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July 19, 2021

This Week in Health Policy for July 19

This Week (July 19 - 23)

HELP full committee hearing on "The Path Forward: A Federal Perspective on the COVID-19 Response."

  • Details: Tuesday, July 20, 2021 at 10:00 AM
  • Witnesses: Rochelle Walensky, MD, MPH, Director, United States Centers for Disease Control and Prevention; Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Janet Woodcock, MD, Acting Commissioner, United States Food and Drug Administration; Dawn O'Connell, Assistant Secretary for Preparedness and Response, United States Department of Health and Human Services.
  • More information available here.

HELP Primary Health and Retirement Security Subcommittee hearing on "Addressing Disparities in Life Expectancy."

  • Details: Wednesday, July 21, 2021 at 10:00 AM
  • Witnesses: TBA
  • More information available here.

Last Week (July 12 - 16)

Health Care Highlights

Democrats announce $3.5t spending target for reconciliation package. This week, Democrats on the Senate Budget committee announced an agreement on a $3.5 trillion spending target for their broad "human infrastructure" plan, which they hope to pass via reconciliation later this year, teeing up talks on specific policy provisions including those on health care, climate, and caregiving. While Democrats have not released many specifics, Senate Majority Leader Chuck Schumer (D-NY) said the bill would extend Medicare coverage to dental, vision, and hearing, which is estimated to cost $358 billion over the next decade. The bill is also reported to include a variety of other health care priorities including expansion of home and community-based services, extension of enhanced Affordable Care Act (ACA) premium subsidies included in the American Rescue Plan, coverage for low-income people in states that have opted out of Medicaid expansion, and funding for caregiving.

The package is expected to be paid for, in part, by prescription drug pricing policies, including repeal of a Trump-era rule aimed requiring pharmacy benefit manager rebates to be passed directly to consumers at the point-of-sale, which was initially projected to cost $177 billion. The fate of other Democratic priorities such as Medicare drug price negotiation and lowering the Medicare eligibility age to 60 are unclear, in light of uncertain support across the caucus and demands from Senators Mark Warner (D-VA) and Joe Manchin (D-WV) that the package be fully paid for. Democrats cannot afford to lose a single Democratic Senator's support if they are to advance the package with 50 votes — reaching the required 51 votes to pass a reconciliation bill once Vice President Kamala Harris steps in as the tie breaker. Senator Schumer plans to move forward on passage of the budget resolution by next Wednesday, July 21, setting the stage for development of the policy details of a reconciliation bill by committees of jurisdiction.

House releases HHS spending bill. The House released this week its fiscal year (FY) 2022 spending bill for the Departments of Labor, Health and Human Services, and Education, and related agencies (L-HHS), which was approved by the full House Appropriations Committee on Thursday (July 15). Under the measure, the Department of Health and Human Services (HHS) would get $119.8 billion in discretionary funding in fiscal 2022, a $22.9 billion increase from fiscal 2021. Much of that boost would head to the National Institutes of Health, which would get $49 billion in fiscal 2022, a $6.5 billion bump of which $3 billion would be allocated President Joe Biden's proposed biomedical research body, the Advanced Research Projects Agency for Health (ARPA-H). The bill also includes $10.6 billion for the Centers for Disease Control and Prevention, a $2.7 billion increase.

Most Republicans on the committee opposed the legislation, saying it was too expensive and would eliminate the long-standing "Hyde Amendment," which bans federal funds for abortions in most circumstances. The bill would also omit the "Weldon Amendment," which in previous bills has prohibited discrimination against health-care providers that refuse to offer or refer patients for abortion services; ends a long-standing prohibition on federal funds for syringes for safe drug use programs; and includes a new provision that would limit funds to foster care programs that don't comply with nondiscrimination regulations, including gender identity and sexual orientation. The full House will vote on the Labor-HHS spending bill the week of July 26 as part of a "minibus" appropriations bill that includes funding for other federal agencies, House Majority Leader Steny Hoyer (D-MD) told members on Thursday.

CMS Issues Proposed CY2022 Medicare Physician Fee Schedule. On Tuesday (July13), the Centers for Medicare & Medicaid Services (CMS) issued their Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) Proposed Rule. The proposed rule sets the CY 2022 PFS conversion factor at $33.58, a decrease of $1.31 from the CY 2021 PFS conversion factor of $34.89. The change is driven by a required budget neutrality adjustment and expiration of the 3.75 percent payment increase provided for CY 2021 by the Consolidated Appropriations Act of 2021 (CAA). CMS also notes that it is engaged in an ongoing review of payment for Evaluation and Management (E/M) visit code sets and proposed a number of refinements to current policies for split (or shared) E/M visits, critical care services, and services furnished by teaching physicians involving residents.

Among the key changes, CMS plans to allow providers to continue providing certain telehealth services added during the public health emergency (PHE) until the end of 2023, aiming to gather more information about how the flexibilities have affected patients and the program before determining if they should be made permanent. The rule also makes changes to the Quality Payment Program (QPP), including a proposal to sunset the traditional Merit-based Incentive Payment System (MIPS) by 2027 and shift towards implementation of MIPS Value Pathways (MVPs), aimed at connecting activities and measures relevant to a specialty, medical condition, or episode of care. The rule also proposes changes to the Medicare Diabetes Prevention Program (MDPP), aimed at boosting supplier enrollment and increasing beneficiary participation, among other priorities.

Biden's competition order tackles health care consolidation. Last Friday (July 9), President Biden signed an Executive Order on Promoting Competition in the American Economy, tackling among other items, consolidation and anti-competitive behavior in the prescription drug, hospital, health insurance, and hearing aid markets. The order includes 72 initiatives across a dozen federal agencies, and represents what the administration is calling a "whole-of-government competition policy." Among other items, President Biden said that the order "commits the government to full and aggressive enforcement of antitrust laws." The order says Americans are paying too much for prescription drugs and healthcare services, stating that "hospital consolidation has left many areas … with inadequate or more expensive healthcare options" and that "patent and other laws have been misused to inhibit or delay … competition from generic drugs and biosimilars." Among other items, the order directs federal agencies to issue a comprehensive plan within 45 days to counter high drug prices; stop pharmaceutical manufacturers from paying generic counterparts to delay entry into the market; revise merger guidelines and supporting price transparency efforts; standardize plan options in the National Health Insurance Marketplace; and allow hearing aids to be sold over the counter. The administration released a fact sheet in advance of the order outlining a detailed summary of key actions.

Medicare opens NCD on Alzheimer's treatment. CMS announced this week it is opening a National Coverage Determination (NCD) analysis, a process they still "will allow the agency to carefully review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease." The announcement comes following the Food and Drug Administration's (FDA) controversial approval of Biogen Inc.'s new Alzheimer's treatment, Aduhelm, estimated to cost $56,000 per patient annually and spurring a debate about the drug's effectiveness and FDA's approval standards. Following the NCD analysis, CMS will post a proposed national coverage determination, which will be open to a second 30-day public comment period, followed by a final decision for a national policy which could range from Medicare coverage of this product type, coverage with evidence development, non- coverage, or deference to Medicare Administrative Contractors. A proposed decision is expected to be posted within 6 months and a final within 9 months. Also this week, The Cleveland Clinic and Mount Sinai Health System in New York said they wouldn't administer Aduhelm to patients amid the debate around its effectiveness.

Biden nominates drug czar. President Joe Biden nominated Rahul Gupta, a primary care physician who currently serves as the chief medical and health officer at the March of Dimes, for director of the Office of National Drug Control Policy. He previously was the health commissioner of West Virginia under two governors. According to a White House Statement, "President Biden's nomination of Dr. Rahul Gupta to be the first physician ever to lead the White House Office of National Drug Control Policy is another historic step in the Administration's efforts to turn the tide of our nation's addiction and overdose epidemic … Dr. Gupta brings firsthand experience as a medical doctor and public health official using evidence-based strategies to address the overdose epidemic in West Virginia. We hope he will be confirmed by the Senate soon." The role, often referred to as the "drug czar," has budget authority over dozens of government agencies that address drug addiction and enforcement. Gupta's nomination will require Senate approval.

Hearings and Mark-ups

Energy and Commerce Health Subcommittee Markup: On Thursday (July 15), the House Energy and Commerce Health Subcommittee Markup advanced nineteen bipartisan health care bills, which now head to the full committee for consideration. Bills advanced included those providing resources for substance use recovery, better education on vaccines, and extending Medicaid funding for people in Puerto Rico and other U.S. territories before the financial support expires this fall. H.R. 4406 would mark the longest Medicaid funding extension for U.S. territories since Congress passed the ACA, extending funding for five years for Puerto Rico and eight years for American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. Substance use bills include those aimed at regulating the distribution of controlled substances (H.R. 2355), declaring methamphetamine an emerging threat (H.R. 2051), and broadening a grant program that bolsters the state response to the opioid crisis (H.R. 2379). Among the other approved bills are those aimed at improving vaccine information and resources among children (H.R. 2347), seniors (H.R. 1978), and other vulnerable groups.

Senate Judiciary Hearing on Anticompetitive Conduct in Prescription Drug Markets. On Tuesday (July 13), the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights held a hearing entitled, "A Prescription for Change: Cracking Down on Anticompetitive Conduct in Prescription Drug Markets." Chair of the subcommittee, Senator Amy Klobuchar (D-MN), said among other things that lawmakers will have a hard time objecting to her legislation (S. 1428) aimed at lowering prescription drug prices by limiting deals between name brand and generic manufacturers, known as "pay-for-delay" deals. The U.S. intellectual property system was a key focus during the hearing, with witnesses divided over reforming it. Alden Abbott, senior research fellow at the Mercatus Center at George Mason University, said Congress should be careful in tweaking the patent framework and should only legislation "in cases of clear abuses." Geoffrey Levitt, appearing on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), said that the current patent system enables drug companies "to develop new medicines that save lives" and "alleviate the burden of disease." Rachel Moodie, head of legal and intellectual property and biosimilars at the pharmaceutical company Fresenius Kabi, however, said the pharmaceutical industry "is not currently operating as a true free market system" due to patent practices that cut down on competition and increase costs. She noted that "the sheer volume of patents strategically thicketed" around a drug is particularly problematic.

Reports, Studies, and Journals

CDC: Provisional Drug Overdose Death Counts. U.S. drug overdose deaths surged to a record high of 93,331 in 2020, a nearly 30 percent increase from the year before and the largest single-year uptick ever recorded, according to preliminary data from the Centers for Disease Control and Prevention. Increases were most notable in the South and West.

CDC: Acceptability of Adolescent COVID-19 Vaccination Among Adolescents and Parents of Adolescents - United States, April 15-23, 2021. In April 2021, 52% of unvaccinated adolescents aged 13-17 years and 56% of parents of unvaccinated adolescents aged 12-17 years reported intent for adolescent COVID-19 vaccination. The most common factors that would increase vaccination intent were receiving more information about adolescent COVID-19 vaccine safety and efficacy

JAMA: Use of Medications for Treatment of Opioid Use Disorder Among US Medicaid Enrollees in 11 States, 2014—2018. There is limited information about trends in the treatment of opioid use disorder (OUD) among Medicaid enrollees. From 2014 through 2018, use of medications for opioid use disorder increased among Medicaid enrollees in 11 U.S. states, but the pattern in the other states is not known.

Urban Institute: Filling the Medicaid Gap with a Public Option. Researchers show that a public option that typically pays Medicare rates would considerably reduce the cost of increasing coverage in the Medicaid gap. Using a public option instead of marketplace benchmark premiums would reduce federal premium tax credits for people in the Medicaid gap by about 28 percent.


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