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

 Administration –

  • On June 28, Senate Veterans Affairs Committee Chair Isakson (R-GA) and Ranking Member Tester (D-MT) announced their support for Robert Wilkie to serve as VA Secretary. The committee has yet to schedule a vote on his nomination. Press release: http://bit.ly/2KwmxDQ

 Budget and Appropriations –

  • On June 25, the Senate passed, by a vote of 86-5 a minibus package of appropriations bills (H.R. 5895), including the fiscal year (FY) 2019 Military Construction-VA appropriations bill, which would provide $97.1 billion in discretionary funding for the VA. Press release: http://bit.ly/2KDiG4M Bill text: http://bit.ly/2IzzA2t Report: http://bit.ly/2MAs7lY
  • Also on June 25, the House Appropriations Committee released report language for the House’s proposed Labor-HHS-Education FY2019 appropriations bill. Report: http://bit.ly/2Myduj5
  • On June 28, Senate Appropriations Committee approved by a vote of 30-1 the FY 2019 Labor, HHS, and Education Appropriations bill (S. 3158), which would provide $90.1 billion in discretionary funding for HHS, a $2.3 billion increase from FY2018, and which includes $3.7 billion to fight the opioid crisis. The bill now moves to the full Senate for consideration. Press releases: http://bit.ly/2KdEBmS Bill text: http://bit.ly/2ICRUrq Report: http://bit.ly/2MBupkL

 Legislative Activity –

  • On June 28, Reps. Budd (R-NC) and Harris (R-MD) introduced the Improving Choices in Health Care Act (H.R. 6261), which would require short-term limited duration insurance issuers to renew or continue in force such coverage at the option of the enrollee. Press release: http://bit.ly/2Mzd5x2
  • Also on June 28, Reps. LaHood (R-IL) and Sewall (D-AL) introduced the Emergency Ambulance Transportation Sustainability and Accountability NEATSA) Act (H.R. 6269), which would restructure the payment adjustment for non-emergency ESRD ambulance transports under the Medicare program. Press release: http://bit.ly/2IHVO2m
  • Also on June 28, Rep Walters (D-CA) introduced the Creating Access to Rape kit Exams (CARE) for Survivors Act (H.R. 6273), which would ensure appropriate care by certain 340B covered entities for victims of sexual assault. Press release: http://bit.ly/2IAD1WI  Bill text: http://bit.ly/2MxI7VP
  • Also on June 28, Rep. Latta (R-OH) introduced H.R. 6283, which would allow individuals only enrolled in Medicare Part A to contribute to health savings accounts. Press release: http://bit.ly/2MBbd75 Bill text: http://bit.ly/2MzQgJo

 ACA Implementation –

  • On June 25, Sens. Baldwin (D-WI) and Casey (D-PA) led a group of 15 democratic senators in a letter to HHS Secretary Azar and CMS Administrator Verma calling for transparency and expediency regarding ACA Navigator program funding. Press release: http://bit.ly/2KfmtsN  Letter: http://bit.ly/2Kktfxt
  • On June 26, CMS released the federally-facilitated exchange and federally-facilitated small business health options program enrollment manual. Manual: https://go.cms.gov/2KajyBU
  • On June 27, Sen. Collins sent a letter to Attorney General Sessions urging the Department to reverse its decision to stop defending critical protections for people with pre-existing conditions in ongoing litigation in federal court. Press release: http://bit.ly/2KfNHPX  Letter: http://bit.ly/2Kkv11B

Medicare & Medicaid –

  • On June 26, CMS announced new and enhanced initiatives to improve Medicaid program integrity through greater transparency and accountability, strengthened data, and innovative and robust analytic tools. Press release:  https://go.cms.gov/2Kt6WVS Fact sheet: http://bit.ly/2Ka2agp
  • Also on June 26, HHS Office of Inspector General released a report finding that Medicare Part D plans generally include drugs commonly used by dually eligible beneficiaries. Summary with link to report: http://bit.ly/2MtmmXw
  • On June 27, CMS announced its approval of Oklahoma’s state plan amendment proposal to allow the state to negotiate supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers. Press release: https://go.cms.gov/2KstLc9 Letter to OK: http://bit.ly/2Ku5O48
  • Also on June 27, CMS approved Massachusetts’s waiver to amend its current section 1115 demonstration waiver to extend eligibility for certain individuals, but rejected the state’s request to amend its pharmacy program to include a closed formulary, noting that the state cannot take advantage of both a closed formulary and the Medicaid Drug Rebate Program. Letter: http://bit.ly/2Kj9yGr
  • Also on June 27, CMS released guidance for states on Medicaid coverage of drugs approved by the Food and Drug Administration under the Accelerated Approval Pathway. Guidance: http://bit.ly/2Kg4YsC
  • Also on June 27, U.S. Government Accountability Office (GAO) released a report identifying three broad areas of risk in Medicaid that also contribute to overall growth in program spending: improper payments, supplemental payments, and demonstrations. Summary with link to report: http://bit.ly/2KunpZG
  • On June 28, CMS released an information bulletin providing guidance on the requirements related to the health and welfare of Home and Community-Based Services waiver recipients. Informational Bulletin: http://bit.ly/2KsThhn
  • Also on June 28, HHS OIG announced the results of the “largest health care fraud takedown in history,” in which more than 600 defendants in 58 federal districts were charged with participating in fraud schemes involving about $2 billion in losses to Medicare and Medicaid. Press release with link to other materials: http://bit.ly/2MtBBiQ
  • On June 29, HHS OIG released a study finding that CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities, as required under law. Summary with link to report: http://bit.ly/2Mzcf3j
  • Also on June 29, U.S. District Court for the District of Columbia issued a decision blocking the state of Kentucky from implementing work requirements as a condition of eligibility for its Medicaid program, noting that HHS “never adequately considered whether Kentucky HEALTH would in fact help the state furnish medical assistance to its citizens, a central objective of Medicaid. Decision: http://bit.ly/2KHH99i CMS response: https://go.cms.gov/2KDSya3
  • Also on June 29, CMS posted 2017 financial data to the Open Payments database, which shows that in 2017, applicable manufacturers and group purchasing organizations collectively reported $8.40 billion in payments and ownership and investment interests to physicians and teaching hospitals. Data: http://bit.ly/2jTrfye

 New Payment and Delivery System Reforms –

  • On June 26, CMS released a document on quality measures correlation to clinical episodes for model years one and two for the new Bundled Payments for Care Improvement Advanced model. Document: http://bit.ly/2KqlhlQ
  • On June 29, CMS announced a Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) demonstration, which would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in certain Medicare Advantage plans that involve taking on risk. CMS is also seeking public comment on the demonstration. Comments are due by September 3. Press release: https://go.cms.gov/2My4VF6  RFI: http://bit.ly/2My4Jpm

Mental Health and Substance Use –

  • On June 26, HHS released a report finding that among approximately 30 million annual adult inpatient stays for physical or behavioral health conditions, the co-occurrence of the two increased from 38.4 percent of stays in 2010 to 45.0 percent of stays in 2014. Report: http://bit.ly/2Kv02iF
  • On June 27, HHS Office of Inspector General (OIG) released a report finding that while more than one in three Part D beneficiaries received a prescription opioid in 2017, fewer beneficiaries received high amounts of opioids in 2017 as compared to 2016. Summary with link to report: http://bit.ly/2Kh8t1X
  • Also on June 27, OIG released a toolkit providing detailed steps for using prescription drug claims data to analyze patient’s opioid levels and identify certain patients who are at risk of opioid misuse or overdose. Summary with link to toolkit: http://bit.ly/2KiND1U
  • On June 28, Food and Drug Administration (FDA) released a statement on its efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online. Statement: http://bit.ly/2IDTCbV
  • On June 29, HHS released a report on the relationships between indicators of economic opportunity and the prevalence of prescription opioids and substance use in the U.S. Report: http://bit.ly/2IDnu8F
  • Also on June 29, National Institutes of Health released a request for information (RFI) on developing and testing an integrated approach to address the opioid crisis. Comments are due by July 20. RFI: http://bit.ly/2KExyzV

Drug Prices and Regulation

  • On June 26, Senate Finance Committee Ranking Member Wyden (D-OR) released a report outlining the causes and consequences of high drug prices in Medicare. Press release: http://bit.ly/2KrBNBS Report: http://bit.ly/2KmeDNr
  • Also on June 26, Sens. Warren (D-MA) and Smith (D-MN) submitted a series of questions for the record for HHS Secretary Azar related to the Administration’s drug pricing plan. Press release: http://bit.ly/2KvUynG Questions: http://bit.ly/2KtJJCW
  • On June 28, GAO released a report on the 240B Drug Pricing Program, finding that federal oversight of compliance at contract pharmacies needs improvement. Summary with link to report: http://bit.ly/2KfDa7v
  • Also on June 28, FDA released guidance for industry on assessing user fees under the Biosimilar User Fee Amendments of 2017. Guidance: http://bit.ly/2Mxr7iA

Military & Veterans’ Health –

  • On June 26, GAO released a report on the funding used to support the current VA health record system, VistA and its correlated programs, as well as preparations for the transition to the new electronic health record system. Summary with link to report: http://bit.ly/2Ka2QSZ
  • On June 29, VA released an RFI regarding health care access standards for use in implementing the MISSION Act. Comments are due by July 30. RFI: http://bit.ly/2II3L7F

 Health IT –

  • On June 28, House Energy & Commerce Committee released nearly 300 pages of comments submitted in response to the Committee’s request for information about ways to strengthen medical device cybersecurity. Comments: http://bit.ly/2MxFvY1