Weekly Health Care Policy Update – October 3, 2022

October 10, 2022

In this update: 

  • Administration Updates
    • White House Announces Initiative on Hunger, Nutrition, and Health
  • Legislative Update
    • Congress Passes and Biden Signs Continuing Resolution
    • Congress Passes MOBILE Health Care Act
  • Federal Agencies
    • CMS Announces Medicare Premiums, Deductibles, and Coinsurance for 2023
    • CMS Issues Template for SPAs to Cover Health Home Services for Medically Complex Kids
    • HHS to Offer Replacements for Doses of Covid-19 Antibody Treatment Provided to the Uninsured and Underinsured
    • CMS Releases New Nursing Home Ownership Information
    • HHS OIG Issues Report on FDA Accelerated Approval Program
  • Other Updates
    • CBO Publishes Report on Policy Approaches to Reduce Commercial Hospital and Physician Prices
    • GAO Issues Recommendations on Strengthening Medicare Telehealth Oversight
    • District Court Judge Rules that HHS Must Restore 340B Payments in 2022
    • CDC Preliminary 2021 Suicide Statistics Show First Increase in 2 Years
    • Harvard Study Quantifies Flooding Risk to Hospitals from Hurricanes
    • Judge Rules Anti-Poaching Lawsuit Can Move Forward
  • New York State Updates
    • Governor Hochul Extends Disaster Emergencies Due to Health Care Staffing Shortages and the Monkeypox Virus
    • NYS State Plan Amendment Approval Updates
    • DOH Announces Continuation of 25% Rate Adjustment for HCBS and CFTSS
    • OMH Adopts Updated Telehealth Regulations
    • DOH Issues Proposed Rule to Implement Enhanced Adult PDN Reimbursement
    • DOH Issues Public Notice Regarding Children’s 1915(c) Consolidated Waiver Proposed Amendment
  • Funding Opportunities
    • OMH Releases One-Time Grants for Children’s Practitioners Providing or Receiving Certification for Evidence-Based Practices
    • DOH Releases RFA for Comprehensive Adolescent Pregnancy Prevention
    • HCR Releases Fall 2022 Multifamily Programs RFP

Administration Updates

White House Announces Initiative on Hunger, Nutrition, and Health
On September 28th, President Biden hosted a White House Conference on Hunger, Nutrition, and Health, laying out a goal for ending hunger and reducing diet-related disease by 2030. As part of the initiative, the White House announced the collective commitment by 64 public and private organizations of $8 billion for efforts across the five pillars of the Administration’s National Strategy, which are: 

  • Improving food access and affordability;
  • Integrating nutrition and health;
  • Empowering consumers to make and have access to healthy choices;
  • Supporting physical activity for all; and
  • Enhancing nutrition and food security research.

Specific health-related initiatives include various programs in the “food is medicine” movement, such as those that offer medically tailored meals, nutritional counseling and dietary assessments, and food vouchers through partnerships between health providers and community-based organizations. It also includes nutritional training for medical professionals through various professional organizations.
 
A fact sheet on these commitments is available here. The conference website, which includes the National Strategy document, is here.

Legislative Update

Congress Passes and Biden Signs Continuing Resolution
On September 29th, the Senate voted 72-25 to pass a stopgap continuing resolution (CR) funding bill, the “Continuing Appropriations and Ukraine Supplemental Appropriations Act of 2023,” to fund the government through December 16th. On September 30th, House lawmakers passed the bill 230-201 and President Biden signed it.  The bill extends current federal funding levels for health care programs, as well as extending various expiring programs through the CR expiration date, including: 

  • The federal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program under the Health Resources and Services Administration (HRSA);
  • The Medicare-Dependent Hospital Program; and
  • The Enhanced Low-Volume Adjustment Program.

The bill also reauthorizes the Food and Drug Administration (FDA) user fee program and provides emergency funding for Ukraine and disaster assistance. This is expected to be the last vote in either chamber until after the November midterm elections.
 
A summary of the bill is available here.
 
Congress Passes MOBILE Health Care Act
On September 29th, the House passed the Maximizing Outcomes through Better Investments in Lifesaving Equipment for Health Care Act, or the MOBILE Health Care Act (S. 958) by a vote of 414-7. The bill had earlier passed the Senate by unanimous consent and will now go to President Biden for his signature.
 
The bill allows HRSA to award Section 330 operating grants to existing federally qualified health centers (FQHCs) under the New Access Point program to establish new delivery sites that are mobile-only (not associated with an additional permanent full-time site). This would only apply to FQHCs who already receive grants and therefore operate an existing full-time site. This ability would begin January 1, 2024.

Federal Agencies

CMS Announces Medicare Premiums, Deductibles, and Coinsurance for 2023
On September 27th, the Center for Medicare and Medicaid Services (CMS) released 2023 premium, deductible, and coinsurance amounts for Medicare Parts A and B. The standard monthly premium for Medicare Part B enrollees will be $164.90, a decrease of $5.20 from 2022. The annual deductible for all Medicare Part B beneficiaries will be $226 in 2023, a $7 reduction from 2022. CMS attributes the reduction to lower-than-projected spending on the Alzheimer’s drug Aduhelm, as well as other Part B items and services.
 
The Medicare Part A inpatient hospital deductible will be $1600 in 2023, an increase of $44 over 2022. Beneficiaries will also have to pay a $400 coinsurance amount for the 61st through 90th days of hospitalization in a benefit period. Beneficiaries in skilled nursing facilities will be required to pay coinsurance of $200 per day for days 21 through 100 of extended care services in the benefit period.
 
On September 29th, CMS announced that Medicare Advantage and Medicare Part D prescription drug plan premiums would also be lower for 2023, as compared to 2022. The projected average premium for 2023 Medicare Advantage plans is $18 per month, a roughly 8% drop from the 2022 average premium of $19.52. The average basic monthly premium for standard Part D coverage is projected to be $31.50 compared to $32.08 in 2022.
 
Medicare open enrollment will begin on October 15th and run through December 7th. The announcement for Medicare Parts A and B is available here; the announcement for Medicare Advantage and Part D is available here.
 
CMS Issues Template for SPAs to Cover Health Home Services for Medically Complex Kids
On September 26th, CMS released a State Plan Amendment (SPA) template and implementation guide for the Medicaid option to cover Health Home services for Medicaid-eligible children with medically complex conditions. This new option was passed into law in 2019 as part of a package of Medicaid reforms and was also known as the Advancing Care for Exceptional Kids (ACE Kids) Act.
 
Like the existing Section 2703 Medicaid Health Home option under the Affordable Care Act (ACA), Health Homes operating under the ACE Kids provision will provide the six core Health Home services, based around comprehensive care management. However, ACE Kids Health Homes must limit enrollment to medically complex children, defined as children “with one or more chronic conditions that cumulatively affect three or more organ systems and severely reduces cognitive or physical functioning” or “one life-limiting illness or rare pediatric disease.” States may apply for planning grants for the purposes of developing a State Plan Amendment (SPA) for an ACE Kids Health Home, which may now be awarded (starting October 1st).
 
States will be eligible for a 15 percentage point increase in their Federal Medical Assistance Percentage (FMAP) to a maximum of 90 percent for their expenditures on ACE Kids Health Home services during the first two fiscal year quarters that their SPA is in effect, whereas existing ACA Health Homes receive a flat 90 percent FMAP for eight quarters.
 
CMS’s August guidance on this program is available here. The template, as well as other technical assistance for states, may be found through the Medicaid and CHIP Program (MACPro) portal. More information is available here.
 
HHS to Offer Replacements for Doses of Covid-19 Antibody Treatment Provided to the Uninsured and Underinsured
On September 23rd, the Department of Health and Human Services (HHS) announced a new effort to help uninsured and underinsured Americans access the Covid-19 monoclonal antibody treatment Bebtelovimab. The drug received FDA emergency use authorization in February and became available to the commercial market on August 17th. Under the new initiative, health care providers who use a commercially-procured dose of the monoclonal treatment on an uninsured or underinsured patient may be eligible to have the dose replaced for free by HHS. Health care providers are expected to use their own established methods for determining whether a patient is uninsured or underinsured. Doses for this purpose are expected to be available through September 2023. Bebtelovimab is intended to reduce hospitalization and death among Covid-positive patients at high risk for progression to severe Covid-19 and for whom alternative treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
 
More information is available here.
 
CMS Releases New Nursing Home Ownership Information
On September 26th, CMS released additional data on the ownership of Medicare-certified nursing homes. The release will allow the identification of common owners of nursing homes across nursing home locations, and linked with other data, will allow the identification of performance of facilities under common ownership. CMS hopes this information will provide more transparency for licensing officials, state and federal law enforcement, researchers, and the public. In April, CMS released information on mergers, acquisitions, consolidations, and changes of ownership from 2016 through 2022 for hospitals and nursing homes enrolled in Medicare. The new data includes ownership information for approximately 15,000 nursing homes certified as Medicare Skilled Nursing Facilities (SNFs).
 
The new data is available here.
 
HHS OIG Issues Report on FDA Accelerated Approval Program
On September 29th, the HHS Office of the Inspector General (OIG) issued a report on its investigation into the FDA’s accelerated approval pathway. This approval pathway allows FDA to approve drugs that treat certain serious or life threatening diseases and offer meaningful benefit over existing treatments before confirmatory trials are complete. However, the FDA may require drug sponsors to conduct such confirmatory trials after approval to verify that the drug does provide the predicted benefit. OIG announced the investigation in the wake of the FDA’s controversial approval of the Alzheimer’s drug Aduhelm in 2021.
 
OIG found that since the accelerated approval pathway debuted in 1992, the FDA has approved 278 drugs using the accelerated pathway, and 104 of these have incomplete confirmatory trials. Between 2018 and 2021, Medicare and Medicaid spent more than $18 billion for drugs with incomplete trials that have passed their completion date. In addition, since 1992, 13% of accelerated approval drug applications have been withdrawn, and half of these withdrawals have occurred since January 2021.
 
The OIG report is available here.

Other Updates

CBO Publishes Report on Policy Approaches to Reduce Commercial Hospital and Physician Prices
On September 29th, the Congressional Budget Office (CBO) published a report describing potential federal legislative options to address the high prices commercial insurers pay for hospital and physician services. CBO identifies three general approaches: 

  • Promoting price transparency, which CBO expects could result in “very small price reductions” of under 1 percent within the 10-year projection window;
  • Promoting competition among providers, which CBO expects could result in “small price reductions” of between 1 and 3 percent; and
  • Capping the level or growth rate of prices, which CBO expects could result in a “moderate or large” effect of 3 percent or more.

CBO notes that it did not examine approaches that do not target price levels, such as global budgets for hospitals or the adoption of alternative payment models.
 
GAO Issues Recommendations on Strengthening Medicare Telehealth Oversight
On September 26th, the Government Accountability Office (GAO) issued a study on Medicare telehealth services and recommended actions for CMS to strengthen their oversight. GAO recommended the following changes: 

  • CMS currently lacks complete data on the use of audio-only technology and should develop a billing modifier or other method to fully track such visits.
  • CMS should require the use of site of service codes to allow them to fully track telehealth visits furnished in beneficiaries’ home.
  • CMS should perform a comprehensive assessment of the quality of telehealth services, which it currently has no plans to do.
  • The HHS Office of Civil Rights (OCR) should provide additional guidance to help providers explain potential risks related to privacy and security when using video platforms to provide telehealth services.

The full report is available here.
 
District Court Judge Rules that HHS Must Restore 340B Payments in 2022
On September 30th, U.S. District Court Judge for the District of Columbia Rudolph Contreras ruled that HHS must restore 340B drug payments to hospitals for the remainder of the calendar year. The ruling comes after the Supreme Court unanimously decided in June that HHS’s 2018 policy which lowered the reimbursement for drugs provided under the 340B program from 6% above the average sales price to 22.5% below the average sales price was unlawful because the department did not first survey hospitals’ acquisition costs. The plaintiffs in the current case before the district court, the American Hospital Association, America’s Essential Hospitals, and the Association of American Medical Colleges, argued that CMS should immediately restore 340B payments for the current calendar year while it sorts out how to make hospitals whole for payment reductions experienced in prior years.
 
Judge Contreras’ opinion is available here.
 
CDC Preliminary 2021 Suicide Statistics Show First Increase in 2 Years
On September 30th, the Centers for Disease Control and Prevention (CDC) released provisional numbers and rates of suicide for 2021. Though the data are preliminary, CDC does not anticipate material changes when they are finalized. The data indicate a 4% rise in deaths by suicide in 2021, the first increase in 2 years. The 2021 increase nearly erases the 5% decrease in suicides observed from 2018-2020 and puts the suicide rate near its all-time high in 2018. The largest rate increase (8%) occurred men aged 15-24, and significantly more men than women died by suicide in 2021 (38,025 vs 9,621).
 
The suicide data is available in CDC’s Vital Statistics Rapid Release No. 24, available here.
 
Harvard Study Quantifies Flooding Risk to Hospitals from Hurricanes
On September 29th, the Harvard T.H. Chan School of Public Health released a study investigating the flooding risk to hospitals along the Atlantic and Gulf Coasts from Category 1-4 storms. The study finds that even relatively weak storms pose a serious flooding risk and that expected sea level rise due to climate change in this century will increase flooding risk by 22%. Notably, researchers found that in the New York-Newark-Jersey City metro area, a Category 2 hurricane would put 25 (19.5%) of the region’s 128 hospitals at risk of flooding, jeopardizing access to nearly 19% of beds in the metro area.
 
The study is available here and a press release may be found here.
 
Judge Rules Anti-Poaching Lawsuit Can Move Forward
On September 26th, U.S. District Judge for the Northern District Court of Illinois, Andrea Wood, ruled that a class action lawsuit against DaVita, Tenet Healthcare, and affiliates of UnitedHealth Group may move forward. The lawsuit claims that the companies conspired in an agreement to not hire each other’s senior employees, a violation of the Sherman Act creating an unreasonable restraint of trade. Judge Wood did grant UnitedHealth Group’s motion to dismiss claims against it, agreeing that the company should not be held liable for actions by its subsidiary, Surgical Care Affiliates.

New York State Updates

Governor Hochul Extends Disaster Emergencies Due to Health Care Staffing Shortages and the Monkeypox Virus
On September 27th, Governor Hochul issued Executive Order 4.13, which extends through October 27th the provisions in Executive Order 4 and its successors that reinstate many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. However, certain provisions of the Order have expired, including those related to prior authorization and nursing home staffing and revenue requirements.
 
Governor Hochul also issued Executive Order 20.2, which extends through October 27ththe statewide disaster emergency due to the ongoing spread of the monkeypox virus. The Order also: 

  • Allows authorized pharmacists to administer monkeypox vaccinations pursuant to a patient specific order; and
  • Allows physicians and certified nurse practitioners to issue patient specific orders to licensed pharmacists for administration of monkeypox vaccinations.

Executive Order 4.13 is available here and Executive Order 20.2 is available here. SPG has updated its Covid-19 regulatory waiver tracker accordingly, available here.
 
NYS State Plan Amendment Approval Updates
New York State (NYS) has recently received approval from the Centers for Medicare and Medicaid Services (CMS) for the following State Plan Amendments (SPAs) 

  • SPA 22-0072 adjusts rates statewide to reflect a 5.4% Cost of Living Adjustment (COLA) for Health Home Plus and to implement an across-the-board rate increase of 1% for Health Homes serving adults and children. Rates subject to the 5.4% COLA will not be eligible for the 1% increase (approved 9/16/2022).
  • SPA 22-0073 adjusts rates statewide to reflect a 5.4% COLA for Care Coordination Organizations/Health Homes (CCOs/HHs) for individuals with intellectual and developmental disabilities (approved 9/16/2022).
  • SPA 22-0043 allows Licensed Clinical Social Workers (LCSWs) to bill Medicaid directly for services provided within their scope of practice (approved 9/23/2022).
  • SPA 22-0045 allows Licensed Mental Health Counselors (LMHCs) and Licensed Marriage and Family Therapists (LMFTs) to bill Medicaid directly for services provided within their scope of practice (approved 9/23/2022).
  • SPA 22-0044 increases Medicaid reimbursement for the assessment and delivery of Applied Behavior Analysis (ABA) services from $29 per hour to $76.31 per hour (approved 9/23/2022).

DOH Announces Continuation of 25% Rate Adjustment for HCBS and CFTSS
On September 29th, the New York State Department of Health (DOH) announced that the temporary 25% rate adjustment for Children and Family Treatment and Support Services (CFTSS) and Children’s Home and Community Based Services (HCBS) that was previously set to expire on September 30th will continue. Further, CFTSS and HCBS rates will also be adjusted to include the 5.4% Cost of Living Adjustment (COLA), effective April 1, 2022.
 
However, the 29-I Health Facility Core Limited Health Related Services (CLHRS) per diem 25% rate adjustment will end on September 30th. Other Limited Health Related Services (OLHRS) rates will be adjusted by 1%, per the Enacted 2022-23 NYS Budget.
 
The DOH notification is available here. Questions may be submitted to BH.Transition@health.ny.gov.
 
OMH Adopts Updated Telehealth Regulations
On September 28th, the NYS Office of Mental Health (OMH) issued a notice of adoption in the State Register of its expanded telehealth regulations. There were no changes to the final rule compared to the proposed rule. The regulations include the following changes, among others:  

  • Allow for the provision of telephonic (audio-only) services;
  • Allow any authorized provider to deliver mental health services under their scope of practice;
  • Expand the definitions of originating and distant sites;
  • Remove the required in-person initial assessment;
  • Remove additional requirements for Personalized Recovery Oriented Services (PROS) and Assertive Community Treatment (ACT) programs; and
  • Strengthen language around consent and recipient preference.

The adopted rule is available in the State Register here. The proposed regulations are available here and SPG’s summary is available here.
 
DOH Issues Proposed Rule to Implement Enhanced Adult PDN Reimbursement
On September 28th, DOH issued a notice of proposed rulemaking in the State Register that would increase Private Duty Nursing (PDN) fee-for-service reimbursement for services provided to medically fragile adults. The enhanced rate was implemented by the NYS 2022-23 Enacted Budget and will be effective April 1, 2022. The increase will eliminate the disparity between pediatric and adult PDN reimbursement. 
 
The proposed rule is available in the State Register here. Comments may be submitted to regsqna@health.ny.gov through November 27th.
 
DOH Issues Public Notice Regarding Children’s 1915(c) Consolidated Waiver Proposed Amendment
On September 28th, DOH posted a notice in the State Register proposing to amend the 1915(c) Consolidated Children’s waiver to establish and authorize payment for Financial Management Services (FMS) provided to children/youth in the Medicaid fee-for-service delivery system that require any of the following services: 

  • Adaptive and Assistive Technology;
  • Environment Modifications;
  • Vehicle Modifications; and
  • Transitional Services and Goods & Services (newly proposed services).

The FMS will be provided by designated Lead Health Homes Serving Children under a new 1915(b)(4) waiver. The Children’s waiver will be additionally amended to: 

  • Add transitional care coordination services;
  • Add enhanced respite services by adding a medical component;
  • Update vehicle modifications provisions;
  • Update rates for new respite group sizes and planned respite changes to align with the HCBS Settings Final Rule requirements;
  • Update rate reimbursement methodology, including allowances for rural rates;
  • Expand palliative care provider qualifications and update definitions; and
  • Update the professional qualifications for HCBS Level of Care Evaluations to include Local Counties of Mental Health Single Points of Access (SPOAs) staff for children/youth being discharged from institutional levels of care.

The public notice is available in the State Register here. Comments may be submitted to HHSC@health.ny.gov.

Funding Opportunities

OMH Releases One-Time Grants for Children’s Practitioners Providing or Receiving Certification for Evidence-Based Practices
On September 27th, OMH released a Request for Applications (RFA) for one-time funding for licensed, designated, or funded programs to support the implementation of evidence-based practices (EBP) for children and families. Through this RFA, OMH will provide $4.2 million in total funding to offset some of the costs to providers that: 

  • Seek EBP qualification;
  • Achieve EBP qualification;
  • Retain EBP-qualified clinicians; 
  • Integrate EBP data tracking within billing procedures; and 
  • Expand the delivery of EBP services.

This funding is made available through supplemental funding allocated by the federal Coronavirus Response and Relief Supplemental Appropriations Act and the American Rescue Plan Act to the Mental Health Block Grant program. OMH will provide one-time grants of $10,000 per eligible practitioner. Each applicant agency is eligible for up to $200,000 in total funding.
 
The RFA is available here and SPG’s summary of the opportunity is available here. Applications are due on December 30th. Applications will be reviewed in the order received and funding will be distributed on a first come, first serve basis until funds are exhausted.
 
DOH Releases RFA for Comprehensive Adolescent Pregnancy Prevention
On September 29th, DOH released an RFA for funding to support providers of services for prevention of adolescent pregnancy, sexually transmitted infections, and HIV. Through this opportunity, DOH will award $19.7 million in total annual funding to awardees that will be responsible for the following: 

  • Programmatic Component 1: Comprehensive adolescent health education that ensures access to reproductive health care and family planning services; and
  • Programmatic Component 2: Youth-led, multi-dimensional (educational, social, vocational, economic, and recreational) opportunities for adolescents to provide alternatives to sexual activity.

Individual annual awards for the first component will range from $250,000-$550,000, and applicants may apply for up to $80,000 in funding for the second component. Contracts will last for five years, starting on July 1, 2023.
 
Eligible applicants are youth-serving not-for-profit 501(c)(3) organizations, including but not limited to Article 28 health care providers and community-based health and human services providers. Applicants not approved under Article 28 of the NYS Public Health Law to provide family planning services must submit a Letter of Referral Arrangement with one or more family planning providers outlining their intent to collaborate.
 
The RFA is available here. Applications are due on November 29th. Letters of Interest are encouraged, but not required, and may be submitted to capprfa@health.ny.gov by October 13th.
 
HCR Releases Fall 2022 Multifamily Programs RFP
On September 29th, NYS Homes and Community Renewal (HCR) released a Request for Proposals (RFP) that consolidates the availability of funding for the HCR Multifamily Programs. These programs support affordable rental housing for low-to-moderate income individuals and families as part of the State’s five-year plan to combat homelessness and advance the construction and preservation of affordable housing. Awards include 9% Low-Income Housing Tax Credits and subsidy financing to sponsors proposing affordable and supportive multifamily housing projects. Projects may include new construction, rehabilitation, and/or adaptive reuse of site-specific projects that provide multifamily rental housing. Funding is not available for projects proposing to use tax-exempt bond financing.
 
The full RFP is available here. Additional information, including maximum award amounts for each program, is available in each program’s term sheet (accessible here). Applications are due on December 6th.

All applicants are required to request and participate in a TA session prior to application submission. The deadline to request a TA session is November 8th. Additional information on the TA process and the TA request form is available here. Questions may be submitted to 9%RFP@hcr.ny.gov.