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Social determinants of health (“SDOH”) consider the non-clinical factors that can profoundly impact an individual’s well-being. They are extensive and often overlap, including housing instability, food insecurity, the inability to afford and obtain medications and more. Research has indicated that healthcare systems that connect patients to basic resources have observed improvements in population health metrics, fostered trust with their patient base, and experienced reduced hospitalization costs.

Continue Reading CMS Augments “In Lieu Of Services” Medicaid Guidance to Support State Medicaid Managed Care Efforts to Address Social Determinants of Health
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*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options. Continue Reading Adapting To FDA’s Proposal For Diagnosis Support Software

On May 1, 2019, the Department of Justice (“DOJ”) filed an initial brief (the “Brief”) with the U.S. Court of Appeals for the Fifth Circuit (the “Fifth Circuit”) on behalf of the United States, in favor of upholding the lower court’s decision that found the entire Patient Protection and Affordable Care Act (the “ACA”) unconstitutional.

As we discussed previously in our December 2018 blog post, a federal district court judge in Texas struck down the entire ACA by ruling that the “individual mandate,” which was reduced to $0 as part of the 2017 Tax Cuts and Jobs Act, no longer raises revenue and thus is no longer a constitutional exercise of Congress’s taxing power. The judge went on to determine that the unconstitutional individual mandate was inseverable from the rest of the ACA and therefore, the entire ACA was unconstitutional. The decision was then appealed to the Fifth Circuit. Continue Reading Update to Texas v. United States: DOJ Files a Brief in Support of Eliminating the ACA

In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described in the Proclamation, the goal of Awareness Week is to “raise awareness about the prescription opioid and heroin epidemic and to consider concrete follow up activities.” Continue Reading Congress Passes “SUPPORT for Patients and Communities Act” — A Rare Example of Bi-Partisanship

The Texas Medical Association (TMA) and Blue Cross Blue Shield of Texas are launching a new services company, TMA PracticeEdge, to facilitate bringing the benefits of value-based reimbursements to the state’s independent physicians.

Independent practitioners face challenges to participating in (and benefitting from) alternatives to fee-for-service payment, such as having the funds necessary to invest upfront in resources for improved care management. TMA PracticeEdge aims to help providers address the barriers. The company, for example, will offer consultations on basic practice management and administrative simplification, assistance with the implementation of health information technology infrastructure, and experience with risk-based contracts. Additional services will be available for practices interested in creating care teams or developing an Accountable Care Organization.

Continue Reading New Venture Seeks to Support Independent Physicians in Texas

Approximately one-third of Medicaid spending, $136 billion, is on long-term services and supports (LTSS).  While the majority of Medicaid LTSS takes place in institutional settings, such as nursing facilities and mental health facilities, there is an ongoing emphasis on the role of non-institutional facilities. A growing number of states, from 8 in 2004 to 16 in 2012 and an expected 26 through 2014, are adopting a managed care approach to expanding home-and community-based services. This transition is commonly referred to as a “rebalancing” of LTSS systems.

Continue Reading New Approaches – and Increasing Oversight – for Medicaid Managed Long Term Services and Support

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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
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Since its launch in November 2022, ChatGPT (“GPT” stands for Generative Pre-trained Transformer), a type of artificial intelligence model, has gained over a million users. ChatGPT is used by entities in a wide variety of industries. On March 1, 2023, OpenAI, the developer of ChatGPT, updated its data usage policies[1] noting that (i) OpenAI will not use data submitted by customers to train or improve its models unless customers expressly opt-in to share such data, and (ii) OpenAI also will enter into business associate agreements in support of applicable customers’ compliance with the Health Insurance Portability and Accountability Act (“HIPAA”).

Continue Reading ChatGPT And Healthcare Privacy Risks