; Support HR 2646, Helping Families in Mental Health Crisis Act of 2015,A bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis; Support HR 1604, Veterans Mental Health Care Access Act, a bill that expands access to mental health services for veterans; Support H.R. 3183, The Veterans Health Care Freedom Act, a bill which makes significant improvements to the Veterans Choice Program; Support S 1189 The Conrad State 30 and Physician Access Act, a bill that reauthorizes the Conrad 30 and makes other changes to the program to improve patient access to care; Discussed quality measurement, meaningful use and Conditions of Participation; Conversation with CMS about the IOM Vital Signs report and how its recommendations could make quality measurement more meaningful; Spoke with CMS urging the Agency to correct the misimpression that was created statements made during a National Association of Medical Staff Specialists webinar by a CMS employee; Discussion with CMS about proposals contained in the Inpatient Psychiatric Facility PPS proposed rule urging CMS not to finalize two quality measures; Meeting at CMMI to discuss CCJR; Discuss S. 2141the Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015, the TRUST Act, a bill that includes a definition of information blocking and a framework to assess interoperability of certified health IT (a health IT ratings program); Support S.1461 and H.R. 2878 a bill to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015; Oppose S. 1648 Rural Emergency Acute Care Hospital ActTo establish an alternative payment model for CAHs and small, rural hospitals whereby they may transition to become a rural emergency hospital.; Oppose H.R. 3225 Save Rural Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs; Discuss S. 1945 Mental Health Reform Act of 2015, a bill to make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis. It would reauthorize certain federal mental health programs, revise the IMD exclusion, reform SAMHSA, and study parity in mental health laws. Support S. 1893, The Mental Health Awareness and Improvement Act of 2015, a bill to reauthorize and improve programs related to mental health and substance use disorders; Letter asking for modifications to H.R. 3298 Medicare Post-Acute Care Value-Based Purchasing (PAC VBP) Act of 2015, the legislation would establish a value-based purchasing program for LTCHs, IRFs, SNFs and HH agencies. Worked to streamline and improve quality measures; Discussed how to implement the framework in the National Academy of Medicines Vital Signs report to streamline and focus quality measures used in Medicare programs; Discussed Opioid prescribing guidelines with the CDC to provide feedback on the opioid prescribing guidelines they were developing; Discussion with CMS regarding CAH designation status, negative impact of Insurance Consolidations on Medicare Advantage and for modifications to Comprehensive Care for Joint Replacement (CJR) model regarding aspects of the proposed rule; Discussion with CMS about the Emergency Preparedness final rule; Discussion with CMS regarding the 0.2 percent reduction to hospitals payments under the Inpatient Prospective Payment System (PPS); Support S. 524, the Johnson amendment and the Collins amendment, Comprehensive Addiction and Recovery Act of 2016, a bill to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use; Support H.R. 4499, Promoting Responsible Opioid Prescribing Act of 2016, a bill to amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program; Support S. 2220, The Healthy Maternity and Obstetric Medicine Act or Healthy MOM Act guarantees maternity coverage for women who are enrolled in the exchanges established under the Affordable Care Act, as well as women who are covered by individual and group insurance plans and federal employee health benefit plans; Comments to House Ways and Means and Senate Finance Committees on how to improve the physician self-referral (Stark) law; Urged CMS to delay the April 2016 release of the hospital star ratings on the Hospital Compare Website; Supported House and Senate letters urging CMS to delay release of hospital star ratings on the Hospital Compare Website; Support H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, a bill that would reduce health care costs and promote access to quality, affordable health care for all Americans; Letter to Senate HELP Committee draft legislation addressing health information technology (IT) and electronic health records (EHRs); Comments to CMS regarding addressing section 603 of the BBA of 2015 in regulation; Comments to House Energy & Commerce Committee regarding section 603 of the BBA of 2015 as well as site neutral payment policies in general; Statement for the record to House Energy & Commerce Committee on MACRA implementation; Statement for the record to Senate Finance Committee on MACRA implementation; Comments to the Senate Finance Committee Chronic Care document -Conversations with the CDC related to their opioid guidelines for chronic pain as well as a patient education piece about opioids; Discussions with CMS about CAH designation status Health Care Issues; Discussions with Rep. Hudson about H.R. 4365/ S. 2932, the Protecting Patient Access to Emergency Medications Act , a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services; Support H.R. 4650 and S. 2108, Preserving Patient Access to Post-Acute Hospital Care Act of 2016, a bill to amend title XVIII of the Social Security Act to provide for an extension of certain Medicare long-term care hospital payment rules; Supported efforts to encourage Congress to send CMS letters on addressing the issue of colocation of facilities within a hospital; Discussions with Members of Congress on the potential implementation of Unique Device Identification on claims forms; Sponsored a Hill briefing on innovations in post-acute care;Supported House and Senate letters to CMS asking for flexibility when interpreting section 603 of the BBA of 2015 in regulation; Support HR 5547, the Health Care Price Transparency Promotion Act of 2016, a bill to require the sharing of health care price information; Support HR 5273, the Helping Hospitals Improve Patient Care Act of 2016, a bill to address outstanding issues with section 603 of the BBA of 2015 and provide for a socioeconomic adjustment to the Hospital Readmissions Reduction Program; Supported a letter to CMS on implementation of Sec. 603 of the Bipartisan Budget Acts site neutral cuts for off-campus HOPDs; Support H. res. 699 promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2016; Support H.R.4641 - a bill to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication; Support H.R. 4982, the Examining Opioid Treatment Infrastructure Act of 2016, a bill which would require the Government Accountability Office (GAO) to evaluate and report on the capacity, availability and need for inpatient and outpatient treatment for opioid use disorders in the United States; Supports H.R. 3680, the Co-Prescribing to Reduce Overdoses Act of 2015, a bill would establish federal grants to carry out co-prescribing of overdose reversal drugs in areas experiencing significant numbers of opioid overdoses and deaths; Support H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015, a bill that would reauthorize essential residential treatment programs for pregnant and postpartum women and provide grants to states to address the growing epidemic of infants suffering from opioid dependency; Support H.R. 4978, the Nurturing and Supporting Healthy Babies Act, a bill which would require a GAO evaluation of neonatal abstinence syndrome and the availability of treatment for this condition in the nations Medicaid programs; Support H.R. 4599, the Reducing Unused Medications Act of 2016, a bill to permit partial filling of schedule II prescriptions under specific circumstances; Support H.R. 4976, the Opioid Review Modernization Act of 2016, a bill which would provide for more stringent Food and Drug Administration review of new opioids without abuse-deterrent properties, recommendations for labeling of pediatric opioids, and recommendations for prescriber education; Support the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, a bill for achieving fair and sustainable drug pricing; Supporting full alignment of 42CFR substance use records confidentiality requirements with HIPAA privacy rule; Support S. 3173 EHR Regulatory Relief Act, a bill to amend title XVIII of the Social Security Act to provide for a 90-day EHR reporting period for the determination of whether an eligible professional or eligible hospital is a meaningful EHR user and to remove the all-or-nothing approach to meaningful use; Support for H.R. 5713, The Sustaining Healthcare Integrity and Fair Treatment Act of 2016, a bill that would extend 25% rule relief and provide targeted relief to certain LTCHs struggling to meet the new criteria standards; Support for H.R. 6174, the Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.
2016 · third_quarter · Health Issues
H.R. 6, 21st Century Cures Act; S. 2700, FDA and NIH Workforce Authorities Modernization Act; Discussions to clarify or reform the 340B program; Biologics Price Competition and Innovation Act; H.R. 1101 & S. 1287, Viral Hepatitis Testing Act; Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 2228 & S.122, Safe and Affordable Drugs from Canada Act of 2015; Proposals to address prescription drug abuse; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Implementation/Reauthorization of The Biosimilars User Fee Act (BsUFA); H.R. 639 & S. 481, Improving Regulatory Transparency for New Medical Therapies; H.R. 2570 & S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act of 2015; H.R. 3677 Opioid Abuse Prevention and Treatment Act of 2015; S. 524, Comprehensive Addiction and Recovery Act of 2016; H.R. 3012 & S. 2912, Trickett Wendler Right to Try Act of 2016; H.R. 6043 & S. 3335, Fair Accountability and Innovative Research Drug Pricing Act of 2016; H.R. 6174, Closing Loopholes for Orphan Drugs Act; S.3239, RACE for Children Act; Expanded Access (legislation not introduced); H.R. 4207, Medicare Fair Drug Pricing Act of 2015; Clinton's 1993 Health Security Act;
Client expense: $1,920,000 · Firm income: Not reported
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
2016 · third_quarter · Health Issues
Education about the 340(b) drug discount program. H.R. 6174: Closing Loopholes for Orphan Drugs Act. H.R. 6: 21st Century Cures Act. Education about the value of innovative new medicines. S.524: Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Implementation of Affordable Care Act as it relates to a regulatory pathway for biosimilars. H.R. 6: 21st Century Cures Act. H.R. 6174: Closing Loopholes for Orphan Drugs Act. Education about the value of innovative new medicines.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
Client expense: $4,050,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Client expense: $4,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)