Weekly Health Care Policy Update - March 12, 2021

In this update:

President Biden Announces HHS Assistant Secretary for Legislation Nominee
Biden Administration Announces Purchase of Additional J&J Vaccine Doses
President Biden Signs American Rescue Plan into Law
CDC Issues Guidance for Fully Vaccinated Individuals
HHS Announces $250 Million Funding Opportunity for Localities for COVID-19 Health Literacy Projects
CMS Issues Updated Nursing Home Visitation Guidance
HHS Extends Comment Period for Proposed Rule Modifying HIPAA Privacy Rule
CMMI Places Medicare and Rural Demonstration Models under Review
HHS ASPE Releases Brief Criticizing Work Requirements in 1115 Waivers
Congressional Hearings
Supreme Court Cancels Oral Argument on Work Requirements Case
Governor Cuomo Announces $29 Million Empire Pandemic Response Reimbursement Fund
Governor Cuomo Announces Vaccine Eligibility Expansion and Updated Vaccination Guidance
New York State Submits MRT Waiver Extension Request to CMS
This Week’s SPG Updates

Administrative Updates

President Biden Announces HHS Assistant Secretary for Legislation Nominee
On March 11^th, President Biden announced his intention to nominate Melanie Egorin to severe as Assistant Secretary for Legislation at the Department of Health and Human Services (HHS). Dr. Egorin currently serves as the Deputy Staff Director for the Health Subcommittee and professional tax staff for the Committee on Ways and Means in the House of Representatives.

The White House announcement can be found here.

Biden Administration Announces Purchase of Additional J&J Vaccine Doses
On March 10^th, President Biden announced that the federal government will order an additional 100 million doses of the Johnson & Johnson (J&J) Janssen single-shot COVID-19 vaccine. After this addition, the US’s total vaccine order will be 800 million doses across the three currently approved Pfizer, Moderna, and J&J vaccines. Currently, J&J anticipates producing its first 100 million doses of the Janssen vaccine by June.

Legislative Update

President Biden Signs American Rescue Plan into Law
On March 11^th, President Biden signed into law the American Rescue Plan (ARP) Act of 2021, an approximately $1.9 trillion relief package aimed at addressing the nation’s dual COVID-19-related public health and economic crises. The Senate passed an amended version of the original bill on March 6^th, and the House approved that version on March 10^th, both largely along party lines.

SPG’s detailed summary of the ARP is available here.

Regulatory Updates

CDC Issues Guidance for Fully Vaccinated Individuals
On March 8^th, the Centers for Disease Control and Prevention (CDC) issued recommendations for people who are fully vaccinated against COVID-19 to resume normal activities. The CDC considers an individual fully vaccinated two weeks after they receive their last required dose. According to the guidance, fully vaccinated individuals can safely:

Visit with other fully vaccinated people indoors without wearing masks or keeping six feet apart;
Visit with unvaccinated people from one additional household indoors without wearing masks or staying six feet apart, if the members of the household are at low risk for severe disease;
Refrain from quarantine and testing, if they do not have COVID-19 symptoms, after coming in contact with an individual who has COVID-19.

When in public, the CDC recommends that fully vaccinated individuals to continue to maintain at least six feet of distance from people they do not live with and avoid medium and large sized in-person gatherings.

The full guidance can be found here.

HHS Announces $250 Million Funding Opportunity for Localities for COVID-19 Health Literacy Projects
On March 8^th, the Department of Health and Human Services (HHS) Office of Minority Health announced the availability of $250 million in funding for projects that demonstrate the effectiveness of local government implementation of evidence-based health literacy strategies that:

Are culturally appropriate;
Enhance COVID-19 testing, contact tracing, and/or other mitigation measures (such as vaccination); and
Focus on racial and ethnic minority populations and other socially vulnerable populations, including racial and ethnic minority rural communities.

Eligibility for funding is limited to localities, such as cities, counties, parishes, or other subdivisions. Awarded applicants will receive funding for up to two years as follows:

Urban communities: approximately 30 awards of up to $4 million each
Rural communities: approximately 43 awards of up to $3 million each

Applications are due on April 20^th. The full funding opportunity announcement can be accessed here.

CMS Issues Updated Nursing Home Visitation Guidance
On March 10^th, the Centers for Medicare & Medicaid Services (CMS) issued additional guidance expanding indoor visitation in nursing homes. CMS recommends that all facilities should allow indoor visitation for all residents, regardless of the resident’s or visitor’s COVID-19 vaccination status. However, CMS outlined specific scenarios in which indoor visitation should be limited, including if:

The county positivity rate is greater than 10 percent and if less than 70 percent of residents in the facility are fully vaccinated;
The resident has a confirmed case of COVID-19, regardless of the individual’s vaccine status;
The resident is in quarantine, regardless of the individual’s vaccine status;

In the event a new case of COVID-19 is identified among facility residents or staff, CMS recommends that the facility immediately suspend all visitation until at least one round of facility-wide testing has been completed. At the completion of the facility-wide testing, CMS recommends the following:

If the testing reveals no additional COVID-19 cases throughout the facility, visitation can continue in units where there are no COVID-19 cases. Facilities should suspend visitation in the affected areas until testing identifies no new cases of COVID-19 testing for at least 14 days since the last positive result.
If one or more additional positive cases are revealed throughout the facility, visitation for all residents should be suspended until testing identifies no new cases of COVID-19 testing for at least 14 days since the last positive result.

The full guidance is available here.

HHS Extends Comment Period for Proposed Rule Modifying HIPAA Privacy Rule
On March 9^th, HHS published a notice in the Federal Register extending the comment period by 45 days for a proposed rule entitled “Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement,” from March 22^nd to May 6^th. The HIPAA Privacy Rule sets standards for protecting the security of individuals’ protected health information (PHI). This proposed rule, developed under the Trump Administration, would:

Increase the range of permissible disclosures of PHI;
Expand individuals’ right of access to PHI, including by, among other proposals:
- Strengthening their right to inspect PHI in person, including taking notes or pictures;
- Shortening covered entities’ required response time from 30 days to 15 days;
- Reducing identity verification burdens;
- Creating a pathway for individuals to direct the sharing of PHI in an electronic health record (EHR) among covered entities, by requiring them to submit requests to other entities on behalf of individuals; and
- Requiring covered entities to respond to such requests when directed by individuals;
Expand requirements and abilities of covered entities to disclose PHI for the purposes of care coordination and case management.

The notice of extension is available here. The proposed rule can be found here.

CMMI Places Medicare and Rural Demonstration Models under Review
This week, the CMS Innovation Center (CMMI) issued updates on delays to several payment models announced by the Trump Administration. CMMI will delay the implementation of the following models, pending review:

The Primary Care First (PCF) model’s Seriously Ill Population (SIP) Component, which allows PCF participants to take responsibility for high-need Medicare beneficiaries.
- The SIP Component was set to begin on April 1^st but is now postponed indefinitely for review.
The Kidney Care Choices (KCC) model, which creates incentives to avert in-center hemodialysis and incentivize kidney transplantation for Medicare beneficiaries with chronic kidney disease and end-stage renal disease.
- The KCC model’s first performance year was slated to start April 1^st but is now postponed to January 1, 2022.
The Community Health Access and Rural Transformation (CHART) Model’s Community Transformation Track, which provides lead organizations in rural communities with funds to build systems of care, including a transition to a capitated payment amount (CPA) for participant hospitals.
- The deadline for Community Transformation Track letters of intent (LOIs) has been delayed from April 13^th to May 11^th.

Other Updates

HHS ASPE Releases Brief Criticizing Work Requirements in 1115 Waivers
On March 11^th, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) released an issue brief on the effects on coverage and access to care of Section 1115 Medicaid waivers that incorporate:

Work requirements (“community engagement”);
Healthy behavior incentive programs;
Health savings account-like arrangements; and
Capped federal funding and other financing changes.

The report finds that work requirements can lead to significant coverage losses and worse access to care, without improving employment, while the other types of policies examined also cause harmful effects such as beneficiary confusion or administrative challenges.

The issue brief is available here.

Supreme Court Cancels Oral Argument on Work Requirements Case
On March 11^th, the Supreme Court canceled oral argument on the consolidated cases Cochran v. Gresham and Arkansas v. Gresham, which concern the legality of Medicaid work requirements. The Biden Administration had requested last month that the Court forgo considering the cases due to policy changes and instead allow HHS to reconsider and potentially rescind the approvals of the requirements.

Congressional Hearings

Tuesday, March 16^th:

At 10am, the House Appropriations Committee will hold a hearing on “The Role of FEMA and Emergency Management in COVID-19 Response.” More information is available here.

Wednesday, March 17^th:

At 9:30am, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing to consider the nominations of Vivek Murthy to be Surgeon General and Rachel Levin to be an Assistant Secretary of HHS. More information is available here.
At 10am, the House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing on “Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations.” More information is available here.
At 10am, the Senate Finance Committee will hold a hearing to examine COVID-19 in nursing homes. More information is available here.
At 1pm, the House Energy and Commerce Committee Subcommittee on Health will hold a hearing on “Averting a Crisis: Protecting Access to Health Care in the U.S. Territories”. More information is available here.

Thursday, March 18^th:

At 9:30am, the Senate Committee on Aging Committee will hold a hearing on the one-year anniversary of COVID-19, focusing on addressing health care needs for at-risk Americans. More information is available here.
At 10am, the Senate HELP Committee will hold a hearing to examine the COVID-19 response, focusing on an update from federal officials. More information is available here.

New York State Updates

Governor Cuomo Announces $29 Million Empire Pandemic Response Reimbursement Fund
On March 8^th, Governor Cuomo announced the availability of $29 million in funding to support essential workers and first responders with economic needs through the Empire Pandemic Response Reimbursement Fund. The Fund, which will be coordinated by the Office of Children and Family Services (OCFS), is designed to reimburse out-of-pocket child care, transportation, lodging, and other qualifying expenses that enabled essential workers to perform their duties during the COVID-19 emergency.

First responders, health care workers, and many multi-industry workers and their families who earn up to 500 percent of the federal poverty level ($125,470 for a family of four) may apply for the funds to cover out-of-pocket expenses they incurred to respond to COVID-19 that have not been reimbursed by another source. Workers should be referred by employers, unions, or social service providers who can verify employment during the COVID-19 emergency. Up to $1,000 is available per household. Awards will be made to eligible applicants for eligible expenditures on a first-come, first-served basis until funding is exhausted.

Additional information, including a link to sign up to be notified when applications are available, can be accessed here.

Governor Cuomo Announces Vaccine Eligibility Expansion and Updated Vaccination Guidance
On March 9^th, Governor Cuomo announced the following COVID-19 vaccine eligibility expansions:

Beginning March 10^th, all individuals 60 years and older.
Beginning March 17^th, public-facing essential workers from government and not-for-profit entities.

The Governor also announced that starting on March 17^th, vaccine providers (with the exception of pharmacies) will be permitted to vaccinate any eligible individual without needing to prioritize certain populations (e.g., hospitals previously had to prioritize health workers). Pharmacies will continue to be required to serve only individuals over the age of 60, teachers, and child care workers, in accordance with federal policy.

On March 10^th, the Department of Health (DOH) released accompanying updated vaccination guidance. This guidance includes priority requirements for specific provider types, including hospitals and federally qualified health centers (FQHCs). It also clarifies ongoing provider responsibilities, such as (but not limited to):

Obligation to “use it or lose it” by administering all doses within 7 days;
Prohibition on redistributing to other facilities without DOH approval;
Permission to hold a limited duration clinic without notice to DOH; and
Requirement to keep a “standby” list of eligible individuals, and, if doses remain at the close of business, to vaccinate any consenting adult to ensure vaccine is not wasted.

The Governor’s press release is available here. The updated DOH guidance is available here.

New York State Submits MRT Waiver Extension Request to CMS
On March 4^th, the New York DOH submitted ta Section 1115 Demonstration Medicaid Redesign Team (MRT) Waiver extension request to CMS for approval. The extension request seeks a three-year extension (from April 1, 2021 to March 31, 2024) of all current programs and authorities under the State’s current MRT Waiver Demonstration, and the following two programmatic amendments developed by the Medicaid Redesign Team II (“MRT II”):

Transition (carve-out) of the non-emergency medical transportation (NEMT) benefit from managed long-term care (MLTC) to fee-for-service (FFS); and
Transition (carve-out) of pharmacy benefits from Medicaid managed care (MMC) to FFS.

The extension proposal, including the two proposed amendments, contains no changes to member eligibility, scope of benefits, or cost-sharing requirements. If and when the extension proposal is approved by CMS, the State intends to submit a new demonstration proposal and concept paper to CMS that will address health disparities and systemic health care delivery issues that have been highlighted and exacerbated by the COVID-19 pandemic.

The final extension proposal follows a public comment period during which the State received 762 verbal and written comments from individuals, advocacy groups, community providers, and other stakeholders. The final request does not contain any significant content changes in response to public comments, but it does outline public comment “themes” and the associated state response. The State also developed an FAQ document (available here) that summarizes and addresses public comments on the general waiver extension, the MLTC transportation carve-out, and the pharmacy transition to FFS. Comments related to pharmacy transition were focused on the impact to safety net providers that participate in the federal 340B program, the effect on budget neutrality calculations, the threat to care management and value-based payment arrangements, and access to cystic fibrosis therapy.

The final extension request is available here.

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

This Week’s SPG Updates

Please find below links to updated SPG resource documents and all other updates distributed by SPG this week.