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May 19, 2023

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health Subcommittee met to discuss anticompetitive and consolidated markets. The House Energy & Commerce Health Subcommittee held a markup of 17 healthcare bills and moved several forward, including a broad bill to increase transparency, expand oversight of pharmacy benefit managers (PBMs) and extend expiring health provisions, with subcommittee members' full support. The Senate Finance Health Care Subcommittee held a hearing on rural health, and the Senate Health, Education, Labor & Pensions (HELP) Primary Health and Retirement Security Subcommittee held a hearing on mental health and substance use disorder care. The Senate Homeland Security & Governmental Affairs Permanent Subcommittee on Investigations also focused on healthcare and met to examine healthcare denials and delays in Medicare Advantage (MA). Increased urgency to address the debt limit standoff resulted in President Biden cutting short an overseas trip and senior-staff-level meetings ramping up as the impending early June "X date" draws nearer.

CONGRESS

House Energy & Commerce Health Subcommittee Advances Multiple Bills. The markup considered 17 bills, many of which related to competition and transparency or addressed expiring health provisions. Many of the bills were then consolidated into one bill, H.R. 3281, the Transparent PRICE Act. This package includes many transparency provisions; PBM oversight; a two-year reprieve from pending Medicaid disproportionate share hospital payment cuts; and reauthorizations necessary for continued funding for community health centers, the National Health Service Corps, teaching health centers that operate the graduate medical education program, and the special diabetes programs. The package is financed by eliminating remaining funds in the Medicaid Improvement Fund and by including a site-neutral policy impacting payment for physician-administered drugs. Notably, other site-neutral payment policies were not advanced, although Committee Chair Rodgers raised an amendment more broadly addressing site-neutral policies. She later withdrew the amendment, after noting that although the policy needs more work, she intends to bring it back up. She also acknowledged that hospitals are strongly opposed, but noted that there are other ways to support hospitals than paying the wrong amount for certain services. The committee advanced the newly combined Transparent PRICE Act with the support of all members present.

The committee also considered six other bills. Details on the outcomes of these bills are noted below:

  • H.R. 1418, the Animal Drug User Fee Amendments of 2023, as amended, was advanced with a recorded vote of 29 yays and 0 nays.
  • H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act, was advanced with a recorded vote of 28 yays and 0 nays.
  • H.R. 2666, the Medicaid VBPs for Patients (MVP) Act, as amended, was advanced with a recorded vote of 16 yays and 11 nays.
  • H.R. 3285, the Fairness for Patient Medications, was advanced with a voice vote.
  • H.R. 3284, the Providers and Payers COMPETE Act, was advanced with a recorded vote of 27 yays and 0 nays.
  • H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, was advanced with a recorded party line vote of 16 yays and 12 nays.
  • House Ways & Means Committee Holds Hearings on Price Transparency and on Anticompetitive and Consolidated Markets. On May 16, the House Ways & Means Committee met to discuss healthcare price transparency issues. The hearing focused on policies to increase price transparency and barriers that both patients and providers face because of a lack of transparency. Representatives discussed the No Surprises Act and expressed concern with how few hospitals fulfill existing price reporting mandates. Multiple representatives and witnesses also debated the benefits and drawbacks of health savings accounts.

On May 17, the House Ways & Means Health Subcommittee held a hearing on competition and consolidation in the healthcare market. The discussion focused mainly on drug pricing and the use of PBMs. Members were generally aligned around the need for increased transparency into the PBM process and better understanding of the drivers of our comparatively expensive healthcare system. Panelists provided research and support for increasing PBM transparency, updating policies to increase the use of generic drugs, and addressing patients' social needs to prevent unnecessary use of healthcare.

Senate Finance Committee Holds Hearing on Rural Health. On May 17, the Senate Finance Health Care Subcommittee met to discuss improving healthcare access in rural communities. The hearing focused on challenges and benefits faced by healthcare organizations and physicians serving rural areas, and explored potential solutions to bridge the healthcare coverage gap. Senators and witnesses noted that rural communities face significant challenges in accessing healthcare, including limited access to providers, long travel distances and the closure of rural hospitals. The discussion covered provider shortages, infrastructure decline, the significance of telehealth access, the role of value-based care models, and the necessity for policy strategies that consider the unique challenges and assets of rural America.

Senate HELP Committee Holds Hearing on Mental Health and Substance Use Disorder Care. On May 17, the Senate HELP Primary Health & Retirement Subcommittee examined the gaps in access to mental health and substance use disorder care. The hearing explored solutions aimed at improving access and increasing continuity of care through community-based solutions. The subcommittee focused especially on the fentanyl crisis, youth mental health, and issues faced by rural communities when accessing behavioral and mental health care. There was bipartisan consensus on the importance of finding solutions and addressing the current mental health crisis. The witnesses also noted integrated care teams and a continuum of care as important ways to address mental healthcare needs.

Senate Homeland Security & Governmental Affairs Committee Holds Hearing on Healthcare Denials in MA. On May 17, the Senate Homeland Security & Governmental Affairs Permanent Subcommittee on Investigations met to discuss healthcare denials and delays in MA. The hearing focused on issues related to prior authorization and plan transparency with regard to its use. Some members and witnesses noted that many MA plans use third-party companies with algorithms to accept or deny claims. The Senators in attendance agreed that greater oversight is necessary to understand how these algorithms work. On the other side of the Capitol, House Energy and Commerce Republicans wrote to Cigna about press reports that the company uses automation and artificial intelligence technologies to deny claims.

ADMINISTRATION

CMS Updates COVID-19 PHE FAQ Page. On May 12, the Centers for Medicare and Medicaid Services (CMS) issued an updated frequently asked questions document on the end of the COVID-19 public health emergency (PHE). This update includes several new questions under both the Medicare and private insurance sections of the document. CMS is continuing to update the COVID-19 resource page, which includes fact sheets on various issues related to the end of the PHE.

Our team continues to monitor the transition out of the PHE and will provide additional updates as further information is released.

Biden Administration Aims to Streamline School Medicaid Billing. On May 18, the US Department of Education released a notice of proposed rulemaking under the Individuals with Disabilities Education Act that would streamline consent provisions when billing for Medicaid services provided through a student's individualized education program. This would result in a uniform process applicable to all Medicaid-enrolled children, regardless of disability.

Additionally, the US Department of Health and Human Services, through CMS, released a comprehensive guide for Medicaid school-based services to make it easier for schools to deliver and receive payment for healthcare services to millions of eligible students. The guide outlines flexibilities states can adopt to make it easier for schools to get paid for critical school-based health and behavioral health services delivered to children enrolled in Medicaid and the Children's Health Insurance Program, which together provide health coverage to more than half of all children in the United States. A CMS press release can be found here, and a fact sheet on the guide can be found here.

FTC Aims to Tighten Regulation of Health Data Privacy Online. On May 18, the Federal Trade Commission (FTC) released a notice of proposed rulemaking seeking comment on proposed changes to the health breach notification rule. The proposed regulations aim to clarify how the rule applies to health apps and other digital health tools that do not fall under HIPAA, the federal health privacy law that governs data protection by health plans and providers. The proposed changes to the rule come as business practices and technological developments increase both the amount of health data collected from consumers and the incentive for companies to use or disclose that sensitive data for marketing and other purposes. The public will have 60 days after the notice is published in the Federal Register to submit comments on the proposed changes. The FTC press release on the notice can be found here.

COURTS

Federal Appeals Court Temporarily Maintains ACA Coverage of Preventive Medicines. On May 15, the US Court of Appeals for the Fifth Circuit issued a temporary administrative stay in the case Braidwood Management v. Becerra. This follows a March ruling by a district court judge in Texas to strike down the Affordable Care Act (ACA) requirement that health insurance plans cover US Preventive Services Task Force "A" and "B" preventive services without cost-sharing for consumers. The plaintiffs (Texas businesses) asserted that the ACA requirements for the task force to recommend covered preventive services are unconstitutional, and that the requirement to cover preexposure prophylaxis for HIV prevention violates their religious rights. The district court judge sided with the plaintiffs and stuck down the ACA requirement, putting at risk the free coverage of a range of preventive care services. This week's administrative stay means that the federal government can continue enforcing the preventive services requirement while the Fifth Circuit considers the US Department of Justice's motion for a stay pending appeal. The timing for a Fifth Circuit ruling is not yet clear, and either way the case is likely to reach the Supreme Court of the United States.

Appeals Court Weighs FDA Approval of Mifepristone. On May 17, the Fifth Circuit heard arguments in a case brought by a group of conservative medical groups that oppose mifepristone, a drug used as part of the regimen for medication abortions and miscarriage management. The case, Alliance for Hippocratic Medicine v. FDA, is the first abortion case with major national implications since the Supreme Court overturned the national right to abortion under Roe v. Wade in June 2022. Opponents of mifepristone argued that the US Food and Drug Administration (FDA) ignored safety risks with mifepristone when it approved the drug and later removed important safeguards. The federal government has countered that mifepristone has a long track record of safety, and that the FDA acted appropriately and within its congressional authority. The judges did not indicate when they would rule. The pharmaceutical industry has warned that a ruling could undermine the development and approval of new medications. In the meantime, the Supreme Court has ruled that access to mifepristone must remain available while the issue is being litigated.

QUICK HITS

  • The Centers for Disease Control and Prevention National Center for Health Statistics released new data on health insurance coverage estimates from the 2022 National Health Interview Survey, along with selected trends from 2019 to 2022. The data indicates that the national uninsured rate sank to 8.4% last year compared with 10.3% in 2019, as 5.6 million Americans gained health coverage during that time period. These data will be closely watched going forward as Medicaid unwinding from the PHE potentially reverses the trend in expanding health coverage.
  • The US Government Accountability Office (GAO) released a new report finding that the use of non-compete agreements (NCAs) is widespread throughout the US labor market and serves to protect the stated interests of businesses while restricting job mobility, lowering wages for workers and discouraging innovation. In its report, GAO estimated that 18% of workers were subject to NCAs at the time the study was conducted, and 38% of workers have been subject to an NCA at some point in their career. Over half of the 446 private sector employers responding to GAO's survey reported that at least some of their workers had NCAs. Two occupation-specific studies reviewed by the GAO examined healthcare workers, and both found that substantial proportions of certain healthcare workers are subject to NCAs. One of the studies presented results of a 2007 survey of primary care physicians in five states, and estimated that 45.1% of primary care physicians in group practices had an NCA. A 2015 study used results from a survey of 242 certified registered nurse anesthetists nationwide and found that 30.2% of respondents were subject to an NCA.

NEXT WEEK'S DIAGNOSIS

The House will be in session and the Senate is scheduled to be in recess next week, although schedules are subject to change in light of the urgency surrounding the debt ceiling. The full House Energy and Commerce Committee is expected to announce a markup of the bills reported from the Health Subcommittee this week, and additional health-related hearings in the House are possible.

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