Weekly Health Care Policy Update - June 25, 2021

In this update:

Biden Administration Announces Updates on COVID-19 Response
- U.S. to Miss July 4^th Vaccination Goals
- ACIP Meets on mRNA Vaccines and Heart-Related Side Effects
President Biden Endorses Senate Infrastructure Agreement
HHS, Treasury, and DoL Issue RFI on New Prescription Drug Reporting Requirements
HHS OIG Issues Report on COVID-19 Prevalence for Nursing Home Residents
CMS Reports Medicaid Enrollment Increased by 10 Million During COVID-19
CMS Announces $20 Million in Funding to Improve Access to State-based Marketplace Coverage
Treasury Updates FAQs for Coronavirus State and Local Fiscal Recovery Funds
HHS Replaces Members of 340B Administrative Dispute Resolution Board
HHS OIG Issues Report on Cybersecurity in Hospitals
SCOTUS Rejects Appeal by Insurers Seeking Reimbursement for Losses over Claims Covered Under the ACA
Lawmakers Release Draft of Bipartisan 21^st Century Cures 2.0 Act
Federal Officials Offer Vision for ARPA-H
AHA Requests Further Extension of PRF Deadlines
Congressional Hearings
Governor Cuomo Announces End of State Disaster Emergency
OMH Issues Regulatory Waiver to Continue COVID-19 Flexibilities
OASAS Releases Guidance on Continuing COVID-19 Regulatory Flexibilities
Governor Cuomo Signs Safe Staffing and Other Bills
DFS Adopts Emergency Rule Clarifying that Telehealth Includes Audio-Only Visits
OCFS Announces New Round of Essential Workers Scholarship is Open for Applications
OCFS Announces Request for Proposals (RFP) for a Peer-Run Services IPA
OMH and OASAS Announce Discussions on Returning to Treatment in Article 31 Clinics

Administration Updates

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

U.S. to Miss July 4^th Vaccination Goals: On June 22^nd, White House Coronavirus Response Coordinator Jeff Zients acknowledged in a press briefing that the Administration does not expect to achieve its goal of having 70% of adults receive at least one dose of COVID-19 vaccine by July 4^th. Among all adults (18 and older), 65% have received at least one dose, and at the current rate, it will be several more weeks before the 70% mark is achieved. The White House expects to reach its other goal of 160 million fully-vaccinated Americans by mid-July.
ACIP Meets on mRNA Vaccines and Heart-Related Side Effects: On June 23^rd, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met to hear from experts on the association between mRNA COVID-19 vaccines and rare heart-related side effects among young adults. Although ACIP agreed there was a “likely association” between the vaccines and myocarditis and pericarditis, especially in men under 30, officials also stated that early evidence indicates that cases are generally milder than those that occur from other causes. Following the meeting, CDC and a number of major professional associations issued a statement reiterating that they continue to recommend COVID-19 vaccinations to all eligible individuals. CDC will add warnings about the side effect to COVID-19 vaccine fact sheets.

President Biden Endorses Senate Infrastructure Agreement
On June 24^th, President Biden announced his support for a bipartisan infrastructure framework agreed to by a group of 10 senators (five Democrats and five Republicans). The bill includes $579 billion in new spending, focused on physical infrastructure projects, including $312 billion on transportation infrastructure and $266 billion on other projects, including water, broadband, and power infrastructure. Senate Majority Leader Chuck Schumer hopes to have both the bipartisan package and a reconciliation infrastructure bill (including the social spending priorities or “human infrastructure” package) passed in July. Speaker Nancy Pelosi has stated that the House of Representatives will not take up the bipartisan bill until after the reconciliation bill is passed. As a result, the bills’ prospects remain uncertain.

Regulatory Updates

HHS, Treasury, and DoL Issue RFI on New Prescription Drug Reporting Requirements
On June 21^st, the Departments of Health and Human Services (HHS), Treasury, and Labor (DoL) issued a request for information (RFI) on recent new reporting requirements related to their highest-spend prescription drugs. The RFI seeks input on implementation of new requirements in the 2020 year-end omnibus package, the 2021 Consolidated Appropriations Act, under which private health plans, such as Exchange and employer plans (including ERISA-covered plans), must report on, among other items:

The volume of prescriptions for the 50 most frequently dispensed drugs;
The total cost for the 50 most costly drugs;
The increase in expenditures for the 50 drugs with the highest such increase;
Rebates received from drug manufacturers, including the amounts of rebates for each therapeutic class of drugs and for each of the 25 highest-rebate drugs; and
Any associated premium or out-of-pocket cost reductions.

The first reporting deadline under the requirements will be December 27, 2021, and not later than June 1^st of each following year. The RFI asks for input on a number of topics, including the level of detail of information to require, the definition of terms included in the new requirements, whether any plans should be exempted; and general implementation concerns (such as whether issuers have such information readily available. The RFI will be open for 30 days, with comments scheduled to close on July 22^nd.

HHS OIG Issues Report on COVID-19 Prevalence for Nursing Home Residents
On June 22^nd, the HHS Office of the Inspector General (OIG) released a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020. The report concluded that about 40% of such beneficiaries were diagnosed with either COVID-19 or likely COVID-19 in 2020, including about half of Black, Hispanic, and Asian residents. Almost 1,000 more beneficiaries died per day in April 2020 than in April 2019, with overall mortality in nursing homes increasing to 22% in 2020 compared to 17% in 2019. This represents a 32% increase in nursing home deaths last year, with massive spikes occurring in April and December.

CMS Reports Medicaid Enrollment Increased by 10 Million During COVID-19
On June 21^st, the Centers for Medicare and Medicaid Services (CMS) released an Enrollment Trends Snapshot report showing that enrollment in Medicaid and the Children’s Health Insurance Program (CHIP) increased by a net of nearly 10 million (13.9%) from February 2020 to January 2021. Overall, over 80 million individuals are enrolled in Medicaid or CHIP. About 38 million of these enrollees—nearly half—are children (18 or younger). CMS largely attributes the increase to the impact of COVID-19, including the maintenance of effort requirements included in the Families First Coronavirus Response Act (FFCRA), which required states not to disenroll any state residents from Medicaid in order to receive a 6.2 percentage point increase in federal matching funds.

CMS Announces $20 Million in Funding to Improve Access to State-based Marketplace Coverage
On June 21^st, CMS announced that it will offer $20 million to state-run Affordable Care Act (ACA) exchanges to improve access to state-based Marketplace coverage. States may apply for this funding, which is allocated from the American Rescue Plan (ARP), to help modernize or update their systems, programs, or technology to comply with federal Marketplace requirements, such as the new provisions in the ARP that expand premium tax credit subsidies. HHS will make up to 21 cooperative agreement grants that meet application requirements, including those that use HealthCare.gov for eligibility and enrollment, which means that all of the current state-run exchanges could apply. State-run exchanges have enrolled over 3.8 million consumers thus far for the 2021 plan year. Applications are due on July 20^th, and CMS anticipates issuing grant awards in early September.

Treasury Updates FAQs for Coronavirus State and Local Fiscal Recovery Funds
On June 23^rd, the Treasury Department updated its Frequently Asked Questions document on the Coronavirus State and Local Fiscal Recovery Funds included in the ARP. These funds may be used for a wide of purposes. The updated questions include several examples of how recipients may use their funds for health-care related purposes, such as:

Mental health and substance use disorder services, including community-based mental health and substance use disorder programs or school-based mental health programs;
Housing assistance, including rent, utilities, and relocation assistance;
Food assistance; and
Employment or job training services.

HHS Replaces Members of 340B Administrative Dispute Resolution Board
On June 23^rd, HHS published a notice in the Federal Register that replaces all members of the 340B Administrative Dispute Resolution (ADR) Board. The ADR Board was established by a December 2020 rule to resolve claims that (1) drug manufacturers have overcharged 340B covered entities for drugs and (2) covered entities have violated rules on diversion or duplicate discounts. HHS has revoked all previous appointments and is appointing eight members to the Board for two-year terms. Board members represent the Office of the General Counsel (OGC), the Health Resources and Services Administration (HRSA), and CMS.

The announcement is available here.

HHS OIG Issues Report on Cybersecurity in Hospitals
On June 23^rd, OIG issued a report recommending that Medicare should improve oversight of cybersecurity concerns related to Internet-connected medical devices in hospitals. CMS’s survey protocol does not currently include requirements for networked device cybersecurity. The OIG recommended that CMS should implement a way to address this issue in its quality oversight of hospitals. For example, CMS could direct Medicare accrediting organization to examine networked devices’ cybersecurity as part of routine surveys, or amend or add Medicare Conditions of Participation (CoP) related to cybersecurity. CMS concurred with the idea that it should consider additional ways to highlight this issue, but did not commit to directly including cybersecurity of networked devices in its quality oversight.

Other Updates

SCOTUS Rejects Appeal by Insurers Seeking Reimbursement for Losses over Claims Covered Under the ACA
On June 21^st, the Supreme Court declined to hear an appeal by two insurers, Maine Community Health Options and Community Health Choice, seeking full repayment of cost-sharing reductions (CSRs) under the Affordable Care Act (ACA). The Court’s action leaves the case in the hands of lower courts, where, in August 2020, a federal appeals court ruled that the Trump administration violated the law when it stopped paying CSRs to insurers in 2017. However, the same court also determined that insurers were compensated through the practice of “silver loading,” so that the government should only repay CSRs “to the extent that insurers has not recouped their losses through higher premiums.” The Biden Administration has not reinstituted payments to insurers for CSRs. As a result, plans are likely to continue using the silver loading approach.

Lawmakers Release Draft of Bipartisan 21^stCentury Cures 2.0 Act
On June 22^nd, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released a draft of their “21^st Century Cures 2.0” proposal, a followup to the 21^st Century Cures Act passed in 2015. The Cures 2.0 Act proposal includes initiatives such as:

New investments in public health (in particular, pandemic preparedness and response);
New investments and requirements for clinical trials;
Reforms to processes of the Food and Drug Administration (FDA);
Telehealth and innovative/breakthrough technology policies in Medicare and Medicaid; and
Research investments, including $25 billion for various projects and the creation of President Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H), for which a proposal was advanced in an article in Science (see below).

DeGette and Upton are seeking feedback on the discussion draft of the bill. A press release is available here. The draft legislative text is here, and a section-by-section summary is here.

Federal Officials Offer Vision for ARPA-H
On June 22^nd, White House science advisor Eric Lander, National Institutes of Health (NIH) director Francis Collins, and co-authors published an article in Scienceregarding their vision for ARPA-H. ARPA-H is intended to support and speed up research into breakthrough health technologies. Lander and Collins argue that ARPA-H should be a distinct division within NIH, with time-limited projects aiming to solve practical problems across a broad range of topic areas, including cancer and other chronic diseases, infectious diseases, and health care access, equity, and quality. The authors urge a culture and approach like that of the Defense Advanced Research Projects Agency (DARPA), the “flat and nimble” organization which served as the inspiration for Biden’s proposal.

The article is available here.

AHA Requests Further Extension of PRF Deadlines
On June 23^rd, the American Hospital Association (AHA) sent a letter to HHS Secretary Xavier Becerra, requesting a further extension of the timeline for providers to use Provider Relief Fund (PRF) money. Specifically, AHA requests that funds distributed before June 30, 2020 should be useable until the end of the public health emergency (PHE) or until June 30, 2022. Under current HHS guidance, the deadline for such money to be spent is June 30, 2021. This deadline was originally set by the Trump Administration, and the Biden administration has left it unchanged, although it extended the deadline for funds received later.

The letter is available here.

Congressional Hearings

The Senate is in recess until July 12^th.

Thursday, July 1^st:

At 9:30am, the House Select Subcommittee on the Coronavirus Crisis will hold a hybrid hearing entitled “Building Trust and Battling Barriers: The Urgent Need to Overcome Vaccine Hesitancy.” More information is available here.

New York State Updates

Governor Cuomo Announces End of State Disaster Emergency
On June 23^rd, Governor Cuomo announced that New York’s COVID-19 disaster emergency declaration would expire effective 11:59pm on June 24^th. As a result, as of today (June 25^th), emergency provisions in Executive Order 202 and its successors have all expired, except those that have been enacted into law previously. These include: waivers allowing additional telehealth modalities and provider categories; the waiver of provider licensure, registration, and background check requirements and other restrictions related to the delivery of health services; and flexibilities related to COVID-19 testing and collection of specimens. Various State agencies have issued or are planning to issue guidance clarifying the status of emergency COVID-19 policies:

Department of Health (DOH): DOH is expected to issue emergency regulations to allow Medicaid providers to continue to provide telehealth services, including audio-only telephone services.
Office of Mental Health (OMH): OMH has released a regulatory waiver as of June 25^th (see below). Additionally, OMH and the Office of Addiction Supports and Services (OASAS )are holding a webinar today from 3pm to 4:30pm OMH and OASAS will hold a webinar on June 25^th from 3-4:30pm (registration is available here) to provide a statewide status update regarding these topics.
OASAS: Along with the webinar mentioned above, OASAS has released guidance on “Continuing COVID Regulatory Flexibility” (see below).
Office for People with Developmental Disabilities (OPWDD): OPWDD’s Amendment 06 to its 1915(c) waiver, which was approved by CMS and is effective July 1^st, includes changes to permanently adopt telehealth and in-residence service delivery models that were adopted to address COVID-19. Other flexibilities provided in Appendix K may be continued up to six months after the end of the ongoing federal PHE, which is not expected to expire until 2022.
State Education Department (NYSED): NYSED has published an Advisory Notice stating that licensure and scope of practice exemptions pursuant to Executive Order 202 have expired, but NYSED “understands the concern regarding the short notice” and will take this into account into any inquiries into previously authorized activities. However, Title VIII professionals should “exercise good faith efforts” to return to compliance with all professional requirements.

Other updates may be forthcoming for other offices, such as the Office of Children and Family Services (OCFS). The Governor’s announcement is available here.

OMH Issues Regulatory Waiver to Continue COVID-19 Flexibilities
On June 25^th, OMH issued a regulatory waiver to grant temporary relief from various requirements of Title 14 of the New York Codes, Rules, and Regulations (NYCRR), in recognition of the ongoing effects of COVID-19 on operations. Some of the important waived provisions include:

Regulations around the provision of telemental health services, including temporary approvals and audio-only services.
Requirements continuing the reduction of minimum service durations and allowing rounding up of service times.
Requirements to waive timeframes around treatment planning reviews.

These waivers will remain in effect for 60 days or until suspended. The waiver document is available here.

OASAS Releases Guidance on Continuing COVID-19 Regulatory Flexibilities
On June 24^th, OASAS released guidance to address continuing COVID disaster emergency-related flexibilities for OASAS programs. The following telehealth flexibilities will continue until they are permanently adopted into the State’s regulations under 14 NYCRR Part 830:

Allow for the telehealth practitioner’s distant site to be located anywhere within the United States;
Allow for the patient’s originating site to include temporary locations out-of-state;
Allow for telephonic-only services;
Allow for all OASAS services to be provided via telehealth if appropriate;
Permit Certified Recovery Peer Advocates (CRPAs) to deliver telehealth services;
Waive requirement that patients have an initial in-person evaluation prior to receiving telehealth services;
Waive requirements for application and operating certificate designation for certified program approval to deliver telehealth services; and
Waive APG requirements regarding minimum time requirements for service delivery;

The following provider flexibilities will continue for the duration of the federal PHE, which is expected to last through 2021:

Allow DATA 2000 waived practitioners to provide buprenorphine induction via telehealth and telephone-only;
Allow providers to utilize certain video-conference technologies that are not fully compliant with HIPAA rules;
Allow providers to use verbal consent to provide services, as documented in the patient record, until written consent can be obtained (written consent is still required to share patient records)

As of June 25^th, flexibilities regarding background checks have ended:

OASAS providers must resume routine processing of background checks for all prospective employees, including for staff hired on or after June 24^th.
In cases where background checks were abbreviated, required background checks must be submitted by August 25^th.
Staff members with abbreviated background checks and who have regular and substantial contact with patients must be supervised in accordance with OASAS regulations, beginning September 25^th.

Governor Cuomo Signs Safe Staffing and Other Bills
On June 18^th, Governor Cuomo signed the following legislation:

A0108-B/S1168-A which requires hospitals to establish and maintain a clinical staffing committee no later than January 1, 2022. At least half of the members of the committee must be registered nurses, licensed practical nurses, and ancillary members of the frontline team currently providing or supporting direct patient care. The committee will be responsible for developing and overseeing an annual clinical staffing plan, which will include patient-to-nurse ratios or specific guidelines for how many patients are assigned to each nurse. The committee will also be responsible for responding to complaints regarding violations of the adopted staffing plan or staffing variations.
A7119/ S6346 which requires the Commissioner of Health to establish staffing standards for nursing home minimum staffing levels and impose civil penalties for nursing homes that fail to adhere to the minimum standards. Beginning January 1, 2022, nursing homes will be required to maintain daily average staffing hours equal to 3.5 hours of care per resident per day by a certified nurse aide, a licensed nurse, or nurse aide, provided that no less than 2.2 hours of care per resident per day be provided by a certified nurse aide or nurse aide, and no less than 1.1 hours of care per resident per day shall be provided by a licensed nurse.

The Governor has also signed additional non-health care bills:

A7127/S5742, which provides that certain commercial small businesses shall be eligible for rent relief under the “COVID-19 Emergency Protect Our Small Businesses Act of 2021.”
S7230, which exempts amounts received through the COVID-19 Pandemic Small Business Recovery Grant program from personal income tax.
S4402, the “Gender Recognition Act,” modifying rules around name changes, sex designation, and driver’s licenses.

DFS Adopts Emergency Rule Clarifying that Telehealth Includes Audio-Only Visits
On June 23^rd, the Department of Financial Services (DFS) published an emergency rule (available here) to amend Insurance Regulation 62 (11 NYCRR 52) regarding audio-only telehealth services. The emergency rule includes the following clarifications:

The definition of telehealth includes audio-only visits.
An insurer may engage in reasonable fraud, waste, and abuse detection efforts, including to prevent payments for services that do not warrant a separate billable encounter.

DFS expects all regulated plans to continue to reimburse medically necessary audio-only services.

The notice for the emergency rule is available here. The emergency rule is effective June 4^thand will expire July 6^th, but DFS intends to adopt the emergency rule as a permanent rule and will publish a notice of proposed rulemaking in the State Register at a future date.

OCFS Announces New Round of Essential Workers Scholarship is Open for Applications
On June 23^rd, the Office of Children and Family Services (OCFS) announced that a third round of its Essential Workers Scholarship program is now accepting applications. Through this program, essential workers who meet eligibility requirements will be able to use scholarship funds to pay tuition for the childcare provider program of their choice. Payments will be made directly to the childcare program, on behalf of the program, and will be paid up to the market rate for the applicable region. OCFS will make available $25 million of funding available in the current round.

To be eligible for the scholarship, an individual must meet all the following requirements:

Be an essential worker in an essential business/entity as defined in Executive Order 202.6 (available here), including essential health care operations and education workers;
Have a maximum income that does not exceed 300% of the federal poverty level based on the size of the family (as detailed here), supported by income verification; and
Have a child in need of care who is under the age of 13 or who is under the age 19 and physically or mentally incapable of caring for himself or herself, or under court supervision, with no other adults available to care for the child.

Eligible childcare providers must be licensed/registered/permitted or enrolled legally exempt group programs and must be in good standing with OCFS. Childcare providers as selected by parents will be contacted by OCFS to register their program, which is required to receive funds.

Further details on the grant opportunity are available here. Interested essential workers should submit an electronic application, available here. Applications will be accepted on a rolling basis beginning on June 23^rd.

OCFS Announces Request for Proposals (RFP) for a Peer-Run Services IPA
On June 23^rd, the Office of Mental Health (OMH) announced that approximately $2.05 million in total funding is available to support the creation of a single Independent Practice Association (IPA) among peer-operated programs that increase the availability of peer and family support services. At the end of the five-year grant period, the IPA will be expected to be an independent, self-sustaining entity whose future funding will be dependent on its ability to negotiate with managed care programs and handle shared risk contracts under value-based payment models.

Agencies who are eligible to join the IPA must meet all the following requirements:

Be a 501(c)(3) not-for-profit agency;

Have a governing body that is comprised of at least 51% of people with lived experience;
Be member-run, such that the majority of staff has lived experience of mental illness; and
Have experience providing mental health services to individuals with serious mental illness.

The full RFP is available here. Proposals must be submitted through the State’s Grants Gateway portal, available here, by August 31^st. Applicants may submit an optional letter of intent to Carol Swiderski at carol.swiderski@omh.ny.gov by August 20^th. Questions may be directed to carol.swiderski@omh.ny.gov by July 16^th, and answers will be posted on the OMH website by August 10^th.

OMH and OASAS Announce Discussions on Returning to Treatment in Article 31 Clinics
OMH and OASAS will hold a follow-up discussion to their Virtual Clinic Listening Sessions, with a focus on Return to Treatment in Article 31 clinics. Attendees will participate in online facilitated break-out discussions for either child-serving or adult-serving agencies in order to share helpful practices or challenges regarding Return to Treatment and to propose regulatory requirements and support or training that can help support the Return to Treatment process.

Providers can register for one of the following two discussions:

July 8^th from 11:30am to 1pm (registration here)
July 22^nd from 12:30 to 2pm (registration here)