What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, January 23
    • Senate HELP Committee, “Facing 21st Century Threats: Our Nation’s Preparedness and Response Capabilities, Part 2.”
  • Wednesday, January 24
    • Senate Budget Committee, “CBO Oversight Hearing.”
    • Senate Homeland Security & Governmental Affairs, Subcommittee on Investigations, “Combatting the Opioid Crisis: Exploiting Vulnerabilities in International Mail.”

 Notable Policy Events –

  • Thursday, January 25
    • HHS Agency for Healthcare Research and Quality, “National Web Conference on Reducing Provider Burden through Better Health IT Design.” Additional information: http://bit.ly/2mVctHJ
  • Thursday, January 25 – Friday, January 26
    • Medicaid and CHIP Payment and Access Commission, “January Public Meeting.” Additional information: http://bit.ly/2mUXa1G
  • Thursday, January 25 – Saturday, January 27

 

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

Appropriations –

  • On January 18, Rep. McEachin (D-VA) introduced the Advancing Seniors and Kids Act (H.R. 4820), which would extend funding for certain public health programs, including CHIP, community health centers, safety net hospitals, and others. Press release: http://bit.ly/2mVwkX0 Bill text: http://bit.ly/2mT7RBW
  • On January 20, Government appropriations elapsed following Congress’ failure to approve an appropriations bill. On January 18, the House approved by a vote of 230-197 a continuing resolution (H.R. 195) that would authorize funding at fiscal year 2017 enacted levels through January 19; the bill would also reauthorize CHIP for 6 years as well as delay several ACA taxes, including the health insurance tax, the medical device tax, and the Cadillac tax. The Senate has yet to approve the measure. Press release: http://bit.ly/2n0Sffu Bill text: http://bit.ly/2mZ19KH

 Nominations –

  • On January 17, the Senate Finance Committee advanced by a vote of 15-12 the nomination of Alex Azar to be the Secretary of Health and Human Services. The nomination now moves to the full Senate for consideration. Press release: http://bit.ly/2Bd8rOY

 Legislative Activity –

  • On January 16, Sen. Cassidy (R-LA) introduced the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT) (S. 2312), which would provide a moratorium on registration of new non-rural section 340B hospitals and associated sites. Rep. Bucshon previously introduced a similar bill in the House (H.R. 4710). Press release: http://bit.ly/2rg4Y2z Bill text: http://bit.ly/2rhngjW
  • On January 17. Sens. Isakson (R-GA) and Casey (D-PA) introduced the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315), which would clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. Press release: http://bit.ly/2mXh6RD Bill text: http://bit.ly/2mX3V2S
  • Also on January 17, Sens. Markey (D-MA), Paul (R-KY), Hassan (D-NH) and Collins (R-ME) introduced the Addiction Treatment Access Improvement Act (S. 2317), which would provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders. Press release: http://bit.ly/2rhjI1d Bill text: http://bit.ly/2rfp3Gn
  • Also on January 17, House Energy & Commerce Committee Subcommittee on Health advanced three healthcare related bills: The Good Samaritan Health Professional Act of 2017 (H.R. 1876), the Pharmaceutical Information Exchange Act of 2017 (H.R. 2026), and the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 (H.R. __). The bills now move to the full Committee for consideration. Press release: http://bit.ly/2mVN2FO

ACA Market Stabilization & Implementation –

  • On January 17, CMS announced additional special enrollment period opportunities for individuals affected by the 2017 hurricanes in Puerto Rico and the U.S. Virgin Island to enroll in Medicare health and drug plans and health coverage through Healthcare.gov. Press release: http://go.cms.gov/2Bc7fLS
  • On January 18, Internal Revenue Service released a notice providing temporary relief for the first three quarters of 2018 to medical device manufacturers from the ACA’s 2.3 percent excise tax on the sale of certain medical devices. Notice: http://bit.ly/2mXpHUh

Medicare –

  • On January 16, HHS Office of Inspector General released a report finding that 28 percent of Medicare Advantage encounter records reviewed from the first quarter of 2014 had at least one potential error. Summary with link to report: http://bit.ly/2rcSNDw
  • On January 17, U.S. Government Accountability Office (GAO) released a report finding that CMS is lacking information that it could use to assess how opioid prescribing patterns in Medicare are changing over time and whether its oversight efforts to reduce harm are effective. Summary with link to report: http://bit.ly/2BaQpwN
  • Also on January 17, GAO released a report finding that Medicare represented at least half of the market for 22 of the 84 most expensive drugs in Part B in 2015. Summary with link to report: http://bit.ly/2BcTRqP

Medicaid –

  • On January 12, Kentucky Governor Bevin signed an executive order declaring that if the state’s proposed Medicaid work requirements are struck down by the courts, then he would act to roll back the state’s Medicaid expansion. Executive order: http://bit.ly/2rfXIUx
  • On January 16, GAO released a report finding that CMS should take additional steps to ensure that assessments of individuals’ needs for home- and community-based services in Medicaid are conflict-free. Summary with link to report: http://bit.ly/2rjfhTJ
  • On January 17, Senate Homeland Security & Governmental Affairs Committee Chair Johnson (R-WI) released a report “detailing cases involving Medicaid fraud and how the Medicaid program has contributed to the opioid crisis.” Press release with link to report: http://bit.ly/2rf9xtP
  • On January 18, Senate Finance Committee Ranking Member Wyden (D-OR) led a group of 29 senators in a letter to HHS Acting Secretary Hargan expressing concern with recent administrative actions and calling into question the Administration’s authority to approve Medicaid work requirements. Press release: http://bit.ly/2mVNjZj Letter: http://bit.ly/2mV3x56
  • On January 19, the Medicaid and CHIP Payment and Access Commission (MACPAC) and the Medicare Payment Advisory Commission (MedPAC) released a joint data report on beneficiaries dually eligible for Medicare and Medicaid. Report: http://bit.ly/2mWD4E0

 New Payment & Delivery System Models –

  • On January 18, CMS released a list of the 17 new model participants for the 2018 Next Generation ACO Model. There are now 58 participants in the model in total, serving about 2 million patients. Participants: http://bit.ly/2mXkbkn
  • Also on January 18, CMS released a list of clinical episode exclusions and a bundled payment model comparison table for the Bundled Payment for Care Improvement model. Link to download episode exclusions: http://bit.ly/2mXkg7P Comparison table: http://bit.ly/2mXjBTT

 Mental Health and Substance Abuse –

  • On January 16, Senate HELP Committee Ranking Member Murray (D-WA) sent a letter to Acting HHS Secretary Hargan expressing concern following the Department’s decision to suspend the National Registry of Evidence-based Programs and Practices. Press release: http://bit.ly/2rkRcvM Letter: http://bit.ly/2rcTyNa
  • On January 17, Sens. Hassan (D-NH), Blumenthal (D-CT), Feinstein (D-CA), Warren (D-MA) and Shaheen (D-NH) sent a letter to Substance Abuse and Mental Health Services Administration (SAMHSA) Administrator McCance-Katz relaying concerns that the agencies have suspended updates to the National Registry of Evidence-based Programs and Practices. Press release: http://bit.ly/2BdF3In Letter: http://bit.ly/2Bc3G8x
  • Also on January 17, Sen. Hassan (D-NH) led a group of 9 senators in a letter to President Trump urging him to nominate strong, experienced leadership to key drug policy positions and to provide information on all political appointees serving in key drug policy positions. Press release: http://bit.ly/2BcuipW Letter: http://bit.ly/2BcuntK
  • Also on January 17, SAMHSA announced several efforts to advance evidence-based behavioral health practices, including a new technical assistance effort for states and a new funding opportunity to develop a national Center of Excellent dedicated to the implementation of evidence-based practices to treat individuals living with serious mental illness. Press release: http://bit.ly/2Bc3Qgb
  • On January 18, National Governors Association released a comprehensive set of recommendations for federal action to help mitigate the opioid crisis. Recommendations: http://bit.ly/2mVSwQR
  • On January 19, HHS announced an extension of the declaration of a public health emergency for the opioid crisis; the new declaration is valid for 90 days. Declaration: http://bit.ly/2mZ9eib
  • Also on January 19, Sens. Warren (D-MA) and other members of the Massachusetts congressional delegation sent a letter to SAMHSA Administrator McCance-Katz, requesting information on SAMHSA’s efforts to address mental health challenges in Puerto Rico and the U.S. Virgin Islands in the aftermath of Hurricanes Irma and Maria. Press release: http://bit.ly/2Bjha2b Letter: http://bit.ly/2Bjhazd

Veterans Health –

  • On January 17, Department of Veterans Affairs (VA) Office of Inspector General released a report finding that the Veterans Health Administration misused about $3.1 million of medical support and compliance appropriations when developing a system enhancement and mobile health applications. Report: http://bit.ly/2mZ9VYP
  • On January 18, GAO released a report finding that since 2001, the Department of Veterans Affairs (VA) has pursued four separate initiatives to modernize its health information system, obligating about $1.1 billion to 138 different contractors. Summary with link to report: http://bit.ly/2mVCNS1
  • Also on January 18, VA released a proposed rule amending regulations to allow medical records to be released through a health information exchange to outside providers with electronic or written patient consent. Comments are due by March 20. Proposed rule: http://bit.ly/2mVjA2T
  • On January 19, HHS released data on the characteristics and healthcare expenditures of VA health system users, finding that they were more likely than non-VA users to be elderly, non-Hispanic black, lower income, in poorer health, and live in nonmetropolitan areas. Report: http://bit.ly/2Bjx90e

 Health IT –

  • On January 16, HHS Office of the National Coordinator for Health IT (ONC) Director Rucker released a blog post listing various highlights from the 2017 ONC Annual Meeting, and remarking on the agency’s focus on burden reduction and interoperability. Blog post: http://bit.ly/2rdw1vp
  • On January 17, ONC released a blog post outlining the potential promise and potential risks of artificial intelligence in healthcare in the wake of a recent report from JASON, an independent group of science and academic advisors to the federal government on the topic. Blog post: http://bit.ly/2BcVZij

Drug and Device Regulation –

  • On January 16, GAO released a report finding that the Food and Drug Administration (FDA) should make public its plants to issue and revise guidance related to non-biological complex drugs, which make help to speed the development and review of generic versions of brand-name drugs. Summary with link to report: http://bit.ly/2reAbDi FDA statement: http://bit.ly/2rdhJLr House Energy & Commerce Committee statement: http://bit.ly/2rdxOAK
  • Also on January 16, GAO released a report finding that the FDA has not developed performance metrics to evaluate its least burdensome approach to medical device reviews. Summary with link to report: http://bit.ly/2raasvS FDA statement: http://bit.ly/2rjjCpZ
  • Also on January 16, FDA Commissioner Gottlieb released a statement highlighting the new steps the FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs. Statement: http://bit.ly/2rhh2Aw
  • On January 18, FDA released guidance on new steps for strengthening public warning and notification of recalled products. Guidance: http://bit.ly/2Bgcrya Statement: http://bit.ly/2mVIe3e Blog post: http://bit.ly/2mVAU7T

 Misc. –

  • On January 16, HHS announced that six rural hospitals across four states in the Delta region will share $2 million in grants for intensive technical assistance in the areas of finance, operations, technology and quality improvement. Press release: http://bit.ly/2rcgqw9
  • On January 17, HHS and 15 other federal agencies released an interim final Common Rule for the protection of research subjects, which will go into effect on July 19. IFR: http://bit.ly/2Bc94bN
  • On January 18, CMS released a newsletter for its Patients over Paperwork initiative, which describes CMS’ efforts to reduce administrative burden and improve the customer experience while putting patients first. Newsletter: http://go.cms.gov/2mVu2at
  • Also on January 18, Centers for Disease Control and Prevention (CDC) released data finding that overall cigarette smoking among U.S. adults declined from 20.9 percent in 2005 to 15.5 percent in 2016, however nearly 38 million Americans smoked cigarettes every day or some days in 2016. Press release: http://bit.ly/2mVHWta
  • Also on January 18, HHS announced the formation of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights. Press release: http://bit.ly/2BdBwtB
  • On January 19, HHS announced new actions to protect conscience rights and life, including new guidance state Medicaid directors rescinding 2016 guidance that restricted states’ ability to take certain actions against family planning providers, and a new proposed rule that would enforce 25 existing statutory conscience protections. Comments on the proposed rule are due by March 26. Press release: http://bit.ly/2mVUz7M SMD Guidance: http://bit.ly/2mVTFrF Proposed rule: http://bit.ly/2mX8c6F
  • Also on January 19, HHS released data finding that in 2015, the overall median amount paid out of pocket by non-elderly families for healthcare was $51, but median out-of-pocket expenses increased substantially with family income. Press release: http://bit.ly/2mUXHAG Data: http://bit.ly/2mVp5hM