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Kathleen Stratton

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Kathleen M. Stratton is Special Counsel in the Corporate Practice Group in the firm’s Washington D.C. office.

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On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning Medicare Part A and Part B overpayments, and stated that it is continuing its review and evaluation of previously proposed changes to existing overpayment regulations.Continue Reading CMS Proposes to Amend Overpayment Rule-Questions Remain Regarding How the Rule Will be Implemented Should CMS Adopt the False Claims Act’s “Reckless Disregard or Deliberate Ignorance” Standard

The Centers for Medicare and Medicaid Services (“CMS”) has issued a proposed rule which would amend the existing regulations for reporting and returning identified overpayments (the “Proposed Rule”). Specifically, with respect to the meaning of “identification” of overpayment, CMS proposes to eliminate the “reasonable diligence” (or traditional negligence) standard and replace it with the False Claims Act’s (“FCA’s”) standard of “knowing” and “knowingly” (i.e., reckless disregard or deliberate ignorance of a potential overpayment).Continue Reading CMS Proposes to Amend Overpayment Rule, Remove Potential Overpayment and False Claims Act Liability for Mere Negligence

On June 21, 2022 the Supreme Court granted certiorari in Polansky v. Exec. Health Res., 17 F.4th 376 (3d Cir. 2021), allowing the Court to review the Department of Justice’s (“DOJ”) authority to dismiss qui tam suits brought under the False Claims Act (“FCA”), over objections by the relators. The case invites the high Court to decide two key issues: (1) whether the DOJ has the authority to dismiss qui tam suits where it declined to intervene, and (2) what standard of review applies to such requests for dismissal. Continue Reading Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving physician-ownership of a medical device company. The opinion identified six characteristics of the arrangement which greatly reduced the risk of fraud and abuse.Continue Reading OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) revised and finalized draft guidance first issued on May 3, 2019, for co-location of hospitals with other hospitals or healthcare providers[1] (the “Finalized Guidance”). The Finalized Guidance is intended to guide CMS Surveyors in evaluation of such hospitals’ compliance with Medicare Conditions of Participation related to shared space, services, and staff.
Continue Reading CMS Loosens Restrictions on Co-Located Healthcare Providers; Enforcement Interpretation Still to Be Determined

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020 (“Interim Final Rule”).  As described in our December 2020 blog post, the Interim Final Rule established a seven-year nationwide, mandatory MFN Model that would test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals.  The MFN Model, originally set to begin January 1, 2021, would have tied the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries and remove incentives to use higher cost drugs, in order to determine whether this could “control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.”  Had the Interim Final Rule been implemented, Medicare Part B reimbursement would have been significantly reduced starting January 1, 2021.
Continue Reading Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While Keeping the “Most Favored Nations” Drug Reimbursement Program on the Sidelines

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment…
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) filed the unpublished version of the forthcoming Inpatient Prospective Payment Systems (“IPPS”) Final Rule for 2021. One of the more controversial provisions in the IPPS Final Rule finalizes CMS’ proposal, with modification, to require hospitals to report certain market-based payment rate information on their Medicare cost report for cost reporting periods ending on or after January 1, 2021. Specifically, this includes requiring hospitals to report on the Medicare cost report, the median payer-specific charge that the hospital has negotiated with all of its Medicare Advantage organization (“MAO”) payers, by Medicare Severity Diagnosis Related Groups (“MS-DRGs”) (the classification system by which hospitals are paid for patients’ hospital stays). The payer-specific negotiated charges used by hospitals to calculate these medians would be the payer-specific negotiated charges for service packages that hospitals are already required to make public under the requirements finalized in the Hospital Price Transparency Final Rule and, therefore, CMS argues that “the additional calculation and reporting of the median payer-specific negotiated charge will be less burdensome for hospitals.” In addition, CMS also finalized the market-based MS-DRG relative weight methodology, which incorporates this market-based rate information, to inform its calculations for inpatient hospital rates beginning in 2024.
Continue Reading CMS Finalizes Medicare Advantage Price Transparency Requirements, Despite Industry Criticism

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a series of temporary regulatory waivers in order to aid the response to the 2019 Novel Coronavirus (COVID-19), as follows.
Continue Reading CMS Issues Temporary Waivers in Broad Coronavirus Response

On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted.  Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health care industry:
Continue Reading Key Health Care Provisions of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”)

As discussed in our December 13, 2019 blog post on Surprise Billing, states have taken the lead on protecting patients against surprise bills, as the numerous pending bills before the House on the issue have stalled. Now in 2020, two new state surprise billing laws in Texas and the State of Washington have gone into effect, while Congress is trying anew to make something happen on the federal level.
Continue Reading An Update: Despite Resistance, Surprise Billing Restrictions See Continued Legislative Activity