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John Tilton

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John M. Tilton is an associate in the Healthcare Practice Group in the firm's Dallas office.

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The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other changes, this Final Rule will allow CMS to audit a sample of an MA organization’s (“MAO”) diagnoses reported for risk adjustment purposes (from 2018 and later) and then use the audit findings to calculate an extrapolated improper payment amount for the MAO’s contract. This extrapolation technique is controversial for a number of reasons, including whether CMS has the authority to use it in the manner proposed in the Final Rule, and whether it is an actuarially sound method of auditing. As we predicted in February, this Final Rule is now being challenged in court.Continue Reading Medicare Advantage RADV Audit Final Rule Challenged in Court

On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2024 (PY2024). The changes came about in response to stakeholder and participant feedback. All ACO REACH participants should familiarize themselves with the upcoming changes.Continue Reading CMS Announces Changes to ACO REACH Model

The intersection of patient satisfaction and quality of care is central to healthcare today, and a provider’s level of cultural competence can significantly impact his/her performance in both areas. Recent focus on diversity, equity, and inclusion initiatives in healthcare has impacted how policymakers are approaching related issues, such as cultural competence in patient care.[1] Some state governments have determined that a provider’s ability to deliver culturally competent care is an essential component to promoting effective and efficient healthcare delivery.[2] For example, Nevada, Oregon, Connecticut, New Jersey, California, Washington, New Mexico, and the District of Columbia each require some form of cultural competency training in their continuing education requirements for certain healthcare providers. In 2023, Illinois legislators introduced two major bills that mandate cultural competency training: H.B. 2450 and S.B. 2427. While these bills take different approaches, both seek to reduce challenges that patients can face in navigating the healthcare system in the absence of culturally competent care and well-resourced providers, including discrimination, reduced quality of services and insurance inadequacies.Continue Reading Get Prepared – Newly Mandated Cultural Competency Training for Illinois Healthcare Providers

On July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (the “Proposed Rule”) for the 2024 Medicare Physician Fee Schedule (“PFS”). The Proposed Rule, which was issued in the Federal Register on August 7, 2023,  includes updated payment rates, changes to reimbursement for services related to health equity and social determinants of health, increases to payment for cancer care support, and changes to enrollment for mental health providers. CMS projects that the Proposed Rule will lead to growth in the Medicare Shared Savings Program (“MSSP”).Continue Reading CMS Announces Proposed Rule for 2024 Medicare Physician Fee Schedule

Yesterday, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway. See United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway. The Court’s ruling was narrow and avoided the more challenging—and common—issues raised during oral argument (which we previously discussed here).Continue Reading Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

While government enforcement has traditionally been an indirect concern for private equity (“PE”) investors, such as looking at whether a target entity has been sanctioned or could be sanctioned in the future, the current trend in government enforcement has been to target PE firms directly.Continue Reading PE Firms Face Liability for the Conduct of their Portfolio Companies: Are you Paying Attention?

On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”). CMS promotes the Final Rule as improving program integrity and payment accuracy as well as transparency and certainty. One thing that is certain, CMS can expect further challenges to its RADV audit methodology.Continue Reading CMS Issues Long-Awaited Medicare Advantage RADV Final Rule

CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs).Continue Reading CMS Pushes Publication of Final FFS Adjuster for RADV Audits Rule to February 1, 2023

Late last month, the Biden Administration announced the second installment of its recovery plan, dubbed the “American Jobs Plan” (the “Plan”).  The Plan’s $2.3 trillion price tag includes…
Continue Reading The American Jobs Plan and the American Rescue Plan: The Biden Administration Bets Big on Home and Community-Based Services

On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in Florida, pleaded guilty to conspiracy to commit healthcare fraud through a “pernicious telefraud scheme”[1] involving fraudulent Medicare and CHAMPVA (Civilian Health and Medical Program of the Department of Veterans Affairs) claims for medically unnecessary durable medical equipment (“DME”) supplies.  As a result of Wolfe’s criminal plea, Wolfe could face up to 13 years in federal prison. 
Continue Reading OIG Warns Telehealth Industry: “With Great Power Comes Great Responsibility”