What’s Ahead: This Week

Notable Policy Events –

  • Thursday, January 4
    • American Enterprise Institute, “Re-connecting Health Care Policy with Economics: Finding and Fixing Distortive Incentives.” Additional information: http://bit.ly/2qePfjY

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

 Appropriations –

  • On December 22, President Trump signed into law a continuing resolution (CR) (H. J. Res 124) that will fund the federal government through January 19, and will provide funding to states for CHIP through March 31. The day before, the House passed by the bill by a vote of 231-188, and the Senate passed the bill by a vote of 66-32. Press releases: http://bit.ly/2limgXx and http://bit.ly/2lk9WWF CR: http://bit.ly/2ljAgA6

Tax Reform

  • On December 22, President Trump signed into law the Tax Cuts and Jobs Act (H.R. 1). On December 20, the House passed the bill by a vote of 227-203 and the Senate passed the bill by a vote of 51-48. The law reduces the penalty for not having health insurance from $695 to $0. On December 21, as part of the CR, Congress also passed a waiver for the pay-as-you-go rule that would have triggered automatic cuts to Medicare and other programs stemming from tax reform. Press releases from White House: http://bit.ly/2lk9WWF W&M: http://bit.ly/2kEViZI HHS: http://bit.ly/2kScJVY

 Legislative Activity –

  • On December 19, House Veterans Affairs Committee approved by a vote of 14-9 the VA Care in the Community Act (H.R. 4242), which would establish a permanent VA Care in the Community Program. The bill now moves to the full House for consideration. Press release: http://bit.ly/2kEIIJY Summary: http://bit.ly/2kGAwJ2 Section-by-section: http://bit.ly/2kGAW24 Bill text: http://bit.ly/2kEHLkX
  • Also on December 19, Rep. Chu (D-CA) and 9 bipartisan representatives introduced the Ensuring Access to Quality Sober Living Act (H.R. 4684), which would direct the Secretary of Health and Human Services, acting through the Director of the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration, to publish and disseminate best practices for operating recovery housing. Press release: http://bit.ly/2kwSuhp
  • On December 21, Rep. Renacci (R-OH) and four bipartisan cosponsors introduced the Creating Access to Rehabilitation for Every Senior (CARES) Act (H.R. 4701), which would eliminate the three-day prior hospitalization requirement for Medicare coverage of skilled nursing facility services in qualified nursing facilitates. Press release: http://bit.ly/2kG9zW4
  • Also on December 21, Reps. Bucshon (R-IN) and Peters (D-CA) introduced the 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) (H.R. 4710), which would establish a moratorium on the registration of certain new 340B hospitals and associated sites. Press release: http://bit.ly/2l0c6K5
  • Also on December 21, Sens. Booker (D-NJ) and Menendez (D-NJ) introduced the Access to Birth Control Act (S. 2259), which would establish certain duties for pharmacies to ensure provisions of Food and Drug Administration-approved contraception and medication related to contraception. Press release: http://bit.ly/2kGxqEU
  • Also on December 21, Sen. Daines (R-MT), Harris (D-CA), Merkley (D-MA), Klobuchar (D-MN) and Murkowski (R-AK) introduced the Mitigating the Methamphetamine Epidemic and Promoting Tribal Health Act (Mitigating METH Act) (S. 2270), which would make improvements to the account for the state response to the opioid crisis to improve tribal health. Press release: http://bit.ly/2kJkaQf Bill text: http://bit.ly/2kGkQWo

ACA Market Stabilization & Implementation –

  • On December 18. Rep. Costello (R-PA) introduced the Premium Relief Act (H.R. 4666), which would provide for a Patient and State Stability Fund and would fund cost-sharing reduction payments. Press release: http://bit.ly/2kl6vOU Bill text: http://bit.ly/2klUXeh
  • On December 20, House Energy & Commerce Committee Ranking Member Pallone (D-NJ), House Ways & Means Committee Ranking Member Neal (D-MA), Senate Finance Committee Ranking Member Wyden (D-OR), and Senate HELP Committee Ranking Member Murray (D-WA) sent letters to the National Association of Insurance Commissioners, and to two health insurers raising concerns over reports of private companies offering products on the individual health insurance market that may not comply with federal law. Press release with links to letters: http://bit.ly/2kGEd1l
  • On December 21, Sens. Warren (D-MA), Murray (D-WA), and 16 Democratic Senators sent a letter to HHS Acting Secretary Hargan, Secretary of Labor Acosta, and Treasury Secretary Mnuchin calling on them to rescind the Administration’s interim final rules that weaken then birth control requirements under the ACA. Press release: http://bit.ly/2kYJcKo Letter: http://bit.ly/2kYJxg8
  • Also on December 21, Reps. Schrader (D-OR), Reed (R-NY), Gottheimer (D-NJ) and a bipartisan group of 26 Problem Solvers Caucus members introduced the Bipartisan Market Stabilization and Innovation Act (H.R. 4695), which would fund cost-sharing reduction payments, establish a ten-year $115 billion stability fund for states, streamline the 1332 state innovation waiver process, repeal the medical device tax, and alter the employer mandate to provide relief to small businesses. Press release: http://bit.ly/2qcemDF Section-by-section: http://bit.ly/2q6LE7g Bill text: http://bit.ly/2qbTz3b
  • On December 22, CMS released data showing that over 8.8 million people enrolled in coverage through Healthcare.gov during this year’s open enrollment period, which ended on December 15. Last year, 9.2 million people had enrolled through Healthcare.gov by the end of the open enrollment period, which ended January 31. On December 28, CMS released data for the final week of open enrollment, finding that as of December 23, 8.7 million are enrolled in coverage, a slight decrease from last week’s tally, which was due to late cancellations. Press releases: http://go.cms.gov/2qewVHC and http://go.cms.gov/2lcuDE0
  • Also on December 22, CMS released a statement that “the fifth open enrollment period for the Health Insurance Exchange was the most cost effective and smooth enrollment experience for consumers,” and that customer satisfaction was at an all-time high of 90 percent throughout. Press release: http://go.cms.gov/2qec1Im
  • On December 28, CMS released the 2019 actuarial value calculator and methodology for issuers of non-grandfathered health plans offered in the individual and small group markets, both inside and outside of the marketplaces. Methodology: http://go.cms.gov/2ldsc43

Medicare –

  • On December 19, CMS released a payment adjustment fact sheet for eligible clinicians participating in the Medicare Electronic Health Record Incentive Program in 2018. Fact sheet: http://go.cms.gov/2ktW3oq
  • On December 21, CMS released updated data on the Hospital Compare website and on data.medicare.gov, including new data on quality measures and overall hospital star ratings. Press release: http://go.cms.gov/2kUUoYl
  • Also on December 21, CMS released an interim final rule (IFR) with comment establishing policies for assessing the financial and quality performance of the Medicare Shared Savings Program Accountable Care Organizations affected by extreme and uncontrollable circumstances during performance year 2017. Comments are due by February 20. IFR: http://bit.ly/2kI4DzQ
  • Also on December 21, Senate HELP Committee Chair Alexander (R-TN) and Sen. Corker (R-TN) sent a letter to Finance Committee Chair Hatch urging the extension of the Medicare low-volume adjustment payments that are made to small and rural hospitals. Press release: http://bit.ly/2kXQYnK Letter: http://bit.ly/2kYFYGB
  • On December 27, CMS released Part I of the 2019 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part D Payment Policies, which contains key information about proposed updates to the Part C risk adjustment model and the use of encounter data. Comments are due by March 2. Press release: http://go.cms.gov/2lgKMbB Notice: http://go.cms.gov/2ldFYDI

Medicaid and CHIP

  • On December 19, HHS Office of Inspector General released a report finding that although the vast majority of drugs in the Medicaid Drug Rebate Program were classified appropriately, manufacturers may have misclassified 885 (3 percent) of drugs in 2016, resulting in the loss of billions in base and inflation-adjusted rebates. Summary with link to report: http://bit.ly/2kt21G0
  • On December 20, Medicaid and CHIP Payment and Access Commission (MACPAC) released the 2017 edition of MACStats, the Commission’s compendium of data and information on Medicaid and CHIP. Link to stats: http://bit.ly/2ktYp6K
  • On December 21, the Illinois Congressional Delegation sent a letter to CMS Administrator Verma urging her to promptly approve the state’s section 1115 Medicaid demonstration waiver, which is intended improve the delivery of behavioral healthcare in the state. Press release: http://bit.ly/2kXVSkN Letter: http://bit.ly/2kZnYMe
  • Also on December 21, CMS approved Texas’ section 1115 waiver, Texas Healthcare Transformation and Quality Improvement Program,” which extends Texas’ delivery system reform incentive payment program (DSRIP) and uncompensated care funding. Waiver: http://bit.ly/2liWW2L
  • On December 27, CMS released a letter to State Medicaid Directors regarding a new limit on federal financial participation for durable medical equipment in Medicaid, as required by the 21st Century Cures Act. Letter: http://bit.ly/2l7OILD
  • On December 28, CMS approved Mississippi’s section 1115 waiver, which provides family planning services to individuals not otherwise eligible for health coverage, for a period of ten-years. Mississippi is the first state to receive a 10-year waiver extension. Press release: http://go.cms.gov/2ldNjmE

Mental Health and Substance Abuse –

  • On December 18, HHS Office for Civil Rights released several new resources and guidance documents related to the opioid crisis, which “fulfill requirements of the 21st Century Cures Act to ensure that the healthcare sector, researchers, patients, and their families understand how the Heath Insurance Portability and Accountability Act (HIPAA) protect privacy and helps improve health and healthcare nationwide.” Press release with links: http://bit.ly/2kLxUco
  • On December 21, Centers for Disease Control and Prevention (CDC) released a report finding that there were more than 63,000 drug overdose deaths in the U.S. in 2016. Summary with link to report: http://bit.ly/2kW4zMb
  • On December 22, Sens. Warren (D-MA), Capito (R-WV), Grassley (R-IA), and Feinstein (D-CA), and Reps. Clark (D-MA) and Stivers (R-OH) sent a letter to Drug Enforcement Administration Acting Administrator Patterson urging him to update regulations and guidance related to the partial filling of Schedule II controlled substances. Press release with text of letter: http://bit.ly/2l0To5d
  • On December 27, Substance Abuse and Mental Health Services Administration (SAMHSA) announced it is accepting applications for up to $76 million through its SAMHSA Treatment Drug Courts grant program which will be used to help drug courts break the cycle of criminal behavior and incarceration related to drug and alcohol abuse. Applications are due by February 28. Press release: http://bit.ly/2l6rTbe
  • On December 28, SAMHSA announced it is accepting applications for the Garret Lee Smith Campus Suicide Prevention Grant, totaling up to $5.54 million over the next three years. Applications are due by February 20. Press release: http://bit.ly/2livzGM
  • On December 29, Office of National Drug Control Policy released its reaction to the President’s Commission on Combating Drug Addiction and the Opioid Crisis as well as a summary of major actions taken by the Administration this year to address the crisis. Press release: http://bit.ly/2qdhhw2 Reaction: http://bit.ly/2qbUEbf Summary: http://bit.ly/2qbIoYf

Veterans Health –

  • On December 21, VA Office of Inspector General released a report on the timeliness and accuracy of Choice payments processed through the fee basis claims system, finding that from 2014 to 2016, payment errors were made on approximately 224,000 of 2.0 million Choice claims (12 percent) paid. Report: http://bit.ly/2kY6nnY

Health IT

  • On December 21, Indian Health Service (IHS) released a Request for Information (RFI) to assess industry innovations and capabilities that might best address IHS’ emerging enterprise healthcare delivery and modernization needs. Comments are due by February 1. http://bit.ly/2kVxPCM
  • On December 22, Office of the National Coordinator for Health IT announced the establishment of the Health IT Advisory Committee and the Committee’s 2018 meeting schedule. Notice: http://bit.ly/2kFAzVL

 Drug and Device Regulation –

  • On December 18, Food and Drug Administration (FDA) announced a proposed new risk-based enforcement approach to drug products labeled as homeopathic. Comments are due by March 20. Press release: http://bit.ly/2kKm7uT Draft guidance: http://bit.ly/2kODevE
  • On December 19, U.S. Government Accountability Office released a report on pharmaceutical manufacturer profits, research and development spending, and merger and acquisition deals from 2006 to 2015, finding that in 2015, the average profit margin for all drug companies was 17.1 percent. Summary with link to report: http://bit.ly/2kM8Cux
  • Also on December 19, FDA released guidance that would end orphan drug designations for drugs for pediatric subpopulations of common diseases. Comments are due by January 20. Guidance: http://bit.ly/2kuCtZ5
  • Also on December 19, Sens. Klobuchar (D-MN), Collins (R-ME), and Baldwin (D-WI) sent a letter to a pharmaceutical manufacturer requesting information about the manufacturer’s large price increase for a drug that treats glaucoma and a rare genetic disease known as periodic paralysis. The same day, Sen. McCaskill (D-MO) also sent a letter requesting information on the drug’s price increase. Press releases with text of letter: http://bit.ly/2ks5bKk and http://bit.ly/2ktonHz
  • On December 21, Senate Judiciary Committee Chair Grassley (R-IA) and Sen. Klobuchar (D-MN) sent a letter to FDA Commissioner Gottlieb seeking information regarding FDA policies on imported prescription drugs from Canada. Press release: http://bit.ly/2kXaUqX Letter: http://bit.ly/2kXaUXZ

 Misc. –

  • On December 18, CDC released data finding that the percentage of persons under age 65 who were in families with difficulty paying medical bills decreased from 21.3 percent in 2011 to 16.0 percent in the first six months of 2017. Report: http://bit.ly/2kM4udS
  • Also on December 18, Senate HELP Committee Ranking Member Murray (D-WA) and House Energy & Commerce Committee Ranking Member Pallone (D-NJ) sent a letter to HHS Acting Secretary Hargan expressing concern regarding reports that the Administration has prohibited officials at CDC and other parts of HHS from using certain words or phrases in preparing the fiscal year 2019 budget. Letter: http://bit.ly/2kM4Zog
  • On December 20, Reps. Chu (D-CA), Langevin (D-RI), DeGette (D-CO), Bonamici (D-OR), Maloney (D-NY) led 83 representatives in a letter to HHS Acting Secretary Hargan and CDC Director Fitzgerald expressing concern about censorship at the CDC. Press release: http://bit.ly/2ktE4yb Letter: http://bit.ly/2ktoD9v
  • Also on December 20, Senate HELP Committee Ranking Member Murray (D-WA) and 10 democratic Senators sent a letter to HHS Secretary-Nominee Azar requesting information about his reaction to news reports of banned words or phrases, and how he would address these communications restrictions if confirmed. Press release: http://bit.ly/2kVbCol Letter: http://bit.ly/2kSgKtw
  • Also on December 20, National Institutes of Health (NIH) released a study indicating that the body’s coping mechanisms to defend against environmental stressors may hasten aging. Press release: http://bit.ly/2kYwcEt
  • On December 21, CDC released a report finding that life expectancy in the U.S. in 2016 was 78.6 years, a decrease of 0.1 year from 2015; this is the second year in a row that life expectancy has decreased. Summary with link to report: http://bit.ly/2kYe1P4
  • On December 26, HHS released a Request for Information (RFI) on promoting healthcare choice and competition across the U.S. Responses are due by January 25. RFI: http://bit.ly/2l7J3Fe