Weekly Health Care Policy Update – October 1, 2021

October 8, 2021

In this update: 

  • Covid-19 Updates
    • CMS to Pay for Covid-19 Booster Shots
    • CDC Issues Advisory Recommending Covid-19 Vaccinations for Pregnant Women
    • OCR Releases Guidance on HIPAA Protections and Covid-19 Vaccinations
  • Regulatory
    • Biden Administration Issues Second Part of Surprise Billing Rule
    • HHS Opens PRF Round 4 Applications and Round 3 Reconsiderations
    • HHS Awards $1 Billion to FQHCs for Capital Projects
    • GAO Publishes Report on Medicaid Behavioral Health Demonstration
    • MACPAC Holds First Meeting of 2021-2022 Cycle
    • CMS Releases 2022 Medicare Advantage Cost Information
    • SAMHSA Awards $825 Million to Strengthen Community Mental Health Centers
    • HHS Rescinds Requirement for FQHCs to Pass on 340B Discounts for Insulin and EpiPens 
  • Other
    • FCC Issues New Covid-19 Telehealth Program Awards
  • Congressional Hearings
  • New York State Updates
    • Governor Hochul Appoints Dr. Mary T. Bassett as Commissioner of Health
    • Governor Hochul Declares Statewide Disaster Emergency Due to Health Care Staffing Shortages
    • DOH Adds Applied Behavior Analysis to Medicaid Benefit
    • Governor Hochul Announces Availability of Covid-19 Booster Doses for Eligible New Yorkers
    • DOH Proposes to Increase State Nursing Facilities’ Incentive Payments for Training
    • Governor Hochul Announces $19 Million for the OASAS Workforce
    • DOH Updates Covid-19 Guidance for the Authorization of Community-Based Long-Term Services and Supports
    • NYS Releases Third Round of Statewide Health Care Facility Transformation Program Funding

Administration Updates

CMS to Pay for Covid-19 Booster Shots
On September 24th, the Centers for Medicare and Medicaid Services (CMS) announced that following the Food and Drug Administration’s (FDA) recent action to authorize a booster dose of the Pfizer Covid-19 vaccine for certain high-risk populations, and a recommendation from the Centers for Disease Control and Prevention (CDC), the Agency will provide coverage of booster doses without cost sharing. Medicare beneficiaries will pay nothing for Covid-19 vaccines or their administration and there will be no copayment, coinsurance, or deductible. COVID-19 vaccines and their administration, including boosters, will also be covered without cost sharing for nearly all Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries, as well as eligible consumers of most issuers of health insurance in the commercial market, in accordance with the American Rescue Plan Act (ARP) of 2021.
 
The CMS announcement is available here.
 
CDC Issues Advisory Recommending Covid-19 Vaccinations for Pregnant Women
On September 29th, the Centers for Disease Control and Prevention (CDC) issued a Health Advisory for people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future. The CDC is strongly recommending that these individuals get Covid-19 vaccinations either before or during pregnancy, due to the high risk of adverse outcomes from contracting Covid-19 for both mothers and children. More than 125,000 laboratory-confirmed Covid-19 cases have been reported in pregnant people, including more than 22,000 hospitalizations and 161 deaths, with the highest number of deaths occurring in August. As of September 18th, only 31% of pregnant people were fully vaccinated.
 
The CDC Health Advisory can be found here.
 
OCR Releases Guidance on HIPAA Protections and Covid-19 Vaccinations
On September 30th, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released subregulatory guidance on the application of the HIPAA Privacy Rule to Covid-19 vaccination information. OCR stresses that the HIPAA Privacy Rule does not preclude anyone (employers, businesses, individuals, etc.) from asking whether an individual has received a Covid-19 vaccine. OCR reminds the public that the HIPAA Privacy Rule protects individuals from having their health data disclosed by a covered entity or business associate. As such, it would only apply to prevent a medical provider or other covered entity from disclosing a patient’s Covid-19 vaccination status to a non-associate, including the employer, without permission.

The guidance is available here.

Regulatory Updates

Biden Administration Issues Second Part of Surprise Billing Rule
On September 30th, the Biden Administration released an interim final rule with comment (IFC) that establishes the second part of its regulations prohibiting surprise billing, as mandated in the No Surprises Act passed in the 2020 year-end omnibus bill. This second part primarily establishes provisions for the independent dispute resolution (IDR) process, through which out-of-network providers and insurance will determine their reimbursement if open negotiations fail. This process will apply to all services for which balance billing was prohibited in the first surprise billing regulations (e.g., emergency services; non-emergency services furnished at an in-network facility).
 
If the 30-day open negotiation period ends without result, either the provider or insurer may initiate the IDR process. They will jointly select a certified IDR entity and submit offers for payment along with documentation. The IDR entity will then issue a binding judgment. IDRs will begin from the presumption that the Qualifying Payment Amount (QPA), which is generally defined as the issuer’s median contracted rate in that geography, is the appropriate payment, and parties must submit evidence for the IDR to make a different judgment. The allowed timeline, from the end of the open negotiation period to the payment determination, is 53 business days, and issuers must then make payment within 30 business days.
 
The rule also covers new requirements for providers and facilities to provide “good faith estimates.” Starting January 1, 2022, providers must provide such estimates to uninsured or self-pay patients. The estimate must include expected charges for all items to be provided in the visit, including those provided by other providers or facilities. However, HHS will exercise enforcement discretion regarding other providers’ charges until January 1, 2023. If an individual is billed more than $400 above the good faith estimate, the patient may initiate a patient-provider dispute with a select dispute resolution (SDR) entity.
 
The rule is scheduled to be published in the Federal Register on October 7th. Comments will be accepted until 60 days after publication (December 6th). A press release is available here and the full text of the rule is here.
 
HHS Opens PRF Round 4 Applications and Round 3 Reconsiderations
On September 29th, HRSA opened the application portal for Round 4 of the Provider Relief Fund (PRF), which will provide $17 billion across all eligible providers as well as $8.5 billion in ARP funding for rural providers. As covered in previous SPG updates, any provider of health care services and supports may apply to have a percentage of their lost revenue and Covid-19-related expenses reimbursed. HRSA will utilize a single application for both general and rural funds. Applications will be accepted through October 26th.
 
HRSA has also made a PRF Round 3 reconsideration form available for providers who believe their payment amount was incorrect, based on the published methodology. HRSA will only consider potential calculation errors. Providers may not revise or correct their submitted applications, and HRSA will not change its methodology or policy, including statistical adjustments it made to outlier providers. Requests may be sent in through November 12th.
 
Application instructions for Round 4 may be found here. More information on the Round 3 reconsideration process is available here.
 
HHS Awards $1 Billion to FQHCs for Capital Projects
On September 28th, the Health Resources and Services Administration (HRSA) at HHS awarded nearly $1 billion in American Rescue Plan (ARP) funding to nearly 1,300 federally-qualified health centers (FQHCs). This represents more than 90 percent of all FQHCs nationally, and includes over $54 million for 62 health centers across New York. The funding supports major health care construction and renovation projects, including Covid-19-related capital needs, new facilities, renovating and expanding existing facilities, and purchasing new equipment including telehealth technology, mobile medical vans, and freezers to store vaccines. The funds were awarded to health centers serving medically underserved and other vulnerable populations, and communities disproportionately affected by Covid-19 and other conditions.
 
The announcement, as well as funding by state, can be found here.
 
GAO Publishes Report on Medicaid Behavioral Health Demonstration
On September 27th, the Government Accountability Office (GAO) published a report on states’ experiences with the Certified Community Behavioral Health Clinics (CCBHC) demonstration, which began in 2016. The goal of the demonstration is to improve patient access to community- based mental health services, and participating states (Minnesota, Missouri, Nevada, New Jersey, New York, Oklahoma, Oregon, and Pennsylvania) received enhanced federal funding for their Medicaid programs.
 
The report, required by the CARES Act, describes what states reported about how the CCBHC demonstration affected state spending on behavioral health services, and examines CMS guidance for states on Medicaid CCBHC payments. Five of the eight demonstration states reported increased state spending on CCBHCs, likely due to an increased number of individuals receiving treatment as well as an increased array of services provided. Two states noted spending decreases, and one state said effects were unknown.
 
GAO generally concludes that CMS payment guidance for the demonstration “lacked clear and consistent information on better aligning CCBHC payment rates with costs and preventing duplicate payments.” GAO therefore makes two main recommendations in the report: (1) that CMS issue clear and consistent written guidance to help states better align payment rates with clinic costs, and (2) that CMS issue clear and consistent written guidance to help states avoid potential duplication between CCBHC and other Medicaid payments.
 
The GAO report is available here.
 
MACPAC Holds First Meeting of 2021-2022 Cycle
On September 23rd and 24th, the Medicaid Access and Payment Advisory Commission (MACPAC) met for its monthly public meeting, the first of the 2021-2022 cycle. The Commission shared priorities for the 2021- 2022 meeting calendar, which includes a look at prescription drugs and vaccines, as well as two congressionally-mandated activities: (1) an examination of the relationship between Medicaid disproportionate share hospital (DSH) payments, the number of uninsured individuals, and uncompensated care costs for hospitals; and (2) determining whether the Money Follows the Person demonstration criteria for qualified community residences should be aligned with the home and community-based (HCBS) settings rule.
 
Other topics considered include: 

  • How adoption of electronic health records (EHRs) by behavioral health providers can improve clinical integration;
  • Medicaid’s response to Covid-19;
  • Greater use of integrated models for dual eligibles;
  • Beneficiary communications related to eligibility and enrollment;
  • Increased access to nurse midwives and birth centers;
  • Increased access to adult vaccines for non-Medicaid expansion populations (vaccines are mandatorily covered for the expansion population);
  • The efficacy of directed payments to improve access and quality; and
  • Medicaid spending and financing.

New Commission work for this cycle will include: strengthening efforts to monitor access to Medicaid, examining benefit design and direct care workforce of HCBS rebalancing, Medicaid churn, state procurement practices, federal rules and processes for rate-setting, nursing facility staffing, social determinants of health, and disparities and health equity.

Slides from the meeting are available here.
 
CMS Releases 2022 Medicare Advantage Cost Information
On September 29th, the Centers for Medicare and Medicaid Services (CMS) announced 2022 information regarding Medicare Advantage (MA) and Part D plans:  

  • The average MA premium in 2022 will be $19 per month, down from $21.22 in 2021, while the average Part D premium will increase from $31.47 to $33.
  • Enrollment is projected to increase from 26.9 million to 29.5 million.
  • The number of plans participating in the Value-Based Insurance Design (VBID) model has more than doubled, to 1,014 different plan benefit packages. VBID plans offer additional supplemental benefits to their enrollees that help them meet social needs.

The MA Open Enrollment period begins October 15th. A CMS press release is available here.
 
SAMHSA Awards $825 Million to Strengthen Community Mental Health Centers
 On September 28th, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the distribution of $825 million to 231 Community Mental Health Centers (CMHCs) to support the needs of individuals with serious emotional disturbance (SED) or serious mental illness (SMI), including those with co-occurring substance use disorder (SUD). Grantees are required to develop a behavioral health disparities impact statement within 60 days of the award, a quality improvement plan to address care accessibility, and draft procedures consistent with the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care.
 
Allowable services under the grant include: 

  • Training behavioral health professionals to work with schools to address behavioral health issues for school-age youth at risk for SED;
  • Staff training on behavioral health disparities, including building cultural and linguistic competence and engaging/retaining diverse client populations;
  • Expanding capacity and availability of crisis beds;
  • Expanding mobile crisis mental health services for target populations;
  • Developing and implementing outreach strategies and referral pathways for vulnerable populations; and
  • Training and supporting peer staff to address mental health needs that may have arisen because of the pandemic.

The list of grant recipients, including 20 organizations in New York, may be found here.
 
HHS Rescinds Requirement for FQHCs to Pass on 340B Discounts for Insulin and EpiPens 
On September 30th, HHS issued a final rule officially rescinding a December 2020 rule that would have required FQHCs to pass 340B discounts for insulin and injectable epinephrine (EpiPens) on to patients. The rule, published under the Trump Administration, stated that it would reduce out-of-pocket costs for patients, but HHS now states that the infrastructure required by health centers to determine a patient’s eligibility to receive the drugs at the lower price would put undue administrative costs and burdens on the facilities. While the previous rule was technically in effect, no grantees have yet implemented these requirements.
 
The final rule (available here) enacting the rescission is expected to be published in the Federal Register on October 1st, with an expected October 31st implementation date. The December 2020 rule, which is now rescinded, is available here.

Other Updates

FCC Issues New Covid-19 Telehealth Program Awards
On September 29th, the Federal Communications Commission (FCC) announced the award of $41 million to 72 applicants to the second round of FCC Covid-19 Telehealth Program. This program offers funds to health care providers to purchase broadband, devices, and technology systems to support the delivery of remote care. Awards range up to $1 million per applicant. In this distribution, nine providers in New York received awards.
 
The program was initially established in the CARES Act and distributed $200 million in its first round. The December 2020 year-end omnibus bill added a second round of $250 million, of which $83 million has now been distributed (after a $42 million allocation in August). Once $150 million has been distributed, all applicants who have not yet received an award will be provided an opportunity to supplement their applications.
 
The announcement is available here.

Congressional Hearings

Thursday, October 7th:

  • At 10am, the House Veterans’ Affairs (VA) Subcommittee on Technology Modernization will hold a hearing on the VA Electronic Health Record Transparency Act of 2021 and IT reform and data collection bills. More information is available here.

New York State Updates

Governor Hochul Appoints Dr. Mary T. Bassett as Commissioner of Health
On September 29th, Governor Hochul announced that she will appoint Mary T. Bassett, MD, MPH, as Commissioner of the New York State Department of Health (DOH), effective December 1st.
 
Dr. Bassett currently serves as the director of the François-Xavier Bagnoud Center for Health and Human Rights at Harvard University and is a professor in the department of Social and Behavioral Sciences at the Harvard T.H. Chan School of Public Health. Dr. Bassett served as Commissioner of the New York City Department of Health and Mental Hygiene from 2014 to 2018.
 
The Governor’s press release is available here.
 
Governor Hochul Declares Statewide Disaster Emergency Due to Health Care Staffing Shortages
On September 27th, Governor Hochul signed an Executive Order (available here) declaring a statewide disaster emergency due to staffing shortages in hospitals and other health care facilities as a result of the State’s mandate that certain health care workers be vaccinated against Covid-19. The Order reinstates many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. Specifically, it temporarily suspends or modifies specific regulations that include the following:
 
Licensure and Registration

  • Allows certain health care providers who are licensed in other states or in Canada or other approved countries, or who are licensed but not registered in New York State, to practice in New York. This includes: 
    • Physicians and physician assistants;
    • Registered nurses, licensed practical nurses, and nurse practitioners;
    • Clinical nurse specialists, specialist assistants, and similar titles;
    • Radiologic technicians;
    • Respiratory therapists and respiratory therapy technicians;
    • Midwives; and
    • Licensed master social workers and licensed clinical social workers.
  • Allows recent graduates of certain health care programs to practice in New York State under supervision.
  • Waives re-registration fees, creating an expedited re-registration process, and eliminating barriers to re-enter the workforce for retirees.

Scope of Practice

  • Allows physician visits for nursing home residents to be conducted via telemedicine.
  • Allows general hospitals to use qualified volunteers or personnel affiliated with different hospitals.
  • Permits additional personnel (e.g., EMT-paramedics, midwives) to administer Covid-19 and influenza vaccines.
  • Allows physicians and practitioners to use non-patient specific regimens to facilitate Covid-19 testing and vaccination.
  • Provides flexibility to emergency medical services personnel, including: 
    • Allowing the use of community paramedicine, alternative destinations, treatment in place through telemedicine, and other services as approved by the Commissioner of Health, and
    • Allowing EMTs to provide other emergent and non-emergent services beyond settings currently authorized, such as hospitals.

Prior Authorization

  • Suspends requirements for preauthorization review for scheduled surgeries.
  • Suspends concurrent review for inpatient and outpatient hospital services.
  • Suspends retrospective review for inpatient and outpatient hospital services at in-network hospitals.
  • Tolls statutory timeframes for hospitals to submit internal and external appeals.

Other

  • Allows hospitals and nursing homes to safely discharge, transfer, or receive patients as necessary due to staffing shortages.
  • Provides flexibilities for clinical labs to increase testing capacity, including by employing recent graduates.

The Governor has also directed a 24/7 Operations Center, led by DOH, to constantly monitor staffing operations and trends statewide, provide guidance to health care facilities, and troubleshoot acute situations. The State is monitoring the need for and is prepared to deploy medically-trained National Guard members as necessary.
 
The Governor’s press release is available here. Governor Hochul also released data on vaccination rates (available here) indicating that 92 percent of nursing home staff, 92 percent of hospital staff, and 89 percent of adult care facility staff were compliant with the mandate as of September 27th when the mandate went into effect.
 
DOH Adds Applied Behavior Analysis to Medicaid Benefit
On September 29th, DOH published a Notice of Adoption in the State Register (available here) that includes Applied Behavior Analysis (ABA) in the Medicaid Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) benefit under a new Section 505.39 of the Social Services Law. In the notice, DOH confirms that it will reimburse for ABA services when provided in accordance with Article 167 of the New York State Education Law (available here), which includes the provision of services by unlicensed individuals as part of a multi-disciplinary team. DOH also indicates that it will reimburse for ABA services at rates approved by the Division of the Budget.
 
The previously published proposed regulations for ABA services are available here. Questions may be submitted to regsqna@health.ny.gov.
 
Governor Hochul Announces Availability of Covid-19 Booster Doses for Eligible New Yorkers
On September 27th, Governor Hochul announced that New York State will begin to implement Covid-19 vaccine booster doses as part of the State’s Covid-19 vaccination program. The New York State Clinical Advisory Task Force endorsed the Centers for Disease Control and Prevention (CDC) statement recommending a booster shot of the Pfizer-BioNTech Covid-19 vaccine for certain populations and for those in high-risk occupational and institutional settings. Accordingly, the following four groups of New Yorkers who previously received the Pfizer-BioNTech Covid-19 vaccine are eligible for the booster dose at least six months after their initial vaccine series: 

  • Individuals 65 years and older or residents in long-term care settings;
  • Individuals 50-64 years old with underlying medical conditions;
  • Individuals 18-49 years old with underlying medical conditions, based on individual benefits and risks; and
  • Individuals 18-64 years old who are at increased risk of Covid-19 exposure and transmission because of occupational or institutional setting, based on individual benefits and risks.

The Governor’s press release is available here. The State has launched a new website with additional information regarding the booster shots, which is available here.
 
DOH Proposes to Increase State Nursing Facilities’ Incentive Payments for Training
On September 29th, DOH posted a notice in the State Register (available here) outlining its intent to increase state nursing facilities’ incentive payments to provide training to improve community discharge rates. These funds will be available from October 1, 2021 through March 31, 2022 to help providers recover from the Covid-19 pandemic. The estimated annual net aggregate increase in gross Medicaid expenditures of the proposed nursing home training enhancement is $150 million.
 
The proposed training enhancement is contingent upon CMS approval of the State’s spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for home and community-based services (HCBS) contained in the American Rescue Plan (ARP). Stakeholders may submit public comments on the proposed training enhancements via email to spa_inquiries@health.ny.gov. 
 
Governor Hochul Announces $19 Million for the OASAS Workforce
On September 23rd, Governor Hochul announced that New York State has secured $19 million in federal funding through the Substance Abuse Prevention and Treatment (SAPT) block grant program to support the Office of Addiction Services and Supports (OASAS) workforce. This funding may be used for: 

  • Recruitment and retention incentives, including longevity and differential pay;
  • Tuition, exam, and application fees;
  • Continuing education courses and loan forgiveness;
  • Workforce development, training, and ongoing support; and
  • Career development, including the development or enhancement of fellowship programs.

Providers eligible for funding will receive an email with a survey link which must be completed to accept the award. The deadline for completing the survey is October 1st.
 
The Governor’s press release is available here. Additional information on the funding is available here. Questions may be sent to COVIDFunds@oasas.ny.gov.
 
DOH Updates Covid-19 Guidance for the Authorization of Community-Based Long-Term Services and Supports
On September 30th, DOH released an updated guidance document (available here) regarding the authorization of community-based long-term services and supports covered by Medicaid to: 

  • Extend the due date for personal assistants in the Consumer Directed Personal Assistance Program (CDPAP) to obtain an annual health assessment from September 30th to December 31st; and
  • Allow telehealth Uniform Assessment System (UAS-NY) Community Health Assessments (CHAs) to resume as an option for all assessments (in addition to the in-person mode).

Telehealth CHAs must be completed via videoconference. Telephone assessments are not permitted except for individuals being assessed for 1915(c) Traumatic Brain Injury (TBI) and Nursing Home Transition and Diversion (NHTD) programs. Questions may be submitted to mltcinfo@health.ny.gov.
 
NYS Releases Third Round of Statewide Health Care Facility Transformation Program Funding
On September 30th, the New York State Department of Health (DOH) and the Dormitory Authority of the State of New York (DASNY) released a Request for Applications (RFA) for Phase Three of the Statewide Health Care Facility Transformation Program (SHCFTP III). A total of $208.3 million in funding is available to be awarded through this RFA. Like the previous two phases of this program, SHCFTP III awards will support capital projects, debt retirement, working capital, and certain non-capital projects directly related to a capital project with the goal of facilitating health care transformation activities. Such transformation activities may include, but are not limited to, mergers, consolidations, acquisitions, or other activities intended to: 

  • Create financially sustainable systems of care;
  • Preserve or expand essential health services;
  • Modernize obsolete facility physical plants and infrastructure;
  • Foster participation in alternative payment arrangements (such as contracts with managed care organizations or accountable care organizations);
  • Increase the quality of resident care or experience (for residential facilities); or
  • Improve health information technology infrastructure, including telehealth.

The full RFA is available here and SPG’s detailed summary is available here. Applications are due on January 12, 2022.