June 26, 2023 This Week in Health Policy for June 26 This Week (June 26 - 30) This week, Congress will begin a two-week recess for the Fourth of July. The Senate is scheduled to return July 10 and the House is scheduled to return July 11. The next edition of This Week in Health Policy will be July 14. Last Week (June 19 - 23) Health Care Highlights Biden signs EO to increase access to contraception. On Friday (June 23), the one-year anniversary of the Supreme Court's ruling to strike down Roe. V Wade, President Biden signed an executive order (EO) to strengthen access to contraception. Among other things, the EO directs federal departments and agencies to consider ways to increase access to over-the-counter contraception, including emergency contraception, improve access and affordability of contraception for women with private health insurance, improve contraception coverage through Medicare, and support family planning services and supplies through Medicaid. Click here for a fact sheet on the EO. Click here for a fact sheet on broader federal efforts to defend reproductive rights. CMS unveils plans for national Alzheimer's drug registry. On Thursday (June 22), CMS announced plans to create a nationwide patient registry portal for providers to submit information on patients taking FDA-approved Alzheimer's drugs. The announcement comes shortly after CMS said that Medicare coverage for Alzheimer's drugs that receive full FDA approval would be contingent on participation in a patient registry. Click here for the CMS fact sheet. CMS proposes new pathway for reimbursing breakthrough devices. On Thursday (June 22), CMS issued a proposed procedural notice detailing a new voluntary pathway, called the Transitional Coverage for Emerging Technologies (TCET) pathway. The TCET pathway would be available to medical products that the FDA considers "breakthrough devices." Device makers that participate in the program would be able to have CMS officials review early data and provide feedback on study designs to better address payer concerns in an effort to reduce the timeline for medical device coverage to no more than 6 months after FDA approval. Click here for a fact sheet. Click here for the proposal. Click here for a blog post on the new pathway. House passes employer health plan package. On Wednesday (June 21), the House passed the CHOICE Arrangement Act (H.R. 3799) in a 220-209 party-line vote. The bill, which is not expected to be taken up by the Senate, codifies a 2018 rule that permits more employers and self-insured individuals to join an Association Health Plan (AHP), which was blocked in court; codifies a 2019 rule that allows employers to use individual coverage health reimbursement arrangements (ICHRAs) to help employees pay for ACA exchange coverage; and ensures smaller employers with self-funded health plans have access to stop-loss insurance coverage to protect against the risk of high dollar claims. Schumer unveils AI framework for Congress. On Wednesday (June 21), Senate Majority Leader Chuck Schumer (D-NY) unveiled a framework that Congress can use when considering how it should approach artificial intelligence. The SAFE Innovation Framework highlights five policy objectives for AI centered around security, accountability, societal benefits, data, and innovation. Click here for a press release. Click here for the framework. SAMHSA warns of link between long COVID and mental health. On Wednesday (June 21), HHS' Substance Abuse and Mental Health Services Administration (SAMHSA) issued an advisory warning that people with long COVID may be at a greater risk of depression, anxiety, brain fog, psychosis, obsessive-compulsive disorder and post-traumatic stress disorder. Click here for the advisory. PhRMA files lawsuit against CMS' drug price negotiation rules. On Wednesday (June 21), the Pharmaceutical Research and Manufacturers of America (PhRMA), along with the National Infusion Center Association (NICA) and Global Colon Cancer Association (GCCA), filed a lawsuit challenging CMS' drug price negotiation process. The ruling comes days after Merck and Bristol Myers Squibb separately filed their own lawsuits challenging the Inflation Reduction Act negotiation process. Hearings, Markups, and Other Committee Action The Senate Health, Education, Labor & Pensions Committee held a hearing on labor-related bills. On Wednesday (June 21), the Committee advanced along party lines three labor bills. During the hearing, ranking member Bill Cassidy (R-LA) criticized Chair Bernie Sanders (I-VT) for prioritizing the labor legislation over negotiations on key health program reauthorizations, including the Pandemic and All-Hazards Preparedness Act (PAHPA), which expire on Oct. 1.
The House Energy and Commerce Health Subcommittee held a hearing: "Responding to America's Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act" On Wednesday (June 21), the Subcommittee held a hearing during which they considered bipartisan policies to prevent deaths from people diagnosed with substance use disorders, as well as reauthorizing portions of the SUPPORT Act. During the hearing, some Democratic lawmakers raised concerns about separate proposals to allow telehealth as an excepted benefit for private employers.
The Committee on Education and the Workforce Subcommittee on Health, Employment, Labor and Pensions held a hearing: "Competition and Transparency: The Pathway Forward for a Stronger Health Care Market." On Wednesday (June 21), the Subcommittee held a hearing that largely focused on hospital consolidation and vertically integrated PBMs. During the hearing, lawmakers and witnesses spoke favorably about policies such as site-neutral payment reform, which they argued can prevent patients and payers from paying hospital-level prices for non-hospital care, as well as "honest billing" practices, to increase transparency into hospital billing and the site of service. Lawmakers and witnesses also criticized anti-competitive PBM practices and discussed ways to increase transparency into their business, including giving plan sponsors access to more granular data.
The House Energy and Commerce Oversight and Investigations Subcommittee held a hearing: "MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors." On Thursday (June 22), the Subcommittee held a hearing on MACRA. During the hearing, lawmakers expressed bipartisan interest in addressing the program's problems and improving physician reimbursement, but there was little consensus on policies to move forward.
The Senate Appropriations Committee held a markup of FY 2024 appropriations bills. On Thursday (June 22), the Committee advanced the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024." The bill would give FDA a $20 million net increase in FY 2024, and does not include partisan provisions included in a House version of the bill, such as language to walk back FDA's updated safety program for mifepristone.
Reports, Studies, and Journals JAMA Network Open: Trends in Maternal Mortality and Severe Maternal Morbidity During Delivery-Related Hospitalizations in the United States, 2008 to 2021. A study from HHS researchers found in-hospital delivery-related maternal mortality rates declined by 57% between 2008 and 2021. The study found advanced maternal age, racial or ethnic minority group status, cesarean delivery and comorbidities were associated with higher odds of mortality and severe maternal morbidity. US Census: Population and Housing Unit Estimates Tables. The latest data show that the nation's median age increased by 0.2 years to 38.9 years between 2021 and 2022. Seventeen states had a median age above 40.0 in 2022, led by Maine with the highest at 44.8, while Utah has the lowest median age to 31.9. ———————————————
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