The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 4 - October 11. 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
House
Nothing of note.
Senate
On October 12, the Judiciary Committee will hold the first of four hearings to consider the nomination of Amy Coney Barrett to be an Associate Justice of the Supreme Court.
NON-CORONAVIRUS REGULATORY UPDATE
On October 5, the Food and Drug Administration (FDA) released a notice entitled Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year (FY) 2021. The notice announced that the FDA application with a priority review voucher fee has fallen to $1.4 million in FY 2021, compared to $2 million in FY 2020.
On October 8, the Centers for Medicare & Medicaid Services (CMS) released the Star Ratings for 2021 Medicare Advantage (MA) and Part D prescription drug plans. A fact sheet is available here.
On October 8, CMS released the draft Hospice Item Set Manual V3.0.
On October 8, CMS published a correction to the final rule entitled Contract Year 2021 Policy and Technical Changes to the MA Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program.
On October 8, CMS updated the repayment terms for the Accelerated and Advance Payment Program, allowing providers to delay repayments for one year. After the first year deadline, Medicare will automatically recoup 25% of Medicare payments for 11 months, after which recoupment will increase to 50% for another 6 months. CMS will then issue letters requiring repayment of any outstanding balance, subject to an interest rate of 4%. A fact sheet of the changes is available here and a FAQ is available here.
On October 9, CMS released the Trends in Subsidized and Unsubsidized Enrollment Report finding that subsidized enrollment on the individual market stayed stable in 2019, but the unsubsidized portion of the market continued to decline in 2019.
Press reports indicate that CMS is close to finalizing the plan to deliver drug-discount cards to seniors, with letters announcing the $200 discount cards reportedly being sent to 39 million Medicare beneficiaries next week. Eligible seniors are expected to be those who are enrolled in a Part D plan and not receiving the program’s low-income subsidies. According to the reports, beneficiaries may begin receiving the cards later this month, although many beneficiaries are not expected to receive the cards until after the election.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On October 5, President Trump released an Executive Order (EO) entitled the EO on Saving Lives Through Increased Support For Mental- and Behavioral-Health Needs. The EO establishes a cross-agency Coronavirus Mental Health Working Group to create a report within 45 days, outlining a plan to improve service coordination between stakeholders, executive departments, and agencies to assist individuals in receiving effective treatment and recovery services. The EO also encourages the working group to consider using grant programs to encourage and reward states and organizations to improve mental health and reduce suicide risk, through outreach, education, and case management.
On October 5, OMB received a final rule from CMS entitled CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730).
On October 8, OMB received a final rule from CMS entitled CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732).
CORONAVIRUS UPDATE
Legislative
On October 9, Senate Majority Leader Mitch McConnell (R-KY) said it was “unlikely” that Congress would reach a deal on an additional coronavirus relief package before the November 3 election. On October 10, it was reported that a number of GOP Senators have expressed strong reservations about the parameters of a $2 trillion relief package being negotiated between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steve Mnuchin.
Regulatory
On October 5, the Centers for Disease Control and Prevention (CDC) issued updated guidance regarding the airborne spread of COVID-19. The CDC found that under certain conditions, people with COVID-19 infected others who were more than six feet away or shortly after the COVID-19-positive person left an area. The CDC identified that this transmission occurred in poorly ventilated and enclosed spaces, involving activities that caused heavier breathing, like singing or exercise.
On October 5, the CDC released a study finding that children and adolescents can efficiently transmit COVID-19 and can serve as the source for COVID-19 outbreaks within families.
On October 6, the FDA released additional guidelines for data and information requirements in order to receive Emergency Use Authorization (EUA) for a COVID-19 vaccine. The recommendations include tracking participants for two months after receiving the second vaccine shot and data requirements similar to what is required for full FDA drug approval. The White House approved the guidelines after the standards were published as part of the briefing materials for the National Vaccine Advisory Committee meeting scheduled on October 22. President Trump tweeted later that night that the “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Operation Warp Speed (OWS) Co-chair Moncef Slaoui also urged manufacturers not to apply for EUA until they have significant amounts of vaccines to deploy.
On October 6, CMS announced the agency will withhold or terminate Medicare and Medicaid reimbursement from hospitals that fail to comply with daily COVID-19 and flu federal data reporting requirements. Hospitals have 14 weeks, falling around mid-January, to comply with requirements before funding is withheld. Economic and Consumer Policy Subcommittee Chairman Raja Krishnamoorthi (D-IL) warned that the changes could negatively affect patients’ health care access.
On October 6, the National Institutes of Health (NIH) announced six Rapid Acceleration of Diagnostics initiative contracts totaling $98.35 million for point-of-care and other COVID-19 testing innovations.
On October 7, the FDA announced the agency will end the premarket review of lab-developed COVID-19 tests for EUA, due to lack of legal authority and in order to focus on reviewing EUA requests for point-of-care tests, home collection tests, at-home tests or diagnostics. Energy & Commerce Chairman Frank Pallone (D-NJ), Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) called the move “reckless” and raised concern that without FDA review, faulty COVID-19 tests may be allowed to enter the market.
On October 8, the Defense Advanced Research Projects Agency awarded Moderna $56 million to fund the development of a mobile manufacturing prototype of nucleic acid for vaccines and therapeutics, including the company’s COVID-19 vaccine, mRNA-1273.
On October 8, the NIH launched the Serological Sciences Network for COVID-19 to increase the nation’s antibody testing capacity and study the immune response to COVID-19, to speed up testing, treatments, and vaccine development.
On October 8, a NIH-funded study published in the New England Journal of Medicine found that remdesivir shortens the recovery time for hospitalized COVID-19 patients, but the treatment did not reduce the risk of death.
On October 8, the NIH began a clinical trial testing the treatment of hospitalized COVID-19 patients with hyperimmune intravenous immunoglobulin and remdesivir.
On October 9, CMS issued cease and desist letters to laboratories testing for COVID-19 without appropriate certification.
White House
On October 5, President Trump returned to the White House after a three day stay at Walter Reed Medical Center to treat COVID-19. President Trump tweeted “Feeling really good! Don’t be afraid of Covid. Don’t let it dominate your life. We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!” Additionally, a number of President Trump’s staff and advisors also tested positive including his campaign manager Bill Stepien, advisor Hope Hicks, informal advisers Kellyanne Conway and Chris Christie, Press secretary Kayleigh McEnany, RNC Chairwoman Ronna McDaniel, and White House senior adviser Stephen Miller. A number of senior military leaders have also tested positive including chairman of the Joint Chiefs of Staff Mark Milley, Vice Commandant of the Coast Guard Adm. Charles Ray, and Marine Corps Assistant Commandant Gary Thomas.
On October 6, President Trump ended COVID relief negotiations until after the election, but asked for standalone funding of $25 billion for Airline Payroll Support, $135 billion for the Paycheck Protection Program for Small Business, and $1,200 stimulus check funding. On October 7, White House Chief of Staff Mark Meadows and Treasury Secretary Steven Mnuchin indicated that they were considering a slimmed-down stimulus package with the president’s funding requests. Federal Reserve Chair Jerome Powell called for additional relief spending to avoid “a weak recovery, creating unnecessary hardship for households and businesses." Some Republicans called for negotiations to restart, including Lindsey Graham (R-SC) and Susan Collins (R-ME). On October 8, Speaker Pelosi indicated that she would not agree to a standalone bill for airlines without a broader relief package. On October 9, Treasury Secretary Mnuchin restarted negotiations with Speaker Pelosi, offering a $1.8 trillion package after President Trump reversed course by stating he wants a deal.
Other
On October 6, Moderna slowed enrollment of the company’s Phase III COVID-19 trial due to a lack of enough Black, Latino and Native American participants. Moderna instructed research centers to focus on increasing participation among minority volunteers.
On October 6, the Committee for a Responsible Federal Budget released a report analyzing COVID-19 relief spending entitled Comparing Fiscal Multipliers. The report recommends that Congress pursue relief strategies with high fiscal multipliers -- higher outputs produced for each dollar spent -- including direct government purchases, tax cuts for those likely to spend the money rather than save it, policies that encourage work and capital investment, and policies that target structural damage in the economy.
On October 6, GlaxoSmithKline and Vir Biotech began the Phase III clinical trial for the companies’ COVID-19 antibody drug, VIR-7831, used for the early treatment of patients who are at high risk of hospitalization.
On October 7, Lilly announced that the company is seeking EUA for the COVID-19 monoclonal antibody treatment, bamlanivimab. The company said it could have up to one million doses of the treatment by the end of the year.
On October 7, Regeneron announced that the company is seeking EUA for the COVID-19 monoclonal antibody treatment, REGN-COV2. As part of a contract with OWS, the company will provide 70,000 to 300,000 potential treatment doses at no cost, if approved. President Donald Trump called the treatment a "cure" as part of his COVID-19 treatment last weekend and is urging FDA Commissioner Stephen Hahn to approve the EUA.
On October 7, Moderna announced that the company would not enforce patents tied to its COVID-19 vaccine during the pandemic and would consider licensing them to other companies after the crisis. This would allow other companies to manufacture and distribute Moderna’s COVID-19 vaccine, increasing the availability of the vaccine.
On October 8, Lilly released data showing that the company’s COVID-19 treatment combination of baricitinib and remdesivir reduced the recovery time and improved clinical outcomes for COVID-19 patients, compared with remdesivir.
On October 8, the Healthcare Distribution Alliance released a list of principles to ensure the safe and efficient distribution of FDA-approved COVID-19 vaccines. The report recommends utilizing existing pharmaceutical distribution infrastructure, securing the vaccine supply, effectively streamlining efforts with federal and state governments, and ensuring clear communication and transparency to promote vaccine confidence.
As of October 9, the U.S. had 7,745,319 confirmed COVID-19 cases resulting in 214,641 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.
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
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
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20
Revisions to Medicare Part A Enrollments (CMS-4194)l Proposed Rule; Received 9/9/20
Transparency in Coverage (CMS-9915); Final Rule; Received 9/11/20
Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II; Notice; Received 9/21/20
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
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Proposed Rule; Received 9/29/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Final Rule; 10/5/20
CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732); Final Rule; 10/8/20
HHS-FDA
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/2020
HHS-OCR
HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Proposed Rule; Received 7/31/20
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 October 6, OIG released a report entitled HHS Made Some Progress Toward Compliance With the Geospatial Data Act (GDA). The report found that HHS made some progress to comply with the GDA but had not maintained a department wide inventory of all geospatial data assets and had not designated a senior agency official for geospatial information. OIG identified a lack of department wide oversight and coordination in its implementation of geospatial-related responsibilities. OIG recommended for HHS to ensure the full implementation of the covered agency's responsibilities, maintain an inventory of all geospatial data assets, and appoint a Senior Agency Official for Geospatial Information. A summary of the report is available here.
On October 6, OIG released a report entitled Colorado Improperly Claimed Millions in Enhanced Federal Medicaid Reimbursement for New Adult Group Beneficiaries Because of a Data Processing Error. The report found that Colorado claimed reimbursement for Medicaid services to some beneficiaries who were enrolled in the new adult group but who later became ineligible for Medicaid coverage, resulting in over $1.9 million in improper claims. OIG recommended that Colorado refund the improper Medicaid reimbursements and establish adequate system controls to ensure that eligibility determinations transfer correctly from the Colorado Benefits Management System to the Medicaid Management Information System to prevent payments from being made on behalf of ineligible beneficiaries. A summary of the report is available here.
On October 6, OIG released a report entitled Medicare Critical Care Services Provider Compliance Audit: Clinical Practices of the University of Pennsylvania. The report found that Clinical Practices complied with Medicare billing requirements most of the time but there were some errors in correctly identifying and billing critical care services for physician services, resulting in $151,588 in overpayments. OIG recommended that Clinical Practices refund estimated overpayments to the Medicare administrative contractor and strengthen policies and procedures to ensure that critical care services billed to Medicare are adequately documented and correctly billed. A summary is available here.
On October 8, OIG released a report entitled Update on Oversight of Opioid Prescribing and Monitoring of Opioid Use: States Have Taken Action To Address the Opioid Epidemic. The report finds that states have created policies and procedures and passed laws and regulations related to opioids, including implementing opioid-related prevention, detection, and treatment programs. A summary of the report is available here.
Congressional Budget Office (CBO)
On October 8, CBO released a report entitled Monthly Budget Review for September 2020. The report estimated that the federal budget deficit was $3.1 trillion in FY 2020, $180 billion less than the shortfall that CBO projected in September 2020. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On October 6, the Supreme Court began its new term hearing oral arguments for Rutledge v. Pharmaceutical Care Management Association, concerning the regulation of pharmacy benefit managers (PBMs) and drug costs for commercial health plans. The case will determine whether independent pharmacies should receive invoiced wholesale prices for drugs instead of PBMs-dictated prices. A decision on the case is expected this spring.
On October 6, Willis Towers Watson released a report predicting that global health care benefit costs will increase by more than 8% in 2021. Health care benefit cost increases are expected to remain stable in the U.S., at 7.3% in 2021.
On October 6, a study published by RAND Corp. entitled Comparing Insulin Prices in the United States to Other Countries found that insulin prices were five to 10 times higher in the U.S. than in other countries.
On October 7, Vice President Mike Pence and Sen. Kamala D. Harris (D-CA) participated in the first vice presidential debate. The debate included discussions about the Administration’s COVID-19 response and the Supreme Court case on the Affordable Care Act.
On October 7, the Commission on Presidential Debates announced that the Oct. 15 presidential debate between Democratic nominee Joe Biden and President Trump will be held virtually. President Trump immediately announced that he will not participate in the next debate if it is held virtually.
On October 7, the Commonwealth Fund released a report estimating that 7.7 million workers lost jobs with employer-sponsored health insurance (ESI) through June because of COVID-19. The report estimated that 6.9 million dependents were covered by the ESI of these workers, totaling 14.6 million people affected by a loss of ESI.
On October 8, the Kaiser Family Foundation released a report entitled the 2020 Employer Health Benefits Survey. The report found that the marketplace for employer-based health coverage was stable and the share of workers in self-funded plans increases. The report also found that in 2020, the average annual premiums for ESI insurance are $7,470 for individual coverage and $21,342 for family coverage, about a 4% increase from 2019.
On October 8, HCA Healthcare announced that the company will give back $1.6 billion in federal bailout payments and pay back $4.4 billion in Medicare loans received as part of the Coronavirus Aid, Relief, and Economic Security Act.
On October 8, the Working Families Party, including progressive groups and Democratic members, released a 2021 agenda entitled the People’s Charter including support for free, universal health care; home and community based services; and taking “hospital and health insurance profits out of [health care].”