Weekly Health Care Policy Update – February 12, 2024

In this update: 

  • Federal Agencies
    • CMS to Host Webinar on Transforming Maternal Health Model on February 28th
    • HRSA Begins Solicitation Process for Multiple OPTN Contracts
    • HHS OCR and Montefiore Reach Settlement to Resolve HIPAA Case
    • HHS ACL Issues Final Rule Updating Older Americans Act
    • CDC Updates Recommendations for Syphilis Testing
  • Other Updates
    • Census Bureau Dropping Proposal to Change Disability Statistics
    • WHO Releases Report on Global Cancer Burden
    • Study Finds that Health-Based Housing Program Reduced Outpatient Visits
    • AHA Outlines 2024 Priorities
  • New York State Updates
    • DFS Issues Proposed New Market Conduct Regulations for PBMs; Seeks Public Input on PBM Practices
    • DOH Releases Seventh Monthly Edition of the State’s Public Health Emergency Unwind Dashboard
    • OASAS Adopts Regulations for New CASAC-Provisional Credential

Federal Agencies

CMS to Host Webinar on Transforming Maternal Health Model on February 28th
On February 28th at 1pm ET, the Centers for Medicare & Medicaid Services (CMS) will host a webinar on the Transforming Maternal Health (TMaH) Model. TMaH is a 10-year program in which CMS will partner with State Medicaid agencies to implement whole-person approaches to maternal care in their Medicaid programs. This may include increased access to midwives, freestanding birth centers, and doula services, as well as helping health systems achieve CMS’s new “Birthing-Friendly” designation for hospitals.

Through more personalized care and increased access to maternal care providers, CMS hopes to lower instances of severe maternal morbidity in participating states. Each participating State Medicaid agency will be eligible for up to $17 million in funding during the model’s 10-year period. CMS encourages maternity care providers, managed care plans, and other interested parties to attend the webinar.

Registration is available here.

HRSA Begins Solicitation Process for Multiple OPTN Contracts
On February 6th, the Health Resources and Services Administration (HRSA) announced new actions as part of the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. Leveraging new authorities signed into law in September 2022, HRSA will issue request for proposals (RFPs) for multiple vendor contracts, breaking up the decades-long sole contracting arrangement with the United Network for Organ Sharing (UNOS). Additional actions include a new discovery and development phase for OPTN matching systems and new data reporting requirements for pre-waitlist practices.

HRSA is also separating the Board of Directors and issuing a solicitation for a non-profit with experience in the procurement and transplantation process to support this new OPTN Board. Responsibilities for this non-profit include establishing a nominating committee, conducting a special election, soliciting recommendations on by-law modernization, and supporting the new Board’s managerial responsibilities.

The announcement is available here.

HHS OCR and Montefiore Reach Settlement to Resolve HIPAA Case
On February 6th, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced a settlement with Montefiore Medical Center over potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. In 2015, an internal investigation at Montefiore found that one of their employees stole protected electronic health information of over 12,000 patients, selling the information to an identity theft ring. OCR noted that the case showed the importance of attending to “cyber-attacks from malicious insiders.”

Under the settlement, Montefiore agreed to pay OCR $4.75 million and implement a corrective action plan, and OCR will monitor Montefiore for two years to ensure compliance.

The announcement is available here.

HHS ACL Issues Final Rule Updating Older Americans Act 
On February 6th, the HHS Administration for Community Living (ACL) issued a final rule to update regulations for implementing programs authorized by the Older Americans Act (OAA). The rule is the first substantial update to most programs since 1988 and includes a wide range of technical clarifications and updates, including: 

  • Clarifying the requirements for state and area plans on aging;
  • Improving consistency of definitions among programs;
  • Specifying the broad range of older Americans who are eligible to receive services under the OAA; and
  • Addressing emergency preparedness and response for older adults, including lessons from the Covid-19 pandemic.

The rule will take effect on March 15th, but regulated entities have a grace period until October 1, 2025 to come into compliance with all provisions. The announcement is available here.

CDC Updates Recommendations for Syphilis Testing 
On February 8th, the Centers for Disease Control and Prevention (CDC) issued new recommendations for syphilis testing amidst a surge in cases. These recommendations are the CDC’s first on laboratory testing for syphilis. A recent report from the CDC found that syphilis cases are currently the highest since the 1950s, with congenital syphilis up 937% in the past decade. Experts cite a slew of reasons for the spike in cases, including more risky sexual behavior, fewer sexual health clinics, and missed testing due to Covid-19.

The recommendations are available here.


Other Updates

Census Bureau Dropping Proposal to Change Disability Statistics 
On February 6th, the Census Bureau announced that it would not go forward with a set of proposed changes to the American Community Survey. The Bureau had proposed a new set of more detailed questions regarding participants’ difficulties with functional abilities like hearing, seeing, and walking. It also proposed to use the international standard cutoff for disability, which would not include people reporting “some difficulty.”

Testing within the Bureau found that making these changes could lower the measured disability rate by as much as 40%, leading to a break in the data series and potential downstream issues such as changes in program eligibility and services. Many disability advocates had objected to the changes during the public comment period.

The announcement is available here.

WHO Releases Report on Global Cancer Burden
On February 1st, the International Agency for Research on Cancer (IARC) within the World Health Organization (WHO) released new estimates on the global cancer burden. With data from 115 countries, the IARC found that most countries do not sufficiently prioritize cancer and palliative care services. When considering core health services available to all citizens, only 39% of countries covered basic cancer management services. In 2022, there were an estimated 20 million new cancer cases with lung, breast, and colorectal cancers among the most prevalent cancers. Lung cancer was the leading cause of cancer deaths. Researchers found that about 1 in 5 people develop cancer in their lifetimes, projecting a 77% increase in incidence by 2050. 

The announcement is available here.

Study Finds that Health-Based Housing Program Reduced Outpatient Visits
On February 5thHealth Affairs published a new study from researchers at Harvard and Brigham and Women’s Hospital on the effects of a primary care-based housing intervention program. The study sought to examine interventions addressing housing-related needs that went beyond homelessness.

In the program, Brigham Health instituted screening for housing needs at 15 primary care clinics and created a social care team to address any discovered health-related social needs (HRSNs). About 20 percent of patients screened positive for homelessness or unstable housing. As a result, Brigham hired two housing advocates, who supported more than 1,000 patients over the study’s 2.5-year evaluation period. The advocates assisted patients with shelter placement, landlord negotiation, and other housing support services.

The study found that patients enrolled in the housing program had fewer primary care and outpatient visits per year compared to those not enrolled. For patients who obtained new housing through program support, many reported mental and physical health benefits.

The article is available here.

AHA Outlines 2024 Priorities
On February 1st, the American Hospital Association (AHA) released its 2024 Advocacy Agenda, outlining its priorities for the year. Pressing policy priorities for AHA include: 

  • Advocating against site-neutral payment and site-of-service policies;
  • Protecting the 340B Drug Pricing Program;
  • Supporting the CMS Hospital at Home program;
  • Eliminating proposed patient to provider staffing ratios in certain settings; and
  • Extending rural hospital programs.

More generally, the AHA will also advocate for more funding for public insurers, federal protections for violence against health care workers, mitigating physician and nursing shortages, telehealth services, protecting non-profit hospital tax-exempt status, and managing artificial intelligence (AI) and cyber safety. 

The announcement is available here


New York State Updates

DFS Issues Proposed New Market Conduct Regulations for PBMs; Seeks Public Input on PBM Practices
On February 6th, the New York State (NYS) Department of Financial Services (DFS) issued new proposed regulations for Pharmacy Benefit Managers (PBMs). DFS proposed an initial set of PBM market conduct rules in August 2023; however, DFS withdrew these regulations based on stakeholder feedback. The new proposed regulations intend to: 

  • Prohibit PBMs from barring any in-network pharmacies from providing mail order or delivery services, which will increase patients’ access to home delivery from their community pharmacy;
  • Require PBMs to list formularies and pharmacy directories online and prohibit PBMs from punishing a consumer who relies on said information;
  • Require PBMs to post a telephone number and email address for consumer questions, and require PBMs to respond in a reasonable amount of time;
  • Prohibit anti-competitive practices that steer consumers away from their community pharmacy to larger pharmacies affiliated with the PBM;
  • Prohibit PBMs from passing losses onto pharmacies when the PBM mistakenly approved dispensing a drug and then seeks to retroactively deny reimbursement to the pharmacy;
  • Reduce administrative burdens and costs on small pharmacies by allowing them to submit information to and receive information from PBMs electronically; 
  • Prevent the abuse of audits against small pharmacies who are not affiliated with a PBM by requiring PBMs to apply the same audit standards across all in-network pharmacies.

DFS concurrently issued a Request for Information (RFI) seeking public comment, evidence (including written datasets, cost analyses, comparative data, studies, and documented facts), and personal experiences related to PBM conduct in New York State. Specific areas of interest include network adequacy requirements, midyear formulary changes, drug manufacturer rebates, and product list restrictions on pharmacies. The RFI is available here.  

The DFS press release is available here. The proposed regulations are available here. Public comment on the proposed regulations may be submitted to PBMRegs@dfs.ny.gov through February 16th. There will also be a 60-day comment period following publication of the proposed regulations in the State Register.

DOH Releases Seventh Monthly Edition of the State’s Public Health EmergencyUnwind Dashboard
On February 6th, the NYS Department of Health (DOH) released the seventh issue of the State’s Public Health Emergency (PHE) Unwind Dashboard, a monthly enrollment report on the renewal process for New York’s Medicaid, Child Health Plus, and Essential Plan populations. All individuals in these programs will need to renew their eligibility through May 31st.

This seventh issue includes the renewal status, demographics, and program transitions of enrollees who had a December 31, 2023 coverage end date. The report shows that 78 percent of the 764,726 individuals in this cohort have renewed their coverage across the NY State of Health marketplace and Local Departments of Social Services. The report does not include information on former enrollees who found coverage through non-public sources, such as employer-based insurance.

The seventh issue and previous reports may be accessed here. This process will continue each month until each enrollee cohort has had their eligibility redetermined.

OASAS Adopts Regulations for New CASAC-Provisional Credential
On February 7th, the NYS Office of Addiction Services and Supports (OASAS) adopted final regulations that create an additional credential for Credentialed Alcoholism and Substance Abuse Counselors (CASACs). The new credential will be called the CASAC-Provisional (“CASAC-P”) and will allow individuals with a bachelor’s or master’s degree in human services to be hired in OASAS-certified programs with minimum qualifications while they are working towards their credential as a full CASAC. OASAS will also streamline the credentialing process and expedite the process for obtaining a renewal for a credential. OASAS intends for these changes to address the ongoing workforce crisis, specifically the expiration of the “social work exemption” in 2022.

The final regulations are available here. A summary of updates to the regulations is available here.