Health Care Watch: November 1, 2020
The following Health Care Watch provides a summary of legislative and regulatory health care activities from October 26 - October 31. 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
On October 30, Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) introduced the Holding Providers Harmless From Medicare Cuts During COVID–19 Act of 2020, which would delay proposed cuts to Medicare reimbursement rates, as part of the Medicare Physician Fee Schedule, for two years.
The House is scheduled to return on November 16 and the Democrats and Republicans are scheduled to hold their leadership elections that week.
Senate
On October 26, the Senate confirmed Judge Amy Coney Barrett 52-48 to be an Associate Justice of the Supreme Court. Judge Barrett’s confirmation secures a 6-3 conservative majority in the high court.
On October 27, Finance Chairman Chuck Grassley (R-IA), Finance Ranking Member Ron Wyden (D-OR), Sen. Todd Young (R-IN), and Sen. Ben Cardin (D-MD) released a letter from October 23 asking Health and Human Services (HHS) about the agency’s oversight of the organ procurement organizations (OPO) and transplantation system. The Senators voiced their concern with potential gaps in federal oversight of OPOs that may result in fraud, abuse, and waste of the Medicare program.
The Senate is scheduled to return on November 9.
NON-CORONAVIRUS REGULATORY UPDATE
On October 26, Food & Drug Administration (FDA) published a final standard Memorandum of Understanding (MOU) entitled Addressing Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration. State pharmacy boards that sign the MOU will be given additional time to investigate complaints about compounded human drug products from their state that may be distributed to other states. A summary of the MOU is available here.
On October 26, the Centers for Medicare & Medicaid Services (CMS) announced that consumers can preview 2021 healthcare plans and prices on HealthCare.gov. The Federal Marketplace Open Enrollment Period runs from November 1, 2020 to December 15, 2020, for coverage starting on January 1, 2021.
On October 27, CMS published the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare Common Procedure Coding System proposed rule. The rule would establish methodologies for adjusting DMEPOS fee schedule amounts using information from the competitive bidding program; certain policies and procedures regarding the submission and evaluation of Healthcare Common Procedure Coding System (HCPCS) Level II code applications; and procedures for making benefit category determinations and payment determinations for DME, prosthetics, orthotics, and other new items and services under Part B. The rule also proposes to classify continuous glucose monitors as DME under Part B and establish related fee schedule amounts. A summary is available here. A fact sheet on the rule is available here.
On October 27, CMS announced the 2021 DMEPOS Competitive Bidding Program (CBP) Single Payment Amounts and Contract Offers. The 2021 program will include off-the-shelf back and knees braces. CMS is not awarding competitive bidding contracts for the 13 product categories for Round 2021 that were previously competed because the payment amounts did not achieve expected savings. These new payment amounts and contracts go into effect on January 1, 2021.
On October 28, CMS released the October 2020 Skilled Nursing Facility Quality Reporting Program data, the last scheduled refresh of this data until the January 2022 refresh.
On October 28, CMS launched the Nursing Home Resource Center to bring together information, guidance, and data on nursing homes that is important to facilities, frontline providers, residents and their families.
On October 29, CMS announced seven finalists to advance to the final round of the Artificial Intelligence (AI) Health Outcomes Challenge. The competition includes participants proposing AI solutions for predicting patient health outcomes, aimed at revolutionizing healthcare for potential use by the Center for Medicare & Medicaid Innovation (CMMI).
On October 29, the Departments of Health & Human Services, Labor, and Treasury released a final rule entitled Transparency in Coverage to increase price transparency in private plans (most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets). Under the rule, plans must make available to beneficiaries personalized out-of-pocket cost information, and underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based tool and in paper form upon request. An initial list of 500 “shoppable” services will be required to be available via the tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for plan years that begin on or after January 1, 2024. Plans must also make available to the public three separate machine-readable files that include detailed pricing information on in-network provider negotiated rates, historical out-of-network allowed amounts, and drug pricing information. These data files must be displayed in a standardized format and updated monthly. They must be made public for plan years that begin on or after January 1, 2022. The rule also finalizes amendments related to the medical loss ratio (MLR) program that allow plans to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers. A summary of the rule is available here.
On October 29, the HHS Office of the National Coordinator for Health IT (ONC) released an interim final rule to extend the compliance dates and timeframes by one year, to April 5, 2021, to meet certain requirements related to information blocking and Conditions and Maintenance of Certification requirements, as part of the 21st Century Cures Act Final Rule.
On October 29, CMS released a final rule entitled calendar year (CY) 2021 Home Health Prospective Payment System Rate Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements. This rule updates the home health (HH) prospective payment system (PPS) payment rates and wage index for CY 2021, implements rules for telehealth services for home health, implements the permanent home infusion therapy services benefit and supplier enrollment requirements, and aligns the Home Health Value-Based Purchasing Model data submission requirements and New Measures data reporting requirements with exceptions during the COVID-19 public health emergency (PHE). The HH PPS payment rate update proposes an estimated $390 million or 1.9% in increased payments to home health agencies in CY 2021.
On October 30, CMS released Part II of the 2022 Medicare Advantage and Part D Advance Notice. Part I of the Advance Notice, which dealt exclusively with the Medicare Advantage (MA) risk adjustment model, was published on September 14. Under the notice, MA and Part D plans will see an estimated 2.82% increase in revenue in 2022. The notice indicates that CMS will apply a 5.9% statutory minimum coding intensity adjustment to risk scores. The final 2022 Rate Announcement must be published by April 5, 2021, although it is expected to be released in January (CMS states intends to release it “a few months earlier” than required). Comments on both Part I and Part II of the Advance Notice are due by November 30.
On October 30, the Drug Enforcement Administration released a final interim rule entitled Implementation of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment. As mandated by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018, the rule expands the types of practitioners that may provide medication-assisted treatment and expands the options available for a physician to be considered a qualifying physician. The comment period is open until December 29.
On October 30, the FDA released a revised guidance document entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 Public Health Emergency (PHE). The guidance aims to expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during the PHE.
On October 30, the FDA released a list of drug and biologic essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times, as part of President Trump’s Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. Under the EO, the FDA must work with other Federal entities on strategies for acquiring products on the list, accelerating domestic manufacturing, and identifying and addressing supply chain vulnerabilities.
On October 30, the CMMI released multiple updated publications, including the 53 Direct Contracting Entities participating in the Implementation Period, the Direct Contracting (DC)/Kidney Care Choices (KCC) Rate Book, and the DC/KCC Risk Adjustment.
On October 30, HHS and the American Society of Nephrology launched the KidneyX Artificial Kidney Prize to accelerate the development of artificial kidneys toward human clinical trials. This competition offers up to $10 million in prizes. Phase 1 of the competition sets the goal of finding solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys.
On October 30, HHS published the final 2020-2025 Federal Health IT Strategic Plan, outlining federal health IT goals and objectives, with a focus on individuals’ access to their electronic health information. A summary of the plan is available here.
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
CORONAVIRUS UPDATE
Legislative
On October 27, Speaker Pelosi announced a relief package will not be passed before the election but will aim for passing a legislation before the end of the year. Speaker Pelosi also outlined the need for additional funding for state and local governments, schools, childcare, tax credits, unemployed insurance, and OSHA and liability rules. Senate Majority Leader Mitch McConnell predicted that a package would be passed at the beginning of the year.
On October 27, the Congressional Research Service released a report entitled COVID-19 and the Uninsured: Federal Funding Options to Pay Providers for Testing and Treatment. The report provides federal funding options under the Families First Coronavirus Response Act that can be used to pay providers for COVID-19-related testing and treatment for uninsured individuals through the Uninsured Fund and a newly created Medicaid option for testing.
On October 28, Sen. Jeff Merkley (D-OR), Health, Education, Labor & Pensions Committee Ranking Member Patty Murray (D-WA), Kirsten Gillibrand (D-NY), Minority Leader Chuck Schumer (D-NY), Finance Committee Ranking Member Ron Wyden (D-OR), Cory Booker (D-NJ), and Maria Cantwell (D-WA) raised concerns to HHS regarding the potential loss of federal COVID-19 and other health-related funding for Department of Justice-identified “anarchist jurisdictions,” as part of the Memorandum on Reviewing Funding to State and Local Government Recipients That Are Permitting Anarchy, Violence, and Destruction in American Cities, originally released on September 2.
On October 30, the Select Subcommittee on the Coronavirus Crisis released a report entitled Inefficient, Ineffective and Inequitable: the Trump Administration’s Failed Response to the Coronavirus Crisis. The report reviewed the first six months of the PHE, calling the Trump Administration’s response to COVID-19 “among the worst failures of leadership in American history.” The report found that the White House publicly downplayed the severity of the pandemic, contradicting internal reports; interfered with scientific guidance; and left states to take independent action, rather than providing a federally funded national plan.
Regulatory
On October 26, HHS released data showing that only 62% of hospitals are reporting all mandated COVID-19 data. CMS previously announced that hospitals risk losing Medicare and Medicaid funding if they do not comply with daily reporting requirements by mid-January.
On October 27, Operation Warp Speed Chief Operating Officer Gen. Gustave Perna predicted that hundreds of millions of doses will be distributed in the first three months of 2021.
On October 28, the Health Resources and Services Administration announced $333 million in first round performance payments to over 10,000 nursing homes for demonstrating significant reductions in COVID-19-related infections and deaths between August and September.
On October 28, the Departments of HHS, Labor and Treasury released an Interim Final Rule with Comment (IFC) that establishes payment policies related to COVID-19 vaccines, and other COVID-19-related policies. The IFC includes the following COVID-19 payment policies:
Medicare: The rule establishes that any vaccine that receives FDA Emergency Use Authorization (EUA) or is licensed under a Biologics License Application (BLA) will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. Medicare will also pay directly for the COVID-19 vaccine and its administration for MA beneficiaries for CY 2020 and 2021. The rule increases the number of providers that can administer a COVID-19 vaccine to beneficiaries, enrolling new or non-traditional providers as “Medicare mass immunizers.” The rule also establishes additional Medicare hospital inpatient and outpatient payments to support Medicare patients’ access to COVID-19 therapies and treatments.
Medicaid and CHIP: State Medicaid and CHIP agencies must provide vaccine administration with no cost sharing for most beneficiaries during the PHE. In the future, states may have to evaluate cost sharing policies and may have to submit state plan amendments.
Private Plans: Private plans must cover a COVID-19 vaccine and its administration without cost-sharing. Plans must also cover without cost sharing a vaccine, regardless of whether an in-network or out-of-network provider delivers the services, during the PHE.
Uninsured: For uninsured individuals, providers will be able to reimburse COVID-19 vaccine administration through the Provider Relief Fund
CMS also released a set of toolkits for providers, states, and insurers to help the health care system prepare to swiftly administer the vaccine once it is available. A fact sheet is available here. A summary of the rule is available here. The comment period is open until December 28.
On October 28, FDA Center for Biologics Evaluation and Research Director Peter Marks released an op-ed in USAToday entitled I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe and effective. Marks outlined the FDA’s evaluation process a COVID-19 vaccine would need to clear before being authorized and reassured the public that the process will not be rushed.
On October 28, HHS and the Department of Defense (DoD) announced a $375 million agreement with Lilly to purchase 300,000 doses of the company’s COVID-19 investigational antibody therapeutic bamlanivimab, LY-CoV555, with the option to purchase an additional 650,000 doses through June 2021 for up to an additional $812.5 million.
On October 28 through 29, the Centers for Disease Control and Prevention (CDC) Clinical Laboratory Improvement Advisory Committee held meetings discussing challenges and opportunities with COVID-19 lab reporting.
On October 28 through 30, the CDC Advisory Committee on Immunization Practices held meetings discussing early COVID-19 vaccine allocation and ways to monitor safety after a vaccine reaches the market.
On October 30, HHS and DoD awarded Hologic, Inc $119 million to increase domestic COVID-19 diagnostic testing capacity, allowing Hologic to expand production capacity for COVID-19 tests 13 million COVID-19 tests per month by January 2022.
On October 30, HHS Secretary Alex Azar met with state governors regarding local, state, and federal COVID-19 response and recovery efforts and vaccine distribution and administration planning. HHS published the agency’s response to technical questions on the vaccine planning and distribution effort.
White House
On October 30, President Trump suggested doctors were attributing deaths due to COVID in order to maximize reimbursements. Former Vice President and the American Medical Association denounced these comments.
Other
On October 26, AstraZeneca announced the company’s COVID-19 vaccine candidate, AZD1222, produced similar immune responses in older and younger adults, with lower adverse responses among older trial participants.
On October 26, Lilly announced the company will end the Phase III clinical trial of its monoclonal antibody treatment, bamlanivimab, plus remdesivir for hospitalized COVID-19 patients, due to "lack of clinical benefit.” Other studies of bamlanivimab to treat COVID-19 will continue. In early October, Lilly submitted a request for EUA for bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients.
On October 26, the Pharmaceutical Care Management Association issued guiding principles for safe and effective COVID-19 vaccine development, distribution, allocation and mass immunization.
On October 27, Ariadne Labs and Surgo Foundation launched a COVID-19 vaccine allocation planner to estimate the size of different populations, the number of vaccine doses that may be available to each state, and the percent vaccine coverage achievable, under various scenarios.
On October 27, the Kaiser Family Foundation (KFF) released a report entitled Racial and Ethnic Disparities in COVID-19 Cases and Deaths in Nursing Homes. The report found that nursing homes with higher shares of Black or Hispanic residents were more likely to report at least one COVID-19 death and reported more severe case outbreaks than nursing homes with lower shares of Black or Hispanic residents.
On October 27, Nevada, Oregon, and Washington joined California’s COVID-19 Scientific Safety Review Workgroup to review the safety and efficacy of any COVID-19 vaccine that receives FDA approval.
On October 27, Pfizer announced it has yet to record enough COVID-19 cases among trial participants to determine whether the vaccine is effective, delaying the company’s predicted timeline for a COVID-19 vaccine.
On October 27, Merck predicted that the company will report results from two potential COVID-19 vaccine early-stage studies before the end of the year. Merck also advanced two late-stage studies of an experimental COVID-19 antiviral drug, molnupiravir, into late-stage testing.
On October 27, Novavax delayed the start of the company’s U.S. COVID-19 vaccine Phase III clinical trials until late November, from an original mid-October start date.
On October 28, Sanofi and GlaxoSmithKline announced an agreement with COVAX, the global coalition for equitable access to COVID-19 vaccines, to make 200 million doses of the company’s experimental COVID-19 vaccine available.
On October 28, Regeneron released results from the company’s COVID-19 investigational antibody cocktail, REGN-COV2, Phase II/III trial supporting that the cocktail significantly reduced viral load and COVID-19-related medical visits. Regeneron previously submitted REGN-COV2 for EUA for patients with mild-to-moderate COVID-19 who are at high risk for poor outcomes
On October 28, data from Lilly’s Phase II study of the COVID-19 neutralizing antibody bamlanivimab was published in the New England Journal of Medicine.
On October 30, Regeneron received a recommendation from the independent data monitoring committee that the company stop enrolling hospitalized patients who require high-flow oxygen or a ventilator in the company’s coronavirus REGN-COV2 antibody cocktail treatment clinical trials.
On October 30, the U.S. set a new single-day record for coronavirus infections (90,456).
As of October 31, the U.S. had 9,075,777 confirmed COVID-19 cases resulting in 230,009 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
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
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Proposed Rule; Received 9/29/20
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 26, OIG released a report entitled Massachusetts Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs. The report found that Massachusetts did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs, resulting in $11.4 million in physician-administered drugs not being invoiced for rebates. OIG also found that Massachusetts did not submit the utilization data necessary to secure rebates for all other physician-administered drugs, resulting in $783,000 worth of claims that could have been eligible for rebates. OIG recommended that Massachusetts refund $11.4 million in missed rebates and work with CMS to resolve other claims in question. Massachusetts did not agree with the OIG recommendations. A summary of the report is available here.
On October 30, OIG released a report entitled Minnesota Did Not Bill Manufacturers for Some Rebates for Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. The report found that Minnesota did not fully comply with Federal Medicaid requirements for billing manufacturers for rebates for drugs dispensed to MCO enrollees, resulting in $6.1 million in uncollected rebates. OIG recommends that Minnesota bill for and collect manufacturers’ rebates for pharmacy drugs and for single-source and top-20 multiple-source physician-administered drugs and other pharmacy and physician-administered drugs not identified in the audit. A summary of the report is available here.
On October 30, OIG released a report entitled Medicare Hospital Provider Compliance Audit: St. Francis Hospital. The report found that St. Francis Hospital did not comply with Medicare billing requirements for all inpatient and outpatient claims, resulting in an estimated $1.6 million in overpayments. OIG recommends that St. Francis Hospital refund the estimated overpayments and strengthen controls to ensure full compliance with Medicare requirements. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On October 26, Florida announced the state’s Agency for Health Care Administration did not receive any bids for the $30 million contract to set up and operate a drug importation program. This setback will likely delay the state’s plan to award a contract to a vendor in December.
On October 26, CMS granted Indiana’s Medicaid expansion program a 10-year extension that requires beneficiaries to work and pay premiums. Indiana is the first state to receive a 10-year extension, with states typically receiving only a two- or three-year extension. The expansion allows for continued health coverage for more than 572,000 people.
On October 27, the Committee for a Responsible Federal Budget released a report entitled A Closer Look at the Record $3.1 Trillion Deficit in fiscal year (FY) 2020. The report found that Medicaid spending was up 12% in FY 2020, over FY 2019, due to higher enrollment and an increase in matching funds to states. The report also found that Medicare spending was up over 19% in FY 2020, over FY 2019, due to accelerated payments to providers that will eventually be paid back.
On October 29, KFF released a report entitled MA 2021 Spotlight: First Look. The report found that Medicare beneficiaries, on average, will have access to 33 MA plans in 2021, with 3,550 MA plans available nationwide.
On October 29, KFF released a report entitled Medicare Part D: A First Look at Medicare Prescription Drug Plans in 2021. The report found that Medicare beneficiaries, on average, will have a choice of 30 stand-alone prescription drug plans and 27 MA prescription drug plans in 2021.
On October 29, KFF released a report entitled More Than Half of All People on Medicare Do Not Compare Their Coverage Options Annually. The report found that 57% of Medicare beneficiaries do not review or compare coverage options annually and one-in-three report difficulty understanding the program or comparing coverage options.