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As individuals continue to live longer beyond retirement and the U.S. population size of those 65 years and older continues to increase, the demand for long-term services and supports (“LTSS”) is also expected to increase.[1] LTSS represents the wide-ranging health and social services that individuals require over an extended period of time, including assistive services.[2] The increasing demand for these services will also likely proportionally increase health care expenditures of LTSS. According to the Congressional Research Service, which analyzed data from the Centers for Medicare & Medicaid Services (“CMS”) National Health Expenditure Accounts (“NHEA”) on the personal health expenditures for LTSS by payer, in 2021, an estimated $467.4 billion was spent on LTSS. This represents 13.2% of the $3.6 trillion spent on personal health care.[3] Notably, the first and second largest payers of LTSS are Medicaid and Medicare, respectively, accounting for 64.1% of all LTSS spending nationwide in 2021.[4] Absent public LTSS funding, individuals must rely on private funding, and in 2021, private sources accounted for just 28.6% of LTSS spending.[5]

Continue Reading The PACE Solution to Increasing Demands for Long-Term Services and Supports in the U.S.
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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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On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.

Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule
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On April 1st, the Centers for Medicare & Medicaid Services (“CMS”) announced its Medicare Advantage (“MA”) Capitation Rates and Part C and Part D Payment Policies for Calendar Year (“CY”) 2025. This announcement builds on the Advanced Notice of Methodological Changes for CY 2025 for MA Capitation Rates and Part C and Part D Payment Policies (“Advanced Notice”) that CMS released on January 31, 2024. 

Continue Reading CMS Announces Medicare Advantage and Part D Rates for CY 2025
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The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than the drug itself, were improperly listed and has asked the court for judgment on the pleadings and an order to delist the patents at issue.

Continue Reading FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA