The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 21 - December 27. 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. The Weekly Health Care Watch is taking a holiday break next week and will publish again on January 10.
BIDEN TRANSITION
On December 21, President-elect Joe Biden and incoming First Lady Jill Biden received the first dose of the Pfizer COVID-19 vaccine.
Biden announced a series of appointments and nominations this week, including:
David Kamin for deputy National Economic Council (NEC) Director;
Bharat Ramamurti for Deputy Director of the NEC Director for Financial Reform and Consumer Protection;
Miguel Cardona for Education Secretary;
Bruce Reed for Deputy Chief of Staff;
Gautam Raghavan for Deputy Director of the Office of Presidential Personnel;
Anne Filipic for White House Director of Management and Administration;
Ryan Montoya for Vice President-elect Kamala Harris’ Director of Scheduling and Advance;
Vinay Reddy for White House Director of Speechwriting; and
Elizabeth Wilkins for Senior Adviser to the Chief of Staff.
NON-CORONAVIRUS LEGISLATIVE UPDATE
Senate
On December 21, Majority Leader Mitch McConnell (R-KY) promised to bring all of Biden’s nominations to the Senate floor.
House
On December 21, Congress passed a $1.4 trillion annual government funding package, which included a $900 billion COVID-19 relief agreement. President Donald Trump voiced his dissatisfaction with the package over the $600 direct stimulus checks, calling for $2,000 checks. After suggesting he may veto the bill, President Trump signed the legislation on December 27.
The package includes (but is not limited to) the following priorities:
$325 billion for small business;
$286 billion in direct economic relief for workers and families (including up to $600 in direct payments per adult and child);
$82 billion for schools;
$69 billion for vaccines, testing and tracing, community health and provider support;
$45 billion for transportation;
$26 billion for nutrition and agriculture;
$25 billion for rental assistance;
$12 billion for support for community development financial institutions and minority depository institutions;
$10 billion for child care; and
$7 billion for broadband.
The package also includes an agreement to protect patients from receiving “surprise” medical bills. Summaries are available for the omnibus provisions, coronavirus provisions, and authorizing provisions.
An LPG summary of the relevant health care provisions can be found here.
NON-CORONAVIRUS REGULATORY UPDATE
On December 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Based Purchasing for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability Requirements (CMS 2482-F). The rule makes significant changes to the Medicaid Drug Rebate Program (MDRP) regulations with respect to the treatment of value-based purchasing (VBP) arrangements (and associated multiple Best Price (BP) and/or “bundled” BP reporting), the definition of key terms “line extension” and “new formulation,” and the price reporting treatment of manufacturer-sponsored patient benefit programs. The rule also includes provisions that aim to encourage the appropriate use of opioids and reduces prescription-related fraud, abuse and misuse. The rule is effective on March 1, 2021; however certain provisions (including the reporting of multiple BP figures for VBP arrangements and the definitions of “line extension” and “new formulation” are effective January 1, 2022). A fact sheet on the rule is available here. A summary of the rule is available here.
On December 21, CMS proposed to update the coverage policy for Autologous Blood-Derived Products for Chronic Non-Healing Wounds, expanding coverage for platelet rich plasma for the treatment of chronic non-healing diabetic, venous, and pressure wounds. Comments on the proposed national coverage determination are due January 20. A summary of the proposed changes is available here.
On December 21, CMS released the monthly Medicaid and Children’s Health Insurance Program (CHIP) Enrollment Trends Snapshot. The snapshot showed a continued increase in enrollment for these programs, with a decline in applications early in the public health emergency (PHE), then an increase in applications beginning in June, with a significant increase in applications between July and August 2020.
On December 21, the Food & Drug Administration (FDA) requested nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health.
On December 22, CMS released the 2020 list of quality and efficiency measures under consideration. Almost all of the measures proposed would be collected digitally, from claims and other electronic sources, and would not require doctors to retrieve data manually. A summary of the proposed measures is available here.
On December 22, the Department of Justice filed a lawsuit against Walmart over allegedly unlawfully dispensing controlled substances from its pharmacies across the country.
On December 22, CMS released guidance to help states restore regular Medicaid and CHIP operations after the COVID-19 PHE, assisting states in transitioning away from the temporary program flexibilities and waivers implemented during the PHE. A summary of the guidance is available here.
On December 22, CMS launched the next phase of the Maternal and Infant Health Initiative to support state Medicaid and CHIP agencies in improving the use, access, and quality of care for women and infants. The launch includes instructional webinars and tools to support states in focusing on postpartum care visits, well-child visits, and decreasing rates of cesarean section births in low-risk pregnancies.
On December 22, Health Resources & Services Administration issued a final rule entitled Implementation of Executive Order on Access to Affordable Life-saving Medications. This rule implements one of President Trump’s drug pricing EOs that aims to lower patients' out-of-pocket costs by requiring Federally Qualified Health Centers (FQHCs) to pass on their 340B drug discounts to patients with high cost-sharing for insulin or Epi-Pens or a high unmet deductible. The rule is effective January 22, 2021.
The FDA will host a meeting entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act on January 27, 2021.
On December 23, the U.S. District Court in Maryland granted a 14-day restraining order to delay the start of the Most-Favored-Nation (MFN) drug pricing model. The MFN model was scheduled to be implemented on January 1, 2021. The suit was brought on by PhRMA, along with the Association of Community Cancer Centers, Global Colon Cancer Association and National Infusion Center Association. The plaintiffs requested both a restraining order and a preliminary injunction. Judge Catherine Blake indicated that she was sympathetic to arguments that the Administration circumvented the rulemaking process by issuing the model via an Interim Final Rule and that the model could harm patients. While the restraining order is active, the judge is reviewing the request for a preliminary injunction further delaying the model. Three other lawsuits have also been filed requesting preliminary injunctions.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On December 21, House Select Subcommittee on Coronavirus Chair Jim Clyburn (D-SC) issued subpoenas for HHS Secretary Alex Azar and Centers for Disease Control & Prevention (CDC) Director Robert Redfield following committee investigations into HHS political appointees interfering with at least 13 COVID-19-related scientific reports produced by the CDC.
On December 21, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Special Committee on Aging Ranking Member Bob Casey (R-PA) sent a letter to HHS Secretary Azar and CMS Administrator Seema Verma emphasizing the “urgent need” to provide COVID-19 vaccines to nursing home and long term care facilities staff and residents.
Regulatory
On December 21, states began receiving Moderna’s COVID-19 vaccine and distributing the vaccine to health care providers.
On December 21, Operation Warp Speed announced it may test a lower dose of Moderna’s COVID-19 vaccine in order to stretch supply.
On December 21, Surgeon General Jerome Adams called for people who have recovered from COVID-19 to consider donating COVID-19 convalescent plasma to help treat COVID-19 patients.
On December 21, CMS updated its Medicare coding and payment for COVID-19 vaccines, following the Emergency Use Authorization of Moderna’s COVID-19 vaccine.
On December 21, the National Institutes of Health (NIH) launched a study of people suffering severe allergic reactions to Pfizer’s COVID-19 vaccine. The NIH study aims to recruit participants with a history of serious allergic reactions and administer the vaccine doses under close clinical supervision.
On December 21, the NIH Rapid Acceleration of Diagnostics initiative awarded $107 million to support new, non-traditional approaches and reimagined uses of existing tools to address gaps in COVID-19 testing and surveillance.
On December 22, HHS Secretary Azar estimated that 50 million people in the U.S. will have received the first of two COVID-19 shots needed for immunization by the end of January.
On December 22, the NIH paused enrollment of its ACTIV trial of blood thinners to treat critically ill COVID-19 patients. Enrollment continues for moderately ill hospitalized COVID-19 patients.
On December 23, HHS and the Department of Defense (DoD) purchased an additional 100 million doses of the Pfizer COVID-19 vaccine to be delivered before July 31, 2021. Pfizer aims to deliver at least 70 million doses by June 30, 2021. The agreement also includes options to purchase an additional 400 million doses of the Pfizer vaccine.
On December 23, HHS and DoD announced a $356 million agreement with Merck to support development and large-scale manufacturing of the investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19.
On December 23, the CDC announced that more than 1 million Americans have received a COVID-19 vaccine.
White House
On December 22, White House Coronavirus Task Force coordinator Deborah Birx announced that she would retire after assisting the Biden Administration in transition.
Other
On December 21, New York Gov. Andrew Cuomo (D) created a Vaccine Equity Task Force to ensure fairness and equity in COVID-19 vaccine distribution.
On December 22, Amazon, CVS Health, and Thermo Fisher Scientific launched an initiative entitled Workplace Employers Alliance for COVID-19 Testing, to emphasize the importance of employer-based testing programs to combat COVID-19. The group will advocate for a comprehensive national testing strategy that includes expanded testing of asymptomatic population
As of December 27, the U.S. had 19,073,662 confirmed COVID-19 cases resulting in 332,723 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); Received 6/6/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
Contract Year 2022 Policy and Technical Changes to the MA Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20
Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372); Final Rule; Received 12/14/20
HHS-IHS
Calendar Year 2021 Reimbursement Rates; Notice; Received 12/2/20
REPORTS
HHS Office of Inspector General (OIG)
On December 22, OIG released a report entitled Onsite Surveys of Nursing Homes During the COVID-19 Pandemic: March 23-May 30, 2020. The report found that states varied in the number of onsite surveys at nursing homes during the early months of the COVID-19 PHE. OIG found that state officials reported ongoing challenges to securing adequate personal protective equipment and surveyors to complete onsite surveys, and there continues to be concerns about mounting backlogs of standard and complaint surveys. OIG recommended that CMS assess the results of the focused infection control survey and revise the survey as appropriate, work with States to help overcome challenges with PPE and staffing and clarify expectations for States to complete backlogs of surveys. A summary of the report is available here.
On December 22, OIG released a report entitled Despite Savings on Many Lab Tests in 2019, Total Medicare Spending Increased Slightly Because of Increased Utilization for Certain High-Priced Tests. A report found that Medicare Part B spending increased slightly to $7.68 billion, a $93 million increase from 2018, despite payment rate reductions on many lab tests. OIG also found that Medicare expenditures on the top 25 tests increased slightly in 2019. OIG concluded that payment rate adjustment required by Protecting Access to Medicare Act of 2014 achieved expected savings for some lab tests that had payment rate reductions in 2019, but the savings that resulted from lower rates were overtaken by increased Medicare spending on lab tests that had no payment rate change in 2019, including certain high-priced genetic tests. A summary of the report is available here.
On December 23, OIG released a report entitled Aspects of Texas' Quality Incentive Payment Program Raise Questions About Its Ability To Promote Economy and Efficiency in the Medicaid Program. The report found that Texas’ Quality Incentive Payment Program (QIPP) may not promote economy and efficiency in Medicaid. OIG found that nursing facilities received less than half of the earned incentive payments; facilities participating in QIPP were generally rated below average in overall quality; facilities that declined in performance continued to receive quality improvement incentive payments; and two local government entities participating in QIPP funded $1.3 million of the non-Federal share of QIPP payments through intergovernmental transfers (IGT). OIG recommended that CMS work with Texas to determine whether the source of IGTs and the practice of using debt instruments to fund the non-Federal share of QIPP payments meets program objectives and promotes economy and efficiency in Medicaid, and reevaluate Texas' QIPP to ensure that it operates in a manner that meets program objectives while promoting economy and efficiency in Medicaid. A summary of the report is available here.
Congressional Budget Office (CBO)
On December 22, the CBO released a report entitled CBO Estimate for Division M of H.R. 133, the Consolidated Appropriations Act, 2021. This report details the breakdown in spending of the omnibus spending bill.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On December 21, the American Hospital Association filed an emergency motion for a stay of enforcement to stop the enforcement of the HHS price transparency rule. The rule is scheduled to take effect on January 1, 2021.
On December 22, the Federation of American Hospitals called for President-elect Biden to address the following issues during his administration: access to health care coverage and medical services; protecting patients in accessing care; a level-playing field for all hospitals, advancing health system, quality, equity, and efficiency; a robust health care workforce; and adequate health system resources.