Health Care Watch: June 21, 2020
The following Health Care Watch provides a summary of legislative and regulatory health care activities from June 15 – 20. 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
Senate
Markups for FY2021 appropriations bills have been delayed amid disputes over what types of riders will be permitted, including additional coronavirus aid and police reform. On June 17, Appropriations Committee Chairman Richard Shelby (R-AL) asserted that “funding the government is a serious responsibility, and I will not allow the appropriations process to be hijacked and turned into a partisan sideshow.” Markups were previously scheduled to begin the week of June 22.
The Senate is expected to consider Sen. Tim Scott’s (R-SC) policing reform legislation the week of June 22. The Senate is not expected to consider another COVID-19 relief package until the week of July 20, at the earliest.
House
On June 18, Speaker Nancy Pelosi (D-CA) announced the House is preparing a $1.5 trillion infrastructure plan that merges traditionally unrelated priorities, such as broadband, roads, education, climate resiliency, and housing. She indicated the package would help the country recovery from the COVID-19 pandemic, whereas prior legislation has helped mitigate its adverse impact. According to Energy & Commerce Committee Chairman Frank Pallone (D-NJ), the legislation will allocate $35 billion to health care infrastructure and $100 billion for broadband. It remains unclear how the bill would be paid for, though Ways & Means Chairman Richard Neal (D-MA) implied it would rely on bonding and deficit spending. H.R. 2 will be used as the vehicle. Speaker Pelosi is aiming to hold a floor vote before the July 4 recess.
Subcommittee and full committee markups for FY2021 appropriations bills are scheduled to begin on July 6 and July 9, respectively. Floor votes are expected to be held during the last two weeks of July. Appropriations Committee Chair Nita Lowery (D-NY) indicated that Democrats will use the appropriation bills to move pandemic-related legislation and police reform.
The House is expected to consider legislation to expand upon the Affordable Care Act (increasing the amount of and expanding eligibility for premium subsidies, for example) during the next Washington work period. The legislation is expected to be offset with policies from the House-passed drug pricing reform legislation.
NON-CORONAVIRUS REGULATORY UPDATE
· On June 16, the White House Office of Management & Budget (OMB) completed its review of a Substance Abuse & Mental Health Services Administration final rule entitled Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders (SUD). Presumably, the rule aligns 42 C.F.R. Part 2 with changes made in the Coronavirus Aid, Relief & Economic Security Act (CARES) Act, including allowing patients with SUD to grant revocable, one-time permission to share their data within the health care setting.
· On June 17, the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking (NRPM) entitled Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third-Party Liability (TPL) Requirements. The NRPM deals with many policies that impact drug covered under Medicaid including: providing manufacturers with regulatory flexibility to promote VBP arrangements; creating minimum standards in state Medicaid DUR programs designed to reduce opioid-related fraud, misuse, and abuse; revising how manufacturers calculate the average manufacturer price (AMP) of a brand drug when there is also a sale of an authorized generic; clarifying how manufacturers should include the value of their patient assistance programs in the calculation of Best Price including when they are impacted by pharmacy benefit managers accumulator programs; defining line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, and innovator multiple source drug for purposes of the Medicaid Drug Report Program. Comments are due by July 19, 2020. A fact sheet is available here.
· On June 18, the Health Resources & Services Administration awarded 310 recipients in rural and underserved communities a total of $107.2 million to train health care workers. According to U.S. Department of Health & Human Services (HHS) Secretary Alex Azar, the grants are intended to address the “stark disparities in health and health care access” that have “contribute[d] to the burden of the COVID-19 pandemic.”
CORONAVIRUS UPDATE
White House Update
On June 16, the Trump administration announced it will provide vaccines for “vulnerable” Americans as part of Operation Warp Speed. The vaccines will be distributed based on a tiered system; priority will be granted to the elderly, those with underlying health conditions, and essential workers. Officials highlighted health insurers “strong interest” in waiving cost-sharing for vaccines. The Administration is targeting a January 2021 deadline to have a vaccine available to the public.
Legislative Update
On June 15, a bipartisan group of 30 Senators requested that Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schumer (D-NY) consider legislation to permanently implement telehealth expansion policies included in previous COVID-19 legislation. According to the letter, such policies have allowed for an 11,718% increase in Medicare beneficiaries’ use of telehealth services over a six-week period. The lawmakers also claim now is an important time for the federal government to measure the impact of virtual care on Medicare, including utilization, quality, health outcomes, and program spending.
On June 15, it was reported that the Pandemic Response Accountability Committee sent a letter to several House and Senate committees claiming that the Trump administration is narrowly interpreting an “ambiguity” of the CARES Act in a way that limits its ability to oversee provisions included in “Division A” of the law.
On June 15, top Democrats on the House Energy & Commerce, Ways & Means, and Education & Labor Committees as well as the Senate HELP and Finance Committees sent a letter to Secretary Azar and CMS Administrator Seema Verma reiterating their prior request for information on the Administration’s plan to expand health coverage through the Affordable Care Act (ACA) marketplaces. The lawmakers also stressed the need for a broad Special Enrollment Period (SEP) on HealthCare.gov to expand coverage options for the underinsured and uninsured.
On June 16, Sens. Chris Coons (D-DE) and Roger Wicker (R-AL) introduced legislation to create a new national service corps of 250,000 people to assist state and local health departments test, trace, and (potentially) vaccinate residents.
On June 16, the Select Coronavirus Crisis Subcommittee launched an investigation into COVID-19 deaths in nursing homes. Chairman Jim Clyburn (D-SC) sent letters to CMS and five for-profit nursing home companies, including Genesis HealthCare, Life Care Centers of America, Ensign Group, SavaSeniorCare, and Consulate Health Care seeking information about whether CMS properly managed the outbreak in nursing homes. Chairman Clyburn suggested CMS deferred too much authority to states and local governments to manage spread in nursing homes. He also claimed guidance released by the Agency has been unclear and poorly enforced.
On June 16, the Capitol Physician issued guidance requiring House members to wear masks during committee hearings and markup.
· On June 17, the Senate HELP Committee held a hearing entitled Telehealth: Lessons from the COVID-19 Pandemic. Chairman Lamar Alexander (R-TN) suggested the three most impactful temporary federal policy changes to expand telehealth access during the pandemic include: (1) waiving Medicare’s “originating site” rule so physicians can be reimbursed for telehealth appointments wherever the patient is located; (2) reimbursing providers for twice as many types of telehealth services under the Medicare and Medicaid programs; and (3) relaxing Health Insurance Portability & Accountability Act regulations to allow physicians to conduct telehealth using common video and communication apps. There was bipartisan support for making several temporary policies permeant, including covering audio-only services under Medicare, modernizing the originating site rule, and expanding the types of services that can be furnished via telehealth. Chairman Alexander wants to pass legislation to prepare for the next pandemic this year; however, many of the policies he is interested in fall under the Finance Committee’s jurisdiction. Witnesses included: Karen Rheuban, MD, Professor of Pediatrics, Senior Associate Dean of Continuing Medical Education and Director University of Virginia Karen S. Rheuban Center for Telehealth; Joseph Kvedar, MD, President, American Telemedicine Association, Professor, Harvard Medical School; Sanjeev Arora, MD, Distinguished and Regents’ Professor, University of New Mexico Health Sciences Center, Founder and Director, Project ECHO/Echo Institute; and Andrea Willis, MD, Senior Vice President, Chief Medical Officer, BlueCross BlueShield of Tennessee.
· On June 17, the Energy & Commerce Committee’s Health Subcommittee held a hearing entitled Health Care Inequality: Confronting Racial and Ethnic Disparities in COVID-19 and the Health Care System. Subcommittee Chair Anna Eshoo (D-CA) highlighted the disproportionate impact of COVID-19 on communities of color, noting the mortality rate for Black Americans is 2.3 times higher their white counterparts. She described the interaction of racism with COVID-19 as a “pandemic within a pandemic” and urged Congress to take steps to promote health care equity across racial and ethnic groups. Witnesses included: Rhea Boyd, MD, Pediatrician and Child Health Advocate, Palo Alto Medical Foundation; Oliver Brooks, MD, President, National Medical Association; and Avik Roy, President, Foundation for Research on Equal Opportunity.
· On June 18, the Senate Armed Forces Committee held a hearing to consider the nomination of General Gustave Perna to be the Chief Operating Officer of Operation Warp Speed. The nomination was endorsed by both the Chairman and Ranking Member. General Perna testified that he is increasingly confident a vaccine will be available by year’s end. When asked if he would collaborate with other nations to secure a vaccine for Americans, he committed to working with countries that align with the nation’s national security interest, which, he claimed, excludes China.
· On June 18, House Oversight & Reform Committee Chair Carolyn Maloney (D-NY), along with Reps. Jim Clyburn (D-SC) and Raja Krishnamoorthi (D-IL), sent a letter to Food & Drug Administration (FDA) Commissioner Stephen Hahn requesting a briefing on the Agency’s policies and procedures to guide its decisions for developing, reviewing, and deploying a potential vaccine.
· On June 19 the House Science, Space & Technology Investigations & Oversight Subcommittee held a hearing entitled Repurposing Therapeutic Drugs for COVID-19: Research Challenges and Opportunities. According to Subcommittee Chairman Bill Foster (D-IL), “political interference” has compromised the FDA’s oversight of chloroquine and hydroxychloroquine. Going forward, he argued scientific research alone should dictate which existing therapies are used as COVID-19 treatments. Witnesses included: Peter Lurie, President, Center for Science in the Public Interest; James Finigan, Director, Respiratory Centers of Excellence, National Jewish Health; Rick Stevens, Associate Laboratory Director for Computing, Environment and Life Sciences, Argonne National Laboratory; and Benjamin Rome, Associate Physician, Brigham and Women’s Hospital; Postdoctoral Research Fellow, Harvard Medical School.
Regulatory Update
On June 15, FDA withdrew the emergency use authorizations (EUAs) it awarded to hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19. The Agency determined the drugs “are unlikely to be effective in treating COVID-19” and that “the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the authorized use.” While the drugs will no longer be distributed to hospitals from the Strategic National Stockpile (SNS), they can still be prescribed off-label.
On June 15, FDA revised guidance for health care providers to state that the co-administration of Gilead’s remdesivir with chloroquine or hydroxychloroquine “is not recommended as it may result in reduced antiviral activity of remdesivir.
On June 15, the National Institutes of Health (NIH) launched a national database for researchers and clinicians to examine COVID-19 medical data. The database is part of NIH’s “National COVID Cohort Collaborative” and will collect demographic information, medications, lab test results, and outcomes data from 35 sites over five years.
On June 16, the FDA revoked the EUA it granted to Chembio’s antibody test, citing accuracy concerns. This marks the first time FDA has retracted an EUA for a COVID-19 test of any kind.
On June 18, the U.S. Department of Labor reported over 1.5 million Americans filed for unemployment benefits for the week ending on June 1; nearly 46 million have filed for unemployment since lockdown orders were initiated in mid-March.
On June 18, CMS posted a second set of COVID-19 nursing home data; the dataset now captures infection and morality rates as of June 7. This data will be updated weekly.
On June 19, NIH’s Nation Cancer Institute Director Ned Sharpless estimated that there will be at least 10,000 deaths from breast and colorectal cancers over the next decade because of delayed or missed care caused by the pandemic.
On June 19, CMS announced the membership of an independent coronavirus commission on safety and quality in nursing homes.
Other
On June 15, the city of Chicago sued Secretary Azar and Administrator Verma for not issuing a broad SEP on HealthCare.gov. Chicago argues HHS was compelled to open the federal marketplace in response the “exceptional circumstances” consumers faced during the pandemic.
On June 15, Germany purchased a 23% stake in CureVac, who is developing a vaccine using messenger RNA technology.
On June 16, researchers from Oxford University concluded the low-cost steroid dexamethasone reduces death by up to one third for COVID-19 patients on a ventilator.
On June 16, over 100 prominent economists urged Majority Leader McConnell, Minority Leader Schumer, Speaker Pelosi, and Minority Leader Kevin McCarthy (D-CA) to immediately pass a “multifaceted relief bill of a magnitude” that is “commensurate with the nearly $16 trillion nominal output gap [the] economy faces over the next decade.” They suggested such legislation should, at minimum, provide additional support for states and local governments, the unemployed, programs that maintain the employer-employee relationship, and efforts to stabilize aggregate demand. They called for Congress to pass the package before CARES Act funding is depleted.
On June 16, the Brookings Institution estimated that Black and Hispanic/Latino Americans have 3.6 and 2.5 higher COVID-19 death rates, respectively, compared to white Americans when age is accounted for. Furthermore, Harvard researchers foundthe starkest age-based racial divide is among Black Americans between the ages of 35-44, who are nine times more likely to die from COVID-19 than their white counterparts.
On June 17, several companies operating in the “gig economy,” like Instacart and DoorDash, asked Congressional leaders to mandate a one-time SEP for HealthCare.gov that lasts for a least eight weeks and removes all “qualifying event” documentation requirements.
On June 17, the Federation of American Hospitals (FAH) launched a website as part of its advocacy efforts for adjusting repayment terms for the Medicare Accelerated and Advanced Payment Program. FAH claims that CMS’ repayment schedule does not account for the continued strain on hospitals. If the terms are not modified, FAH warns that hospitals across the country will no longer be eligible to receive fee-for-service payments on or around August 1. The group is asking Congress to delay the repayment start date into 2021 and waive or reduce interest rate for the loans.
On June 17, the Kaiser Family Foundation (KFF) concluded that at least 69.4 million (approximately one in four) workers are potentially ineligible for the emergency paid sick leave benefits included in the Families First Coronavirus Response Act. Under the law, eligible workers are guaranteed up to 80 hours of paid leave for a health issue arising from COVID-19 through the end of the year.
On June 17, the World Health Organization (WHO) announced it has removed hydroxychloroquine from its “Solidarity” clinical trial. According to Ana Maria Henao Restrepo, head of WHO’s research and development team, new evidence suggests there is “no apparent beneficial effect of hydroxychloroquine” to treat COVID-19.
On June 17, KFF outlined policy “Options to Support Medicaid Providers in Response to COVID-19,” such as advanced payments and increased reimbursements rates.
On June 18, a group of telehealth stakeholders announced the formation of the Taskforce on Telehealth Policy, with the goal of developing consensus recommendations for policymakers on how to maximize the benefits of telehealth while maintaining high standards for patient safety and program integrity. The taskforce – convened by the National Committee for Quality Assurance, Alliance for Connected Care, and the American Telemedicine Association – includes health plans, health-care providers, consumer advocates, and health quality experts from the public and private sector, including Director of the Center for Clinical Standards & Quality at CMS Michelle Schreiber and a non-voting Federal liaison from HHS, Nick Uehlecke. The task force will hold its first meeting on June 29, with final recommendations expected in early September.
On June 18, West Health and Gallup released poll results showing that nine in 10 Americans are “very” or “somewhat” worried that drug manufacturers will raise drug prices because of the pandemic. Furthermore, 88% of respondents claimed to support direct negotiation between the federal government and manufacturers for COVID-19 treatments.
On June 18, Chinese researchers published a study in Nature Medicine suggesting that COVID-19 antibodies may provide immunity for just two or three months, especially in people who exhibited no or mild symptoms.
On June 18, New York announced it will extend its SEP for its ACA marketplace through July 15. Similarly, Maryland and Vermont have extended their deadlines through July 15 and August 14, respectively.
As of June 20, the U.S. had 2,222,576 confirmed COVID-19 cases resulting in 119,131 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
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
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
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
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/20
REPORTS
Government Accountability Office (GAO)
On June 18, 2020 the GAO published a report entitled Public Health Preparedness: HHS Should Take Actions to Ensure it has an Adequate Number of Effectively Trained Emergency Responders. According to GAO, HHS is responsible for leading public health and medical responses, in part by deploying responders enrolled in the national Disaster Medical System (NDMS). This study was conducted to assess the surge capacity of the NDMS. GAO found that HHS’ hiring targets do not consider three key areas: a workforce capable of responding to (1) a nationwide event or multiple concurrent events, (2) the needs of at-risk individuals, and (3) the availability of other medical responders. The report also raised concerns about the quantity and type of training that NDMS responders receive, questioning the largely online nature of their training. GAO issued five recommendations including (1) developing an NDMS workforce target that aligns with broader strategic plans, (2) developing an NDMS workforce target that accounts for the three key areas mentioned above, (3) developing strategies to achieve revised workforce targets, (4) developing a process to evaluate the NDMS responders’ training, and (5) creating a process to prioritize in-person training needs for NDMS responders.
Congressional Budget Office (CBO)
On June 16, CBO issued a report on the “Budgetary Effects of Laws Enacted in Response to the 2020 Coronavirus Pandemic” during March and April 2020.
UPCOMING HEARINGS
Senate
HELP Committee
June 23, 10:00 a.m., 430 Dirksen Senate Office Building
COVID-19: Lessons Learned to Prepare for the Next Pandemic
Witnesses include: William Frist, MD, Former U.S. Senate Majority Leader; Joneigh Khaldun, MD, Chief Medical Executive and Chief Deputy Director for Health, Michigan Department of Health and Human Services; Julie Gerberding, MD, Executive Vice President and Chief Patient Officer, Merck & Co., Inc., Co-Chair, CSIS Commission on Strengthening America’s Health Security; and Michael Leavitt, former HHS Secretary.
House
Education & Labor Committee
June 22, 12:00 p.m., virtual
Inequities Exposed: How COVID-19 Widened Racial Inequalities in Education, Health, and the Workforce
Witness include: Camara Jones, MD, Adjunct Associate Professor, Morehouse School of Medicine; Valerie Rawlston Wilson, Director, Program on Race, Ethnicity, and the Economy, Economic Policy Institute; Avik Roy, MD, Co-Founder and President, Foundation for Research on Equal Opportunity; and John King, Jr, President and CEO, The Education Trust.
Energy & Commerce Committee
June 23, 11:00 a.m., 2123 Rayburn House Office Building
Oversight of the Trump Administration’s Response to the COVID-19 Pandemic
Witnesses include: Anthony Fauci, MD, Director, National Institute of Allergy & Infectious Diseases, NIH; Admiral Brett Giroir, MD, Assistant Secretary for Health, HHS; Stephen Hahn, MD, Commissioner, FDA; and Robert Redfield, MD, Director, CDC.
Appropriations Committee
June 23, 11:00 a.m., virtual
Member Day Testimony for FY2021 Appropriations
Details will be forthcoming.
Veterans’ Affairs Technology Modernization Subcommittee
June 23, 1:00 p.m., 210 House Visitors Center
VA Telehealth During the COVID-19 Pandemic: Expansion and Impact
Details will be forthcoming.
Ways & Means Health Subcommittee
June 25, 2:00 p.m., virtual
Examining the COVID-19 Nursing Home Crisis
Details will be forthcoming.
Budget Committee
June 23, 2:30 p.m., virtual
Health and Wealth Inequality in America: How COVID-19 Makes Clear the Need for Change
Witnesses include: Angus Deaton, Senior Scholar, Princeton University Woodrow Wilson School, Presidential Professor of Economics, University of Southern California; Patrice Harris, MD, Immediate Past President of the American Medical Association; Damon Jones, Associate Professor, University of Chicago Harris School; and Avik Roy, MD, President, Foundation for Research on Equal Opportunity.
OTHER HEALTH POLICY NEWS
On June 15, the Medicare Payment Advisory Commission (MedPAC) released its June 2020 Report to Congress examining Medicare and the health care delivery system. The report includes MedPAC’s recommendation to reform Part D, including capping beneficiaries’ annual drug costs, making plans pay a larger share of drug costs before the catastrophic phase and increasing manufacturers’ share of catastrophic costs. The report also indicates that MedPAC is beginning to analyze how Medicare should pay separately for Part B drugs, including potentially requiring separately payable drugs to exhibit clinical superiority over existing drugs. A high-level overview of the report is available here.
On June 15, the Medicaid & CHIP Payment & Access Commission (MACPAC) issued its June 2020 Report to Congress.
On June 16, the U.S. Court of Appeals for D.C. ruled that the Trump administration lacks the authority to require drug companies to disclose the list price of their products in television advertisements. The Court noted that this price "bears little meaningful relationship to the price that either the federal government or Medicare and Medicaid beneficiaries pay for drugs." The drug transparency rule was first struck down by the U.S. District Court for D.C. in July 2019.
On June 17, the Georgia legislature overwhelmingly approved H.R. 888, legislation to protect patients from surprise medical bills when they are unknowingly treated by an out-of-network provider. Under the bill, insurers would pay the median in-network rate, but providers could appeal this rate to the state insurance commissioner. The measure excludes private ambulance companies. Gov. Brian Kemp (R) is expected to sign it.
On June 22, the Physician-Focused Payment Model Technical Advisory Committee will hold a public meeting to consider two advanced payment models.