The following LPG Weekly Health Care Watch provides a summary update of legislative and regulatory health care activities from May 17 – 25. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
On May 22, leaders of the House Oversight & Reform Committee introduced the Inspector General Independence Act, which aims to protect Inspectors General across the executive branch from being removed for political purposes.
The Senate is in recess and will return the week of June 1. The House will meet for legislative business on May 27.
NON-CORONAVIRUS REGULATORY UPDATE
On May 22, the Centers for Medicare & Medicaid Services (CMS) released the “Contract Year 2021 Policy and Technical Changes to the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program” final rule. CMS indicated that due to Agency resources tied up with the COVID-19 response, CMS only addressed policies from the proposed rule that need to be finalized before the June 1 deadline for MA and Part D plans bids. CMS plans to address other proposals from the proposed rule, including the drug-pricing proposals and quality measures, in a separate final rule expected to be published “later in 2020.” CMS estimates the provisions in the rule will reduce federal spending by $3.85 billion over the next 10 years due to a change in the Part C and D Star Rating methodology. LPG’s summary is available here.
CORONAVIRUS UPDATE
White House Update
On May 18, President Donald Trump sent a letter to the World Health Organization (WHO) criticizing the organization’s initial response to the pandemic. Unless "major substantive improvements" are made within 30 days, President Trump claims the U.S. will permanently withhold funding to WHO, or even withdraw its membership entirely. Earlier that day, U.S. Health & Human Services (HHS) Secretary Alex Azar told the World Health Assembly that WHO “failed at its core mission” and, going forward, it “must become far more transparent and far more accountable.” On May 19, WHO member states unanimously approved a resolution to launch an independent investigation into the organization’s initial handling of the pandemic; the resolution was introduced by the European Union’s 27-member bloc.
On May 18, President Trump announced he has been taking hydroxychloroquine, paired with a daily zinc supplement and an initial dose of the antibiotic azithromycin, for several weeks to prevent contracting COVID-19. Last month, the Food & Drug Administration (FDA) warned that using hydroxychloroquine outside the hospital setting or a clinical trial may cause heart problems. White House Physician Sean Conley was aware of the President’s use of the drug; however, he was not the one to initially recommend that the President take it. On May 25, the President said he is no longer taking the hydroxychloroquine.
On May 19, Assistant Secretary for Mental Health & Substance Use Elinore McCance-Katz warned in a cabinet meeting that lockdown orders are triggering economic trauma and, in turn, an increase in mental health and substance use disorders. She maintained that “[v]irus containment cannot be [the Administration’s] only goal, no matter the cost to Americans.”
On May 20, it was reported that Administration is considering extending the deployment of more than 40,000 National Guard members through July to continue their work fighting the pandemic. Their deployment is scheduled to expire on June 24.
On May 22, the President declared “houses of worship, churches, synagogues, and mosques” to be “essential” services, meaning they should remain opening during the pandemic.
On May 24, the President tweeted that “schools in our country should be opened ASAP” referencing “very good information” available to support re-openning.
Legislative Update
On May 18, Sens. Bill Cassidy (R-LA) and Bob Menendez (D-NJ) introduced the State and Municipal Assistance for Recovery and Transition (SMART) Act, which would create a $500 billion emergency fund to help states and local governments cover rising costs and declining revenue. Under the bill, each state would receive at least $2 billion; the remaining funds would be allocated based on demand.
On May 19, the Energy & Commerce Communications & Technology Subcommittee held a teleconference forum with Federal Communications Commission (FCC) Chairman Ajit Pai to discuss broadband issues related to the pandemic, including its relationship to telehealth. Congress authorized $200 million in the Coronavirus Aid, Relief & Economic Security (CARES) Act to help health care providers perform telehealth services. As of May 19, FCC had approved roughly $33 million to 82 health care providers across 30 states, according to Chairman Pai. Before receiving the funds, recipients must submit certain documents to the FCC to avoid fraud, waste, and abuse. One provider has submitted the necessary documents to actually collect the cash.
On May 21, the Senate Aging Committee held a hearing entitled Caring for Seniors Amid the COVID-19 Crisis. Chair Susan Collins (R-ME) raised concerns with the spread in nursing homes, noting that nursing home residents represent a third of all COVID-19 deaths nationwide. Witnesses included: Mark J. Mulligan, MD, Director, Division of Infectious Diseases and Immunology, Langone Vaccine Center and Director, Thomas Murphy Sr. Professor, Department of Medicine, New York University Grossman School of Medicine; Tamara Konetzka, Professor of Health Services Research, Department Of Public Health Sciences, University of Chicago; and Steven Landers, MD, President and CEO, Visiting Nurse Association Health Group.
On May 21, the Oversight & Reform Select Coronavirus Crisis Subcommittee held a virtual briefing entitled Heroes of the Coronavirus: Protecting Frontline and Essential Workers During the Pandemic. Subcommittee Chair Jim Clyburn (D-SC) stressed the importance of securing personal protective equipment (PPE) for frontline workers, as well as paid leave and enhanced federal payment. Ranking Member Steve Scalise (R-LA) accused China of “hoarding” PPE and vital medical supplies months ago as it attempted to cover up the severity of the virus. He requested that the Subcommittee investigate this issue as soon as possible. Witnesses included: Megan Ranney, MD, Emergency Physician and Associate Professor of Emergency Medicine, Alpert Medical School, Brown University, Co-founder, GetUsPPE; Talisa Hardin, Registered Nurse, University of Chicago Medical Center; Diana Wilson, Emergency Medical Technician, New York City Fire Department; Steve Pettus, Managing Partner, Dickie Brennan & Co.; Eric Colts, Bus Driver, Detroit Department of Transportation; Marcos Aranda, Custodian; Shanti Akers, MD, Pulmonary Critical Care Physician, Phoebe Putney Health System; and Zenobia Shepherd, Mother of Leilani Jordan, who worked at a supermarket and passed away due to coronavirus.
On May 21, Energy & Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) sent a letter to Coronavirus Task Force Coordinator Deborah Birx urging the Administration to develop a national vaccine strategy that outlines plans for development, manufacturing, distribution, provider training, public education, and “broad vaccine access.”
On May 21, Rep. Buddy Carter (R-GA) introduced a proposal to support “America’s pharmaceutical independence.” The MADE in American Act would create a tax credit for domestic manufacturers and establish new measures at the FDA to mitigate drug shortages. Sen. Tim Scott (R-SC) introduced a companion bill in the Senate. Notably, the Pharmaceutical Research & Manufacturers of American (PhRMA) posted a blog on May 21 maintaining that “geographic diversity is key to the stability of a manufacturing supply chain for a medicine.”
On May 22, Sens. Jeanne Shaheen (D-NH) and Tina Smith (D-MN) released “common sense” policies to expand health coverage during the pandemic, including COBRA premium support for the newly uninsured, incentives to promote Medicaid expansion in non-expansion states, and a federal special enrollment period. In addition, their proposal would require all COVID-19 treatment costs to be covered – including for the uninsured. An outline is available here. Thirty-three Senate Democrats have endorsed the bill.
The week of May 25, the House will vote on H.R. 6886, bipartisan legislation to grant businesses more time to spend Paycheck Protection Program (PPP) aid, as well as eliminate a provision requiring recipients to spend 75% of PPP aid on payroll in order to receive full forgiveness.
Majority Leader Mitch McConnell (R-KY) indicated that the Senate will consider a bipartisan bill to approve more funding to the PPP when it returns from the Memorial Day recess. Furthermore, the Senate has not expressed interest in drafting a counter to the House Democrats’ Health & Economic Recovery Omnibus Emergency Solutions (HEROES) deal, though Leader McConnell has acknowledged that more relief may be necessary. Leader McConnell remains committed to including liability protections for businesses (which Democrats oppose) and excluding an extension of enhanced unemployment benefits (which Democrats support).
Regulatory Update
On May 17, the Centers for Disease Control & Prevention (CDC) posted updated guidelines for reopening various sectors of the economy, including health care providers, schools, and businesses. The 60-page document is the agency’s most detailed framework for reopening to date.
On May 18, CMS outlined a new set of criteria for state officials to consider when reopening nursing homes, including: status of COVID-19 in the local community and in nursing homes; adequate staffing, adequate testing, access to PPE, and local hospital capacity. A press release is available here.
On May 18, National Institutes of Health (NIH) Director Francis Collins and Johnson & Johnson Chief Scientific Officer Paul Stoffels published a viewpoint article in JAMA claiming that the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative has selected six therapies to enter into clinical trials by the end of the month. ACTIV is a public-private partnership, led by the NIH, that was established in April to develop a collaborative framework for prioritizing vaccine and therapeutic candidates.
On May 18, HHS detailed how $11 billion in new funding to support testing will be distributed. A recipient list is available here.
On May 19, HHS announced a $354 million, four-year contract between the Biomedical Advanced Research & Development Authority (BARDA) and Phlow Corp. to manufacture generic drugs and pharmaceutical ingredients for COVID-19 treatments that are currently produced internationally. The contract can be extended for a total of $812 million over 10 years.
On May 20, FDA’s Center for Biologics Evaluation & Research (CBER) Director Peter Marks and Center for Drug Evaluation & Research (CDER) Director Janet Woodcock recused themselves from reviewing potential COVID-19 treatments and vaccines because of their participation in “Operation Warp Speed,” the Administration’s initiative to expedite the development and production of vaccines and therapeutics. However, on May 22, FDA Commissioner Stephen Hahn announced that Woodcock will serve on Operation Warp Speed fulltime and temporarily be removed from CDER, while Marks will leave the new initiative and focus solely on CBER.
On May 20, Commissioner Hahn announced he has completed his 14-day quarantine after possible exposure from a White House staff member.
On May 21, BARDA granted AstraZeneca up to $1.2 billion to support the development, production, and delivery of its vaccine candidate (AZD1222), which is being developed in collaboration with researchers at the University of Oxford. As part of Operation Warp Speed, BARDA is working with the drug company to secure 300 million doses AZD1222; the first doses could be delivered as early as October 2020.
On May 21, FDA posted a list of 27 antibody tests that should be removed from the market to be in accordance with a policy the agency updated in April to prevent the sales of inaccurate tests.
On May 22, HHS announced it has begun distributing nearly $4.9 billion from the Provider Relief Fund to skilled nursing facilities (SNFs) “suffering from significant expenses or lost revenue attributable to COVID-19.” Each SNF will receive a flat $50,000 payment, plus $2,500 per bed. All certified SNFs with at least six certified beds are eligible to receive funds.
On May 22, HHS allocated $500 million of the Provider Relief Fund to the Indian Health Service (IHS) and tribal hospitals, clinics, and urban health centers. IHS and tribal hospitals will receive a $2.81 million fixed payment plus 3% of their total operating expenses; IHS and tribal clinics and programs will receive $187,000 plus 5% of the estimated service population multiplied by the average cost per user; and IHS urban programs will receive $181,000 plus 6% of the estimated service population multiplied by the average cost per user.
On May 22, it was reported that testing data reported by the CDC may include both diagnostic and antibody tests. Critics argue that combining test results that diagnose current coronavirus infections with test results that measure whether someone has ever had the virus distort several important metrics and provide an inaccurate picture of the state of the pandemic. The CDC indicated that the issues was caused by some states blending the data before reporting it to the agency. CDC said it will take steps to fix the issue.
Other
On May 18, Chinese President Xi Jinping told the World Health Assembly that “COVID-19 vaccine development and deployment in China, when available, will be made a global public good.” He claimed “this will be China’s contribution to ensuring vaccine accessibility and affordability in developing countries.” On May 19, President Jinping told the World Health Assembly that China will donate $2 billion over the next two years to support COVID-19 response efforts, particularly in developing countries.
On May 19, CMS released updated guidance that includes two CPT codes laboratories can use to bill Medicare for certain serology tests. There is no cost-sharing for traditional Medicare beneficiaries.
On May 18, Moderna announced positive interim Phase I data for its vaccine candidate (mRNA-1273), which has received at least $430 million from BARDA. All eight patients in a safety trial developed antibodies after two doses of the vaccine; this validates existing evidence that suggests the vaccine can advance to Phase II trials, which will also be funded by BARDA.
On May 19, the American Hospital Association (AHA), Association of periOperative Registered Nurses, and Advanced Medical Technology Association (AdvaMed) released a framework for resuming elective surgeries.
On May 19, the Kaiser Family Foundation (KFF) released a report examining how health care utilization and spending have changed so far during the pandemic. As of late April, KFF claimed that the total number of filled prescriptions dropped compared to January and February but may rebound going forward. KFF also noted that “delayed or foregone care may offset some costs but also cause pent-up demand.”
On May 20, Apple and Google launched new contact tracing technology to help public health officials contact, test, treat and advise people who many have been exposed to an infected person. Specifically, Apple and Google created an application programming interface (API) that public health officials can incorporate into their own contact tracing apps.
On May 21, the Alliance of Community Health Plans (ACHP) and the Academy of Managed Care Pharmacy (AMCP) released a survey data detailing how health care consumer behaviors and attitudes have changed because of COVID-19. According to their findings, 72% of U.S. consumers have altered their use of traditional services during the pandemic and only 31% feel “comfortable” visiting their physician’s office. Further, 41% have already delayed care, 42% are not comfortable going to a hospital for any treatment, and 38% plan to delay future care or treatments. Additionally, 28% reported that they have received care virtually over the last three months; 89% of those that used telehealth were satisfied with their experience.
On May 21, the U.S. Department of Labor reported that for the week ending on May 16, 2.4 million Americans filed for unemployment benefits. Since lockdown orders were issued in mid-March, nearly 39 million have filed for unemployment.
On May 21, it was reported that the Chinese government is issuing stay-at-home orders and restricting some travel in parts of the Jilin province because emerging COVID-19 clusters. In addition, Chinese health experts have said the virus in the Northeast region (which includes the Jilin province) is showing different characteristics than the first wave, such as longer incubation periods.
On May 22, KFF released a tracking poll that estimates 82% of Americans consider it likely that they will have an in-person dental or medical appointment over the next three months.
On May 22 the Lancet medical journal published a study linking hydroxychloroquine and chloroquine to increased risk of mortality and cardiovascular complications when used as a COVID-29 treatment for hospitalized patients.
As of May 24, the U.S. had 1,622,990 confirmed COVID-19 cases resulting in 96,046 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments (CMS-3337-P); Proposed Rule; Received 6/6/2019
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/2019
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482-P); Proposed Rule; Received 12/27/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20
Amendments to the HHS-operated Risk Adjustment Data Validation under the Patient Protection and ACA’s HHS-operated Risk Adjustment Program (CMS-9913); Proposed Rule; Received 3/11/20
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare
CY2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Rates (CMS-1736); Proposed Rule; Received 4/21/20
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid, Medicare Cost Plans, and PACE Programs (CMS-4190); Final Rule; Received 4/29/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Proposed Rule: 5/6/2020
CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1734); Proposed Rule; 5/12/20
CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732); Proposed Rule; 5/14/20
HHS-FDA
Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20
HHS-OCR
Nondiscrimination in Health and Health Education Programs or Activities; Final Rule; 4/23/2020
HHS-SAMHSA
Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders; Final Rule; 3/16/20
REPORTS
Government Accountability Office (GAO)
On May 19, GAO published its 2020 annual report, which identifies opportunities for Congress and the Administration to save billions by reducing fragmentation, overlap, and duplication. GAO noted that CMS could save tens of millions of dollars annually by ensuring that states implement Medicaid provider screening and enrollment requirements. GAO also claimed that improved coordination and communication between the Office of the Assistant Secretary for Preparedness & Response (ASPR) and its emergency support agencies – including the Federal Emergency Management Agency, Department of Defense, and Department of Veterans Affairs (VA) —could help mitigate fragmentation during a public health emergency.
On May 20, GAO sent a report to Senate Finance Committee Ranking Member Ron Wyden (D-OR) entitled Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic. GAO found that 82% of nursing homes that were inspected between 2013-2017 were cited for infection control problems before the COVID-19 pandemic; about half of such facilities had persistent problems and were cited over multiple years.
On May 20, GAO posted a “Science and Tech Spotlight” explaining the three types of test for COVID-19: molecular, antigen, and serology.
On May 21, GAO released a report entitled Medicare: CMS Should Provide Beneficiaries More Information about Substance Use Disorder (SUD) Coverage. GAO recommended that CMS include explicit information on the services covered by Medicare for beneficiaries with SUD in its “Medicare & You” publication.
UPCOMING HEARINGS
Senate
None of note.
House
Ways & Means Committee
May 27, 12:00 p.m., Remote Hearing
The Disproportionate Impact of COVID-19 on Communities of Color
Witnesses include: Ibram Kendi, Founding Director, the Antiracist Research & Policy Center, American University; Raynald Samoa, MD, Endocrinologist, City of Hope; Thomas Dean Sequist, MD, Chief Quality & Safety Officer, Partners HealthCare, Professor of Medicine and Health Care Policy at Harvard Medical School, with joint appointments in the Division of General Medicine at Brigham and Women’s Hospital and the Department of Health Care Policy at Harvard Medical School; Alicia Fernandez, MD, Professor of Medicine at University of California San Francisco; James Hildreth, MD, President & Chief Executive Officer, Meharry Medical College; and Douglas Holtz-Eakin, President, the American Action Forum.
Education & Labor Workforce Protections Subcommittee
May 28, 10:15 a.m., 2175 Rayburn House Office Building
Examining the Federal Government’s Actions to Protect Workers from COVID-19
Details will be forthcoming.
Appropriations Military Construction, VA & Related Agencies Subcommittee
May 28, 10:00 a.m., 1324 Longworth House Office Building
Witnesses include: Paul Lawrence, Under Secretary for Benefits, VA; Jennifer MacDonald
Chief Consultant to the Deputy Under Secretary for Health, VA; Jon Rychalski
Assistant Secretary for Management and Chief Financial Officer, VA; Robert Wilkie, Secretary, VA.
OTHER HEALTH POLICY NEWS
On May 19, Washington Gov. Jay Inslee (D) notified state health officials that implementing “Cascade Care,” the state’s forthcoming public option, will be phased in over a “multi-year journey.” He notes that while the plan “may take a preliminary approach in its initial year, [his Administration] fully expect[s] it to flourish in future years.” Reports suggest that health insurers have struggled to build adequate provider networks, as hospitals have been unwilling to accept the plan’s relatively low payment rates.
On May 21, the GAO announced the appointment of three new members to serve on the Medicare Payment Advisory Commission (MedPAC) to replace Chairman Jay Crosson, Kathy Buto, and Warner Thomas. New members include Michael Chernow, Harvard Medical School Professor of Health Care Policy; Betty Rambur, Chair for Practice and Professor of Nursing in the College of Nursing at the University of Rhode Island; and Wayne Riley, President and Professor of Internal Medicine and Health Policy and Management at the State University of New York Downstate Health Sciences University. Chernow, who served on the Commission between 2008 to 2014, will be the new Chairman.