Health Law Advisor

In recent years, the Centers for Medicare & Medicaid Services (CMS) has approved demonstrations under Section 1115 of the Social Security Act, providing federal matching funds for state expenditures for Designated State Health Programs (DSHP) and Designated State Investment Programs (DSIP) that advance the Medicaid program.

But on April 10, CMS published a State Medicaid Director Letter stating CMS “does not anticipate approving new state proposals of section 1115 demonstration expenditure authority for federal DSHP or DSIP funding or renewing existing Section 1115 demonstration expenditure authority for federal DSHP or DSIP funding, including when current DSHP or DSIP authority concludes before the expiration date of the demonstration.”

The reasoning? CMS has concluded that these programs were funded entirely without Medicaid funds prior to their approval, and the additional federal funds that they received “does not render these programs as integral components of section 1115 demonstration programs.” CMS now frowns on the notion that the federal government should: (i) share in the costs of funding these state programs; (ii) reduce state obligations with respect to services that CMS deems not otherwise covered by Medicaid; (iii) and “[serve] primarily as a financing mechanism for states, resulting in increased federal expenditures.”

Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments” (the “CY 2025 PFS Proposed Rule”).

While it’s not easy to reach the end of the title, let alone the 1053-page rule, False Claims Act (FCA) attorneys should note with interest that last topic—Medicare overpayments. As the CY 2025 PFS Proposed Rule would, if finalized, change Medicare regulations regarding requirements for reporting and returning Parts A and B overpayments, stakeholders and their counsel need to understand their obligations.

On January 9, 2024, the Center for Medicare and Medicaid Services (CMS) sent a letter to New York’s Medicaid director approving New York’s Section 1115 Waiver amendment, which the state submitted for approval on September 2, 2022. During the term of the amendment (January 9, 2024 through March 31, 2027), New York aims to fundamentally reform the way health care services are delivered through its Medicaid program by:   

1. Investing in Health Related Social Needs (HRSN) via providers working with Social Care Networks (SCNs) which in turn contract with existing Medicaid managed care ...

In two recent memoranda, the Centers for Medicare and Medicaid Services (CMS) made changes to previously issued survey guidance related to COVID-19 vaccination issues.

On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.

On March 9, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) and the Center for Medicare and Medicaid Services (“CMS”) published their long-awaited final rules that seeks to promote interoperability. Market participants waited longer than usual for this rule due to the Department of Health and Human Services (“HHS”) extending the comment period at the request of a variety of stakeholders.

The ONC’s rule (the “Final Rule”) supports interoperability by prohibiting “information blocking”.  Affected organizations (see below) will want to be considering the impact on contracts and developing compliance policies that reflect the requirements of the Final Rule. One aspect of needed compliance relates to the Final Rule’s exceptions to information blocking including a newly-added “content and manner” exception.

Generally, information blocking is defined as an action by an actor interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information[1]  (“EHI”). Actors include health care providers, health IT developers, health information exchanges, or health information network. In the proposed rule, the ONC proposed seven exceptions to conduct that might otherwise be deemed information blocking. However, in the Final Rule, ONC created eight exceptions. Further, the ONC defined two categories of exceptions: (1) Exceptions that involve not fulfilling requests to access, exchange, or use EHI and (2) Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI. Each of the eight enumerated exceptions are categorized as follows: