10 January 2022 This Week in Health Policy for January 10
HELP Committee Hearing on the Nomination of Robert Califf to be Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services.
Build Back Better negotiations on hold. There has been no reported movement on the Build Back Better Act (BBBA) since Senator Joe Manchin (D-WV) said January 4 that "there [have] been no conversations after I made my statement" December 19, sinking the bill for the time being, and "there [are] no negotiations going on at this time." Democratic leaders and the White House have insisted there are efforts to forge a path forward on the bill, however it's not clear when productive talks will resume. The Senate parliamentarian was supposed to continue meetings this month as part of her deliberations over whether certain provision violate the rules of budget reconciliation. This includes drug pricing measures that apply to the commercial market, including Medicare inflation rebates that are based in part on price increases in the commercial market and a monthly cap on insulin cost sharing in private insurance. Pharmacy benefit manager (PBM) transparency measures also have been mentioned in the past as at risk of violating the so-called Byrd rule. While Manchin opposes the overall bill at this point, he supports government negotiation of drug prices and says the drug-pricing piece of the package should be even stronger. FDA authorizes boosters for ages 12-15, CDC recommends. On Monday (Jan. 3), The Food and Drug Administration (FDA) authorized booster doses of Pfizer Inc.-BioNTech SE's COVID-19 vaccine for adolescents 12 to 15 years old five months after their second shot, down from six months previously set for older people, and it also cleared booster shots for some children ages 5 to 11 with compromised immune systems. On Wednesday (Jan. 5), the Centers for Disease Control and Prevention (CDC) said adolescents ages 12 to 17 "should" get a booster dose of Pfizer's COVID-19 vaccine, just hours after the agency's vaccine advisers voted 13-1 in favor of recommending the booster for teens. "This booster dose will provide optimized protection against COVID-19 and the Omicron variant," CDC Director Rochelle Walensky said Wednesday. "I encourage all parents to keep their children up to date with CDC's COVID-19 vaccine recommendations." Later in the week the FDA also shortened the time between the completion of a primary series of the Moderna COVID-19 vaccine and booster dose to at least five months for people ages 18 and older. According to administration officials, the Biden administration has no plans to change the definition of "fully vaccinated" against COVID-19 to include booster shots, but the CDC is recommending people stay "up -to-date" with any additional vaccine doses for which they are eligible. According to White House chief medical adviser Anthony Fauci, "Right now, optimal protection is with a third shot of an mRNA or a second shot of a J&J." CDC updates shortened isolation guidance. The CDC updated its shortened isolation guidance for people with COVID-19 this week, saying that they can use a rapid antigen test toward the end of their five-day isolation period if tests are available, but did not say people need a negative test to resume activities. The CDC also said people should avoid travel and continue to wear a mask around others for the 10 days after their first symptoms appeared. The CDC also updated its COVID-19 quarantine and isolation guidance for K-12 schools, bringing them in line with those for the general public by saying that infected students, teachers and staff can end isolation five days after testing positive or developing symptoms, or if their symptoms have improved, as long as they continue to wear a mask around others. The CDC has faced widespread pushback against its decision to shorten the recommended isolation and quarantine guidance and not support more testing to resume normal activities, including from groups such as the American Medical Association (AMA), who are critical of the absence of a hard recommendation on an additional COVID-19 test following isolation. In a posting on its website this week, the CDC said they opted to change the guidelines based on emerging scientific evidence concerning when and for how long a person is most likely to transmit the highly infectious Omicron variant. Their update includes instructions but not a recommendation for an isolating individual without symptoms who "has access to a test and wants to test." OTC testing coverage requirement set for next week. The Biden Administration indicated this week that the requirement for private health insurers to cover over-the-counter (OTC) COVID-19 tests would be effective next week. The requirement was a part of President Biden's winter COVID plan announced on December 2, 2021, which stated that they would release guidance by January 15 to clarify that individuals who purchase OTC COVID-19 diagnostic tests will be able to seek reimbursement from their group health plan or health insurance issuer and have insurance cover the cost during the public health emergency. Next week's guidance is expected to detail how private health plans must reimburse their beneficiaries for the cost of the OTC tests, which health insurer and employer groups have said should place limits on what plans must pay and/or limit where Americans can buy them from. Public insurance programs like Medicare are not included in the mandate, however diagnostic companies are lobbying to have them included. The White House and the U.S. Postal Services are also said to be finalizing plans to deliver 500 million coronavirus test kits to Americans via the mail. The Biden administration will reportedly launch a website for people to request the test kits ahead of the first shipments, which are expected by mid-January. Supreme court review of Biden vaccine mandates. Today (Jan. 7), the U.S. Supreme Court held a special session to review challenged to the Biden administration's authority to impose a COVID-19 vaccination mandate for health care workers and a vaccinate-or-test requirements for workers at large businesses. As part of its special session, the court is considering challenges to 1) the Occupational Safety and Health Administration's (OSHA) mandate for businesses with 100 or more employees to establish a mandatory COVID-19 vaccination policy, unless they require workers to be vaccinated or undergo regular testing and wear a face covering at work, and 2) A Centers for Medicare & Medicaid (CMS) mandate that requires healthcare facilities participating in the Medicare and Medicaid programs to establish a policy ensuring eligible workers are fully vaccinated, with exemptions allowed only based on religious beliefs or recognized medical conditions. During the special session, justices are not required to definitively decide whether the federal mandates are lawful, but they will consider whether the requirements can stay in place as lower courts continue to hear challenges to their legality. The OSHA and CMS requirements have both faced challenges in lower courts, with challengers raising questions over federal agencies' authority to issue the rules. The Supreme Court does not have a timetable for issuing its decisions, but rulings could come within days. CMS issues 2023 benefit and payment parameters. On December 28, CMS issued their 2023 proposed Notice of Benefit and Payment Parameters. According to a Fact Sheet, "the proposed rule minimizes the number of significant regulatory changes to provide states and issuers with a more stable and predictable regulatory framework that facilitates a more efficient and competitive market." The proposed rule would require every issuer participating in a federal exchange or a state marketplace using the federal platform to offer at least one standardized plan option starting in 2023 and those plans will receive differential display on healthcare.gov. The proposal would also require network adequacy reviews in all states using healthcare.gov, reinstated prohibitions against discrimination based on sexual orientation or gender, and refine the Affordable Care Act's (ACA) Essential Health Benefits as part of the administration's effort to advance health equity. CMS also proposes to continue a controversial policy under which insurers aren't required to count prescription drug copay assistance toward a patient's deductible, among other items. CMS issues 2023 MA and Part D proposed rule. On Thursday (Jan. 6), CMS issued their CY 2023 Medicare Advantage and Part D Proposed Rule. According to a Fact Sheet, the rule would "lower out of pocket Medicare Part D prescription drug costs and improve consumer protections, reduce disparities, and improve health equity in Medicare Advantage (MA) and Part D." This includes a proposal to require Part D plans to apply all price concessions they receive from network pharmacies to the point of sale, so that the beneficiary can also share in the savings. Other proposals would revise the MA and Part D regulations related to marketing and communications, the criteria used to review applications for new or expanded MA and Part D plans, quality ratings for MA and Part D plans, provider network adequacy requirements, medical loss ratio reporting, special requirements during disasters or public emergencies, and regulations for Dual Eligible Special Needs Plans (D-SNPs) aimed at improving the integration of Medicare and Medicaid and reducing health disparities. National Institutes of Health: Oral Health in America. Oral Health in America: Advances and Challenges is a culmination of two years of research and writing by over 400 contributors. As a follow up to the Surgeon General's Report on Oral Health in America, this report explores the nation's oral health over the last 20 years. Centers for Disease Control and Prevention: Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth — Eight Integrated Health Care Organizations, United States, December 15, 2020-July 22, 2021. In a retrospective cohort of >40,000 pregnant women, COVID-19 vaccination during pregnancy was not associated with preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women. Health Affairs: National Health Care Spending In 2020: Growth Driven By Federal Spending In Response To The COVID-19 Pandemic. US health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. Health Affairs: Extended Postpartum Medicaid Eligibility Is Associated With Improved Continuity Of Coverage In The Postpartum Year. Researchers found that retention of Medicaid coverage as a low-income adult was associated with 1.5 additional months of postpartum insurance enrollment and a 12-percentage-point increase in the probability of continuous insurance coverage during the first year after birth.
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