The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 5 - April 10. 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 April 6, House Education & Labor Chair Bobby Scott (D-VA), Energy & Commerce Chair Frank Pallone (D-NJ), Ways & Means Chair Richard Neal (D-MA), Senate Health, Education, Labor & Pensions Chair Patty Murray (D-WA), and Finance Chair Rob Wyden (D-OR), urgedHealth & Human Services (HHS) Secretary Xavier Becerra to announce the availability of a Special Enrollment Period (SEP) for qualified eligible individuals following the conclusion of the American Rescue Plan premium subsidy program for job-based coverage. They also urged Secretary Becerra to coordinate efforts with the Department of Labor to ensure that consumers are made fully aware of the SEP as well as the availability of premium tax credits and cost-sharing reductions.
On April 6, Reps. Anne Kuster (D-NH), Nanette Barragan (D-CA), Katie Porter (D-CA), and Davide Trone (D-MD) urged HHS Secretary Xavier Becerra to renew the public health emergency (PHE) declared to combat the opioid epidemic and broaden its scope to address the evolving drug epidemic and improve efforts to address mental health in the U.S.
The House will consider the following bills the week of April 12:
The Senate Amendment to H.R. 1868, which will provide relief from the Medicare sequester cuts through 2021;
H.R. 941 TRANSPLANT Act of 2021; and
S. 164 Advancing Education on Biosimilars Act of 2021.
The House is in recess until April 12.
Senate
The Finance Committee will consider the nomination of Chiquita Brooks-LaSure for Administrator of the Centers for Medicare & Medicaid Services (CMS) on April 15.
The Senate is in recess until April 12.
NON-CORONAVIRUS REGULATORY UPDATE
On April 6, CMS withdrew its permission allowing Michigan and Wisconsin to implement Medicaid work requirements.
On April 7, CMS announced that 528,000 consumers signed up for health insurance through HealthCare.gov during the SEP through March 31, including approximately 322,000 signups from March 1 to March 31. Enrollment data is available here.
On April 7, CMS issued a proposed rule entitled FY 2022 Inpatient Psychiatric Facilities (IPF) Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022). For FY 2022, CMS is proposing to update the IPF PPS payment rates by 2.1% based on the proposed IPF market basket update of 2.3%, less a 0.2% productivity adjustment. CMS estimates that total payments to IPFs will increase by 2.3% or $90 million in FY 2022 relative to IPF payments in FY 2021. A fact sheet on the rule is available here.
On April 7, CMS issued a proposed rule entitled Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program.
For FY 2022, CMS is proposing to update the IRF PPS payment rates by 2.2% based on the proposed IRF market basket update of 2.4%, less a 0.2% productivity adjustment. CMS estimates that the overall increase to IRF payments for FY 2022 would be 1.8% or $160 million relative to payments in FY 2021. A fact sheet on the rule is available here.
On April 8, CMS issued a proposed rule entitled Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs); Updates to the Quality Reporting Program and Value-Based Purchasing (VBP) Program for Federal Fiscal Year 2022. CMS estimates that the overall impact of the payment policies in the proposed rule would result in an increase of approximately $444 million in Medicare payments to SNFs in FY 2022. This estimate reflects a $445 million increase from the update to the payment rates of 1.3%, which is based on a 2.3% SNF market basket update, less a 0.8% forecast error adjustment and a 0.2% productivity adjustment, and a $1.2 million decrease due to the proposed reduction to the SNF PPS rates to account for the blood-clotting factors exclusion policy recently authorized by the Consolidated Appropriations Act of 2021. The new policy requires that certain specified blood clotting factors be excluded from the consolidated billing requirements. CMS notes that the impact figures do not incorporate the SNF VBP reductions that are estimated to be $184.25 million in FY 2022. A fact sheet on the rule is available here.
On April 8, CMS issued a proposed rule entitled FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements. For FY 2022, CMS is proposing to increase hospice payments by 2.3% ($530 million) based on an estimated 2.5% inpatient hospital market basket update reduced by a 0.2% productivity adjustment. Hospices that fail to meet quality reporting requirements receive a 2% reduction to the annual market basket update for FY 2022. A fact sheet on the rule is available here.
On April 8, CMS introduced the Hospice Care Index (HCI) as a proposed measure for the Hospice Quality Reporting Program. The HCI aims to strengthen the quality reporting program, while providing families and patients the information they need to decide which hospice is right for them. A video summary of the model background is available here.
On April 8, CMS’ Center for Medicare and Medicaid Innovation (CMMI) announced the 53 organizations participating in Performance Year 2021 of the Global and Professional Direct Contracting Model. A list of participants is available here. Updated FAQs are available hereand Financial FAQs are available here.
On April 8, CMS announced the selected applicants for the Value in Opioid Use Disorder (OUD) Treatment Demonstration, which tests whether a new care management fee and performance-based incentive for OUD treatment services can cut hospitalizations and improve health outcomes for individuals with OUD.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On April 9, the White House released the FY 2022 discretionary budget request for fiscal year 2022. The budget proposal does not include tax proposals, or proposal related to mandatory spending programs like Medicare and Medicaid. The full budget is expected later this Spring, which will include details on taxes and mandatory spending. The discretionary budget request includes $133.7 billion for HHS, a $25.1 billion or 23.1% increase from the 2021 enacted level. The budget includes the following notable proposals:
Preparing for Future Public Health Emergencies:
o $8.7 billion for CDC, an increase of $1.6 billion over the 2021 enacted level; and $905 million for Office of the Assistant Secretary for Preparedness and Response (ASPR) Strategic National Stockpile (SNS) to maintain replenishment of critical medical supplies and restructuring efforts initiated during the COVID-19 pandemic.
Promoting Biomedical Research / Creating a New Research Innovation Agency: $51 billion for o the National Institutes of Health, a $9 billion increase over the 2021 enacted level. Included in this increase is $6.5 billion to establish a new agency, the Advanced Research Projects Agency for Health to drive transformational innovation in health research and speed application and implementation of health breakthroughs. The Agency will initially focus on cancer, diabetes and Alzheimer's research.
Non-COVID Proposals:
o Opioid Crisis: $10.7 billion, an increase of $3.9 billion over the 2021 enacted level, to help end the opioid crisis.
o HIV/AIDS Epidemic: $670 million, an increase of $267 million over the 2021 enacted level, to help end the HIV/AIDS epidemic in the United States.
o Mental Health: $1.6 billion, more than double the 2021 enacted level, for the Community Mental Health Services Block Grant.
o Racial Disparities: $153 million for CDC’s Social Determinants of Health program, an increase of $150 million over the 2021 enacted level, to support all States and Territories in improving health equity and data collection for racial and ethnic populations. Community Living: $551 million for home and community-based services, doubles funding for the Lifespan Respite Care program, increases resources for meal programs for older Americans, and expands services for individuals with disabilities.
A summary of the budget request is available here.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On April 5, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Symbiotica’s home COVID-19 Self-Collected Antibody Test System.
On April 5, Secretary of State Antony Blinken announced the appointment of Gayle Smith for U.S. Global COVID-19 Response and Health Security Coordinator.
On April 5, the FDA issued guidance to provide general recommendations to prospective applicants of abbreviated new drug applications related to generic drug product development and regulatory submissions during the COVID-19 PHE.
On April 7, HHS announced that all Health Resources and Services Administration-funded health centers and Health Center Program look-alikes will be invited to participate in the Health Center COVID-19 Vaccine Program, to expand access to COVID-19 vaccines in underserved communities and those disproportionately affected by COVID-19.
On April 7, the Department of Labor released guidance in the form of FAQs and model notices for the American Rescue Plan’s COBRA premium subsidy program, which went into effect on April 1. The FAQs details who qualify for the subsidy program, how to apply, which plans the premium assistance applies to, how long the program lasts, and other information.
On April 7, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky saidthat B.1.1.7, the COVID-19 variant from the U.K., is the most common variant in the U.S., accounting for about 27% of cases.
On April 7, the National Institutes of Health (NIH) began a Phase II study to determine the risk of allergic reactions to Moderna and Pfizer’s COVID-19 vaccines.
White House
On April 5, White House Senior COVID-19 Adviser Andy Slavitt announced the opening of three additional federally run mass vaccination sites in Columbia, SC, Pueblo, CO, and St. Paul, MN. Last week, the White House announced the opening of five new sites — in Maryland, Wisconsin, Tennessee, Missouri, and Indiana.
On April 6, President Biden announced that all American adults will be eligible for COVID-19 vaccines by April 19, moving up the original deadline of May 1. President Biden also said that he hopes the U.S. will have ample COVID-19 vaccine supply for domestic use by this summer and enough doses to share the inventory with other countries.
On April 6, the Biden Administration announced it will send out 1.5 million doses of Johnson & Johnson’s COVID-19 the week of April 12, a significant decrease from the 11 million delivered the week of April 5.
Other
On April 5, Novavax announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. The crossover ensures the administration of active vaccines to all participants in the trials and has begun for Novavax' Phase IIb trial in South Africa and its pivotal Phase III trial in the U.K.
On April 5, PATH Center for Vaccine Innovation and Access launched clinical trials in Brazil, Mexico, Thailand and Vietnam of the COVID-19 vaccine NDV-HXP-S, a low cost, easier to manufacture vaccine that would increase the global vaccine supply, especially for middle- to low-income countries.
On April 6, the U.S. Army began testing an Army-developed COVID-19 vaccine, SpFN.
On April 6, Moderna and Catalent announced an expansion of the domestic production of the Moderna COVID-19 vaccine, to fill an additional 80 million vials a year.
On April 7, the European Medicines Agency supported the continued use of the AstraZeneca COVID-19 vaccine due to the overall benefits outweighing the risks, following the agency finding a possible link to very rare cases of blood clotting.
On April 7, AstraZeneca paused it’s COVID-19 vaccine clinical trial with children, while the U.K.’s Medicines and Healthcare Products Regulatory Agency examines reports of rare blood clotting in vaccinated adults.
On April 8, Lilly announced it’s Phase III study of baricitinib in hospitalized COVID-19 patients did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation or invasive mechanical ventilation or death.
On April 9, Pfizer asked the FDA to amend its EUA to expand the use of its COVID-19 vaccine for use in children 12 to 15, following positive Phase III results in this age group.
As of April 10, more than 114 million people have received the first dose of COVID-19 vaccines (more than 68 million have received both doses) and more 233 million doses have been distributed, according to the CDC COVID Data Tracker.
As of April 10, the U.S. had 31,085,251 confirmed COVID-19 cases resulting in 561,074 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529); Final Rule; Received 3/19/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule, Received 3/24/21
COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414); Interim Final Rule; 3/29/21
REPORTS
HHS Office of Inspector General (OIG)
On April 6, OIG released a report entitled Medicare Advantage (MA) Organizations (MAOs) Are Missing Opportunities To Use Ordering Provider Identifiers To Protect Program Integrity. The report found that almost half of the MAOs that lack ordering National Provider Identifiers (NPIs) on at least some MA encounter records raised concerns that this hinders their data analysis for program integrity. OIG found that there are unrealized opportunities for MAOs to use ordering NPIs to protect the MA program against fraud and abuse. OIG recommended that CMS encourage MAOs to perform program integrity oversight using ordering NPIs. A summary of the report is available here.
On April 9, OIG released a report entitled Review of the Department of Health and Human Services' Compliance with the Federal Information Security Modernization Act of 2014 for Fiscal Year 2020. The report determined that HHS' information security program was “not effective” and that weaknesses continue to persist in Contingency Planning. OIG identified opportunities where HHS can strengthen its overall information security program. OIG recommend that HHS further strengthen its cybersecurity program and enhance information security controls at HHS. A summary of the report is available here.
On April 9, OIG released a report entitled Noridian Healthcare Solutions, LLC, (NHS) Claimed Unallowable Medicare Nonqualified Restoration Savings Plan Costs Through Its Incurred Cost Proposals. OIG identified $160,315 in unallowable Medicare restoration costs that NHS claimed on its Incurred Cost Proposals for calendar year 2015 and 2016 because it did not calculate these costs in accordance with Federal regulations and the Medicare contracts' requirements. OIG recommended that NHS work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare restoration costs of $160,315 for CYs 2015 and 2016. A summary of the report is available here.
On April 9, OIG released a report entitled Palmetto Government Benefits Administrator, LLC, Overstated Its Excess Plan Medicare Segment Pension Assets as of January 1, 2017. The report found that Palmetto did not correctly update its Excess Plan Medicare segment pension assets from January 1, 2015, to January 1, 2017, in accordance with Federal requirements, resulting in Palmetto overstating its Excess Plan Medicare segment pension assets by $9,196. OIG recommended that Palmetto decrease its Excess Plan Medicare segment pension assets and improve policies and procedures to ensure that going forward, it calculates Medicare segment pension assets in accordance with Federal requirements. A summary of the report is available here.
Congressional Budget Office (CBO)
On April 7, CBO released a report entitled A Public Option for Health Insurance in the Nongroup Marketplaces: Key Design Considerations and Implications. The report describes the key design considerations for a public option health insurance plan and some of their major implications. The report presents a series of key considerations that policymakers designing a public option would face and implications for federal outlays and revenues, health insurance premiums, and health insurance coverage. A summary of the report is available here.
On April 8, CBO released a report entitled Research and Development in the Pharmaceutical Industry. The report assesses trends in spending for prescription drug research and development (R&D) and the introduction of new prescription drugs. CBO found that spending on R&D and the introduction of new drugs have both increased in the past two decades, and the amount of money that drug companies devote to R&D is determined by the amount of revenue they expect to earn from a new drug, the expected cost of developing that drug, and policies that influence the supply of and demand for drugs. A summary of the report is available here.
HEARINGS
House
Energy & Commerce Health Subcommittee
An Epidemic within a Pandemic: Understanding Substance Use and Misuse in America
April 14, 11:00 a.m. WebEx
The hearing will consider the following bills:
· H.R. 654, the Drug-Free Communities Pandemic Relief Act;
· H.R. 955, the Medicaid Reentry Act of 2021;
· H.R. 1384, the Mainstreaming Addiction Treatment Act of 2021;
· H.R. 1910, the Federal Initiative to Guarantee Health by Targeting Fentanyl Act;
· H.R. 2051, the Methamphetamine Response Act;
· H.R. 2067, the Medication Access and Training Expansion Act;
· H.R. 2355, the Opioid Prescription Verification Act;
· H.R. 2364, the Synthetic Opioid Danger Awareness Act;
· H.R. 2366, the Support, Treatment, and Overdose Prevention of Fentanyl Act of 2021;
· H.R. 2379, the State Opioid Response Grant Reauthorization Act; and
· H.R. 2405, the Streamlining Research on Controlled Substances Act".
Coronavirus Crisis Subcommittee
April 15, 10:30 a.m.
Witnesses include CDC Director Dr. Rochelle Walensky, NIAID Director Dr. Anthony Fauci, and HHS Chief Science Officer Dr. David Kessler.
Appropriations Labor, HHS, Education and Related Agencies Subcommittee
April 15, 10:00 a.m., Webex
Senate
Finance Committee
April 15, 9:30 a.m. 215 Dirksen Senate Office Building
OTHER HEALTH POLICY NEWS
On April 5, a study published in Health Affairs found that although urgent care centers keep some lower-acuity patients from visiting emergency departments, the impact was small and was not associated with a drop in total healthcare costs.
On April 5, the Supreme Court suspended the Medicaid work requirement cases from Arkansas and New Hampshire, pending further order of the Court. The Court previously canceled oral arguments scheduled for March 29 following the Biden Administration's intent to withdraw approval for the requirements.
On April 6, a study published in NORC identified that the slow uptake of biosimilars has been due to a combination of market factors and policies that have both delayed and discouraged utilization. The study found that physicians believe biosimilars are equally safe and effective as brand name biologics, and are comfortable prescribing them, while patients also express confidence in biosimilars. The study proposes: issuing additional FDA guidance and real-world data on product outcomes and interchangeability for biosimilars; limiting incentives that encourage high list prices and promote more innovative contracting arrangements to benefit both patients and the system at large; and increasing transparency requirements to both physicians and patients regarding the actual price of the drugs.
On April 7, 40 groups – including patient advocacy groups, the American Medical Association and other specialty physician groups – urged CMS to suspend prior authorization requirements for cervical fusion with disc removal and implanted spinal neurostimulators under the CY 2021 outpatient final and to delay any future prior authorization policies until more data are collected. They are concerned about the expanded use of prior authorization in Medicare in recent years and its impact on access to care.
On April 8-9, MACPAC held its April public meeting. The Commission discussed the following topics:
High-Cost Specialty Drugs: Review of Draft Chapter and Recommendations;
Improving Integration through D-SNP Contracting: Review of Draft Chapter;
Improving Access to Mental Health Services for Adults: Review of Draft Chapter and Recommendations;
Improving Access to Mental Health Services for Adults: Review of Draft Chapter and Recommendations;
Electronic Health Records as a Tool for Integration of Behavioral Health Services: Review of Draft Chapter;
Mandated Report: Non-Emergency Medical Transportation Benefit: Review of Draft Chapter;
Progress on Rebalancing: Lessons from the States;
Ensuring Quality in Medicaid and CHIP;
Votes on recommendations for June 2021 report to Congress;
Update on Work with T-MSIS; and
Panel Discussion: What States are Learning from Expanded Use of Telehealth.