What’s Ahead: This Week

 Hearings and Markups – 

  • Tuesday, October 29
    • House Veterans Affairs Committee, “Full Committee Markup on Pending Legislation.”
  • Wednesday, October 30
    • Senate Finance Committee, Subcommittee on Health Care, “Medicaid: Compliance with Eligibility Requirements.”
    • House Energy & Commerce Committee, Subcommittee on Health, “Safeguarding Pharmaceutical Supply Chains in a Global Economy.”
    • House Veterans’ Affairs, Subcommittee on Health, “Native Veterans’ Access to Healthcare.”
  • Thursday, October 31
    • Senate HELP Committee, “Hearing on Eight Health-Related Bills, Including Legislation on Over-the-Counter Drug Safety.”

Notable Policy Events – 

  • Monday, October 28 – Wednesday, October 30
  • Wednesday, October 30
    • Bipartisan Policy Center, “Surprise Medical Billing.” Additional information: http://bit.ly/2PkPBQW
    • American Bar Association, “Head Start: What You Need to Know Now About the Newly Proposed Stark Regulations.” Additional information: http://bit.ly/346bKXl
  • Thursday, October 31
    • S. Chamber of Commerce, “The Business of Health: Transforming with Transparency.” Additional information: https://uscham.com/2MQuzHY
  • Thursday, October 31 – Friday, November 1
    • Medicaid and CHIP Payment and Access Commission (MACPAC), “October Public Meeting.” Additional information: http://bit.ly/2oi3VhP

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

Legislative Activity –

Committee Actions and Votes –

  • On October 22, House Ways & Means Committee approved by a 24-17 vote an amendment in the nature of a substitute (AINS) to the Lower Drug Costs Now Act of 2019 (H.R. 3). The bill has already advanced out of the Energy & Commerce and Education & Labor Committees; the three versions will be reconciled ahead of consideration by the full House. Press release: http://bit.ly/33S5EcI AINS: http://bit.ly/2N5cpkR
  • Also on October 22, House Ways & Means Committee also advanced several additional bills, including: an AINS to The Pathways to Health Careers Act of 2019 (H.R. 3398) by a 24-16 vote; an AINS to The Medicare Dental Act of 2019 (H.R. 4650) by a voice vote; the Medicare Vision Act of 2019 (H.R. 4665) by a voice vote; the Medicare Hearing Act of 2019 (H.R. 4618) by a voice vote; and the Protecting American Lungs Act (H.R. 4742) by a voice vote. The bills now move to the full House for consideration. Press release: http://bit.ly/2Jgm9rq AINS: http://bit.ly/2pbMO1J and http://bit.ly/2MK4YAN and http://bit.ly/2BzsI46 and http://bit.ly/341boBf
  • On October 23, House Ways & Means Committee approved an AINS to the Protecting American Lungs Act (H.R. 4742) by a 24-15 vote; an AINS to The Inhaler Coverage and Access Now Act (H.R. 4716) by a voice vote; an AINS to The Restoring Access to Medication Act of 2019 (H.R. 1922) by a voice vote; and an AINS to The Primary Care Enhancement Act of 2019 (H.R. 3708) by a voice vote. The bills now move to the full House for consideration. AINS: http://bit.ly/31FiDgp and http://bit.ly/32Ly8EZ and http://bit.ly/2JlHYFV and http://bit.ly/2WcsWYn

Introduced Legislation –

  • On October 21, Rep. Davis (D-IL) and 17 cosponsors introduced the Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768), which would reduce maternal mortality by continuing to invest in evidence-based home visiting models that are addressing the social determinants of maternal health and morbidity. Press release: http://bit.ly/2BHRxuM Bill text: http://bit.ly/2NdUM2c
  • Also on October 21, Sens. Durbin (D-IL) and Brown (D-OH) introduced the Medicare Prescription Drug Savings and Choice Act (S. 2650), which would empower the Secretary of HHS to negotiate for lower prescription drug prices through the creation of Medicare-administered prescription drug plans. Rep. Schakowsky (D-IL) introduced companion legislation in the House (H.R. 4769). Press release: http://bit.ly/35XW0Hu
  • Also on October 21, Sens. Cortez Masto (D-NV) and Roberts (R-KS) introduced the Rural ACO Improvement Act (S. 2648), which would improve the benchmarking process for the Medicare Shared Savings Program. Press release: http://bit.ly/363eVk6
  • On October 23, Reps. Ryan (D-OH), Underwood (D-IL), Gonzalez (R-OH) and Stivers (R-OH) introduced the Healthy Start Reauthorization Act of 2019 (H.R. 4801), which reauthorizes appropriations for the Health Start Program for five years. Press release: http://bit.ly/2MLRZhC
  • Also on October 23, Rep. Davis (R-IL) and 4 bipartisan cosponsors introduced the Opioid Prescription Verification Act (H.R. 4810), which would facilitate responsible, informed dispensing of controlled substance and other prescribed medications. Press release: http://bit.ly/2WcW6qi
  • Also on October 23, Rep. Baird (R-IN) and 38 bipartisan cosponsors introduced the VA DROP Act (H.R. 4817) to direct the Secretary of Veterans’ Administration to ensure that certain VA medical facilities have physical locations for the disposal of controlled substance medications. Press release: http://bit.ly/32QJI1S
  • Also on October 23, Reps. Brindisi (D-NY), Craig (D-MN), and Katko (R-NY) introduced the Seeding Rural Resilience Act (H.R. 4820), which would help farmers and ranchers address mental health concerns in rural areas. Press release: http://bit.ly/2WhcMwP
  • Also on October 23, Sens. Gardner (R-CO) and Coons (D-DE) introduced the Suspicious Order Identification Act of 2019 (S. 2686), which would improve reporting of the distribution of controlled substances. Press release: http://bit.ly/2MJ8j2F
  • Also on October 23, Reps. Trahan (D-MA) and Comer (R-KY) introduced the National Family Caregiver Support Program Cap Elimination Act of 2019 (H.R. 4853), which would eliminate the percentage cap on funding available to carry out the program to provide support services to older caregivers. Press release: http://bit.ly/31LiJDs
  • Also on October 23, Sens. Shaheen (D-NH), McSally (R-AZ), Hirono (D-HI) and Capito (R-WV) introduced the Supporting Eating Disorders Recovery Through Vital Expansion Act (S. 2673), which would provide for eating disorders treatment for members and certain former members of the uniformed services, and dependents of such members. Press release: http://bit.ly/2BCATwB Bill text: http://bit.ly/2pd67HN
  • Also on October 23, Sen. Booker (D-NJ) introduced the Study, Treat, Observe, and Prevent (STOP) Neglected Diseases of Poverty Act (S. 2675), which would provide the necessary tools to address, and ultimately eliminate neglected diseases of poverty. Press release: http://bit.ly/2qKV5tV
  • Also on October 23, Sen. Smith (D-MN) introduced the Older Americans Social Isolation and Loneliness Prevention Act (S. 2677), which would amend the Older Americans Act of 1965 to address social isolation and loneliness among seniors. Press release: http://bit.ly/2NbIeIT Bill summary: http://bit.ly/2JkjMny
  • On October 24, Rep. Trone (D-MD) and Rep. Walberg (R-MI) introduced the Protecting Older Americans from Social Isolation Act of 2019 (H.R. 4859), which would amend the Older Americas Act of 1965 to reduce social isolation among older individuals. Press release: http://bit.ly/2ojCBjp Bill text: http://bit.ly/2JmaG9K

Individual Market and ACA Implementation –

  • On October 22, CMS announced that the average plan year 2020 premium for the second lowest cost silver plan on HealthCare.gov decreased four percent from 2019. Press release: https://go.cms.gov/35XM68N
  • Also on October 22, House Energy & Commerce Committee Ranking Member Walden (R-OR), Health Subcommittee Ranking Member Burgess (R-TX), and Oversight & Investigations Subcommittee Ranking Member Guthrie (R-KY) sent a letter to CMS Administrator Verma raising concerns with the “Navigator” program established under the ACA. Press release: http://bit.ly/2ogL2fi Letter: http://bit.ly/2BGxsok
  • Also on October 22, the Republican Study Committee (RSC) released The RSC Health Care Plan: A Framework for Personalized, Affordable Care, which seeks to protect Americans with pre-existing conditions, reward responsibility, reduce barriers to continuously maintaining insurance and provide a wider array of options. Press release: http://bit.ly/2oc0WHI Report: http://bit.ly/2MIVUM8
  • On October 23, Sens. Shaheen (D-NH), Warner (D-VA) and Baldwin (D-WI) sent a letter to HHS Secretary Azar and CMS Administrator Verma on preventing third-party web brokers from steering individuals towards short-term limited-duration insurance plans. Press release: http://bit.ly/2BIjeDv Letter: http://bit.ly/2Pik1Da
  • On October 24, CMS released an updated list of approved enhanced direct enrollment (EDE) approved partners. List: https://go.cms.gov/2LJgknY
  • On October 25, CMS posted a fact sheet on the federal health insurance exchange 2020 open enrollment, which outlines key updates and enhancements to Healthcare.gov. Fact sheet: https://go.cms.gov/2PjYBFP

Medicare –

  • On October 21, CMS issued a blog outlining its vision to modernize its Medicare program integrity methods. It also issued two Requests for Information (RFIs) asking for input from the healthcare community on the Medicare program integrity challenges involved in the transition from a fee-for-service system to value-based care, and on new techniques and approaches involving advanced data analytics and artificial intelligence. Comments are due by November 20. CMS blog post: https://go.cms.gov/31DWkHV The Future of Program Integrity RFI: https://go.cms.gov/2BF5dXn  Using Advanced Technology in Program Integrity RFI: https://go.cms.gov/2odQ7Fd
  • Also on October 21, U.S. District Court for the District of Columbia ordered CMS to reverse its Medicare payment cuts for basic visits to hospital outpatient clinics, also known as site neutral payments. Order: http://bit.ly/35ZmwQS
  • On October 22, HHS Office of Inspector General (OIG) published an interactive map that displays details on nursing home complaint trends between 2001 and 2015. Summary with map: http://bit.ly/2N5WliS
  • Also on October 24, Department of Justice announced that a total of 13 people now stand convicted in a $189 million Medicare kickback scheme. Press release: http://bit.ly/2BJjySx

Medicaid –

  • On October 17, CMS issued guidance alerting impacted manufacturers to exclude authorized generic drug sales from the calculation of their average manufacturer prices (AMP) for purposes of the Medicaid drug rebate program. Program release: http://bit.ly/2pSQYeF
  • On October 24, CMS posted an information bulletin on outcome-based certification for electronic visit verification (EVV) systems, describing CMS’ plan for a streamlined, outcomes-based approach to certify EVV systems used for all Medicaid personal care services and home health services requiring an in-home visit by a provider. Bulletin: http://bit.ly/2NbQXuD

New Payment and Delivery System Models –

  • On October 24, CMS released a request for applications (RFA) for the Kidney Care Choices Model, which will build upon the existing Comprehensive End Stage Renal Disease (ESRD) Care Model structure. Applications are due by January 22. Information: http://bit.ly/2Pk6tHe RFA: http://bit.ly/343kDRj
  • Also on October 24, CMS also released an RFA for the Primary Care First Model. Applications are due by January 22. Information: http://bit.ly/2Pu5tkf RFA: http://bit.ly/2WcwHNo
  • On October 25, CMS released a fact sheet on the Independence at Home Demonstration year five results. Information: http://bit.ly/2qGjMHO Fact sheet: http://bit.ly/2Nig66G

Payment and Medical Device Prices and Regulation –

  • On October 23, HHS Office for Civil Rights (OCR) imposed a $2.15 million civil monetary penalty against a health system for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Press release: http://bit.ly/32GXFPv
  • On October 24, FDA posted a blog on helping reduce drug shortages, stating that we need manufacturers to sell quality, not just medicine. Blog post: http://bit.ly/2MNfKpV
  • Also on October 24, FDA Acting Commission Sharpless released a statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products. Statement: http://bit.ly/33ZE79t
  • On October 25, Senate Finance Committee Chair Grassley (R-IA) posted a Q&A about his ongoing insulin price investigation. Q&A: http://bit.ly/2pVZEBc

Substance Use and Mental Health –

  • On October 18, Sen. Shaheen (D-NH) sent a letter to Senate Appropriations Committee Chair Shelby (R-AL) and Vice Chair Leahy (D-VT), Subcommittee on Labor, Health and Human Services, Education and Related Agencies Chair Blunt (R-MI) and Ranking Member Murray (D-WA) urging them to provide flexibility for funding used to treat substance use disorders. Press release: http://bit.ly/33WQP8X Letter: http://bit.ly/2qD6An2
  • On October 21, Sen. Shaheen (D-NH) sent a letter to HHS Secretary Azar urging him to distribute unused funds from previous fiscal years to the Drug Free Communities (DFC) Program to prevent and reduce youth substance use. Press release: http://bit.ly/31KcLT2 Letter: http://bit.ly/31GZfQ7
  • On October 24, MACPAC released a Report to Congress examining access to medication-assisted treatment under Medicaid, finding that utilization management policies vary widely across the country and the extent to which these policies pose barriers to addiction treatment is unclear. Summary with link to report: http://bit.ly/2okFP6g
  • Also on October 24, FDA Acting Commissioner Sharpless released a statement on the agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis. Statement: http://bit.ly/2PhRnSM
  • Also on October 24, U.S. Government Accountability Office (GAO) released a report on the prevalence of recovery homes, which found that four of the five states reviewed said they conducted or were conducting investigations on recovery homes, and three states had established oversight programs. Summary with link to report: http://bit.ly/2p4bGZn
  • Also on October 24, GAO released a report on opioid use disorder services for pregnant and postpartum women and children, and cited benefits and challenges with providing OUD services through telehealth in schools. Summary with link to report: http://bit.ly/2JCapjh
  • Also on October 24, House Energy & Commerce Committee republicans posted a release on the one-year anniversary of the SUPPORT Act, stating that the fight against the opioid crisis continues and that Congress can do more. Press release: http://bit.ly/2pVQX9O
  • Also on October 24, the White House Office of Science and Technology Policy (OSTP) released a report on health research and development to stem the opioid crisis. Press release: http://bit.ly/2Ph5uYx Report: http://bit.ly/2BKSORA

Health Data and IT –

  • On October 21, HHS Office of the National Coordinator for Health IT (ONC) posted a blog on pharmacy health IT, and discussed one of the Fast Healthcare Interoperability Resources (FHIR)-based care coordination platforms that is now operating in all 50 states. Blog post: http://bit.ly/32IZuvl
  • On October 23, ONC posted a blog discussing new data that shows nearly one-third of hospitals can access Prescription Drug Monitoring Program (PDMP) data within their Electronic Health Record (EHR). Blog post: http://bit.ly/32TltQg

Veterans and Military Health –

  • On October 21, VA announced a new process for responding to Privacy Act requests from claimants received by the Veterans Benefits Administration (VBA) for access to their claims files by redacting third-party personally identifiable information from claims files. Press release: http://bit.ly/32IV4Vk
  • On October 22, VA and the Department of Defense (DOD) pledged up to $50 million in new research on traumatic brain injury with the launch of the Long-Term Impact of Military-related Brain Injury Consortium. Press release: http://bit.ly/369GrN8
  • Also on October 22, VA OIG released a report which found that the VA’s management of mobile devices generally met information security standards, however, the OIG did find vulnerabilities associated with configuration management. Summary with link to report: http://bit.ly/32HNo5Q
  • On October 24, VA OIG released a report which identified failures to implement aspects of the VA Accountability and Whistleblower Protection Act of 2017. Summary with link to report: http://bit.ly/2NaBRW4
  • On October 25, VA adopted a final rule which establishes parameters and authority for the new Center for Innovation for Care and Payment designed to develop innovative approaches to testing payment and service delivery models to reduce expenditures while preserving or enhancing the quality of care furnished by VA. Final rule: http://bit.ly/2MKSRmT

Public Health –

  • On October 18, Sens. Stabenow (D-MI), Blunt (R-MO) and 27 senators sent a letter to Senate Majority Leader McConnell (R-KY) and Minority Leader Schumer (D-NY) urging them to pass the bipartisan Community Health Investment, Modernization, and Excellence (CHIME) Act of 2019 (H.R. 2328) to fund the Community Health Center Fund for five years. Press release: http://bit.ly/2PdUqvf Letter: http://bit.ly/32JPQZH
  • On October 22, HHS awarded $16 million to help primary care practices address patients’ unhealthy alcohol use. Press release: http://bit.ly/32RrpJX
  • Also on October 22, House Committee on Oversight & Reform, Subcommittee on Economic & Consumer Policy Chair Krishnamoorthi (D-IL) sent a letter to FDA Acting Commissioner Sharpless urging the implementation of the final e-cigarette flavor ban. Press release: http://bit.ly/2MGhMYz Letter: http://bit.ly/2N5KjWx
  • On October 23, HHS awarded $319 million in scholarship and loan repayment awards for clinicians and students through the National Health Service Corps (NHSC). Press release: http://bit.ly/2qxizT4
  • On October 24, FDA issued a warning letter notifying an e-cigarette company to remove nearly 100 flavored electronic nicotine delivery system products from the market for not having required marketing authorization. Summary with letter: http://bit.ly/2pPxZ4S
  • Also on October 24, CDC announced the updated number of confirmed and probable injury cases and deaths associated with e-cigarette product use to 1,604 injury cases and 34 deaths. Press release: http://bit.ly/35YPgcm
  • On October 25, HHS announced approximately $2.27 billion in Ryan White HIV/AIDS Program grants were awarded in fiscal year 2019. Press release: http://bit.ly/2Wg2IUF

Misc. –

  • On October 21, Sen. Warren (D-MA) and Reps. Pocan (D-WI) and Doggett (D-TX) sent letters to five private equity firms to examine the role of private equity in the rise of surprise medical billing. Press release: http://bit.ly/2N6OT6Q Letters: http://bit.ly/2PkGlvS
  • On October 23, Senate HELP Committee Ranking Member Murray (D-WA) and Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Secretary Azar on President Trump’s proclamation seeking to deny visas based on health care coverage. Press release: http://bit.ly/32QwaDy Letter: http://bit.ly/2MLHefe