What’s Ahead: This Week

 Hearings and Markups –

  • Tuesday, May 7
    • Senate HELP Committee, “Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers (Part II).”
    • Senate Judiciary Committee, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
  • Wednesday, May 8
    • Senate Finance Committee, “Medicare Physician Payment Reform After Two Years: Examining MACRA Implementation and the Road Ahead.”
    • Senate Aging Committee, “The Older Americans Act: Protecting and Supporting Seniors as they Age.”
    • House Ways & Means Committee, “Paid Family and Medical Leave: Helping Workers and Employers Succeed.”
    • House Oversight & Reform Committee, Subcommittee on National Security, “Veteran and Active-Duty Military Suicides.”
    • House Appropriations Committee, “FY2020 Labor, Health and Human Services, Education, and Related Agencies.”
  • Thursday, May 9
    • House Energy & Commerce Committee, Subcommittee on Health, “Lowering Prescription Drug Prices: Deconstructing the Drug Supply Chain.”
    • House Oversight & Reform Committee, “Trump Administration’s Response to the Drug Crisis – Part II.”

 Notable Policy Events –

  • Monday, May 6
    • American Bar Association (ABA), “Conference Call Briefing: Competition Advocacy, State Occupational Licensing, and Private Certification – Perspectives from Federal Agencies and State Attorneys General.” Additional information: https://bit.ly/2GU40O3
  • Tuesday, May 7
    • Bloomberg Government, “2019 Spring Hill Watch Breakfast.” Additional information: https://bit.ly/2ZQetCN
  • Wednesday, May 8
  • Thursday, May 9
    • House Mental Health Caucus, “Briefing: Let’s Improve Medication Choices for Medicare Beneficiaries with Depression.”
  • Thursday, May 9 – Friday, May 10
    • Defense Strategies Institute, “DOD/VA and Government Health IT Summit.” Additional information: https://bit.ly/1OGqrCD
  • Friday, May 10
    • National Press Club, “News Conference with Former FDA Commissioner Scott Gottlieb.” Additional information: https://bit.ly/2Lm5MNo


Weekly Wrap-Up: Notable Health Care Developments From Last Week                                                                                        

Legislative Activity:


 Committee Activity and Executive Action:

  • On April 30, the House Judiciary Committee approved by voice vote several bills intended to address drug prices, including: the Preserve Access to Affordable Generics and Biosimilars Act (H.R. 2375), which would prohibit pharmaceutical companies from engaging in “pay-for-delay” practices; the CREATES Act (H.R. 965), which would allow biosimilar manufacturers to more easily obtain samples of biologic drugs from branded manufacturers; the Stop STALLING Act (H.R. 2374), which would enable the Federal Trade Commission (FTC) to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar; and the Prescription Pricing for the People Act of 2019 (H.R. 2376), which would require the FTC to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations. The measures now move to the full House for consideration. Press release: https://bit.ly/2ZSTcZiR. 2375 bill text: https://bit.ly/2PGytmR H.R. 965 bill text: https://bit.ly/2Jbc5kk H.R. 2374 bill text: https://bit.ly/2VBkvbh H.R. 2376 bill text: https://bit.ly/2VcznNS
  • Also on April 30, the House Appropriations Committee, Subcommittee on Labor-HHS-Education approved its FY 2020 funding bill. The bill provides a total of $189.8 billion in discretionary funding, including $99.0 billion for HHS, which is an increase of $8.5 billion over the FY 2019 HHS enacted level. It now moves to the full Committee for markup. Press release: https://bit.ly/2LfI71e Bill text: https://bit.ly/2WoNXya
  • On May 1, the House Appropriations Committee, Subcommittee on Military Construction-VA approved its FY 2020 funding bill. The bill provides a total of $108.1 in discretionary spending, including $94.3 billion for the Department of Veterans Affairs, which is an increase of $7.8 billion over the FY 2019 VA enacted level. The bill now moves to the full Committee for consideration. Press release: https://bit.ly/2GXybF8 Bill text: https://bit.ly/2UTZwff

 Introduced Legislation:

  • On April 29, Senate Finance Committee Chair Grassley (R-IA) and Sen. Klobuchar (D-MN) introduced companion Senate legislation (S. 1224) to the Stop STALLING Act, which would enable the Federal Trade Commission (FTC) to deter filing of certain citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar. Press release: https://bit.ly/2VH2zMg
  • Also on April 29, Senate Finance Committee Chair Grassley (R-IA) and 5 bipartisan cosponsors introduced the Prescription Pricing for the People Act (S. 1227), which would require the FTC to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations. Reps. Collins (R-GA), Nadler (D-NY), Cohen (D-TN), and Meadows (R-NC) introduced companion legislation in the House (H.R. 2376). Press release: https://bit.ly/2UVHl95 Bill text: https://bit.ly/2Y2P0Va
  • On April 30, Reps. Sensenbrenner (R-WI) and Higgins (D-NY) introduced the Ensuring Access to Quality Complex Rehabilitation Technology Act (H.R. 2408), which would create a separate benefit category under Medicare to cover complex wheelchair and other adaptive equipment for people with severe medical needs. Press release: https://bit.ly/2DKTeZT
  • Also on April 30, Reps. DeGette (D-CO) and Stewart (R-UT) introduced the Tobacco to 21 Act (H.R. 2411), which would raise the legal smoking age to 21. Sens. Schatz (D-HI) and Young (R-IN) introduced companion legislation in the Senate (S. 1258). Press release: https://bit.ly/2H13XjI
  • Also on April 30, Reps. Moulton (D-MA) and Fitzpatrick (R-PA) introduced the Healthcare Extension and Accessibility for Developmentally Disabled or Underserved Population (HEADs UP) Act of 2019, which would direct the Health Resources and Services Administration (HRSA) to designate people with intellectual and developmental disabilities (I/DD) as a medically underserved population. Press release: https://bit.ly/2VcvtV0
  • On May 1, Rep. Dingell (D-MI) and 5 bipartisan cosponsors introduced the Access to Breast Cancer Diagnosis Act (H.R. 2428), which would require insurance plans to cover breast cancer diagnoses in the same manner that screenings are covered. Press release: https://bit.ly/2GYbGPc
  • Also on May 1, Reps. Katko (R-NY) and Napolitano (D-CA) introduced the Mental Health Professionals Workforce Shortage Loan Repayment Act of 2019 (H.R. 2431), which would authorize a loan repayment program for mental health professionals who work in shortage areas. Press release: https://bit.ly/2XZVdRx
  • Also on May 1, Reps. Schneider (D-IL), Brooks (R-IN), Kuster (D-NH), and Stefanik (R-NY) introduced the Opioid Workforce Act of 2019 (H.R. 2439), which would create 1,000 additional residency positions over five years in hospitals with addiction medicine, addiction psychiatry, or pain management programs. Press release: https://bit.ly/2WjiTjn Bill text: https://bit.ly/2GPaY6W
  • Also on May 1, Reps. Brindisi (D-NY) and Marchant (R-TX) introduced the Jobs and Premium Protection Act (H.R. 2447), which would repeal the annual fee on health insurance providers enacted by the ACA. Sens. Barrasso (R-WY), Gardner (R-CO), and Sinema (D-AZ) previously introduced companion legislation in the Senate (S. 80). Press release: https://bit.ly/2Jj75u3
  • Also on May 1, Rep. DeLauro (D-CT) and 15 cosponsors introduced the Medicare for America Act of 2019 (H.R. 2452), which would extend the option to buy into an enhanced Medicare benefit to individuals who are uninsured or those who do not have employer-sponsored insurance. Press release: https://bit.ly/2DVMUyP
  • Also on May 1, Reps. Richmond (D-LA), Huffman (D-CA), and Norton (D-DC) introduced the Choose Medicare Act (H.R. 2463), which would establish a Medicare Part E public health plan and allow everyone with private insurance the option of Medicare. Sen. Merkley (D-OR) and 14 Democratic cosponsors introduced companion legislation in the Senate (S. 1261). Press release: https://bit.ly/2IXrtkT Bill text: https://bit.ly/2VbNRO7
  • Also on May 1, Reps. Trone (D-MD), Armstrong (R-ND), Sherrill (D-NJ), and Riggleman (R-VA) introduced the State Opioid Response Grant Authorization Act (H.R. 2466), which would authorize for five years the State Opioid Response and Tribal Opioid Response Grants, which have only been funded for two years by Congress beginning in 2018. Press release: https://bit.ly/2GX43IL Bill text: https://bit.ly/2GRZwYf
  • Also on May 1, Sens. Smith (D-MN) and Cassidy (R-LA) introduced the Reducing Administrative Costs and Burdens in Health Care Act (S. 1260), which would direct the HHS Secretary to take steps toward reducing unnecessary administrative costs across the health care system by at least 50 percent. Press release: https://bit.ly/2GY7HmU Bill text: https://bit.ly/2IVTcSY
  • Also on May 1, Sen. Scott (R-FL) introduced the Protecting Patients from Surprise Medical Bills Act (S. 1266), which would aim to protect patients from surprise medical bills. Press release: http://bit.ly/2PMGHK8
  • Also on May 1, Sens. Stabenow (D-MI), Burr (R-NC), Brown (D-OH), and Scott (R-SC) introduced the Patient Access to Cellular Transplant (PACT) Act (S. 1268), which would amend title XVIII of the Social Security Act to ensure that hospitals receive adequate payment for the acquisition of the hematopoietic stem cells under the Medicare program. Reps. Kind (D-WI), Marchant (R-TX), Bilirakis (R-FL), and Matsui (D-CA) introduced companion legislation in the House (H.R. 2498). Press release: https://bit.ly/2ZU3WGU
  • On May 2, House Majority Leader Hoyer (D-MD) and Rep. Roe (R-TN) introduced the School-Based Allergies and Asthma Management Program Act (H.R. 2468), which would increase the preference given in awarding certain allergies- and asthma-related grants to states that require certain public schools to have allergies and asthma management programs. Press release: https://bit.ly/2PIH0pk Bill text: https://bit.ly/2PJnnxm
  • Also on May 2, Reps. Ruiz (D-CA), Walorski (R-IN), Schneider (D-IL), and Bilirakis (R-FL) introduced H.R. 2477, which would establish a system to notify individuals approaching Medicare eligibility and simplify and modernize the eligibility enrollment process. Sen. Casey (D-PA) and 5 bipartisan cosponsors introduced companion legislation in the Senate (S. 1280).
  • Also on May 2, Rep. Phillips (D-MN) introduced the Supporting Family Mental Health in CAPTA Act (H.R. 2503), which would update CAPTA to improve mental health care delivery, improve access to developmental screenings and early intervention services, and support research on effective practices to prevent child abuse and neglect. Sen. Smith (D-MN) previously introduced companion legislation in the Senate (S. 1160). Press release: https://bit.ly/2Y56EaQ Bill text: https://bit.ly/2Ybn1Tl
  • Also on May 2, Reps. Roybal-Allard (D-CA), Simpson (R-ID), Clark (D-MA), and Herrera Beutler (R-WA) introduced the Newborn Screening Saves Lives Reauthorization Act (H.R. 2507), which would reauthorize federal activities that assist states in improving and expanding their newborn screening programs, supporting parent and provider newborn screening education, and ensuring lab quality and surveillance. Press release: https://bit.ly/2vCjNvC
  • Also on May 2, Rep. Turner (R-OH) and 9 bipartisan cosponsors introduced the Reforming and Expanding Access to Treatment (TREAT) Act (H.R. 2511), which would allow for payments to states for substance abuse services furnished to inmates in public institutions. Press release: https://bit.ly/2IXJ8ck
  • Also on May 2, Senate Homeland Security & Governmental Affairs Committee Chair Johnson (R-WI) and 8 Republican cosponsors introduced the Repeal Insurance Plans of the Multi-State Program (RIP MSP) Act (S. 1313), which would eliminate Multi-State Plans under the ACA. Rep. Meadows (R-NC) introduced companion legislation in the House (H.R. 2524). Press release: https://bit.ly/2PMNzXV Bill text: https://bit.ly/2Llb2Ry

 ACA and Individual Market –

  • On April 29, Congressional Budget Office (CBO) issued a cost estimate of H.R. 1010, which would provide that the Administration’s Short-Term, Limited Duration Insurance rule would have no force or effect. CBO estimates that if enacted, roughly 1.5 million fewer people would purchase short-term plans over the 2020-2029 period, of which 500,000 would instead purchase coverage on the individual market. The measure is estimated to decrease the deficit by $8.9 billion over the 2019-2029 period. Summary with link to report: https://bit.ly/2UUxLmV
  • Also on April 29, Department of Labor issued a policy statement noting that the Department will not pursue enforcement actions against parties for potential violations stemming from actions taken in good faith reliance on the Association Health Plan rule’s validity before the U.S. District Court’s ruling in the State of New York v. United States Department of Labor case. Press release: https://bit.ly/2WcQkUB Policy statement: https://bit.ly/2vyuCiq
  • On May 1, CMS issued a request for information (RFI) on ideas for innovative programs and waiver concepts that states could consider in developing a State Relief and Empowerment Waiver plan (1332 waiver). Comments are due by July 2. CMS blog post: https://go.cms.gov/2VCtN6N RFI: https://tinyurl.com/y34buaz5 Senate Finance Committee Ranking Member Wyden statement: https://bit.ly/2JdZ09F

 Medicare –

  • On April 30, CMS issued a proposed rule which would establish a specific process that Accrediting Organizations (AOs) with Medicare-approved accreditation programs would be required to follow if there is a sale, transfer, and/or purchase of assets related to the ownership of an AO. Comments on the proposal are due by July 1. Press release: https://tinyurl.com/yyljodkf Proposed rule: https://tinyurl.com/y3vapsoo
  • Also on April 30, House Ways & Means Committee Ranking Member Brady (R-TX) and Health Subcommittee Ranking Member Nunes (R-CA) penned a letter to Ways & Means Committee Chair Neal (D-MA) calling for a committee hearing on H.R. 1834, the Medicare for All Act of 2019. Press release: https://bit.ly/2UZ6Hmi Letter: https://bit.ly/2VclnDV
  • On May 1, CBO released a report describing the primary features of single-payer systems and some of the design considerations and choices that policymakers will face in developing proposals for establishing such a system in the U.S. Summary with link to report: https://bit.ly/2J7d1pA Senate Finance Committee Chair Grassley statement: https://bit.ly/2JePLWM
  • On May 2, CMS Administrator Verma posted a blog on the agency’s improvements to Medicare recovery audits to protect taxpayer dollars and carry out the Patients Over Paperwork initiative. Blog: https://tinyurl.com/y6e5ur3s
  • Also on May 2, HHS Office of Inspector General (OIG) issued a data brief that showed that trends in deficiencies at nursing homes show that improvements are needed to ensure the health and safety of nursing home residents. HHS OIG had previously made several recommendations to CMS to help ensure resident health and safety. Summary with link to report: https://bit.ly/2Y8izod
  • On May 3, CMS released draft guidance clarifying how hospitals sharing a campus or building as another health care entity can meet Medicare’s conditions of participation. Comments are due by July 2. Draft guidance: https://go.cms.gov/2IYi4JY

Medicaid –

  • On April 30, the Senate Finance Committee majority staff released a report recommending that greater transparency and auditing of supplemental payments in the Medicaid program is needed. Press release: https://bit.ly/2vDXGVz Report: https://bit.ly/2Wneufc
  • On May 2, CMS released the Medicaid Provider Reassignment Regulation final rule, which removes a state’s ability to divert portions of Medicaid provider payments to third parties outside of the scope of the statute. Press release: https://go.cms.gov/2VJRc6q Final rule: https://bit.ly/2IX0LJh Press release from Senate HELP Committee Ranking Member Murray (D-WA) and House Education and Labor Committee Chair Scott (D-VA): https://bit.ly/2VK6ubk
  • Also on May 2, Senate Finance Committee Ranking Member Wyden (D-OR) and House Energy & Commerce Committee Chair Pallone (D-NJ) penned a letter to CMS Administrator Verma, urging the Administration to maintain protections for access to care in Medicaid. Press release: https://bit.ly/2DYdCa3 Letter: https://bit.ly/2vDme17

 Payment and Delivery System Reform –

  • On April 30, CMS posted the Notice of Funding Opportunity (NOFO) frequently asked questions document for the Maternal Opioid Misuse (MOM) model. FAQ: https://tinyurl.com/y4sekjj9
  • Also on April 30, CMS posted materials from the April 18 NOFO Application Webinar for the Integrated Care for Kids (InCK) model. Materials: https://tinyurl.com/y6pyvwf3
  • On May 2, CMS announced an overview webinar for May 29 on the Medicare Diabetes Prevention Program (MDPP) billing and claims process. Webinar: https://tinyurl.com/yyu87pes
  • On May 3, CMS announced a Q&A webinar for May 15 on the InCK NOFO. Webinar: https://bit.ly/2H1WSjV

Drug and Medical Device Prices and Regulation –

  • On April 29, HHS, in partnership with the American Society of Nephrology, announced 15 winning teams for Phase 1 of the KidneyX Redesign Dialysis prize competition. Press release: https://bit.ly/2vtF5M4
  • Also on April 29, Senate Finance Committee Chair Grassley (R-IA) delivered floor remarks on the value of oversight to finding legislative solutions to rising prescription drug prices. Transcript: https://bit.ly/2vABmMH
  • On April 30, Department of Justice (DOJ) announced that U.S. WorldMeds LLC has agreed to pay $17.5 million to resolve allegations that it paid kickbacks to patients and physicians to improperly induce prescriptions of its drugs. Press release: https://bit.ly/2VbjCGX
  • On May 1, FDA Center for Biologics Evaluation and Research Director Marks posted a blog on the agency’s efforts to advance the development of gene therapy. Blog: https://bit.ly/2PMLfQQ
  • Also on May 1, Senate Finance Committee Ranking Member Wyden (D-OR) issued a statement noting that drugmaker AbbVie will not say if it will stop tying executive bonuses to Humira sales in 2019. Press release: https://bit.ly/2vDk3KZ
  • On May 2, CMS Administrator Verma delivered remarks at the Medical Device Manufacturers Association Annual Meeting, in which she outlined the agency’s strategy to improve patients’ access to emerging technologies. Transcript: https://go.cms.gov/2vC41RG Press release: https://go.cms.gov/2J0xihh
  • Also on May 2, FDA Principal Deputy Commissioner Abernethy and Center for Devices and Radiological Health Director Shuren announced new efforts to protect women’s health and help ensure the safety of breast implants. Press release: https://bit.ly/2JebluM
  • On May 3, HHS OIG released a report finding that Medicaid could save hundred of millions by excluding authorized generic drug transactions to secondary manufacturers from brand name drugs’ average manufacturer price calculations. Summary with link to report: https://bit.ly/2PHeggu

 Substance Use and Mental Health –

  • On April 29, the White House Council of Economic Advisors released a report associating federal government drug subsidy programs like Medicare Part D with an increase in opioid overdose deaths. Report: https://bit.ly/2LkuEVX
  • On May 3, Centers for Disease Control and Prevention (CDC) released a report finding that during 2015-2016, age-adjusted cocaine-involved and psychostimulant-involved death rates increased by 52.4 percent and 33.3 percent, respectively. Report: https://bit.ly/2IYtzRD
  • Also on May 3, the White House Office of National Drug Control Policy released a National Drug Control Strategy, a plan for substantially reducing the impact of the opioid crisis on the lives of Americans, including by reducing the number of drug overdose deaths by 15 percent within 5 years. Strategy: http://bit.ly/2WvoJhK


Health Data and Health IT –

  • On May 1, HHS released a report on the department’s 2018 HHS Data Strategy and efforts to enhance the HHS evidence-based portfolio. Summary with link to report: https://tinyurl.com/y45kf8k9
  • On May 2, HHS released a report finding that patient outcomes improved in some areas of care when clinicians consulted other providers for additional medical expertise through telehealth. Summary with link to report: http://bit.ly/2vCBf3b

Veterans and Military Health –

  • On April 29, Department of Veterans Affairs (VA) announced a partnership with Cigna to improve safety and quality of care for veterans with chronic pain who are at risk for opioid misuse. Press release: https://tinyurl.com/y594k3lj
  • On April 30, VA announced a partnership with Microsoft to enhance opportunities for education, recreation, and therapy with mobility limitations in select VA rehabilitation centers. Press release: https://bit.ly/2WgEVTX
  • Also on April 30, VA announced planned events for National Women’s Health Week, which will take place from May 12 through May 18. Press release: https://bit.ly/2DY2Bpd
  • Also on April 30, VA and CMS announced an agreement which will give VA the ability to monitor medical prescriptions issued outside the VA through Medicare Part D. Press release: https://bit.ly/2H2r9iM
  • Also on April 30, U.S. Government Accountability Office (GAO) published a report showing that the star rating system that the Veterans Health Administration (VHA) uses to rank medical centers on overall quality may not effectively measure quality of care. GAO recommended that VHA use preview reviews to improve their system. Summary with link to report: https://bit.ly/2GY5ff2
  • On May 1, VA announced the launch of a digital campaign to encourage mental health conversations among veterans. Press release: https://tinyurl.com/y3au56rx
  • On May 2, the House Veterans’ Affairs Committee launched a bipartisan women Veterans Task Force. Press release: https://bit.ly/2ZRmfMI
  • On May 3, VA issued a statement on the effective end of veteran homelessness in Lexington, Kentucky. Press release: https://tinyurl.com/yxooaq7m

 Misc. –

  • On April 29, HHS Secretary Azar issued a statement to mark National Infant Immunization Week. Press release: https://bit.ly/2Viw9IR
  • On April 30, Centers for Disease Control and Prevention (CDC) published a report on service provision, hospitalizations, and chronic conditions in adult day services centers using data from the 2016 National Study of Long-Term Care Providers. The report shows that about 64 percent of adult day services centers had hospitalizations among participants. Report: https://bit.ly/2DMo4RU
  • On May 2, HHS Office for Civil Rights (OCR) announced the issuance of the final conscience rule, which allows health care entities and providers to deny care on the basis of religious or moral objections. Press release: https://bit.ly/2ZJzI9g Fact sheet: https://bit.ly/2JdF86z Final rule: https://bit.ly/2VEAZPQ Senate HELP Committee Ranking Member Murray (D-WA) statement: https://bit.ly/2vDDvqO House Energy & Commerce Committee Chair Pallone and House Education and Labor Committee Chair Scott statement: https://bit.ly/2LjA9nI
  • On May 3, HHS Office of HIV/AIDS and Infectious Disease Policy issued an RFI to help inform the development of the Sexually Transmitted Diseases Federal Action Plan. Comments are due 30 days following the date of publication in the Federal Register. RFI: https://bit.ly/2LoQTtI