Weekly Health Care Policy Update - April 23, 2021

In this update:

Biden Administration Announces Updates on Combatting COVID-19
Senate Finance Committee Votes on Nominations of Chiquita Brooks-LaSure and Andrea Palm
House Democrats Reintroduce Drug Price Negotiation Bill, H.R.3
HHS Renews COVID-19 Public Health Emergency Declaration
FCC Announces Application Filing Window for Round 2 of COVID-19 Telehealth Program
CMS Issues Federal Marketplace Navigator Funding Opportunity
HHS Releases Report on 2021 Marketplace Open Enrollment Period
FDA Revokes EUA for Solo Use of Bamlanivimab Monoclonal Antibody Therapy
OIG Audit Finds Humana’s Medicare Advantage Risk Adjustment Resulted in $198 Million of Overpayments
Congressional Hearings
Governor Cuomo Issues Executive Order 202.102
DFS Revises Surprise Billing Rule to Incorporate Out-of-Network Emergency and Resulting Inpatient Services
Updated Guidance Documents
This Week’s SPG Updates and Grant Opportunities

Administrative Updates

Biden Administration Announces Updates on Combatting COVID-19
This week, the Biden Administration announced new updates on the COVID-19 response:

On April 19^th, the Department of Health and Human Services (HHS) announced that it will award $150 million from the American Rescue Plan (ARP) to up to 100 Federally Qualified Health Center (FQHC) Look-Alikes to strengthen their vaccine efforts and enhance their services in response to COVID-19. FQHC Look-Alikes are community health centers that meet most of the same requirements as FQHCs and may also be reimbursed through the FQHC per-diem visit rate, but do not receive Section 330 grants. The funding will be made available through the Health Resources and Services Administration (HRSA). Applications are due on May 14^th. The full press release is available here. Additional information on the grant and its application process is available here.
On April 21^st, President Biden announced that the United States has passed the Administration’s revised goal of administering 200 million COVID-19 vaccine shots in his first 100 days in office. The President also called on small and medium-sized employers to take advantage of the paid leave tax credit established by the ARP to offer full paid time off to their employees to facilitate their vaccination and recovery from side effects. More information on the refundable tax credit is available here.

Senate Finance Committee Votes on Nominations of Chiquita Brooks-LaSure and Andrea Palm
On April 22^nd, the Senate Finance Committee voted on the nominations of Chiquita Brooks-LaSure to be Administrator of the Centers for Medicare and Medicaid Services (CMS) and of Andrea Palm to be Deputy Secretary of HHS. The Committee voted to recommend Palm, who previously served as the Secretary of Wisconsin’s Department of Health Services, by a vote of 20-8. However, it deadlocked, 14-14, on Brooks-LaSure’s nomination. Senator John Cornyn (R-TX) has placed a hold on LaSure’s nomination, citing the Administration’s rescission of Texas’s 1115 Medicaid waiver, further slowing down the process. However, Brooks-LaSure’s confirmation is not expected to be held up permanently.

Legislative Updates

House Democrats Reintroduce Drug Price Negotiation Bill, H.R.3
On April 22^nd, Representatives Frank Pallone (D-NJ), Richard Neal (D-MA), and Bobby Scott (D-VA) reintroduced H.R. 3, the “Elijah E. Cummings Lower Drug Costs Now Act,” a bill is aimed at lowering the cost of prescription drugs. The bill would:

Empower HHS to negotiate prescription drug prices in Medicare and make the negotiated prices available to commercial insurance plans;
Cap Medicare beneficiaries’ out-of-pocket spending on prescription drugs at $2,000 per year;
Require drug manufactures to pay a rebate to the federal government if they increase prices faster than inflation; and
Reinvest federal cost-savings in the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to support research and development of new breakthrough treatments.

The House first passed the bill in December 2019, but it was not considered by the Senate at the time. Although the bill is not expected to pass the Senate now, some components may be incorporated into Democrats’ remaining legislative agenda.

Regulatory Updates

HHS Renews COVID-19 Public Health Emergency Declaration
On April 21^st, HHS announced the renewal of the COVID-19 public health emergency (PHE) declaration under the Public Health Service Act. The Administration has previously indicated that it intends to extend the COVID-19 PHE at least through the end of 2021.

The renewal declaration may be found here.

FCC Announces Application Filing Window for Round 2 of COVID-19 Telehealth Program
On April 15^th, the Federal Communications Commission (FCC) announced that the application filing window for Round 2 of the COVID-19 Telehealth Program will open April 29^th. Applications may be submitted for seven days, through May 6^th. Round 1 provided a total of $200 million to 539 applicants to support health care providers’ response to COVID-19 by providing support for telehealth. Awardees used funds to help furnish telecommunications services, information services, and devices necessary to enable telehealth services. The FCC last month adopted a Report and Order detailing differences in Round 2, such as new evaluation metrics (including prioritizing applicants who were not awarded in Round 1) and extending the period for which funding can be received from 6 months to 12 months.

The Report and Order is available here. Applications for the program may be filed through the online portal, available here, during the window.

CMS Issues Federal Marketplace Navigator Funding Opportunity
On April 21^st, CMS announced that it will award $80 million in grant funding for Navigators on the HealthCare.gov federal Marketplaces for the 2022 plan year. This will fund approximately 120 awards. Eligible applicants include not-for-profit organizations (with or without 501(c)(3) status), small businesses, and other public or tribal organizations. Navigators are funded to assist consumers seeking to enroll in Marketplace plans, including by:

Conducting public education activities to raise awareness about Marketplace plans;
Facilitate consumer selections of a qualified health plan (QHP);
Referring consumers to local offices or ombudsmen; and
Providing targeted assistance to serve underserved or vulnerable populations.

More information is available here. Applications are due July 1^st.

HHS Releases Report on 2021 Marketplace Open Enrollment Period
On April 21^st, HHS released a report on enrollment in individual Marketplace health insurance coverage for the 2021 plan year during the Open Enrollment period. Nationally, about 12 million consumers selected a Marketplace plan during this year’s Open Enrollment, a 5% increase from 2020. The large majority of consumers (88%, up from 87% last year) continue to receive Advance Premium Tax Credits (APTC) to subsidize their coverage and receive an average discount of 85% of the total premium as a result. This report will not reflect final 2021 Marketplace enrollment, since HHS opened a Special Enrollment Period for all Americans, currently extending through August 15^th.

The full report is available here.

FDA Revokes EUA for Solo Use of Bamlanivimab Monoclonal Antibody Therapy
On April 16^th, the Food and Drug Administration (FDA) revoked its Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab, when used alone, for the treatment of mild to moderate COVID-19, citing an increase in viral COVID-19 variants. The FDA indicated that health care providers may continue to use alternative monoclonal antibody therapies:

Casirivimab and imdevimab, administered together; or
Bamlanivimab and etesevimab, administered together.

The full press release is available here.

Other Updates

OIG Audit Estimates Humana’s Medicare Advantage Risk Adjustment Resulted in $198 Million of Overpayments
On April 19^th, the HHS Office of the Inspector General (OIG) released a report estimating that Humana’s Medicare Advantage program had been overpaid by almost $198 million due to unsubstantiated risk adjustment submissions. Specifically, of the 1,525 Hierarchical Condition Categories (HCCs) associated with the sample OIG examined, OIG found that 203, or more than 13%, were unvalidated, resulting in inflated capitation payments for the associated enrollees. Humana disagreed with the findings.

The report is available here.

Congressional Hearings

Tuesday, April 27^th:

At 10:00 AM, the Senate Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security will hold a hearing to examine curbing COVID cons, focusing on warning consumer about pandemic frauds, scams, and swindles. More information is available here.

Wednesday, April 28^th:

At 10:00 AM, the Senate Appropriations Subcommittee on Department of the Interior, Environment, and Related Agencies will hold a hearing to examine health disparities in Indian Country, focusing on a review of the Indian Health Services COVID response and future needs. More information is available here.
At 10:00 AM, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing to examine the response to COVID-19, focusing on using lessons to address mental health and substance use disorders. More information is available here.
At 11:00 AM, the House Energy and Commerce Committee will hold a hearing on the Long Haul: Forging a Path through the Lingering Effects of COVID-19. More information is available here.
At 2:00 PM, the House Ways & Means Subcommittee on Health will hold a hearing on charting the path forward for telehealth. More information is available here.
At 3:00 PM, the Senate Appropriations Subcommittee on Military Construction and Veterans Affairs, and Related Agencies, will hold a hearing to examine the VA telehealth program, focusing on leveraging recent investments to build future capacity. More information is available here.

New York State Updates

Governor Cuomo Issues Executive Order 202.102
On April 19^th, Governor Cuomo signed Executive Order 202.102 (available here), which extends all disaster emergency provisions outlined in Executive Order 202 and its successors that have not been otherwise superseded, modified, or expired through May 19^th.

Additionally, this Order rescinds the directive in Executive Order 202.88 that placed a requirement on providers of COVID-19 vaccines who were allocated a supply of COVID-19 vaccine to administer the entire supply within one week of receiving it, with a potential civil penalty or reduction of future vaccine allocations if they failed to comply.

DFS Revises Surprise Billing Rule to Incorporate Out-of-Network Emergency and Resulting Inpatient Services
On April 7^th, the New York State (NYS) Department of Financial Services (DFS) posted a notice of revised rulemaking in the State Register (available here) to expand NYS’s surprise billing regulations to cover out-of-network emergency department (ED) services and inpatient services that follow such an ED visit. The original 2014 rule established the Independent Dispute Resolution (IDR) process to handle disputes concerning surprise bills for emergency services provided by out-of-network physicians or other providers at in-network hospitals or when referred by an in-network provider. Under this amendment, consumers will also be protected from surprise bills if they receive emergency care at a hospital that does not participate in their insurance plan’s network.

The amended regulation also expands and clarifies the responsibilities of health care plans, hospitals, and IDR entities in relation to the IDR process, including notices, timeframes, and the determination of a reasonable fee. Specific requirements, in the case of disputes involving emergency care provided at a non-participating hospital, include:

Health plans are required to notify consumers if a bill is a covered surprise bill, and that if it is, they may submit an assignment of benefits (AOB) form and will then not be responsible for out-of-pocket costs greater than their in-network responsibility.
Non-participating hospitals providing emergency care are required to provide their patients with claim forms and AOB forms, and, for patients who submit an AOB, to bill them only for their in-network cost-sharing.

Public comments will be accepted through May 22^nd.

Updated Guidance Documents
Recently released New York State COVID-19 guidance documents are listed below.

Guidance for Management in Opioid Treatment Programs During the COVID-19 Pandemic (4.19.21)

This Week’s SPG Updates and Grant Opportunities

Please find below links to updated SPG resource documents and grant opportunity summaries.