Weekly Health Care Policy Update – May 13, 2022

May 20, 2022

In this update: 

  • Covid-19 Updates
    • Provider Groups Ask HHS for PHE Extension, HHS Reiterates Commitment to 60-Day Notice
  • Congressional Updates
    • Legislation to Standardize MA Prior Authorizations Will Receive Floor Vote
    • Senate Fails to Pass Abortion Rights Bill
  • Federal Agencies
    • CMS Finalizes Rule on Reassignment of Medicaid Provider Claims for Employee Benefits
    • DOL to Hold Webinar on Mental Health Parity Compliance
    • HHS Launches “Climate and Health Outlook” Informational Series
    • CDC Reports Provisional Overdose Data for 2021
    • Rules Being Reviewed by OMB
  • Other Updates
    • Leapfrog Group Releases Latest Hospital Ratings
    • KFF Estimates 14.2 Million Could Lose Medicaid Coverage at End of PHE
    • Health Innovation Alliance Releases Report on Improving Interoperability
  • Legislative Hearings
  • New York State Updates
    • Governor Hochul Announces New Pharmacy Benefits Bureau
    • DOH Issues Invitation for LHCSAs to Expand Private Pay Home Care Services Pilot Program to NYC
    • Commissioner Bassett Issues Guidance on Abortion Policy, Governor Hochul Announces Funding for Abortion Providers
    • OMH Issues Memo on Prescription of Controlled Substances After PHE
    • Governor Hochul Signs Legislation Requiring BH/SUD Training for First Responders
    • OPWDD Provides Additional Flexibility to Use Abbreviated or Alternate Training Materials
  • Funding Opportunities
    • HRSA Issues Additional FY 2023 FQHC Service Area Competition
    • HRSA Offers $5 Million to Increase Cancer Screening at FQHCs
    • DOH RFA for HIV/STI/HCV Prevention and Related Services for Young People
    • Morgan Stanley Opens Application Period for Children’s Mental Health Innovation Awards

COVID-19 Updates

Provider Groups Ask HHS for PHE Extension, HHS Reiterates Commitment to 60-Day Notice
On May 10th, a collection of major health care provider groups sent a letter to Secretary of Health and Human Services (HHS) Xavier Becerra urging him to extend the Covid-19 Public Health Emergency (PHE), which is currently set to expire on July 15th. The letter, which was cosigned by the American Hospital Association, the American Medical Association, and 12 other health care organizations, argues that cases of Covid-19 are continuing to rise across the nation and that the PHE has offered providers the regulatory flexibilities and authorities needed to respond to Covid-19. The letter specifically notes examples such as: 

  • The Food and Drug Administration’s (FDA) use of Emergency Use Authorizations (EUAs) for Covid-19 vaccines, tests, and treatments;
  • Maintenance of Medicaid enrollment and the pause on state redeterminations of Medicaid eligibility; and
  • Operational flexibilities for providers regarding staff and overall capacity.

Also on May 10th, HHS released a letter directed to state governors, which says that HHS does “not yet know when the PHE will end.” The letter reiterates that HHS committed to provide “at least 60-days’ notice before any expiration or termination of the PHE,” which currently would be May 16th. If the PHE is not allowed to lapse in July, it could likely be extended through the end of 2022.
 
The letter from provider organizations can be found here. The HHS letter can be found here. 

Congressional Updates

Legislation to Standardize MA Prior Authorizations Will Receive Floor Vote
On May 12th, the Improving Seniors’ Timely Access to Care Act (H.R. 3173) crossed the threshold of 290 cosponsors in the House of Representatives. Under current House rules, this means that the House will eventually be required to give the bill a floor vote, regardless of whether the bill is reported out of committee.
 
The bill would establish new requirements on Medicare Advantage (MA) plans for prior authorization processes. Specifically, it would require MA plans to: 

  • Enact electronic prior authorization programs that can provide real-time authorizations of “routinely approved” items and services;
  • Submit information to HHS on their prior authorization programs, such as the percentage of approved and denied requests and the average response time;
  • Provide information to providers and enrollees on their prior authorization criteria and policies; and
  • Meet other criteria for prior authorization programs as established by HHS to provide beneficiary protections.

The bill is expected to progress through the House later this year and be taken up by the Senate, where it currently has 24 bipartisan cosponsors (12 Democrats and 12 Republicans).

Senate Fails to Pass Abortion Rights Bill
On May 11th, the Senate failed to advance a bill by Senator Richard Blumenthal (D-CT) to codify Roe v. Wade by a 49-51 vote. Senator Bob Casey, a historic supporter of abortion restrictions, supported the bill, while Senators Joe Manchin (D-WV), Susan Collins (R-ME), and Lisa Murkowski (R-AK) voted against the legislation. Senators Collins and Murkowski opposed this bill as being too broad but have said they would support a narrower alternative to codify Roe.

Federal Agencies

On May 12th, the Centers for Medicare and Medicaid Services (CMS) published a final rule that explicitly authorizes State Medicaid programs to make payments for employee benefits to third parties on behalf of individual practitioners, with their consent. In general, Medicaid payments may not be made to anyone other than the provider of care. However, the new rule creates an exception to handle situations in which “a Medicaid program that is functioning as the practitioner’s primary source of revenue” may fulfill “basic employer-like responsibilities”, such as making payments to third parties for health and welfare benefits, training costs, and other customary benefits.
 
This reverses the Trump Administration’s interpretation of this clause, which sought to prohibit all such payments not explicitly authorized in statute. This policy would have removed states’ ability to withhold union dues from Medicaid home care workers’ payments. California, led by then-Attorney General Xavier Becerra, filed a lawsuit seeking to overturn that rule, which currently remains on appeal and will now likely be dismissed.
 
The final rule is available in the Federal Register here.

DOL to Hold Webinar on Mental Health Parity Compliance
On May 24th at 2pm, the Department of Labor (DOL) Employee Benefits Security Administration will hold a webinar to offer assistance on complying with recent changes to the Mental Health Parity and Addiction Equity Act (MHPAEA). The webinar will cover changes to parity requirements made by the Consolidated Appropriations Act of 2021 and the DOL’s 2022 MHPAEA Report to Congress. It will also address FAQs and provide other compliance tools.
 
More information is available here. Registration is required and available here.
 
HHS Launches “Climate and Health Outlook” Informational Series
On May 6th, the HHS Office of Climate Change and Health Equity announced the launch of a public information series called the Climate and Health Outlook. This series aims to connect weather forecasts to health resources to provide actionable information on climate-related health hazards. The first edition of the Outlook focuses on extreme heat, and provides estimates of which U.S. counties are likely to experience extreme heat, identifies vulnerable populations that could be affected by heat exposure, and lists targeted resources to help reduce the health effects of extreme heat.
 
A press release with more information is available here and the first edition on extreme heat is available here.
 
CDC Reports Provisional Overdose Data for 2021
On May 11th, the Centers for Disease Control and Prevention (CDC) released its provisional 2021 data on drug overdoses, showing that over 107,000 Americans are estimated to have died of drug overdoses last year, the highest total on record. Because overdose deaths are often initially reported without a cause of death, CDC uses predicted death figures that are adjusted for incomplete reporting.
 
This estimated death toll represents a 15% increase over 2020, and 50% higher than in 2019, before the pandemic. Most deaths were attributable to fentanyl and other synthetic opioids, up 23% over 2020. Estimated deaths in New York City increased by 17%, to 2,508, while estimated deaths in the rest of the state increased by about 7%, to 3,218.
 
The full CDC data set is available here.
 
Rules Being Reviewed by OMB
Currently, the following health care-related rules are under review at the Office of Management and Budget (OMB) before publication in the Federal Register:
 
Prospective Payment System (PPS) and Other Payment Rules

  • Proposed rule on calendar year (CY) 2023 revisions to payment policies under the Physician Fee Schedule and other Medicare Part B revisions
  • Proposed rule on the CY 2023 Home Health PPS and Home Infusion Therapy Services payments
  • Proposed rule on CY 2023 Hospital Outpatient PPS policy changes and Ambulatory Surgical Center (ASC) payment updates
  • Proposed rule on CY 2023 changes to the End-Stage Renal Disease (ESRD) PPS

Rural Hospitals

  • Proposed rule establishing Conditions of Participations (CoPs) for Rural Emergency Hospitals (REHs) and modifying CoPs for Critical Access Hospitals (CAHs)

 Medicaid and BHP

  • Proposed rule on the 2023 Basic Health Program (BHP) federal funding methodology and changes to the BHP regulations
  • Proposed rule to establish mandatory reporting requirements for reporting the Core Set of quality measures in Medicaid and the Children’s Health Insurance Program (CHIP)

Other

  • Proposed rule on the 340B Drug Pricing Program and administrative dispute resolution
  • Proposed rule on nondiscrimination in health programs and activities from the Office of Civil Rights

Other Updates

Leapfrog Group Releases Latest Hospital Ratings
On May 10th, the Leapfrog Group released its Spring 2022 Leapfrog Hospital Safety Grade data, which assessed almost 3,000 general acute care hospitals across 30 measures of patient safety. Overall, 33% of hospitals received an “A” grade, 24% received a “B” grade, 36% received a “C” grade, 7% received a “D” grade, and 1% received a “F” grade. Most hospitals (57.2%) received the same ratings in 2021 and 2022, with 20.3% scoring higher in 2022 and 22.4% scoring lower.
 
“A”-rated hospitals in the New York Metro region include Lenox Hill Hospital, Mather Hospital, Mount Sinai Hospital, North Shore University Hospital, NYC Health + Hospitals – Metropolitan, NYC Health + Hospitals – Queens, NYU Langone, NYU Langone – Brooklyn, NYU Langone – Long Island, St. Francis Hospital & Heart Center, and White Plains Hospital.
 
The full data is available here.
 
KFF Estimates 14.2 Million Could Lose Medicaid Coverage at End of PHE
On May 10th, the Kaiser Family Foundation (KFF) released a report finding that the eventual end of the Covid-19 PHE could cause 5.3 to 14.2 million Medicaid enrollees to lose eligibility. If the PHE expires as currently scheduled on July 15th, states would be required to begin initiating renewals no later than August and to complete them by no later than the end of September 2023.
 
The 6.2 percent enhanced Federal Medical Assistance Percentage (FMAP) states are currently receiving would end on September 30, 2022. KFF estimates that total Medicaid enrollment will have grown by 25% from 2019 through that date, an increase of 22.2 million enrollees, with the continuous enrollment requirement responsible for approximately 18.7 million of these enrollees. The authors further estimate that states will have received approximately $100.4 billion in enhanced federal Medicaid funding, more than double the estimated state costs for the additional enrollees.
 
The report is available here.
 
Health Innovation Alliance Releases Report on Improving Interoperability
On May 11th, the Health Innovation Alliance, a coalition of health care stakeholders focused on health IT, released a report in response to the Office of the National Coordinator’s (ONC) Health Interoperability Outcomes 2030 initiative, which asked stakeholders to submit ideas for what interoperability could achieve by 2030. The report outlines six areas of focus along with various recommendations within each area. The six areas are: 

  • Data at the point of care;
  • Medical devices;
  • A HIPAA safe harbor for patient information requests;
  • Information sharing with medical researchers and innovators;
  • Social determinants of health; and
  • Public health data collection and reporting.

The full report is available here. 

Legislative Hearings

Past Hearings:

  • On May 12th, the Senate Budget Committee held a hearing entitled “Medicare for All: Protecting Health, Saving Lives, Saving Money.” A recording of the hearing is available here.

Tuesday, May 17th:

  • At 10am, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a hearing to examine the Fiscal Year (FY) 2023 Budget Request for the National Institutes of Health (NIH). More information is available here.

Wednesday, May 18th:

  • At 10am, the House Judiciary Committee will hold a hearing entitled “Revoking Your Rights: The Ongoing Crisis in Abortion Care Access.” More information is available here.
  • At 10am, the Senate Health, Education, Labor, and Pensions Committee will hold a hearing entitled “Cybersecurity in the Health and Education Sectors.” More information is available here.

Thursday, May 19th:

  • At 10am, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies will hold a hearing to examine the FY 2023 Budget Request for the Food and Drug Administration (FDA). This hearing is rescheduled from its original date of April 27th. More information is available here.

New York State Updates

Governor Hochul Announces New Pharmacy Benefits Bureau
On May 11th, Governor Hochul announced the creation of a Pharmacy Benefits Bureau within the Department of Financial Services (DFS). The Bureau will be tasked with licensing and supervising the Pharmacy Benefit Manager (PBM) industry in New York, including receiving the disclosure and transparency submissions that required under new laws enacted in January. PBMs will be required to file information that includes: 

  • Information on the PBM’s owners and ownership interests;
  • A list of all pharmacies the PBM is contracted with;
  • Information on the 10 highest-cost drugs (by total claims cost) per State-regulated health plan;
  • Information on the 10 most-rebated drugs per State-regulated health plan; and
  • Program integrity information such as ongoing litigation and challenges, appeals, and complaints in which the PBM is involved.

The Bureau will also take over DFS’s current functions in investigating drug price spikes. The 2022-2023 Enacted Budget allocates $5 million to fund and staff the new bureau. As the program develops, the State intends for costs to be offset through the application of fees, assessments, and penalties imposed directly on the PBM industry.
 
The Governor’s press release is available here. PBMs are required to register with the Bureau by June 1st, as per DFS guidance available here. First annual reports must be submitted by PBMs by July 1st.
 
DOH Issues Invitation for LHCSAs to Expand Private Pay Home Care Services Pilot Program to NYC
On May 6th, the Department of Health (DOH) issued its Phase Two invitation to Licensed Home Care Services Agencies (LHCSAs) who wish to participate in the NY State of Health’s (NYSoH) Private Pay Home Care Services Pilot Program. This pilot is an initiative of the second Medicaid Redesign Team (MRT II) to create an option for individuals who are not eligible for Medicaid to shop for private pay home care services on NYSoH that would be provided by LHCSAs.
 
In Phase One, the pilot program operated only in Long Island and Westchester County. Under Phase Two, the pilot program will expand to cover the whole eight-county downstate region, including New York City, and applicants must serve all eight counties (unless they are Phase One LHCSAs that do not operate in New York City). All interested LHCSAs, whether they currently participate in Phase One or not, must apply under this invitation to continue participating in the program. Applicants must have at least 350 employed home care workers and meet other requirements.
 
Additional details are available here. Questions may be submitted to NYSOHHomeCare@health.ny.gov.
 
Commissioner Bassett Issues Guidance on Abortion Policy, Governor Hochul Announces Funding for Abortion Providers
On May 6th, Commissioner Bassett sent a letter to abortion providers to clarify New York’s policy on abortion care. The letter notes that: 

  • Abortion is legal in NYS when the patient “is within 24 weeks from the commencement of pregnancy, or there is an absence of fetal viability, or the abortion is necessary to protect the patient’s life or health.”
  • DOH now defines “commencement of pregnancy” to begin with the implantation of blastocyst(s), rather than the time of conception.
  • To determine whether an abortion is necessary to protect the health of a patient, providers should consider the following factors: physical, emotional, psychological, familial, and age of the patient.
  • No parental consent is required for abortions in New York, regardless of age.

In addition, this week Governor Hochul announced the following investments to support abortion providers in anticipation of the Supreme Court overturning Roe v. Wade: 

  • $25 million Abortion Provider Support Fund to expand provider capacity and ensure patient access, to be distributed through grants and provider reimbursement requests; and
  • $10 million for reproductive health care centers for security grants, to be administered through a request for proposals.

Commissioner Bassett’s letter can be found here. The Governor’s press release is available here.
 
OMH Issues Memo on Prescription of Controlled Substances After PHE
On May 10th, the New York State Office of Mental Health (OMH) released a memorandum concerning the resumption of in-person visits for patients who are prescribed controlled substances following the federal Covid-19 PHE. During the PHE, the requirement for at least one in-person medical evaluation prior to issuing a prescription for controlled substances via telehealth was waived, allowing for such evaluations to be conducted virtually. Unless Congress or HHS extends this flexibility, the initial in-person requirement will resume at the conclusion of the PHE. However, as noted in the OMH memorandum, there are certain situations in which the in-person medical evaluation requirement may be waived.
 
As such, when the PHE ends, programs must ensure practitioner compliance with the following: 

  • Patients who have been seen in-person prior to or during the PHE by the practitioner prescribing the controlled medication may continue to be prescribed such medications via telehealth.
  • Patients who have never been seen in-person must be seen in-person by the prescribing practitioner at least once prior to the renewal or new prescription for a controlled substance (programs are strongly encouraged to begin scheduling in-person appointments before the end of the PHE to manage practitioner workload and mitigate patient risk).
  • Patients who were seen in-person prior to or during the PHE, but have their medications prescribed by another practitioner (the covering practitioner), must be seen in-person by the prescribing practitioner within two years of the last in-person visit.

The memorandum is available here.
 
Governor Hochul Signs Legislation Requiring BH/SUD Training for First Responders
On May 6th, Governor Hochul signed legislation (S7144/A7686) amending the Mental Hygiene Law to include firefighters and emergency medical services (EMS) personnel as first responders that must receive the following trainings if located within the catchment area of a crisis stabilization center: 

  • Crisis intervention team training;
  • Mental health first aid;
  • Implicit bias training; and
  • Naloxone training.

The Governor’s press release is available here.
 
OPWDD Provides Additional Flexibility to Use Abbreviated or Alternate Training Materials
On May 9th, the Office for People with Developmental Disabilities (OPWDD) released updated guidance that provides relief and flexibility in agency training programs given current staffing shortages and the “direct care hiring crisis.” If required initial and annual trainings contain the appropriate elements outlined in the document, flexibilities in the provision of such trainings are permitted, such as abbreviated training and alternate training delivery methods (e.g., webinars, video recordings, and self-certification documentation). Agencies remain responsible for ensuring that employed staff develop the knowledge and skills required to successfully perform the duties of the position.
 
The guidance also indicates that all recertification/annual training due dates are extended until March 31, 2023. Annual training should continue, and agencies should prioritize refresher training for staff based on the length of time since their last certification or recertification or based on staff need.
 
The guidance is available here. Questions may be submitted to TalentDevelopment@opwdd.ny.gov. 

Funding Opportunities

HRSA Issues Additional FY 2023 FQHC Service Area Competition
On May 5th, the Health Resources and Services Administration (HRSA) posted a new Service Area Competition (SAC) opportunity for fiscal year (FY) 2023. Through the SAC, organizations may apply to participate in the federally-qualified health center (FQHC) program by taking over a grant in an existing service area. FQHCs are typically approved for a three-year period and, if they seek to renew, must reapply to the SAC. For this opportunity, there are additional SACs open in all boroughs of New York City.
 
Applications are due July 5th. More information is available here. 
 
HRSA Offers $5 Million to Increase Cancer Screening at FQHCs
On May 11th, HRSA released a Notice of Funding Opportunity (NOFO) for the Accelerating Cancer Screening (AxCS) program, which will offer up to $500,000 over two years to 10 FQHCs to increase the number of patients they screen for cancer and, if appropriate, help access follow-up care.
 
Awardees will be required to implement at least one activity within each of four focus areas: 

  • Access and affordability;
  • Patient experience;
  • Screening; and
  • Workforce development.

 They must also document and establish a relationship with a National Cancer Institute-designated Cancer Center, which may involve training personnel and referral linkages.  
 
The NOFO is available here. Applications are due June 15th.
 
DOH RFA for HIV/STI/HCV Prevention and Related Services for Young People
On May 5th, DOH released a Request for Applications (RFA) for the following two components of a procurement: 

  • HIV/STI/HCV Prevention and Related Services for Young Gay Men/Young Men Who Have Sex With Men with a Focus on Communities of Color (Component A); and
  • HIV/STI/HCV Prevention and Related Services for Young People Through the Use of Youth Health Advocates (Component B).

The RFA will provide a total of $5.4 million annually to service providers that develop and/or enhance comprehensive HIV/STI/HCV programs for the target populations above. Annual awards will not exceed $200,000 per awardee. The program aims to address issues related to health equity and the key social determinants of health impacting HIV/STI/HCV and the sexual health needs of the priority populations.
 
Eligible applicants are not-for-profit 501(c)(3) organizations that provide services within the region for which they are applying. Applicants may submit up to one application for each component of the RFA. Contracts will last for five years beginning on March 1, 2023.
 
The RFA is available here. Applications are due on June 22nd.
 
Morgan Stanley Opens Application Period for Children’s Mental Health Innovation Awards
On May 2nd, the Morgan Stanley Alliance for Children’s Mental Health began accepting applications for its Children’s Mental Health Innovation Awards. This initiative aims to identify and fund mental health care solutions for children and young adults nationwide, with the goal of connecting innovative ideas with capital. Applicants may apply to receive up to $100,000 in funding.
 
Eligible applicants are not-for-profit 501(c)(3) direct-service organizations. Applications must present an innovative solution for tackling stress, anxiety, depression, or other mental health issues in children or young adults.
 
Additional details are available here. Applications are due on July 15th. There will be a briefing session on May 18th at 3pm, registration for which is available here.