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On June 16, 2023, nearly half of the State Attorneys General[1] penned a letter (the “Letter”) to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) advocating for broader privacy protections surrounding reproductive health care information. Specifically, the Letter targeted the Notice of Proposed Rulemaking (the “Proposed Rule”) published by OCR in April of 2023, which proposed a number of revisions to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).[2]

Continue Reading State Attorneys General Pen Letter to OCR Advocating for Greater Privacy Protection of Reproductive Health Care Information
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All types of healthcare providers depend on medical directors to oversee clinical operations and consult with administrative leadership on facility, unit, or clinical service line plans and performance. Medical directors function at the intersection of administration and clinical care, weighing in on matters as varied and important as accreditation, capital expenditures for equipment, staffing, standard operating procedures, and peer review. In addition to clinical skills, they ideally need excellent people skills to balance competing priorities and communicate effectively with different stakeholders. They are a valuable resource and partner for compliance professionals. With proper support, medical directors can support an organization’s compliance efforts and help mitigate risk for both employee issues and healthcare regulatory matters. This article outlines five key best practices in contracting for medical director services:

Continue Reading Do Your Medical Director Arrangements Meet the Top Five Best Practices?
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For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. 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. On review, the Fifth Circuit held 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, temporarily suspending more recent modifications to the FDA’s approval. 

Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 
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The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records[1] outside of the United States, its territories, or Canada.[2] Significantly, the prohibition also extends to qualified electronic health records that are stored through a third-party or subcontracted computing facility or cloud service provider.[3]

Continue Reading Florida Bans Offshoring of Certain Patient Information
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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
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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
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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
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In light of the increasing demand for mental health treatment and simultaneous provider shortages, the private insurance industry is rolling out targeted initiatives to increase mental health support for members by mitigating many of the barriers to entry facing the mental health industry today.

Continue Reading Payor-Led Initiatives to Strengthen Mental Health Resources
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On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to order the manufacturer’s drug (the “Drug”) from a particular provider and therefore did not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP. Ultimately, the crux of this decision came down to the unique manufacturing and distribution of the Drug, which (i) is the only available potentially curative treatment for an ultra-rare disorder; (ii) pursuant to its FDA approval, can only be manufactured at a single facility, located on the campus of a treatment center (the “Treatment Center”); (iii) can only be administered within 3 hours after being manufactured; and thus, can only be administered at the single Treatment Center site.

Continue Reading OIG Advisory Opinion Alert: Medical Flights for Patient Access