May 22, 2023 This Week in Health Policy for May 22 This Week (May 22 - 26) The House is scheduled to be in session next week while the Senate is scheduled to be in recess. Meanwhile, talks are expected to continue around the debt ceiling ahead of an expected early June "X date" when the US will breach the cap. Last Week (May 15 - 19) Health Care Highlights FTC seeks comment on health data privacy regulations. On Thursday (May 18), the Federal Trade Commission (FTC) issued a notice of proposed rulemaking seeking comment on proposed changes to the health breach notification rule to clarify how the rule applies to health applications and other direct-to-consumer technologies that do not fall under HIPAA. For example, the rule proposes requiring vendors of personal health records and related entities that do not have to comply with HIPAA to notify individuals, the FTC, and in some cases, the media of breaches involving personally identifiable health data. The rule will be open for comment for 60 days. Click here for a press release. DOE issues rule to streamline school Medicaid billing. On Thursday (May 18), the Department of Education issued a notice of proposed rulemaking to streamline consent requirements and remove barriers for students with disabilities when billing Medicaid or the Children's Health Insurance Program (CHIP) for services provided through a student's individualized education program. Similarly, the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), released a comprehensive guide for school-based health care services covered by Medicaid. Click here for a press release on the initiatives and here for a fact sheet on the comprehensive guide. FTC takes action on PBMs and biometric data. On Thursday (May 18), the FTC warned that use of consumers' biometric information and related technologies powered by artificial intelligence and machine learning could violate the FTC Act if the products tout false or unsubstantiated claims about the accuracy or efficacy of such information. In addition, the FTC on Wednesday (May 17) ordered two group purchasing organizations (GPOs) that negotiate drug rebates on behalf of pharmacy benefit managers (PBMs) to provide information and records on their business practices. The FTC this week also sued to block biopharmaceutical company Amgen's $27.8 billion acquisition of Horizon Therapeutics on the basis that it would use its market power to leverage better deals with PBMs and health plans to increase prices for the acquired drugs. Appeals court hears case challenging FDA approval of Mifepristone. On Wednesday (May 17), the Fifth Circuit heard arguments in a case, Alliance for Hippocratic Medicine v. FDA, after a federal district court judge struck down FDA's approval of mifepristone, a drug used as part of the regimen for medication abortion and miscarriage management. The Supreme Court has ruled that Mifepristone can remain available while the appeals case is heard. Federal appeals court temporarily maintains ACA preventive coverage provisions. On Monday (May 15), the US Court of Appeals for the Fifth Circuit issued a temporary administrative stay in the case Braidwood Management v. Becerra, halting a March district court judge's ruling that struck down the Affordable Care Act's (ACA) requirement that health insurers cover preventive services with an "A" or "B" grade from the US Preventive Services Task Force without cost sharing. PHE waiver updates. Late Friday (May 12), CMS said it would continue to allow hospital-employed physical therapists, occupational therapists, speech language pathologists, diabetes self-management training and medical nutrition therapy providers to bill Medicare for telehealth services through the end of calendar year 2023. In addition, CMS said it would exercise enforcement discretion through the end of CY 2023 on telehealth frequency limitations, as well as rules to allow teaching physicians to supervise residents virtually. CMS also issued a new FAQ on Medicaid redetermination that discusses changes related to the Consolidated Appropriations Act, including reestablishment of premiums. Hearings, Markups, and Other Committee Action House Energy and Commerce Health Subcommittee markup of 17 bills to lower health care costs and expand access to care. On Wednesday (May 17), the Subcommittee advanced seven bills to the full committee, including H.R. 3281, the Transparent PRICE Act, which was amended to include the remaining 10 bills before the subcommittee that aim to add transparency to hospital outpatient department billing, Medicare-covered clinical diagnostic laboratory tests, pharmacy benefit manager practices, vertical consolidation, and more.
House Ways and Means Health Subcommittee hearing on "Health Care Price Transparency: A Patient's Right to Know." On Tuesday (May 16), the Committee held a hearing aimed at examining how a lack of transparency in America's health care system increases costs and prevents patients from being effective health care shoppers. Witnesses included employer, provider, government, health technology and think tank representatives. During the hearing, there was some bipartisan agreement on the need to increase transparency and ensure compliance with recent transparency regulations, however there was a fundamental disagreement on the way forward and the limitations to these efforts. Witnesses discussed various payment and care delivery models aimed at injecting transparency and reducing administrative burden and complexity to drive down prices and improve access to care. This included models such as Direct Primary Care (DPC), transparent health plans like Sidecar Health, and all-inclusive and transparently priced surgical centers. Other panelists discussed how transparency efforts including access to cost, claims and quality data can be leveraged to drive patients to lower-priced and higher-quality providers, cautioning that much work remains including improving data accuracy and utility. The Democratic witness, however, spoke about the limitations to price transparency and fundamental flaws in our system, noting that health care entities are favored by non-market-driven opportunities and advocating for an all-payer approach and other fundamental changes to the system, in addition to improved transparency on cost and outcomes.
Senate Health, Education Labor & Pensions Subcommittee on Primary Health and Retirement Security hearing on "A Crisis in Mental Health and Substance Use Disorder Care: Closing Gaps in Access by Bringing Care and Prevention to Communities." On Wednesday (May 17), the Subcommittee held a hearing which centered on the escalating mental health crisis, with a particular focus on opioid use disorder (OUD), which lawmakers and witnesses noted is being exacerbated by the increasing workforce shortages. Flexible health services, including telehealth and mobile health services, were among some of the proposed solutions. During the hearing, lawmakers heard testimony from a panel of four witnesses who each provided their unique perspective on the crisis.
House Ways and Means Committee Health Subcommittee hearing on "Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets." On Wednesday (May 17), the Subcommittee held a hearing during which both Democrats and Republicans raised concerns about the impact of anticompetitive practices and consolidated health care markets on health care spending. Lawmakers heard from a panel of four experts representing academia, the insurance industry, independent pharmacies, and patients all of whom spoke about the need for greater transparency into PBM practices, particularly around rebates, and the need to address misaligned incentives in the US health care system that drive hospital consolidation and vertical integration. One witness also stressed the importance of addressing high list prices set by pharmaceutical companies
Senate Finance Committee Subcommittee on Health Care hearing on "Improving Health Care Access in Rural Communities: Obstacles and Opportunities." On Wednesday (May 17), the Subcommittee heard from a panel of witnesses representing rural health centers (RHCs), federally qualified health centers (FQHCs), rural health systems, and academics. Both Republicans and Democrats on the Subcommittee raised concerns about the challenges facing rural health care providers, with many voicing support for innovative solutions like expanded telehealth, integrated care models, and partnerships with local medical schools to train and recruit a local workforce. Several witnesses spoke about the importance of telehealth payment parity, including audio-only visits in areas where there is no broadband connectivity, as well as solutions that bring care to patients and reduce transportation barriers to care.
Senate Homeland Security & Government Affairs Subcommittee on Investigations hearing on "Examining Health Care Denials and Delays in Medicare Advantage." On Wednesday (May 17), the Subcommittee held a hearing to learn more about instances in which Medicare Advantage plans deny treatments or other health care services that require prior authorization. During the hearing, lawmakers heard from a panel of witnesses representing the Office of Inspector General, Medicare policy analysts, lawyers, and patients. Lawmakers and witnesses discussed the algorithms used in reviewing claims with many suggested greater transparency and oversight is needed to understand how those algorithms work.
House Committee on Veterans' Affairs Joint Health and Oversight and Investigations Subcommittee hearing on "VHA Recruitment and Retention: Is Bureaucracy Holding Back a Quality Workforce?" On Wednesday (May 17), the Joint Subcommittees held a hearing on to learn more about the Veterans Health Administration (VHA) recruitment and retention efforts. During the hearing, lawmakers heard from VA representatives, a GAO witness, along with staffing and provider representatives. Lawmakers and witnesses discussed the improvements in hiring, recruitment and retention practices since the passage of the PACT Act, as well as other ways to streamline processes and ensure a robust workforce across VA facilities.
House Appropriations Agriculture, Rural Development, Food and Drug Administration Subcommittee markup of "Fiscal Year 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill." On Thursday (May 18), the Subcommittee approved by voice vote a fiscal year 2024 spending bill for the FDA that would eliminate the agency's ability to allow mail-order mifepristone and prevent HHS from banning menthol in cigarettes and from setting maximum nicotine levels in cigarettes.
Reports, Studies, and Journals Kaiser Family Foundation: Medicaid Enrollment and Unwinding Tracker. The report found at least 192,000 people have been removed from Medicaid rolls since states began redetermining eligibility in April, with the percentage of those removed varying by state. Government Accountability Office: Noncompete Agreements: Use if Widespread to Protect Business' Stated Interests, Restricts Job Mobility, and May Affect Wages. The report found that use of non-compete agreements is widespread in the US labor market, with GAO estimating 18% of workers were subject to NCAs. GAO reviewed two occupation-specific studies that found about one-third of nurse anesthetists and 45.1% of primary care physicians were subject to NCAs at the time of their studies. Centers for Disease Control and Prevention: Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2022. The latest CDC data show the national uninsured rate fell to 8.4% in 2022 compared with 10.3% in 2019. The report showed the majority of people of all ages, 61%, were enrolled in private health plans in 2022, compared with 39.5% enrolled in a public plan. ———————————————
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