Weekly Health Care Policy Update - April 30, 2021

In this update:

Biden Unveils American Families Plan in Address to Joint Session of Congress
Biden Nominates Assistant Secretary for Mental Health and Substance Use
Census Bureau Releases House Apportionment for the Next Decade
CMS Proposed FY 2022 IPPS and LTCH Payment Rule
HHS Issues Second Part of FY 2022 Notice of Benefit and Payment Parameters Rule
CMS Releases Updated Hospital Star Ratings
CMMI Extends Comprehensive Care for Joint Replacement Model through 2024
CMS Revises LTC Facility Testing Requirements and Survey Tool
HHS Waives Provider Training Requirements for Buprenorphine Prescribing
HHS Announces $1 Billion for Health Center Projects
PCORI Announces $25 Million in Funding for COVID-19 Outcomes Research Support Projects
Mother Cabrini Health Foundation Statewide Grants Program Application Period Begins
FDA and CDC Lift Pause on Johnson & Johnson COVID-19 Vaccine
CDC Issues Guidance that Fully Vaccinated People May Reduce Mask Use Outdoors
Congressional Hearings
NYS Legislature Repeals Certain Executive Orders; Governor Cuomo Extends and Modifies Previous Directives
Governor Cuomo Signs Legislation Regarding Nursing Home CON Process
Updated Guidance Documents

Administration Updates

Biden Unveils American Families Plan in Address to Joint Session of Congress
On April 28^th, in his first address to a joint session of Congress, President Biden unveiled a proposal for the American Families Plan (AFP), a package of $1.8 trillion in spending and tax cuts focused on childcare, education, and taxes. The AFP is intended to be complementary to the American Jobs Plan (AJP) infrastructure proposal released last month. Some of the AFP’s spending increases would be offset by increasing the top tax rate, increasing capital gains taxes for those earning more than $1 million, and increasing funding for IRS enforcement.

The AFP does not contain most health care priorities, other than a provision to make permanent the enhanced Affordable Care Act (ACA) subsidies included in the American Rescue Plan (ARP) Act passed earlier this year. In particular, Democratic proposals on prescription drug pricing and Medicare expansion were not included, although the White House noted that Biden still “has a plan to” allow Medicare to negotiate prescription drug prices, lower the Medicare eligibility age to 60, create a public option, and close the Medicaid coverage gap.

A fact sheet on the AFP is available here.

Biden Nominates Assistant Secretary for Mental Health and Substance Use
On April 23^rd, President Biden nominated Dr. Miriam E. Delphin-Rittmon to be Assistant Secretary of Mental Health and Substance Abuse at the Department of Health and Human Services (HHS). Dr. Delphin-Rittmon, a clinical psychologist, currently serves as Commissioner of the Connecticut State Department of Mental Health and Addiction Services. She previously served as Deputy Commissioner of the Connecticut Office of Multicultural Health Equity and as Senior Advisor to the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA). Dr. Delphin-Rittmon is also currently an Associate Adjunct Professor in the Yale University Department of Psychiatry.

Census Bureau Releases House Apportionment for the Next Decade
On April 26^th, the Census Bureau released new state population counts based on the 2020 census. The data resets the congressional balance of power by reapportioning the House of Representative’s 435 congressional districts among the 50 states for the next decade. In the realignment, Texas will gain two additional House seats, and Florida, North Carolina, Colorado, Oregon, and Montana will each gain one additional seat. New York, Illinois, Michigan, Pennsylvania, Ohio, and West Virginia each lose one House seat.

Regulatory Updates

CMS Proposes FY 2022 IPPS and LTCH Payment Rule
On April 27^th, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule setting the fiscal year (FY) 2022 policy for Medicare payments for inpatient and long-term care hospital (LTCH) services. Overall, CMS anticipates the proposed changes would increase operating, capital, and other hospital payments in FY 2022 by $3.4 billion, or a 2.8 percent increase, before the effect of cuts to supplemental payments. Specifically, Medicare Disproportionate Share Hospital (DSH) payments and uncompensated care payments are being cut by $0.9 billion, for a net overall increase of $2.5 billion. For LTCHs, CMS anticipates an overall payment increase in FY 2022 of $52 million, or a 1.4 percent increase.

Highlights of the rule include:

Repeal of the Trump Administration’s requirement for hospitals to report the median payer-specific negotiated charge with Medicare Advantage insurers on its Medicare cost reports (retroactive to January 1, 2021);
A five-year phase in of 1,000 new Medicare-funded medical residency slots beginning in FY 2023;
Extension of add-on payments for new COVID-19 treatments until the end of the fiscal year during which the Public Health Emergency (PHE) ends (likely September 30, 2022);
Allowing accountable care organizations in the BASIC track of the Medicare Shared Savings Program to forego automatic advancement to a higher risk level, instead of remaining at the same risk level for 2022;
Use of a measure suppression policy in the Hospital Readmissions Reduction Program, Hospital-Acquired Condition Program and Hospital Value-Based Purchasing Program to mitigate the impact of COVID-19 on a hospital’s quality score;
Permanent reinstatement of the imputed floor-wage-index for all-urban states for FY 2022;
Creation of a new quality measure for Covid-19 vaccination rates among hospital personnel; and
Extension of the New Technology Add-on Payments (NTAP) for 14 products for which the NTAP was scheduled to expire for FY 2022.

Additionally, as with other payment rules issued this year, CMS has issued two Requests for Information (RFIs) for stakeholder input. The first RFI seeks comment on closing the health equity gap, including through expanded quality measure development and data collection and the potential development of a health equity score measure modeled off the Health Equity Summary Score used for Medicare Advantage plans. The second seeks comment on the use of the Fast Healthcare Interoperability Resources (FHIR) standard in support of digital quality measurement in quality reporting programs (QRPs).

A fact sheet on the rule is available here. The full text of the proposed rule is available here. The rule will be open for comment for 60 days and finalized by August 1^st.

HHS Issues Second Part of FY 2022 Notice of Benefit and Payment Parameters Rule
Today (April 30^th), HHS published the second part of the FY 2022 Notice of Benefit and Payment Parameters (NBPP) final rule, which establishes rules in the individual and small group commercial markets as regulated by the ACA. This proposed rule was originally published by the Trump Administration in November 2020. HHS also intends to propose additional rulemaking for the 2022 payment notice later this year.

In the finalized NBPP:

HHS has reverted to the previous methodology to calculate the Premium Adjustment Percentage Index (PAPI) and cost-sharing parameters for regulated plans, based on projections of average per-enrollee employer-sponsored insurance (ESI) rather than projections of private health insurance premiums generally. As a result, the maximum required contribution for 2022 will be 8.09% and the maximum cost-sharing limit will be $400 lower per person than originally proposed (at $8,700 for individuals and $17,400 for families, with correspondingly lower limits for households with lower incomes).
HHS will not finalize many proposed updates to the risk adjustment model, with the exception of (1) the pricing adjustment for hepatitis C drugs, (2) requirements for reporting temporary premium credits in risk adjustment reporting, and (3) the proposal to use the three most recent consecutive years of risk data available, without updating between proposed and final rules if more data is available (so that the 2022 model will continue to rely on data from 2016-18).
HHS will not finalize the requirement to require all exchanges to conduct Special Enrollment Period (SEP) verification for at least 75% of new enrollments of newly-purchasing consumers.
HHS will finalize other policies concerning SEPs, including that individuals with subsidized COBRA continuation coverage may qualify for a SEP to enroll in coverage if their subsidies are ending.
HHS is finalizing a rule to collect prescription drug data directly from pharmacy benefit managers (PBMs) on a confidential basis for HHS’s internal understanding of drug costs.

The full text of the final rule is available here.

CMS Releases Updated Hospital Star Ratings
On April 28^th, CMS released updated acute care hospital and Critical Access Hospital (CAH) quality star ratings for 2021. The new ratings are the first to use the updated star rating methodology CMS established in its CY 2021 Outpatient Prospective Payment System (OPPS) rule, finalized in December 2020. The new model uses averages rather than the previous latent variable model to determine the weight assigned to quality measures, meaning that each measure in each group is weighted equally. Under the new methodology, about 32% of hospitals scored higher star ratings, 45% of hospitals received the same star rating as before, and 23% received worse ratings. On net, 59 more acute care hospitals received the highest (5-star) rating under the new system, while 45 fewer acute care hospitals received the lowest (1-star) rating.

The new ratings can be found here.

CMMI Extends Comprehensive Care for Joint Replacement Model through 2024
On April 29^th, CMS issued a final rule that would extend the Comprehensive Care for Joint Replacement (CJR) model through the end of 2024. The rule also modifies program parameters, such as the definition of an episode, target price calculations, and reconciliation periods. It also finalizes modifications to the 2020 year, including a three-month extension and flexibilities to account for the impact of COVID-19. The extension is projected to save $217 million over three years.

The full text of the rule is available here. More information on the CJR model can be found here.

CMS Revises LTC Facility Testing Requirements and Survey Tool
On April 27^th, CMS issued revisions to an August 25, 2020 interim final rule (IFC) which established long-term care (LTC) facility testing requirements for staff and residents related to COVID-19. The revisions define “fully vaccinated” and “unvaccinated” people and clarify how the testing requirements apply to each group. CMS also revised the COVID-19 Focused Survey for Nursing Homes to reflect the revised testing requirements.

The interim final rule can be found here.

HHS Waives Provider Training Requirements for Buprenorphine Prescribing
On April 28^th, HHS published updated guidance on the use of buprenorphine to treat opioid use disorder. The new guidelines expand the types of providers who can prescribe buprenorphine and eliminate an eight-hour training previously required to obtain the required “X-waiver” from HHS. The training exemption will allow DEA-registered physicians, physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists, certified registered nurse anesthetists (CRNAs), and certified nurse midwives to prescribe buprenorphine to up to 30 patients. In January, in the Trump Administration’s version of this guidance, HHS had originally proposed to eliminate the X-waiver requirement entirely.

The guidance is available here. Providers can learn more via SAMHSA’s Quick Start Guide and FAQs.

Grant Updates

HHS Announces $1 Billion for Health Center Projects
On April 27^th, HHS announced the availability of $1 billion to support major construction and renovation projects at Health Resources and Services Administration (HRSA)-funded federally qualified health centers (FQHCs) across the country. FQHCs may use the funding for COVID-19 capital needs and to construct new facilities, renovate and expand existing facilities, and purchase new equipment. All HRSA-funded health centers are eligible for the funds, which were made available through the American Rescue Plan.

The press release is available here. Applications are due on June 24^th at 5pm. More information is available here.

PCORI Announces $25 Million in Funding for COVID-19 Outcomes Research Support Projects
On April 22^nd, the Patient-Centered Outcomes Research Institute (PCORI) announced the availability of $25 million for research support projects. This funding is part of the Eugene Washington PCORI Engagement Awards, which seek to enable capacity-building activities to help patients participate across all phases of patient-centered outcomes research/comparative effectiveness research. These funds are not directed for research projects themselves, but rather to strengthen patient knowledge, researcher skills, and engagement tools.

This specific opportunity seeks to explore needs to build capacity for stakeholder engagement in research related to:

the urgent and unique needs related to the long-term effects of post-acute COVID-19;
the impact of COVID-19 on disproportionately affected populations;
the impact of COVID-19 on social isolation and loneliness; and
engaging, educating, and promoting informed decision making around COVID-19 vaccines.

A Letter of Intent is not required for this funding opportunity. The application deadline is May 24^th at 5pm. More information can be found here.

Mother Cabrini Health Foundation Statewide Grants Program Application Period Begins
On April 29^th, the Mother Cabrini Health Foundation opened the online grants portal for its Statewide Grants Program. As covered previously by SPG, this program offers funds to support not-for-profit organizations that sponsor activities, programs, and initiatives to enhance access to affordable, high-quality health care and related services. The Foundation will also host a webinar on May 4^th from 3pm to 4pm to review the Statewide Grants program and application process. Registration is available here.

Other Updates

FDA and CDC Lift Pause on Johnson & Johnson COVID-19 Vaccine
On April 23^rd, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) ended the 11-day pause on the Johnson & Johnson’s COVID-19 vaccine. The decision followed the recommendation of the CDC’s Advisory Committee on Immunization Practices (ACIP), which agreed that use of the vaccine should proceed without limitation on who can receive it. ACIP found that even for the highest-risk group (women aged 30-39), the risk of rare and dangerous blood clots and/or low platelets is lower than the risk of COVID-19. However, the vaccine label and fact sheet will now include a warning of the risk and encourage those with symptoms to seek medical care. CDC Director Rochelle Walensky reported that the side effect has appeared in only 1.9 cases per million people vaccinated.

CDC Issues Guidance that Fully Vaccinated People May Reduce Mask Use Outdoors
On April 27^th, the CDC announced new recommendations on recommended COVID-19 protocols. CDC now considers it safe for fully vaccinated individuals to be outside without a mask, except for crowded outdoor events like concerts and sporting events. Other restrictions for vaccinated and unvaccinated individuals have also been loosened. Dr. Walensky said the decision was based on the low risk of transmission outdoors as well as the improving COVID-19 situation, including rising vaccination rates and lower case counts. The CDC still recommends masks for all Americans in indoor spaces.

Congressional Hearings

Tuesday, May 4^th:

At 11am, the House Oversight and Reform Subcommittee on Economic and Consumer Policy will hold a hearing on “The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients.” More information is available here.
At 11:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs.” More information is available here.

Wednesday, May 5^th:

At 12pm, the House Education & Labor Subcommittee on Health, Employment, Labor, and Pensions (HELP) will hold a hearing entitled “Lower Drug Costs Now: Expanding Access to Affordable Care.” More information is available here.

New York State Updates

NYS Legislature Repeals Certain Executive Orders; Governor Cuomo Extends and Modifies Previous Directives
This week, the New York State Legislature passed three concurrent resolutions to repeal certain directives contained in Executive Orders issued by Governor Cuomo in response to the COVID-19 pandemic. The concurrent resolutions:

Repeal the requirement for food sales to accompany alcoholic beverage sales in bars and restaurants;
Classify individuals who volunteer to take on significant government work as Public Officers, who must comply with government disclosure and transparency rules; and
Eliminate compliance rules for providers who administer the COVID-19 vaccine, including the required administration of all vaccine supply within one week of receipt, the obligation to notify the State Department of Health (DOH) if unable to administer the entire supply on the 5^th day after receipt, and the requirement to verify that the individual receiving the vaccine is in an appropriate priority group.

Correspondingly, on April 27^th Governor Cuomo signed Executive Order 202.105 (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 27^th.

The Order also ends the following requirements:

In keeping with CDC guidance, individuals who are fully vaccinated against COVID-19 are no longer required to wear masks outdoors, except in crowded settings and venues.
Certain vaccine providers to prioritize certain groups for vaccination, such as teachers and individuals with comorbidities.
Vaccine providers are no longer required to prioritize groups for COVID-19 vaccination and no longer face penalties for administering COVID-19 vaccines to individuals who do not certify to being in a priority group.

Governor Cuomo Signs Legislation Regarding Nursing Home CON Process
On April 24^th, Governor Cuomo signed legislation (A5684/S4893A) which amends the Certificate of Need (CON) process for nursing homes. Under the new law, the Public Health and Health Planning Council (PHHPC) will consider character and competence of nursing home operators before approving any CON applications to establish new nursing homes or change the ownership of existing ones. Applications from applicants who have not “demonstrated satisfactory character, competence, and standing” for at least three years will be denied. Disqualifying factors include operating a nursing home that has:

A two-star or lower quality rating from CMS;
A history of regulatory violations that threatened to harm patient health, safety, or welfare and were recurrent or not promptly corrected;
Been in receivership;
Closed due to decertification or licensure revocation; or
Been involuntarily terminated from participating in Medicare or Medicaid.

PHHPC will be expected to provide notice and a comment period for any such CON applications as well as to adopt rules regarding determinations of a consistently high level of care.

The bill also enhances existing transparency requirements for nursing home operators. New requirements include:

Operators must provide residents with information on any common or family ownership of entities providing services to the nursing home in the residency agreement.
Operators must provide 90-day notice to DOH, residents, staff, and the long-term care ombudsman before entering any new such relationships.
Operators must provide 90-day notice to DOH before entering an agreement with any management, operations, staffing, or other entity involved in operating the facility.
DOH must also notify the long-term care ombudsman of any proposed sales of real property as well as such facility operating agreements described above.
If any such agreement (of either type) is signed, the operator must provide notice to DOH, residents, staff, and the long-term care ombudsman within 5 days.

Finally, after a change of ownership, the new operators must maintain direct care staff for a 60-day transition period without reducing their wages, benefits, or terms of employment.

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