Weekly Health Care Policy Update – February 16, 2024

February 23, 2024

In this update: 

  • Federal Agencies
    • CMS Publishes AHEAD Policy Documents on Global Budgets and Model Overlaps
    • HHS Finalizes Revisions to SUD Privacy Rules to Align with HIPAA
    • CMS Issues Accrediting Organization Proposed Rule
    • HHS Expands TEFCA by Adding Two Additional QHINs
    • AHRQ Opens Nominations for U.S. Preventive Services Task Force
    • FTC and HHS Issue RFI on Pharmaceutical Competition
  • Other Updates
    • Judge Dismisses PhRMA’s Price Negotiation Lawsuit
    • CDC Publishes Report on Living Alone and Depression
  • New York State Updates
    • DOH Proposes New SHIN-NY Statewide Data Infrastructure and Common Participation Agreement
    • Governor Hochul Releases FY 2024-25 Executive Budget 30-Day Amendments

Federal Agencies

CMS Publishes AHEAD Policy Documents on Global Budgets and Model Overlaps
On February 14th, the Centers for Medicare and Medicaid Services (CMS) published new policy documents on the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) model covering the model’s hospital global budget methodology and its policy on overlaps with other CMS Innovation Center (CMMI) models. The global budget methodology provides details of example budget calculations and lays out how certain specialty hospital types, like Critical Access Hospitals (CAHs), will be treated under AHEAD. The documents were released alongside a CMMI webinar on the methodology.

The global budget methodology document is here. The document on model overlaps is available here.

HHS Finalizes Revisions to SUD Privacy Rules to Align with HIPAA
On February 8th, the Department of Health and Human Services (HHS) announced it was finalizing a rule to modify regulations on the confidentiality of medical records for patients with substance use disorders (SUD), also known as 42 CFR Part 2 or simply Part 2. As directed by Congress in the CARES Act of 2020, the rule is intended to align SUD patient confidentiality with standard HIPAA protections. Currently, Part 2 requires, among other things, a patient’s written consent before every downstream disclosure of information.

HHS originally proposed these modifications in December 2022. In general, the rule will: 

  • Permit the use and disclosure of Part 2 records based on a single patient consent, given once, for all future treatment, payment, and health care operations (TPO), unless and until revoked by the patient;
  • Permit the redisclosure of Part 2 records in manners permitted by the HIPAA Privacy Rule, such as emergencies, public health surveillance, and scientific research, with certain exceptions, in particular for proceedings against the patient;
  • Create new patient rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, matching those available under the HIPAA Privacy Rule;
  • Expand prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings;
  • Provide new HHS enforcement authority, including the imposition of civil monetary penalties for violations of Part 2;
  • Align Part 2 requirements to notify HHS and affected patients of breaches with HIPAA; and
  • Update the requirements for the HIPAA-required Notice of Privacy Practices that practices must provide to patients in order to address rights related to Part 2. In particular, HHS clarifies that a single disclosure may cover both Part 2 and HIPAA.

In general, HHS finalized the rule as proposed, with limited and technical modifications and clarifications. Some notable changes include: 

  • Creating an option for a person to file a complaint with HHS for a violation of Part 2, aligned with the similar HIPAA process;
  • Fully aligning the definition of de-identification of records with HIPAA;
  • Increasing the standard for “reasonable diligence” which permits a safe harbor for investigative entities who unknowingly receive or use Part 2 records without a court order; and
  • Expressly excluding family, friends, and other informal caregivers from requirements to develop formal policies and procedures.

The final rule was published in the Federal Register today (February 16th) and will go into effect on April 16th, with a grace period for compliance of 24 months after publication (i.e., until February 2026). The text of the rule is available here.

CMS Issues Accrediting Organization Proposed Rule 
On February 8th, CMS issued a proposed rule to strengthen oversight of accrediting organizations (AOs). CMS-approved AOs are responsible for surveying the more than 9,000 accredited providers and suppliers that participate in the Medicare and Medicaid programs on a range of health and safety metrics. Providers who are accredited by an AO are thereby found to meet applicable participation requirements. In this rule, CMS intends to address several concerns about the current AO process, including: 

  • Providers who have been terminated Medicare or Medicaid but remain accredited;
  • Potential conflicts of interest for AOs who also provide fee-based consulting services to providers; and
  • Inconsistent survey results due to varying practices among different AOs, such as notifying facilities in advance of onsite surveys.

The proposed rule would align with CMS’s National Quality Strategy by holding AOs accountable to the same set of standards as the State Survey Agencies (SAs) that perform compliance assessments for Medicare-participating nursing homes.

The announcement is available here.

HHS Expands TEFCA by Adding Two Additional QHINs
On February 12th, HHS announced that two additional organizations–CommonWell Health Alliance and Kno2—joined the Trusted Exchange Framework and Common Agreement (TEFCA) as Qualified Health Information Networks (QHINs). These two organizations join the five other QHINs first announced at the end of last year, as covered by SPG in its December 15, 2023 update here.

The seven QHINs are critical to fulfilling the goals of TEFCA, which include establishing a blueprint of nationwide interoperability, increasing patient access to their health information, and simplifying connectivity for health care entities.

The announcement is available here.

AHRQ Opens Nominations for U.S. Preventive Services Task Force 
On February 14th, the Agency for Healthcare Research and Quality announced that it is soliciting nominations for the U.S. Preventive Services Task Force (USPSTF). The USPSTF is an independent panel of experts in evidence-based medicine and prevention efforts, tasked with making clinically-effective recommendations regarding preventive services (including screening tests, counseling services, and preventive medicine) and general health promotion. The USPSTF is currently the subject of a lawsuit, Braidwood Management vs. Becerra, in the Fifth Circuit, challenging its ability to mandate coverage of preventive services under the Affordable Care Act (ACA).

Interested individuals can self-nominate or be nominated by a larger organization to serve a four-year term. Nominations must be submitted by March 15th to be considered for the January 2025 start date. The nomination overview is available here.

FTC and HHS Issue RFI on Pharmaceutical Competition
On February 14th, HHS and the Federal Trade Commission (FTC) issued a Request for Information (RFI) on the market concentration and contracting practices of drug wholesalers and group purchasing organizations (GPOs). In light of pervasive generic drug shortages in recent years, the agencies are interested in examining the role that wholesalers and GPOs play in this market. This RFI is part of the Biden Administration’s ongoing initiative to limit anticompetitive practices in health care.

Public comments are due by April 14th. The RFI is available here.

Other Updates

Judge Dismisses PhRMA’s Price Negotiation Lawsuit
On February 12th, a federal district judge in Texas dismissed a pending lawsuit challenging Medicare’s new drug pricing power, per the Biden Administration’s request. The suit, brought by the Pharmaceutical Research and Manufacturers of America (PhRMA), argued that the Medicare negotiation program is unconstitutional and violates due process for the manufacturers involved. Although this represents one victory for the Biden Administration, there are currently eight other lawsuits on the same topic that are still ongoing.
 
CDC Publishes Report on Living Alone and Depression
On February 15th, the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics published a new report on living alone and feelings of depression among American adults. The researchers estimated self-reported feelings of depression among adults while considering whether they lived alone or with others. Overall, 16% of American adults lived alone in 2021, reporting higher rates of feelings of depression (6.4%) compared to those living with others (4.1%).
 
The report is available here.

New York State Updates

DOH Proposes New SHIN-NY Statewide Data Infrastructure and Common Participation Agreement
On February 14th, the New York State (NYS) Department of Health (DOH) issued proposed regulations that aim to enhance the functions and capabilities of the Statewide Health Information Network for New York (SHIN-NY). The regulations seek to: 

  • Create new statewide data infrastructure to improve interoperability;
  • Establish a single, statewide common participation agreement governing data exchange; and
  • Enable health care facilities that are required to connect to the SHIN-NY to do so directly, rather than through a Regional Health Information Organization (RHIO), also known as a Qualified Entity (QE).

Statewide Data Reporting Infrastructure
The proposed rule would expand the capabilities of the SHIN-NY to include the following functions: 

  • A single data matching process for patient demographic information submitted by SHIN-NY participants;
  • A statewide provider directory to serve as a standardized resource for resolving provider and facility identities;
  • A single, statewide patient consent management system, with network-wide policies that must be honored and implemented by all RGIOs; and
  • A secure, statewide repository to store all data from SHIN-NY participants.

Common Participation Agreement
Under the proposed rules, DOH would create a single, statewide participation agreement for entities connecting to the statewide data infrastructure. Each QE would be required to use this statewide agreement. Entities would be required to be in compliance with HIPAA and other federal regulations, including the use of a Business Associate Agreement (BAA) or Part 2 Qualified Service Organization status, as applicable. Under the agreement, QEs would be required to facilitate access to “all of a patient’s information by all persons or entities authorized to access information in the SHIN-NY”, subject to patient consent. The common participation agreement would eliminate the current variation in the terms and conditions established by different QEs.

Direct Connection to the SHIN-NY
Under the rule, health care entities would have the option to participate in SHIN-NY data exchange and reporting directly, without contracting with a QE. Currently, all entities under Section 18(1)(c) of the Public Health Law are required to establish a connection to the SHIN-NY through a QE. This includes: 

  • Article 28 hospitals and nursing homes;
  • Article 36 home care agencies;
  • Article 40 hospices;
  • Article 44 health maintenance organizations (HMOs); and
  • Article 47 shared health facilities.

DOH would be permitted to waive the QE requirement for facilities that demonstrate their own capacity to provide secure bi-directional access and that sign the common participation agreement.

DOH argues that this rule will allow for improved reporting and analytics to support statewide public health surveillance and Medicaid initiatives, including those part of the new New York Health Equity Reform (NYHER) 1115 Demonstration Waiver.

The proposed regulations are available here. Comments may be submitted to regsqna@health.ny.gov through April 15th.

Governor Hochul Releases FY 2024-25 Executive Budget 30-Day Amendments
On February 15th, Governor Hochul released 30-Say Amendments to her Fiscal Year (FY) 2024-25 Executive Budget proposal. Changes to the Health and Mental Hygiene (HMH) bill language include, but are not limited to: 

  • Requiring that pregnant and postpartum individuals give informed consent prior to testing for alcohol, cannabis, or other drugs;
  • Clarifying that hospitals applying for the Health Care Safety Net Transformation funding must apply in conjunction with at least one partner organization;
  • Making several clarifications and additions to Emergency Medical Services (EMS) and Hospital at Home provisions;
  • Providing DOH with additional contracting flexibilities for the Medicaid 1115 waiver;
  • Establishing a process for Medicaid managed care plans to discontinue services following the State’s Request for Proposal (RFP) process, if applicable (e.g., the plan does not complete proposal or is not awarded);
  • Requiring consumer self-direction in the Consumer Directed Personal Assistance Program (CDPAP);
  • Eliminating conflicts of interest between CDPAP Fiscal Intermediaries (FIs), Licensed Home Care Service Agencies (LHCSAs), and Managed Long Term Care (MLTC) plans; and
  • Repealing the FI RFP and replacing it with an FI authorization process, which would require FIs to be authorized by DOH by January 1, 2025. FIs that are operating prior to January 1, 2024 may continue to provide services without authorization “until such time as the commissioner determines that the continued provision of services through unauthorized fiscal intermediaries is no longer necessary to ensure access to services.”

The Amendments are available here. The updated financial plan is available here.