The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 2 - November 7. 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.
ELECTION UPDATE
White House
On November 7, Democrat Joe Biden defeated President Trump to become the 46th president of the United States after crossing the winning threshold of 270 Electoral College votes with a win in Pennsylvania and Nevada. President-elect Biden will become the oldest man ever sworn into the office. His running mate, Senator Kamala Harris (D-CA) will become the first woman, and first woman of color, on a winning presidential ticket.
As of November 8, Alaska, Arizona, Georgia, Nevada, North Carolina, and Pennsylvania have yet to finalize ballot counts. If the current results and trends hold, President-elect Biden will have won with 306 Electoral College votes – the same number that President Trump earned in the 2016 election – and the popular vote by nearly three percentage points with more than 74 million votes.
President Trump declined to concede, promising to challenge the results and calling for recounts across battleground states. Trump’s campaign filed or announced intent to file lawsuits in Pennsylvania, Michigan, Arizona, Nevada, and Georgia.
Congress
As of November 8, Democrats are expected to hold onto a slim House majority, though the party lost eight seats to Republicans (FL-26 and -27, IA-1, MI-3, MN-7, NM-2, OK-5, and SC-1) while flipping just one (GA-7). Twenty-four House races remain uncalled.
Republicans are currently expected to hold a narrow majority in Senate, with Democrats gaining just one seat (after Sens. Gardner, McSally, and Jones lost). Both of Georgia’s Senate races will go to a runoff election January 5, 2021, due to no candidates receiving more than 50% of the vote.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
The House is scheduled to return on November 16 and the Democrats and Republicans are scheduled to hold their leadership elections that week.
Senate
The Senate is scheduled to return on November 9.
NON-CORONAVIRUS REGULATORY UPDATE
On November 2, Centers for Medicare & Medicaid Services (CMS) published a final rule entitled End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. The rule updates and makes revisions to the 2021 ESRD PPS and increases the payment rate by 1.6% for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. The rule also updates requirements for the ESRD Quality Incentive Program. A summary of the rule is available here. A fact sheet on the rule is available here.
On November 3, CMS launched a new toolkit entitled the Long-Term Services and Supports Rebalancing Toolkit for state Medicaid agencies to strengthen their infrastructure and develop home and community-based services (HCBS) and promote high quality, person-centered HCBS to safely transition older adults and individuals with disabilities back to their homes and communities, and decrease reliance on nursing home care. A fact sheet on the toolkit is available here.
On November 3, the Office of Management and Budget (OMB) concluded review of the final rule from CMS entitled Medicaid and CHIP Managed Care (CMS-2408-F).
On November 3, OMB received a proposed rule from CMS entitled Health and Human Services (HHS) Notice of Benefit and Payment Parameters for 2022 (CMS-9914).
On November 3, OMB received a notice from the Food and Drug Administration (FDA) entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act ; Draft Guidance for Industry; Availability (2019-522).
On November 4, HHS published a notice of proposed rulemaking entitled Securing Updated and Necessary Statutory Evaluations Timely. The rule would require agencies to submit plans for periodic reviews of all regulations older than 10 years. A summary of the rule is available here.
On November 5, OMB received a final rule from CMS entitled CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1736).
On November 5, CMS released a notice with request for comment entitled Request for Renewal of Deeming Authority of the National Committee for Quality Assurance for Medicare Advantage Health Maintenance Organizations and Preferred Provider Organizations. The proposed notice announces that CMS is considering granting approval of the National Committee for Quality Assurance’s renewal application for Medicare Advantage “deeming authority” of Health Maintenance Organizations and Preferred Provider Organizations.
On November 6, the Federal Communications Commission opened the Connected Care Pilot program, making $100 million available for telehealth services for low-income patients and veterans. Health care providers can apply for funding through December 7.
On November 6, CMS released a notice entitled Medicare Program: CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. The notice details that the inpatient hospital deductible will be $1,484 for calendar year (CY) 2021. The daily coinsurance amounts for CY 2021 will be: $371 for the 61st through 90th day of hospitalization in a benefit period; $742 for lifetime reserve days; and $185.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period. Deductibles and coinsurance amounts are effective January 1, 2021.
On November 6, CMS released a notice entitled Medicare Program: CY 2021 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. The notice details that the monthly Part A premium for CY 2023 beginning January 1, 2021 will be $471. The premium for certain other individuals as described in this notice will be $259. Premiums are effective on January 1, 2021.
On November 6, CMS released a notice entitled Medicare Program: Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2021. The notice details that the standard monthly premium for Medicare Part B enrollees will be $148.50 in 2021, an increase from $144.60 in 2020, and the annual deductible for Medicare Part B beneficiaries is $203 in 2021, an increase from $198 in 2020. The Medicare Part A inpatient deductible is $1,484 in 2021, an increase from $1,408 in 2020.
On November 6, CMS released a notice with request for comment entitled Application from the Joint Commission for Continued Approval of its Hospice Accreditation Program. The proposed notice acknowledges the Joint Commission’s application for the continued recognition as a national accrediting organization for hospices that want to participate in the Medicare or Medicaid programs.
The FDA will host a meeting on the Reauthorization of the Biosimilar User Fee Act for fiscal years 2023 through 2027 on November 19.
2021 Medicare Open Enrollment is open and will run through December 7, 2020.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On November 2, House Speaker Nancy Pelosi (D-CA) and Majority Leader Mitch McConnell (R-KY) independently called to pass a COVID-19 relief package before the end of the year. Further details have not yet been discussed.
On November 5, Speaker Pelosi expanded COVID-19 testing efforts for the House, making tests available to lawmakers at no cost during the next six weeks. This expansion in testing is in response to multiple lawmakers testing positive for COVID-19 in September and new D.C. travel restrictions requiring visitors to test negative within 72 hours of traveling to the district. The U.S. Air Force will provide up to 2,000 antigen tests per week.
Regulatory
On November 2, an internal report from White House Coronavirus Task Force Coordinator Deborah Birx was released urging state officials to promote consistent messaging about mask use, physical distancing, hand washing, and limiting indoor gatherings and encouraged pursuing “aggressive action” for testing and surging personnel. Birx’s warned leaders about the winter, calling it the “most concerning and most deadly phase of this pandemic.”
On November 2, the Centers for Disease Control and Prevention (CDC) issued a request for information for a Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions for a centralized national reporting platform for COVID-19 testing results.
On November 3, the FDA alerted clinical laboratory staff and health care providers that COVID-19 antigen tests can result in false positive results, such as when users do not follow the instructions. The FDA recommended for labs to take extra precautions with properly processing COVID-19 tests.
On November 5, CDC Advisory Committee on Immunization Practices Chair Dr. José Romero predicted that the first doses of an authorized COVID-19 vaccine will be prioritized for health care workers and support personnel. Romero also identified essential workers, people 65 and older, and anyone with underlying medical conditions associated with getting seriously ill from COVID-19 as a priority to receive a COVID-19 vaccine, depending on approval classifications.
On November 5, D.C. District Judge James Boasberg ordered the Small Business Administration to disclose names, addresses, and loan amounts for all borrowers that participated in the Paycheck Protection Program and Economic Injury Disaster Loan program.
On November 6, HHS and the Department of Defense (DoD) announced a Cooperative Research and Development Agreement with Humanigen to assist in developing the potential COVID-19 treatment, lenzilumab. Humanigen also announced positive interim Phase III results and is expected to pursue an Emergency Use Authorization for lenzilumab.
The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase III COVID-19 vaccine clinical trials for Johnson & Johnson, Moderna, AstraZeneca, and Pfizer at 20 federal medical facilities across the U.S.
White House
None of note.
Other
On November 2, Public Citizen urged Gilead to relinquish the FDA priority review voucher the company received for remdesivir, calling the company’s use of the voucher “unnecessary and inappropriate” considering Gilead’s expected revenues. Public Citizen called for Gilead to reduce the price of remdesivir to $1 per dose.
On November 3, former prime minister of New Zealand and administrator of the United Nations Development Programme Helen Clark said that the World Health Organization (WHO) needs greater freedom from politics when recommending measures to fight global health threats.
On November 5, the U.S. set a new single-day record for coronavirus infections (116,255).
November 5, AstraZeneca Chief Executive Pascal Soriot predicted that AstraZeneca will have results from the late-stage COVID-19 vaccine trials of AZD1222 later this year. Soriot also noted that the company would be able to supply hundreds of millions of doses by January, if the FDA authorizes the vaccine.
On November 5, Regeneron restarted the company’s COVID-19 antibody drug clinical trial for hospitalized patients after the U.K. independent data monitoring committee approved of the trial’s safety and efficacy.
On November 5, a study published in the JAMA Network entitled Changes in Health Services Use Among Commercially Insured US Populations During the COVID-19 Pandemic found that in March and April 2020 commercially insured individuals significantly reduced the use of preventive and elective care and increased use of telemedicine, but not enough to offset reductions in in-person care.
On November 5, the WHO ACT Accelerator program is securing COVID-19 treatments, including monoclonal antibodies treatments and dexamethasone, as part of the effort to ensure equitable access to COVID-19 tests, treatments, and vaccines, according to leaked draft documents. Notably, remdesivir was not included on the list of priority drugs.
On November 6, Novartis released Phase III efficacy and safety data, finding that canakinumab failed to help COVID-19 patients with COVID-19 pneumonia and cytokine release syndrome survive without invasive ventilation.
As of November 6, the U.S. had 9,879,323 confirmed COVID-19 cases resulting in 237,192 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center. COVID-19 is now the third leading cause of death in the U.S., according to Scientific American.
On November 6, the International Coalition of Medicines Regulatory Authorities and the WHO released a joint statement calling for COVID-19 vaccines and treatments to be upheld to rigorous scientific standards of review, transparency of clinical trial results, and data sharing between regulators for multi-country approval.
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); Received 6/6/19
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Proposed Rule; Received 11/3/20
CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1736); Final Rule; 11/5/20
HHS-FDA
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act ; Draft Guidance for Industry; Availability (2019-522); Notice; 11/3/20
HHS-OIG
Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement; Final Rule; Received 7/21/20
REPORTS
HHS Office of Inspector General (OIG)
On November 2, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Visiting Nurse Association (VNA) of Central Jersey Home Care and Hospice, Inc. The report found that VNA of Central Jersey did not comply with Medicare billing requirements for some home health claims, resulting in at least $2 million in overpayments. OIG recommended that VNA of Central Jersey refund incorrectly billed claims overpayments and strengthen its procedures for billing home health services. A summary of the report is available here.
On November 6, OIG released a report entitled CMS Did Not Ensure That Medicare Hospital Payments for Claims That Included Medical Device Credits Were Reduced in Accordance With Federal Regulations, Resulting in as Much as $35 Million in Overpayments. The report found that CMS did not ensure that Outpatient Prospective Payment System (OPPS) payments for claims that included medical device credits were reduced in accordance with Federal regulations, resulting in an estimated $35.4 million in overpayments. OIG recommended that CMS work with the Medicare Administrative Contractors (MACs) to recover from hospitals OPPS overpayments and revise the OPPS regulations or the Manual instructions to resolve the conflict between these requirements for OPPS claims with medical device credits. A summary of the report is available here.
On November 6, OIG released a report entitled Cahaba Safeguard Administrators, LLC, Claimed Some Unallowable Medicare Pension Costs Through Its Incurred Cost Proposals. The report found that Cahaba CSA claimed $127,002 unallowable Medicare pension costs because it based its claim for Medicare reimbursement on an incorrectly calculated allocable pension cost. OIG recommended that Cahaba CSA work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare pension costs. A summary of the report is available here.
On November 6, OIG released a report entitled Cahaba Government Benefits Administrators, LLC, Did Not Claim Some Allowable Medicare Pension Costs Through Its Incurred Cost Proposals. The report found that Cahaba GBA did not claim $593,158 on its Incurred Cost Proposals because it based its claim for Medicare reimbursement on an incorrectly calculated allocable pension cost. OIG recommends that Cahaba GBA work with CMS to ensure that its final settlement of contract costs reflects an increase in Medicare pension costs. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On November 2, a study published in Health Affairs entitled Net Spending On Retail Specialty Drugs Grew Rapidly, Especially For Private Insurance And Medicare Part D found that specialty drugs accounted for 37.7% of retail and mail-order prescription spending in 2017, although specialty drugs make up a small portion of retail prescriptions filled. The study found that spending tripled for Medicare Part D beneficiaries and more than doubled for people with private insurance from 2010 to 2017.
On November 3, the California ballot initiative that would require clinics to have a doctor on site during dialysis treatments failed to pass.
On November 3, the Oklahoma ballot measure to redirect a portion of Tobacco Settlement Endowment Trust funds to help pay for the state’s 10% share of Medicaid expansion failed to pass.
On November 5, Johnson & Johnson, McKesson Corp., Cardinal Health Inc., and AmerisourceBergen Corp. reached a tentative $26 billion settlement paid over 18 years with the group of state attorneys general to settle more than 3,000 lawsuits associated with the opioid epidemic. The deal is pending federal court approval.
On November 3, Cigna Corp. resurrected claims against Anthem Inc. over the $54 billion failed merger, due to an antitrust ruling. Previously, the Delaware Chancery Court denied both company’s damages claims.
On November 4, the Biden campaign launched BuildBackBetter.com, Biden’s transition team website. The site currently lists the following as transition priorities: COVID-19; economic recovery; racial equity; and climate change.