Weekly Roundup: January 13, 2023

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Top Administration Science Official Stepping Down from COVID Response Team
Today, the Biden Administration announced that Dr. David Kessler, the administration’s top Covid response science official is stepping down next week. For the past two years, Dr. Kessler helmed the administration’s pandemic response, and was instrumental in efforts to develop and distribute COVID vaccines, booster campaigns, treatments, and tests. More recently, Dr. Kessler aided federal planning efforts to shift COVID vaccine and treatment options to the private health insurance market later this year. This complicated transition occurred at the anticipated wind down of the public health emergency (PHE) and transferred responsibility from the White House back to the Department of Health and Human Services. (HHS).
Improvements in Cancer Treatment and Screening Continue to Shrink Cancer Death Rate
Today, the American Cancer Society (ACS) reported that overall cancer deaths continued to drop, contributing to a 33% decline in cancer deaths since 1991 and nearly 4 million deaths averted. ACS attributes this progress to improvements in cancer screening and treatment as well as smoking reductions. However, they caution that breast, prostate, and certain other cancers with significant racial disparities in mortality are becoming more common. ACS states that excess cancer deaths for Black, Native American, and other people of color may be attributed to structural racism and socioeconomic factors that increase exposure to cancer risk factors. ACS also asserts that these factors can create barriers to accessing cancer prevention, early detection, and treatment for Black, Native American, and other people of color. Further, they also note that it may take several years for the negative consequences of COVID-19’s disruptions to cancer screening and treatment to impact mortality and advanced-stage disease rates.
Federal Trade Commission Publishes Proposed Rule to Ban Noncompete Clauses
Last week, the Federal Trade Commission (FTC) released a proposed rule to prohibit employers from imposing noncompete clauses on workers. Specifically, the FTC’s new rule would make it illegal for an employer to:
  • Enter into or attempt to enter into a noncompete with a worker;
  • Maintain a noncompete with a worker; or
  • Represent to a worker, under certain circumstances, that the worker is subject to a noncompete.
The proposed rule would apply to independent contractors and anyone who works for an employer, whether paid or unpaid. It would also require employers to rescind existing noncompetes and actively inform workers that they are no longer in effect. The proposed rule would generally not apply to other types of employment restrictions, like non-disclosure agreements. However, other types of employment restrictions could be subject to the rule if they are so broad in scope that they function as noncompetes. This rule is particularly relevant for physicians and patients. While non-competes can protect physician groups from termination by larger employers, overly restrictive non-competes may limit employment opportunities and impact patient access to care.
Administration Action
  • This Monday, the U.S. Department of Health and Human Services (HHS) awarded nearly $245 million in Bipartisan Safer Communities funding to support youth mental health and strengthen the mental health care workforce, including funding for school-based mental health programs. Mental health support has been a top priority for this Administration with President Biden signing the bipartisan legislation into law in June. HHS awarded $185.7 million from the Substance Abuse and Mental Health Services Administration (SAMHSA) funding. HHS also awarded nearly $60 million from the Health Resources and Services Administration (HRSA) funding to invest in making mental health a part of primary care training to help prepare primary care providers to support and treat the mental health needs of children and adolescents.
  • On January 11, Xavier Becerra, Secretary of the Department of Health and Human Services, renewed the COVID-19 public health emergency (PHE), which began on Jan. 27, 2020, for another 90 days, extending its affiliated waivers. The Trump and Biden administrations have renewed the COVID-19 declaration more than 10 times so far. The Biden administration has promised to give stakeholders 60 days’ notice before letting the COVID-19 PHE expire. Although some sectors have started winding down or making COVID-era waivers permanent, several others are set to expire with the PHE if Congress or states do not act. For instance, the prescription of controlled substances via telehealth and telehealth as an excepted benefit and nursing home COVID-19 waivers in 15 states are set to expire at the end of the PHE.
  • Earlier this week, the Department of Health and Human Services (HHS) announced its timeline of activities to implement the Medicare Drug Price Negotiation Program by 2026, as required in the Inflation Reduction Act of 2022. This spring, CMS plans to publish initial guidance for the drug negotiation program as well as three information collection requests for public comment related to the small biotech exception, data elements used in negotiations and required information for counteroffers. The final guidance, exceptions request and negotiation requirements will be published in the summer, prior to CMS beginning negotiations with manufacturers. On September 1 of this year CMS will select the first ten drugs to be included in the price negotiation program and begin a year-long negotiation process with their manufacturers.
Congressional Action
  • On Monday, the Republican Steering Committee chose Representative Jason Smith (R- MO) to chair the House Ways and Means Committee. Rep Smith is replacing former Rep Kevin Brady (R-TX) who retired from Congress at the end of the last term, beating out Reps. Vern Buchanan (R-FL), who was the early favorite, and Arian Smith (R-NE). In his statement released following his selection, Rep Smith outlined his policy agenda for the committee, which included utilizing the tax code to increase jobs, grow wages, and build financial and health care security for families, reasserting Congress’s oversight responsibility by investigating politically motivated leaks of taxpayer information by the Internal Revenue Service and rolling back efforts by the Biden Administration to use the agency to target the middle class, and unleashing American energy production that rebuilds America’s energy independence while lowering costs for consumers.
  • On January 10, the U.S. District Court for the District of Columbia ruled that HHS may determine how to repay hospitals enrolled in the 340B drug discount program after years of underpayments. This decision is the latest case in a legal dispute between hospitals that receive discounted drugs through the 340B program and the federal government related to Medicare payment formulas. In June 2022, the Supreme Court ruled that the Trump Administration’s cuts to payment rates for drugs hospitals acquired through the 340B drug discount program were illegal. The District Court noted in its ruling that CMS has multiple routes it can use to go about repaying 340B hospitals for the pay cuts that would avoid calculating individual claims and decided HHS should have the opportunity to produce the appropriate remedy for its underpayments.
  • CMS reports that about 15.9 million people have signed up for 2023 individual market health insurance coverage through the Marketplaces since the start of the 2023 Marketplace Open Enrollment Period (OEP) on November 1. This snapshot shows activity through January 7, 2023 for the 33 Marketplaces using HealthCare.gov and through December 31, 2022 for the 18 State-based Marketplaces (SMBs) in 17 states and the District of Columbia that are using their own enrollment platforms. The total plan selections include 3.1 million people who are new to the Marketplace and 12.8 million people who had active coverage in 2022, which represents a 13% increase from this time last year.
  • On Tuesday, CMS awarded the first 200 of 1,000 Medicare-funded physician residency slots to bolster the healthcare workforce and fund additional positions in hospitals serving underserved communities. Approximately three-quarters of the new positions will be for primary care, including obstetrics and gynecology, and mental health specialties. The FY2022 Inpatient Prospective Payment System (IPPS) final rule established policies to implement the 1,000 residency slots, which will phase in over five years, to qualifying hospitals authorized by the Consolidated Appropriations Act, 2021. CMS awarded the first round of residency positions to 100 teaching hospitals across 30 states, Washington, D.C., and Puerto Rico. The residency positions are effective July 1, 2023.
  • On December 14, 2022, CMS released their annual Medicare Advantage (MA) and Part D Proposed Rule for 2024 (fact sheet) which governs requirements for MA and Part D plans. Among its provisions, the rule includes stricter prior authorization requirements, increases beneficiary marketing protections, better incorporates health equity into Star Ratings, provider directories, and quality improvement programs, improves access to behavioral health, and expands access to the Medication Therapy Management (MTM) program.
  • CMMI may consider testing (subscription required) the use of value-based payments for prescription drugs among a list of several potential demonstrations to lower drug costs. CMMI and state Medicaid directors are also considering the possibility of tying prices to the clinical value of prescription drugs. Medicaid officials are encouraged by the potential for value- and subscription-based payments to combat the financial burden of paying for drugs granted accelerated approval from the Food and Drug Administration (FDA)—though administrative hurdles exist to implementing such models.
  • The American Academy of Pediatrics (AAP) published its first clinical practice guideline (CPG) outlining evidence-based evaluation and treatment of children and adolescents with overweight and obesity. Within the CPG, the AAP set ages at which kids and teens should be offered medical treatments such as drugs and surgery, in addition to intensive diet, exercise, and other behavioral and lifestyle interventions. In general, the group advises doctors to offer adolescents 12 and older who have obesity access to appropriate drugs and teens 13 and older with severe obesity referrals for weight-loss surgery. The guideline aims to reset the inaccurate view of obesity as a “personal problem,” and take into consideration that obesity is a complex, chronic disease.
  • Doctors for America, a non-profit association of physicians and medical students published a press release calling for the Federal Food and Drug Administration (FDA) transparently address outstanding questions about the new Alzheimer’s treatment Iecanemab. FDA granted the drug accelerated approval earlier this month, which Doctors for America and other advocates have questioned due to irregularities in the review process and potential conflicts of interest. With the drug manufacturer recently applying for traditional approval, the non-profit is calling upon FDA to convene an independent advisory council to review clinical evidence of the drug’s efficacy, safety, and if FDA has addressed the conflict-of-interest concerns
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