November 22, 2021 This Week in Health Policy for November 22 This Week (November 22 - 26) The House and Senate are scheduled to be in recess next week. Last Week (November 15 - 19) Health Care Highlights House approves Build Back Better Act. The House this morning (Nov. 19) approved by a 220-213 vote, the Build Back Better Act (H.R. 5376) reconciliation bill, a more than $1.6 trillion package of social spending measures on health, climate, low-income tax credits and many other issues, paid for with tax increases on corporations and individuals. House leaders were able to draw requisite support from moderates and progressives, whose competing perspectives had precluded a vote over the past several weeks given the interplay with the infrastructure bill — which was signed by the President on Monday — and moderates insisting upon first receiving estimates from the Congressional Budget Office (CBO). The Congressional Budget Office estimated that on net the bill would increase the deficit by $367 billion from fiscal 2022 through 2031, reflecting $1.64 trillion in spending increases offset by $1.27 trillion in additional revenue. The estimate doesn't include additional revenue from tax enforcement funding, which CBO separately estimated would raise $207 billion, a decrease from White House estimates that were closer to $400 billion. A slimmed-down compromise proposal to address prescription drug prices was found to save $79 billion, which is far less than the $456 billion estimated under an earlier iteration of the plan, which had fewer exemptions for medicines subject to negotiation. Most of the drug pricing-related savings in Democrats' spending package would come from repealing a Trump-era regulation on drug rebates that was never implemented. Majority Leader Chuck Schumer (D-NY) said he wants the Senate to complete work on the bill before the December holiday recess so the House can then vote to clear it for the president. Changes are likely to be made as several senators are opposed to various parts of the bill and the parliamentarian will have to determine if its provisions meet the criteria for reconciliation. See attached WCEY Alert "An Overview of Health Care Provisions in the House-Passed Build Back Better Act (H.R. 5376)" for more detail on health care provisions. HHS rule on prescription drug and health spending reporting. On Wednesday (Nov. 17), the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury ("the Departments"), as well as the Office of Personnel Management (OPM) released an interim final rule with request for comments (IFC), entitled "Prescription Drug and Health Care Spending." The rule is the fourth in a series that the Departments are issuing to implement the No Surprises Act and transparency requirements of the Consolidated Appropriations Act (CAA), 2021. The IFC requires that plan sponsors, issuers, and FEHB carriers submit information including general plan and coverage information; information on average monthly premiums and drug spending for patients, compared to their employers and/or group health plans/health insurance issuers; and total health care spending broken down by type of cost. The new data submission requirements will apply starting with data from the 2020 calendar year, but the Departments are deferring enforcement until December 27, 2022 to give regulated entities time to come into compliance. The Departments anticipate releasing their first public report in June 2023 and biennially thereafter. (Fact Sheet, Press Release, Interim Final Rule.) Cures 2.0 legislation unveiled. A bipartisan group of lawmakers unveiled their Cures 2.0 legislation, which would make some pandemic-related telehealth flexibilities permanent, allow Medicare to cover breakthrough medical devices for four years and create a new agency to invest in medical research for difficult conditions. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health (NIH) and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country, such as Alzheimer's disease. In addition to establishing a new advanced research agency for health, the legislation would also authorize the full $6.5 billion the administration has requested to run the agency for the first three years. The new legislation builds on the 21st Century Cures Act of 2016, with both packages led by Reps. Dianne Degette (D-CO) and Fred Upton (R-MI). "The federal government has shown, time and time again, that when it's given the resources needed to accomplish the impossible, there's not much it cannot do," the pair said in a statement. The duo aimed to unveil their legislation earlier this year, but delays in its roll-out means it is unlikely to make it to President Biden's desk before the end of the year, as they initially hoped. DeGette said she expects this bill will take less time to pass compared to the 2016 law "because there is such an overwhelming support for the concept of it in both the Republican conference and the Democratic caucus." FDA approves COVID-19 boosters for all adults, CDC also recommends. This Friday (Nov. 19), the Food and Drug Administration (FDA) authorized booster doses of Moderna Inc. and Pfizer Inc.-BioNTech SE's COVID-19 vaccines for all adults, a decision that was quickly followed by a recommendation to open up shot eligibility to all adults 18 and older from a Centers for Disease Control and Prevention (CDC) advisory committee. Following CDC Director Rochelle Walensky's expected sign off, all adults who received a second shot of either Pfizer or Moderna at least six months ago will most likely be able to get a booster shot by this weekend. California, Colorado and New Mexico moved ahead of Friday's federal guidance by moving forward with expanded eligibility for COVID-19 booster shots to all adults in their states. Biden taps Califf for FDA Chief. Last Friday (Nov. 12),President Biden nominated Robert Califf to run the FDA, taking the place of acting FDA Commissioner Janet Woodcock. Califf previously served as FDA commissioner during the final year of the Obama administration and is currently a senior adviser at Alphabet's Verily and Google Health units. If confirmed, Califf's likely focus would be on improving drug competition and boosting patient access to innovative treatments. Sen. Joe Manchin (D-WV) has voiced opposition to the selection, saying "Califf's nomination and his significant ties to the pharmaceutical industry take us backwards not forward." His nomination will likely require the support of Senate Republicans to confirm. CMS announces largest Medicare Part B premium increase. Last week, the Biden administration announced the largest Medicare Part B premium increase in 15 years, noting it took into account the potential cost of the controversial drug Aduhelm, in case CMS approves its coverage, as well as usual cost growth combined with the need to make up for Congress' move to decrease premiums in 2021. The administration acknowledged the jump in premiums from $148.50 in 2021 to $170.10 in 2022 is steep, but CMS senior officials say the 5.9% adjustment in 2022 Social Security benefits will more than cover the increase for most Medicare beneficiaries. The annual deductible for Part B beneficiaries is $233, a $30 increase from this year's deductible. OSHA stops enforcing vaccine mandate. The Occupational Safety and Health Administration (OSHA) has paused enforcement of guidance requiring businesses with 100 or more employees to require employees be vaccinated or test once a week following a ruling from an appellate court. The ruling, issued by the New Orleans-based U.S. Court of Appeals for the Fifth Circuit, comes ahead of a Judicial Panel on Multidistrict Litigation lottery to determine which federal appeals court will be assigned to adjudicate the many legal challenges to the measure now pending across the country. Barring a long-lasting injunction, employers will have to comply with other parts of the rule by December 5. OSHA intends to release new guidance on individual exemptions from vaccine requirements under the agency's COVID-19 emergency temporary standard (ETS) shortly. HHS delays drug rule allowing multiple prices, rescinds break-through medical device rule. The HHS delayed by six months provisions of a Trump-era Medicaid drug contract rule that lets manufacturers give states different prices for the same products. Drugmakers currently offer the same low price to all state Medicaid plans, which is commonly referred to as a drug's "best price." Portions of the rule went into effect in March, but some provisions that would have taken effect on Jan. 1, 2022 are now delayed until July 1, 2022. The Biden administration also rescinded a Trump-era rule on Friday (Nov. 12) that would have given medical device companies faster Medicare payments for life-saving products. Hearings and Markups E&C passes nine health care bills out of committee. On Wednesday (Nov. 19), the Energy & Commerce (E&C) Committee advanced nine health care bills out of committee, including those focused on fostering medical research, supporting the health care workforce, and expanding access to preventative services. The bills include:
More information available here. Reports, Studies, and Journals GAO: Information on the Transition to Alternative Payment Models by Providers in Rural, Health Professional Shortage, or Underserved Areas. GAO's analysis of CMS data found that a smaller percentage of providers eligible to participate in Advanced APMs (eligible providers) in rural or health professional shortage areas (shortage areas) participated in them each year from 2017 through 2019 compared to providers not located in these areas. Peterson-KFF Health System Tracker: How do health expenditures vary across the population? This collection of charts is continuously updated and explores trends in health spending variation across the population through an analysis of the Medical Expenditure Panel Survey (MEPS) data. The most recent year of available data is 2019. National Bureau of Economic Research: The Impact of Provider Payments on Health Care Utilization: Evidence from Medicare and Medicaid. Provider payments are the key determinant of insurance generosity within many health insurance programs covering low-income populations. The estimates indicate that the provider payment reform led to a 6.3% increase in the targeted services provided to eligible beneficiaries, indicating an implied payment elasticity of 1.3 ———————————————
——————————————— House-passed Build Back Better Act
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