Summary: California lawmakers have greenlighted emergency loans to support struggling hospitals facing financial challenges across the state. These loans will serve as a critical lifeline, helping eligible hospitals stabilize operations and navigate through turbulent times. Assembly Bill 112, passed by the California Senate and Assembly and expected to be signed by California Governor Gavin Newsom, establishes the Distressed Hospital Loan Program and the Distressed Hospital Loan Program Fund, which are designed to provide interest-free cashflow loans to not-for-profit hospitals, public hospitals in significant financial distress, and governmental entities representing a closed hospital (i.e., a hospital that closed after January 1, 2022). Understanding the qualifications and limitations outlined in the proposed legislation, including loan repayment terms and loan forgiveness options, is crucial for potential hospital participants.…

Continue Reading A Lifeline Amidst Turbulent Times: California Lawmakers Approve Emergency Loans for Struggling Hospitals

The growth of private equity and other financial sponsor investments in the health care industry has led many states across the country to adopt expansive oversight authority over health care transactions. With the enactment of New York State’s budget for the State Fiscal Year 2023-2024, signed into law on May 3, 2023, the movement for more oversight in New York is coming this summer.…

Continue Reading New Notice and Public Disclosure Requirements for Material Health Care Transactions in New York

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions. …

Continue Reading OIG 2022 Advisory Opinions: Year in Review

On April 27, 2023, the state of Washington enacted a landmark privacy law aimed at protecting the privacy of health data not covered by HIPAA. This law, named the “My Health My Data Act,” covers a very wide range of entities, consumers, and data. It also contains a private right of action. Companies should soon begin evaluating the scope of this law and its requirements before it comes into effect March 31, 2024 (for “small businesses,” June 30, 2024).…

Continue Reading Washington State Enacts Landmark Privacy Law Aimed at Digital Health Industry

On April 12, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule updating key regulations pertaining to Programs of All-Inclusive Care for the Elderly (“PACE”) (the “Final Rule”). Overall, these changes, summarized below, will offer significant administrative and operational flexibilities. Except as otherwise noted, the requirements of the Final Rule are effective January 1, 2024.…

Continue Reading CMS Releases CY2024 Final Rule for PACE Organizations

On April 17, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the U.S. Department of Health and Human Services (“HHS”) Notice of Benefit and Payment Parameters for 2024 Final Rule (the “Notice”) that includes standards for issuers and Marketplaces, and requirements for agents, brokers, web-brokers and others. The Notice implements various changes previously proposed by CMS, including (i) requiring provider networks to comply with network adequacy standards and delaying the implementation of appointment wait time standards, (ii) standardizing plan options, (iii) adding special enrollment periods to increase ease of obtaining coverage, (iv) strengthening markets, and (v) bolstering program integrity.…

Continue Reading CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

Companies regularly are required to interpret ambiguous and vague regulatory provisions. Today, the United States Supreme Court heard oral arguments in a pair of consolidated cases to determine whether a defendant’s subjective interpretation of an ambiguous regulation is relevant to determining the knowledge (or scienter) element of the False Claims Act or, as the Seventh Circuit held in the case below, that once a defendant can articulate an objectively reasonable interpretation its contemporaneously held subjective belief is irrelevant to the knowledge inquiry. The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs.…

Continue Reading Supreme Court Hears Arguments on False Claims Act Scienter Standard

On April 12, 2023, OCR issued a Notice of Proposed Rulemaking (“NPRM”) to strengthen HIPAA’s protections around reproductive health care privacy. The NPRM responds to President Biden’s Executive Order 14076, which directed HHS to consider ways to strengthen privacy protections for reproductive health care services, following the Supreme Court’s rule in Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and ultimately resulting in renewed concern over patient privacy and reproductive healthcare.…

Continue Reading OCR Announces Proposed Rulemaking to Strengthen Reproductive Health Privacy

In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable takeaways were exposed. By providing data on enforcement actions and insight into areas of noncompliance, the reports assist HIPAA entities to mitigate risk, prioritize compliance efforts, and promote industry accountability.…

Continue Reading HHS OCR Delivered Annual Reports to Congress

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. …

Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State