Health Care Policy Update – Weekly Wrap-up and What’s Ahead


 What’s Ahead: This Week

 Hearings and Markups –

  • Tuesday, April 9
    • Senate Finance Committee, “Drug Pricing in America: A Prescription for Change, Part III.”
    • House Appropriations Committee, Subcommittee on Interior-Environment, “Indian Health Service Budget Request for FY2020.”
    • House Appropriations Committee, Subcommittee on Labor-HHS-Education, “Public Witness Day.”
  • Wednesday, April 10
    • Senate Veterans’ Affairs Committee, “VA MISSION Act: Implementing the Veterans Community Care Program.”
    • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Priced Out of a Lifesaving Drug: Getting Answers on the Rising Cost of Insulin.”

Notable Policy Events –

  • Tuesday, April 9
    • Bipartisan Policy Center (BPC), “Comparative Effectiveness Research: Recent Applications and Future Investments.” Additional information: https://bit.ly/2UlPPuV
    • Cato Institute, “25 Years of Patient Care.” Additional information: https://bit.ly/2YM3cTB
    • Information Technology and Innovation Foundation (ITIF), “The Critical Role of the National Institutes of Health (NIH) in Boosting Economic Competitiveness.” Additional information: https://bit.ly/2TW4S9b
    • Center for Medicare & Medicaid Innovation (CMMI), “Webinar: Medicare Advantage Value-Based Insurance Design Model – Hospice Intervention.” Additional information: https://bit.ly/2TYxDCj
  • Wednesday, April 10
    • American Society of Clinical Oncology (ASCO), “Closing the Rural Cancer Care Gap.” Additional information: https://bit.ly/2WD1WjK
    • Justice in Aging, Center for Advocacy, and Medicare Rights Center, “Webinar: Current Issues Facing Medicare Beneficiaries.” Additional information: https://bit.ly/2D8pKVx
  • Thursday, April 11 – Friday, April 12
    • Medicaid and CHIP Payment and Access Commission (MACPAC), “April Public Meeting.” Additional information: http://bit.ly/2FVOmkI

 

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

Legislative Activity –

  • On April 1, Reps. Delgado (D-NY), Larson (D-CT), and Higgins (D-NY) introduced the Medicare-X Choice Act (H.R. 2000), which would create a public option health plan available for purchase on the individual and small business exchanges. Sens. Bennet (D-CO), Kaine (D-VA), introduced companion legislation in the Senate (S. 981). Press release: https://bit.ly/2HVFnTZ Bill text: https://bit.ly/2UcRaUy
  • Also on April 1, House Energy & Commerce Committee, Subcommittee on Oversight & Investigations Chair DeGette (D-CO) and Reps. Reed (R-NY), Schrier (D-WA), and Guthrie (R-KY) introduced H.R. 2011, which would make permanent a new Food and Drug Administration (FDA) policy that was put in place in December to help accelerate the approval process for biosimilars. Press release: https://bit.ly/2K3lDzO
  • Also on April 1, Sens. Shaheen (D-NH), Tester (D-MT), King (I-ME), and Harris (D-CA) introduced the Improving Health Insurance Affordability Act (S. 961), which would expand eligibility for the refundable credit for coverage under a qualified health plan. Press release: https://bit.ly/2CXeyL7 Bill text: https://bit.ly/2I9covj
  • Also on April 1, Sens. Sanders (I-VT), Harris (D-CA), Warren (D-MA), and Gillibrand (D-NY) introduced S. 962, which would extend and expand funding for community health centers and the National Health Service Corps. House Majority Whip Clyburn (D-SC) introduced companion legislation in the House last week (H.R. 1943). Press release: https://bit.ly/2JOH7QE Bill text: https://bit.ly/2FYP2af
  • Also on April 1, Sens. Shaheen (D-NH) and 14 cosponsors introduced the Marketplace Certainty Act (S. 964), which would expand cost-sharing reduction assistance in the individual market. Press release: https://bit.ly/2CXeyL7 Bill text: https://bit.ly/2WI1Ze8
  • Also on April 1, Sens. Portman (R-OH) and Bennet (D-CO) introduced S. 966, which would modernize the physician self-referral prohibitions to promote care coordination in the Merit-based Incentive Payment System (MIPS) and the facilitate physician practice participation in alternative payment models (APMs) under the Medicare program.
  • Also on April 1, Sens. Shaheen (D-NH), Baldwin (D-WI), and Merkley (D-OR) introduced the Reducing Costs for Out-of-Network Services Act (S. 967), which would establish limitations on cost-sharing for out-of-network services in the individual market and prohibit balance billing for such services. Press release: https://bit.ly/2CXeyL7 Bill text: https://bit.ly/2UsGS1L
  • Also on April 1, Sens. Scott (R-FL) and Hawley (R-MO) introduced the Transparent Drug Pricing Act (S. 977), which would require pharmacies to inform patients the cost to purchase drugs out-of-pocket instead of using insurance, insurers to inform patients the total costs of their prescription drugs 60 days prior to open enrollment, and manufacturers to charge less than or equal to  the prices of the same prescription drugs in other developed countries. Press release: https://bit.ly/2OItykE
  • On April 2, the Senate passed by voice vote the Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839), which would extend protection for Medicaid recipients of home and community-based services against spousal impoverishment, establish a state Medicaid option to provide coordinated care to children with complex medical conditions through health homes, and prevent the misclassification of drugs for purposes of the Medicaid drug rebate program. Having previously passed the House, the bill now moves to the President for signature. Bill text: https://bit.ly/2TYVUIE
  • Also on April 2, Reps. Langevin (D-RI) and McMorris Rodgers (R-WA) introduced the Lifespan Respite Care Reauthorization Act of 2019 (H.R. 2035), which would authorize $200 million in funding over the next five years for the program. Senate Aging Committee Chair Collins (R-ME) introduced companion legislation in the Senate (S. 995). Press release: https://bit.ly/2UrtU4E Bill text: https://bit.ly/2Vj7qzK
  • Also on April 2, Rep. Meadows (R-NC) introduced H.R. 2038, which would allow state-based, market-oriented prescription drug negotiations to lower pharmaceutical drug prices and increases consumer choice and access. Press release: http://bit.ly/2UsikqQ
  • Also on April 2, Sens. Capito (R-WV) and Tester (D-MT) introduced the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (S. 988), which would prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Press release: https://bit.ly/2kxcqCs
  • On April 3, the House Energy & Commerce Committee approved 12 bills to lower prescription drug costs and preserve the ACA’s consumer protections, including the CREATES Act (H.R. 965). Of the 12 bills, 7 were approved by voice vote. The bills now move to the full House for consideration. Press release with list of bills: https://bit.ly/2UgVQZB
  • Also on April 3, Reps. Blumenauer (D-OR) and Mullin (R-OK) and 19 bipartisan cosponsors introduced the Overdose Prevention and Patient Safety Act (H.R. 2062), which would align 42 CFR Part 2 with patient privacy protections currently in place under HIPAA. Sens. Manchin (D-WV) and Capito (R-WV) and 10 bipartisan cosponsors introduced companion legislation in the Senate (Protecting Jessica Grubb’s Legacy Act, S. 1012). Press release: https://bit.ly/2G17T4z
  • Also on April 3, Reps. Horsford (D-NV) and Reed (R-NY) introduced the Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 (H.R. 2069), which would require drug manufacturers to publicly justify large price increases and launch prices for high-cost drugs. Press release: https://bit.ly/2VmrPUD
  • Also on April 3, Reps. Sarbanes (D-MD), Stefanik (R-NY), Tonko (D-NY), and Upton (R-MI) introduce the School-Based Health Centers Reauthorization Act (H.R. 2075), which would reauthorize the School-Based Health Centers (SBHC) program through 2024. Sens. Stabenow (D-MI) and Capito (R-WV) introduced companion legislation in the Senate (S. 1013). Press release: https://bit.ly/2K7es9X Bill text: https://bit.ly/2uNpjep
  • Also on April 3, the House passed by a vote of 240-186 H. Res. 271, which condemns the Trump Administration’s actions against the Affordable Care Act. Resolution: https://bit.ly/2ONoQCc
  • Also on April 3, Sens. Thune (R-SD) and Rounds (R-SD) introduced the Tribal Veterans Health Care Enhancement Act (S. 1001), which would allow the Indian Health Service to cover the cost of a copayment of an Indian or Alaska Native veteran receiving medical care or services from the Department of Veterans Affairs. Press release: https://bit.ly/2G28vHi
  • On April 4, Rep. Aderholt (R-AL) introduced the Stopping Consumption of Tobacco by Teens (SCOTT) Act (H.R. 2084), which would raise the minimum age to buy tobacco products and require more age verification for the online sale of vaping products. Press release: https://bit.ly/2U4gveE
  • Also on April 4, Rep. Schakowsky and 10 Democratic cosponsors introduced the Consumer Health Options and Insurance Competition Enhancement (CHOICE) Act (H.R. 2085), which would add a public health insurance option to the Affordable Care Act’s individual marketplaces. Companion legislation was introduced by Sens. Brown (D-OH), Whitehouse (D-RI) and 4 Democratic cosponsors in the Senate (S. 1033). Press release: https://bit.ly/2OTN4ut
  • Also on April 4, Rep. Brownley (D-CA) introduced H.R. 2094, which would increase the maximum age for children eligible for medical care under the CHAMPVA program. Sen. Brown (D-OH) and 10 Democratic cosponsors introduced companion legislation in the Senate (S. 1034).
  • Also on April 4, Rep. DeSaulnier (D-CA) introduced the National Public Health Act (H.R. 2095), which would require HHS to establish a list of public health crises as well as a list of products that contribute to such crises. Press release: https://bit.ly/2HYTGax
  • Also on April 4, Reps. Palmer (R-AL) and Gosar (R-AZ) introduced the Retirement Freedom Act (H.R. 2108), which would allow individuals to choose to opt out of the Medicare Part A benefit. Sens. Cruz (R-TX), Paul (R-KY), and Lee (R-UT) introduced companion legislation in the Senate (S. 1030). Press release: https://bit.ly/2uPIC6R
  • Also on April 4, Rep. Wasserman Schultz (D-FL) and 11 cosponsors introduced the Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction (PROTECT) Act (H.R. 2111), which would provide for a Reducing Youth Use of E-Cigarettes Initiative. Sen. Blumenthal (D-CT) introduced companion legislation in the Senate (S. 1048). Press release: https://bit.ly/2Kb4aFI
  • Also on April 4, Sens. Barrasso (R-WY) and Smith (D-MN) introduced the Rural Health Clinic Modernization Act (S. 1037), which would update how advanced practice clinicians are utilized by RHCs, update the statute regarding lab requirements and delivery of telehealth services, and increase reimbursements for RHCs. Press release: https://bit.ly/2WKbeuk Bill text: https://bit.ly/2KoURCj
  • Also on April 4, Sens. Duckworth (D-IL) and 4 cosponsors introduced the Healthcare Opportunities for Patriots in Exile (HOPE) Act of 2019 (S. 1041), which would allow deported veterans who committed non-violent crimes the opportunity temporarily reenter the United States to receive medical care from a VA facility for service-connected medical conditions. Press release: https://bit.ly/2UkWfdE
  • Also on April 4, Sens. Young (R-IN) and Jones (D-AL) introduced the Nursing Where It’s Needed (WIN) Act (S. 1045), which would expand the authority of the HHS Secretary to permit nurses to practice in health care facilities with critical shortages of nurses through programs for loan repayment and scholarships for nurses. Press release: https://bit.ly/2UxAzu8 Bill text: https://bit.ly/2Vqp3xM

ACA and Individual Market –

  • On April 4, CMS released an informational bulletin establishing submission deadlines for health insurance issuers to submit Rate Filing Justifications for single risk pool coverage in the individual and small group markets effective on or after January 1, 2020. Issuers in a state without an Effective Rate Review Program must submit by June 3; issuers in a state with an Effective Rate Review Program must submit by July 24. Bulletin: https://go.cms.gov/2YTJ7Ld
  • On April 5, CMS released a list of entities approved to use Enhanced Direct Enrollment (EDE), a new pathway that allows consumers to apply for and enroll in an Exchange plan directly through an approved issuer or web-broker. List: https://go.cms.gov/2SyEB0x
  • Also on April 5, CMS released guidance on the submission deadline for applicants seeking prior year coverage through special enrollment periods in the federally-facilitated exchanges. Guidance: https://go.cms.gov/2G0bvTd

 Medicare –

  • On April 1, CMS announced that Medicare Advantage (MA) and Part D plans will begin rejecting or denying claims for drugs, services, and items prescribed or furnished by an individual or entity on the Preclusion List. Fact sheet: https://go.cms.gov/2JZnTIj
  • Also on April 1, CMS released the 2020 MA and Part D Rate Announcement and Final Call Letter, which will allow MA plans more flexibility in offering supplemental benefits and increase MA payment rates by an estimated 2.53%. Press release: https://go.cms.gov/2YNpGnf Fact sheet: https://go.cms.gov/2FSvX9C Rate Announcement and Final Call Letter: https://go.cms.gov/2TQxT6g
  • Also on April 1, CMS Office of Minority Health released a Mapping Medicare Disparities Tool, which identifies areas of disparities between subgroups of Medicare beneficiaries in health outcomes, spending, and utilization. Tool: https://go.cms.gov/2FVGm3f
  • On April 4, HHS released a report on patterns of care and home health utilization for community-admitted Medicare patients, which found that there are many important differences between patients based on length of home health care use, not just based on source of admission, and that the source of admission may be a more important differentiator among patients who use home health care for longer periods. Summary with link to report: https://bit.ly/2WRNvIP
  • On April 5, CMS released the final Medicare Advantage and Part D Flexibility Final Rule, which implements several provisions in the Bipartisan Budget Act of 2018, including allowing MA plans to offer telehealth benefits, and improves program quality and accessibility and clarifies program integrity policies. Press release on telehealth: https://go.cms.gov/2G2dR3M Fact sheet: https://go.cms.gov/2FUNH2Z Final rule: http://bit.ly/2FVUdGL
  • Also on April 5, CMS released guidance to part D plan sponsors, noting that plans should submit bids for calendar year 2020 consistent with the current safe harbor rules for rebates on prescription drugs, however, if there is a change in the rules as a result of the current rulemaking process, CMS will conduct a demonstration that would test an efficient transition for beneficiaries and plans to such a change. Guidance: http://bit.ly/2VDld4g

 Medicaid –

  • On April 4, Senate Finance Committee Chair Grassley (R-IA) penned an op-ed calling on legislators to amend the current disproportionate share hospital payment formulas and to commit to the temporary payment cuts imposed by the ACA. Op-ed: http://bit.ly/2UiXBW6

Drug and Medical Device Prices and Regulation –

  • On April 2, Food and Drug Administration (FDA) announced a public hearing to be held on May 13 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products. FDA Commissioner Gottlieb statement: https://bit.ly/2IiifhV
  • Also on April 2, FDA announced a series of new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products. FDA Commissioner Gottlieb statement: https://bit.ly/2I3CIqE
  • Also on April 2, FDA released a discussion paper on developing a novel and tailored approach to help developers bring artificial intelligence devices to market. FDA Commissioner Gottlieb statement: https://bit.ly/2Kdnr9g Discussion paper: https://bit.ly/2UuwkPP
  • Also on April 2, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) sent letters to three pharmacy benefit managers requesting information about their role in the cost of insulin. Press release with links to letters: http://bit.ly/2G0x7yz
  • On April 3, FDA Commissioner Gottlieb and Deputy Commissioner Abram issued a statement on the agency’s new efforts in 2019 to improve the quality of compounded drugs. Statement: https://bit.ly/2I1M8ny

 Substance Use and Mental Health –

  • On April 1, FDA announced a public scientific workshop to be held on May 15 to further discuss scientific understanding and treatment options for youth tobacco addiction and cessation, with a focus on e-cigarette cessation. FDA Commissioner Gottlieb statement: https://bit.ly/2VaJTRu
  • Also on April 1, U.S. Government Accountability Office released a report finding that of the estimated 56.8 million Americans with a behavioral health condition, an estimated 39.7 million did not receive treatment. Summary with link to report:  http://bit.ly/2FZEExA
  • On April 2, HHS released a final report on work-focused interventions for depression, which summarized current knowledge regarding the adoption and benefits of work-based depression programs and identified opportunities to expand these programs. Summary with link to report: https://bit.ly/2FRKdhR
  • Also on April 2, FDA announced the issuance of two warning letters to operators of websites that illegally market potentially dangerous and unapproved opioids, including tramadol. Press release: https://bit.ly/2IiifhV
  • Also on April 2, HHS Office of Inspector General (OIG) released a report finding that Substance Abuse and Mental Health Services Administration (SAMHSA) followed grant regulations and program-specific requirements when awarding State Targeted Response (STR) to the Opioid Crisis grants. Summary with link to report: https://bit.ly/2Uiiv7P
  • On April 4, FDA announced a partnership with Customs and Border Protection (CBP) to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through International Mail Facilities (IMFs) and Ports of Entry. Press release: https://bit.ly/2uKRlXU

Veterans and Military Health –

  • On April 1, Department of Veterans Affairs (VA) Secretary Wilkie commended the Veterans’ Family, Caregiver, and Survivor Federal Advisory Committee for their crosscutting recommendations addressing several areas that affect veterans. Press release: https://bit.ly/2G1uDRO
  • Also on April 1, VA announced that it, in partnership with SAMHSA, convened seven teams in Arlington, VA, for the Mayor’s Challenge to Prevent Suicide Among Service Members, Veterans, and their Families. Press release: https://bit.ly/2CJ3RvF
  • On April 2, U.S. Government Accountability Office (GAO) issued a report showing that, despite spending over $4 billion annually on IT, VA does not have IT systems that fully support critical services (e.g. health care, disability benefits), some VA IT management processes do not effectively implement federal IT acquisition law, and cybersecurity management has weaknesses. GAO recommends that VA improve its IT management. Summary with link to report: https://bit.ly/2uR7hYE

 Misc. –

  • On April 2, HHS Inspector General Levinson submitted his resignation, effective May 31. HHS Secretary Azar statement: https://bit.ly/2VsVaNi
  • On April 4, Senate HELP Committee Chair Alexander (R-TN) announced that the committee received more than 400 responses to its request for information on ways to lower healthcare costs, and noted that he is working with Ranking Member Murray (D-WA), and Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR), on bipartisan steps to address healthcare costs. Press release: http://bit.ly/2UkKu6S
  • On April 5, HHS OIG released a report finding that, although the Administration for Community Living (ACL) resolved nearly all audit recommendations, it did not always do so in accordance with federal timeframe requirements. Summary with link to report: https://bit.ly/2YRFaqj