What’s Ahead: This Week


Notable Policy Events –

  • Wednesday, April 17
    • Alliance for Health Policy (AHP), “Right Care, Right Patient, Right Time: The Role of Comparative Effectiveness Research.” Additional information: https://conta.cc/2D1rZK7
    • Better Medicare Alliance (BMA), “Medicare Advantage 101: A Primer.” Additional information: https://bit.ly/2X5smuH

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

 Legislative Activity –

  • On April 8, the House Ways & Means Committee unanimously approved the Prescription Drug Sunshine, Transparency, Accountability, and Reporting (STAR) Act (H.R. 2113), which would provide for manufacturer price transparency and require certain manufacturers to report on product samples provided to health care providers, as well as the Public Disclosure of Drug Discounts Act (H.R. 2115), which would require PBMs to report their aggregate rebates, discounts, and other price concessions for prescription drugs to a public website. The bills now moves to the full House for consideration. Press releases: https://bit.ly/2D6heGq and https://bit.ly/2Uug9my H.R. 2113 Bill text: https://bit.ly/2KpwDHK
  • Also on April 8, Reps. Kind (D-WI), Kelly (R-PA), Guthrie (R-KY), and Doyle (D-PA) introduced the Medicare Advantage Quality Payment Relief Act (H.R. 2131), which would address a technical issue that subjects MA quality bonus payments to a benchmark cap. Sens. Daines (R-MT) and King (I-ME) introduced companion legislation in the Senate (S. 1114). Press release: https://bit.ly/2Iortct
  • On April 9, Reps. Speier (D-CA) and Titus (D-NV) introduced the Promoting Integrity in Medicare Act (PIMA) (H.R. 2143), which would prevent physicians in certain specialties from referring patients to ancillary medical services in which they have an ownership interest and are offered in their offices. Press release: https://bit.ly/2WXSM1l Bill text: https://bit.ly/2KqkJh2
  • Also on April 9, Rep. Schakowsky (D-IL) and 5 bipartisan cosponsors introduced the Home Health Care Planning Improvement Act of 2019 (H.R. 2150), which would authorize nurse practitioners, certified nurse-midwives, clinical nurse specialists, and physician assistants to certify patient eligibility for home health services under Medicare. Press release: https://bit.ly/2YZSWXS
  • Also on April 9, Rep. Biggs (R-AZ) and 13 cosponsors introduced the Freedom for Families Act (H.R. 2163), which would make funds in a health savings account available for expenses during a period of leave for birth, adoption, or family illness. Press release: https://bit.ly/2Ibdyr6
  • Also on April 9, Sens. Roberts (R-KS), King (I-ME), Isakson (R-GA), and Manchin (D-WV) introduced S. 1089, which would repeal the amendments made by the ACA which disqualify expenses for OTC drugs under health savings accounts and health flexible spending arrangements. Press release: http://bit.ly/2Gq7x6H
  • On April 10, Rep. Kind (D-WI) and 226 bipartisan cosponsors introduced the Protect Medical Innovation Act (H.R. 2207), which would repeal the medical device excise tax. Press release: https://bit.ly/2Z4vI2V Bill text: https://bit.ly/2uXZ5pN
  • Also on April 10, Rep. Meadows (R-NC) introduced H.R. 2209, which would establish the position of Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative responsible for conducting trade negotiations related to policies and practices of foreign governments that fail to appropriately reward U.S. pharmaceutical innovation.
  • Also on April 10, House Diabetes Caucus Co-chair DeGette (D-CO) and 11 bipartisan cosponsors introduced the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (H.R. 2235), which would cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate foot and ankle care and modify the requirements for diabetic shoes to be included under Medicare. Press release: https://bit.ly/2IuElha
  • Also on April 10, Sens. Rubio (R-FL) and Sinema (D-AZ) introduced the Better Examiner Standards and Transparency (BEST) for Vets Act (S. 1101), which would ensure that only licensed health care providers are conducting medical disability examinations on behalf of the VA. Press release: https://bit.ly/2v04KvG Bill text: https://bit.ly/2Z2jGqI
  • Also on April 10, Sens. Rubio (R-FL), Feinstein (D-CA), Capito (R-WV), and Manchin (D-WV) introduced the Women and Lung Cancer Research and Preventative Services Act of 2019 (S. 1107), which would encourage more research in the prevention and treatment of lung cancer in women, particularly for those who have never smoked. Press release: https://bit.ly/2P3l9IJ
  • Also on April 10, Sens. Capito (R-WV), Stabenow (D-MI), Wicker (R-MS), and Menendez (D-NJ) introduced the Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act (S. 1126), which would encourage early assessment and diagnosis of Alzheimer’s. Reps. Sanchez (D-CA) and LaHood (R-IL) introduced companion legislation in the House (H.R. 2283). Press release: https://bit.ly/2IrcOx9 Bill text: https://bit.ly/2X2nkz4
  • Also on April 10, Sen. Sanders (I-VT) and 14 cosponsors introduced the Medicare for All Act of 2019 (S. 1129), which would establish a single-payer national health insurance program. Press release: https://bit.ly/2X8YQ7v Bill text: https://bit.ly/2IokGPY
  • On April 11, Sens. Smith (D-MN) and Cassidy (R-LA) introduced the Protecting Access to Biosimilars Act (S. 1140), which would subject insulin to a new FDA pathway for biosimilar approval to bring low-cost, generic insulin products to market. House Diabetes Caucus Co-chairs DeGette (D-CO) and Reed (R-NY) previously introduced companion legislation in the House (H.R. 2011). Press release: https://bit.ly/2X8wdab
  • Also on April 11, Senate Veterans’ Affairs Committee Ranking Member Tester (D-MT) and Sen. Blackburn (R-TN) introduced S. 1154, which would establish an advisory committee on the implementation of an electronic health record by the VA.
  • Also on April 11, Sens. Bennet (D-CO), Murkowski (R-AK), and Casey (D-PA) introduced the Inclusive Aging Act (S. 1159), which would establish the Office of Inclusivity and Sexual Health in the Administration on Aging, establish a rural grant program to fund training and resources for care, and reauthorize the National Resource Center on LGBT Aging. Press release: https://bit.ly/2UvtIC0 Bill text: http://bit.ly/2Iun73A
  • Also on April 11, Sen. Enzi (R-WY) and 24 cosponsors introduced S. 1170, which would establish additional criteria for determining when employers may join together in a group or association of employers that will be treated as an employer under section 3(5) of ERISA for purposes of sponsoring a group health plan. Press release:  http://bit.ly/2GgJkzg
  • Also on April 11, Sens. Capito (R-WV) and Shaheen (D-NH) introduced the Rural Access to Hospice Act (S. 1190), which would remove a statutory barrier in current law that inhibits seniors’ access to hospice in rural communities across the country, allowing them to receive hospice care from their local primary care provider. Press release: https://bit.ly/2Z7by8v Bill text: https://bit.ly/2YZLzQa
  • Also on April 11, Sens. Cassidy (R-LA) and Durbin (D-IL) introduced the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209), which would allow generic manufacturers, after substance patents and exclusivities expire, to enter the drug market based on their assessment of the secondary patent validity and the risk of legal action by the brand. Press release: https://bit.ly/2GdAD8T Bill text: https://bit.ly/2GaCag3
  • Also on April 11, Sen. Warren (D-MA) and 6 cosponsors introduced the Consumer Health Insurance Protection Act (S. 1213), which would set up an ombudsman program to track consumer complaints about insurers, set limits on insurance company profits to match those that private insurers can earn in Medicare and Medicaid, require all short-term insurance products to meet ACA standards, and block the recent regulations on association health plans, among other things. Press release: https://bit.ly/2DbpViR Bill text: https://bit.ly/2UhqEo1

ACA and Individual Market –

  • On April 8, CMS released a set of frequently asked questions on the 2018 benefit year cost-sharing reduction data submission process. FAQ: https://go.cms.gov/2VFTJer
  • On April 9, House Oversight & Reform Committee Chair Cummings (D-MD), Energy & Commerce Committee Chair Pallone (D-NJ), Ways & Means Committee Chair Neal (D-MA), Education & Labor Committee Chair Scott (D-VA), and Judiciary Committee Chair Nadler (D-NY) penned letters to the Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the White House requesting documents and information regarding the involvement of White House officials in the Administration’s decision to not defend the constitutionality of the ACA. Press release: https://bit.ly/2D5rI98 Letter to DOJ: https://bit.ly/2Datupt Letter to HHS: https://bit.ly/2v2Nea4 Letter to White House: https://bit.ly/2Gc3ESp

 Medicare and Medicaid –

  • On April 8, HHS published a report on the opportunities and challenges of integrating care through dual eligible special needs plans (D-SNPs). The report also identifies a menu of administrative flexibilities under existing SNP authority to improve access to integrated services and care coordination for duals. Summary with link to report: https://bit.ly/2v2cQnq
  • Also on April 8, HHS released a report on the lifetime risk of needing and receiving long-term services and supports (LTSS), finding that that 70 percent of adults who survive to age 65 develop severe LTSS needs before they die and 48 percent receive some paid care over their lifetime. Report: https://bit.ly/2IuHXjx
  • Also on April 8, HHS released a report finding that although about two-thirds of all adults ages 65 and older not on Medicaid could fund at least two years of paid home care using only their income and easily liquidated assets, only about one-half of those with severe LTSS needs have enough savings to cover paid home care for that time. Report: https://bit.ly/2D6OywL
  • On April 9, CMS proposed to update its national coverage policy for Ambulatory Blood Pressure Monitoring (ABPM), which would use a device to track blood pressure over 24-hour cycles. Comments on the proposal are due on May 9. Proposed decision: https://go.cms.gov/2VJlQti
  • On April 10, members of the Minnesota congressional delegation penned a letter to CMS Administrator Verma urging the agency to protection funding for Minnesota’s Basic Health Plan (BHP), MinnesotaCare. Press release with text of letter: https://bit.ly/2v1nV87

Payment and Delivery System Reforms –

  • On April 8, CMS posed the Fifth Annual Report for the State Innovation Models (SIM) Round 1 Model Test Awards. Report: https://bit.ly/2UapHOw
  • On April 10, CMS announced that it will be holding an informational overview webinar on the AI Health Outcomes Challenge on April 18. Registration: https://bit.ly/2P7ZAXB
  • On April 11, CMS announced a Notice of Funding Opportunity (NOFO) application webinar for the Integrated Care for Kids (InCK) model on April 18. Registration: https://bit.ly/2Z3zdqp

 Drug and Medical Device Prices and Regulation –

  • On April 8, Food and Drug Administration (FDA) approved the first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment. Press release: https://bit.ly/2GgPEZ7
  • Also on April 8, Senate Finance Committee Ranking Member Wyden (D-OR) posted responses from pharmaceutical manufacturers in response to requests for information raised during the committee’s February hearing on drug prices. Press release: http://bit.ly/2VKYxQ0
  • On April 9, Senate Finance Committee Chair Grassley (R-IA) issued a statement on his priority to lower the cost of prescription drugs, noting his support for the CREATES Act and the Preserve Access to Affordable Generics and Biosimilars Act. Press release: https://bit.ly/2VCVbOB
  • On April 10, FDA issued a warning to the public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion. Press release: https://bit.ly/2IgbNJ9
  • Also on April 10, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) penned a letter to the HHS Office of Inspector General (OIG) seeking more information regarding pharmacy benefit manager (PBM) business practices, specifically spread pricing in Medicaid. Press release: https://bit.ly/2UMgbFG Letter: https://bit.ly/2v3kmyd

 Substance Use and Mental Health –

  • On April 8, Sen. Durbin (D-IL) and 10 senators penned a letter to JUUL Labs CEO Burns criticizing its partnership with Altria and questioning its marketing tactics to appeal to children. Press release: https://bit.ly/2Z6TPhn Letter: https://bit.ly/2IeDnGz
  • On April 9, FDA Regulatory Programs Deputy Center Director Throckmorton issued a statement on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids. Statement: https://bit.ly/2D01KUn
  • On April 10, HHS announced its intent to release a Notice of Funding Opportunity (NOFO) for a new Rural Communities Opioid Response Program (RCORP) initiative called RCORP Medication-Assisted Treatment Expansion. Recipients will receive up to $725,000 for a three-year performance period. Press release: https://bit.ly/2DapbKB


Veterans and Military Health –

  • On April 8, Department of Veterans Affairs (VA) announced an increase to the Department’s goals for contracting with Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran-Owned Small Businesses (VOSB) by 5 percent. Press release: https://bit.ly/2v1QnHd
  • Also on April 8, U.S. Government Accountability Office (GAO) outlined its 30 priority open recommendations for the VA as of March 2019. The recommendations involve improving oversight of veterans’ access to timely health care, management of human capital, and management of information technology. Summary with link to report: https://bit.ly/2UW13Fy
  • On April 10, GAO issued a report recommending that VA needs to address challenges like complex referral and appointment scheduling processes and a lack of timely payments to community providers as it implements the Veterans Community Care program. Summary with link to report: https://bit.ly/2G6MBRS

 Health IT –

  • On April 8, National Institutes of Health (NIH) published a study finding that physicians may overprescribe antibiotics to children during telemedicine visits. Press release: https://bit.ly/2I6gWDE
  • On April 9, DOJ announced federal indictments and law enforcement actions in one of the largest health care fraud schemes involving telemedicine and durable medical equipment, totaling over $1.2 billion in losses. Press release: https://bit.ly/2D6KM6N
  • On April 11, Senate Finance Committee Chair Grassley (R-IA) penned a letter to HHS Secretary Azar seeking details on the Department’s plans to implement new information and cybersecurity policies to mitigate several vulnerabilities found in an OIG audit. Press release: https://bit.ly/2D6MdBZ Letter: https://bit.ly/2uZjn2h

 Misc. –

  • On April 8, GAO outlined its 54 priority open recommendations for HHS as of March 2019. The recommendations involve improving the Medicare program’s payment policy and design, oversight and accountability of Medicaid spending, and security of health IT. Summary with link to report: https://bit.ly/2GivKN8
  • On April 10, HHS Office of the Assistant Secretary for Health announced a new organizational structure aimed at strengthening its public health portfolio. The changes include moving the Office of Adolescent Health to within the Office of Population Affairs and merging the Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) and the National Vaccine Program Office (NVPO) into a newly renamed office, the Office of Infectious Disease and HIV/AIDS Policy (OIDP). Press release: https://bit.ly/2GlkOyy
  • Also on April 11, HHS’ Ignite Accelerator announced 19 teams selected for the eighth round of the Internal Innovation Training and Incubator Program. Press release: https://bit.ly/2Uh7pek