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Publications
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04.18.2024Expansion of Hospital Tort Liability in WashingtonUpdatesThe Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians, and potentially for other independently contracted hospital-based providers.
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06.07.2023The Wide Reach of the New Washington Privacy LegislationUpdatesThis Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act. The original impetus for the Act was the protection of reproductive rights, and it was signed into law alongside several other pieces of legislation focused on providing abortion and gender-affirming protections. However, because of the broad and vague definition of “consumer health data” covered by the legislation and because it applies to a wide range of entities, the Act may reach much further than might be justified by its original purpose.
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06.02.2023US Supreme Court Clarifies Knowledge Requirement in False Claims Act Cases—Raising New Interpretive IssuesUpdatesA defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted false claims for payment in violation of the False Claims Act, the U.S. Supreme Court ruled on June 1, 2023.
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06.01.2023Consumer Rights and Business ObligationsUpdatesAs detailed in Part 1 of this ongoing series, Washington Governor Jay Inslee signed the state’s My Health My Data Act into law on April 27, 2023. In this installment, we provide an overview of the consumer rights bestowed by the Act and the obligations it imposes upon regulated entities and small businesses.
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02.13.2023New CMS Rule Requires Extrapolation of Medicare Advantage RADV Audit FindingsUpdates
The Centers for Medicare and Medicaid Services has codified regulatory changes to its Medicare Advantage Risk Adjustment Data Validation audit program of risk adjustments submitted by Medicare Advantage Organizations. Most significantly, CMS will begin applying contract-level extrapolation to its RADV audit findings beginning with audits of calendar year 2018, which will significantly increase MAO exposure based upon alleged overpayment findings.
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02.07.2023DOJ Withdraws Healthcare Antitrust Policy StatementsUpdatesThe U.S. Department of Justice, Antitrust Division, recently withdrew three sets of healthcare policy guidelines. This Update discusses the DOJ's decision and its implications for the industry.
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07.08.2020Antitrust Enforcers Unlikely to Lessen Scrutiny of Healthcare Mergers During PandemicUpdates
COVID-19 has financially stressed the U.S. healthcare system in several ways.
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06.17.2020HHS Announces Targeted CARES Act Provider Relief Fund Payments to Medicaid and CHIP Providers and Safety Net HospitalsUpdatesThe U.S. Department of Health and Human Services (HHS) recently announced two new targeted distributions from the CARES Act Provider Relief Fund (the Provider Relief Fund) to assist in the response to the medical and economic consequences of the COVID-19 pandemic
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04.29.2020Congress and HHS Make Additional $170 Billion Available to Healthcare Providers to Address COVID-19 Testing, Treatment, and LossesUpdatesIn recent days the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic.
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04.14.2020HHS to Distribute First Tranche of $100 Billion to Healthcare Providers for COVID-19 LossesUpdatesThe CARES Act, which became law on March 27, 2020, appropriates $100 billion to the Public Health and Social Services Emergency Fund to reimburse providers for unreimbursed expenses and lost revenue attributable to the novel coronavirus pandemic.
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03.31.2020Healthcare Industry Implications of the CARES ActUpdatesThe Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus pandemic’s impact on the American economy and its workers.
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03.25.2020Guide to Federal Health Program Waivers Concerning the COVID-19 CrisisUpdatesThe federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to receive reimbursement for services to Medicare, Medicaid, and Children’s Hospital Insurance Program (CHIP) beneficiaries
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03.23.2020Healthcare Industry Implications of the Families First Coronavirus Response ActUpdates
By a vote of 363-40 the U.S. House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act, on March 14, 2020. The bill now proceeds to the U.S. Senate, and the White House has voiced its support for the legislation.
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03.09.2020AseraCare Settlement Ends Medical Judgment False Claims Act Case With a WhimperUpdatesThe U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a clinician’s medical judgement.
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01.13.2020DOJ Recovers More Than $3 Billion in False Claims Act Cases in FY 2019UpdatesThe Department of Justice (DOJ) recovered more than $3 billion in settlements and judgments from civil cases involving the False Claims Act (FCA) in the fiscal year ending September 30, 2019, according to statistics released by DOJ on January 9, 2020.
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12.17.2018Belated Government Dismissal of False Claims Act Cases: DOJ Maneuvering in Post-Escobar and Granston Memo EraUpdates
On November 30, 2018, the solicitor general filed an amicus brief in the U.S. Supreme Court supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the government’s brief disclosed for the first time that it would dismiss the relators’ qui tam complaint on remand, allegedly because discovery would interfere with federal agency responsibilities.
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08.14.2017Ninth Circuit Raises Bar for Approving Changes in State Medicaid ReimbursementUpdatesThe U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers for Medicaid beneficiaries.
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08.15.2016The Impact of Parallel Criminal-Civil Investigations on Life Sciences CompaniesArticlesIn 2014, the U.S. Justice Department finalized its $192.7 million settlement with Endo Pharmaceuticals of claims related to alleged off-label promotion by announcing that the whistleblower in the False Claims Act civil lawsuit that led to the settlement was awarded $33.6 million.
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09.25.2015
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09.22.2015Pharma and Medical Device Industry Victory in Off-Label Marketing DecisionUpdatesThe U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug, thereby helping to clarify lingering uncertainty over the scope of First Amendment protection afforded statements by drug representatives, at least in states located in the Second Circuit.
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03.02.2015Supreme Court Strikes Down State Professional Boards’ Antitrust ImmunityUpdatesIn a ruling with significant implications for state professional licensing boards and their members, on February 25, 2015, the United States Supreme Court found that practitioner-controlled state boards do not have inherent immunity from federal antitrust liability if they operate without active supervision by disinterested state actors.
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06.04.2014Medicare Appeals Panel Invalidates National Coverage Determination Prohibiting Coverage for Gender Reassignment SurgeryUpdatesOn May 30, 2014, the Departmental Appeals Board (DAB) issued a decision invalidating the long-standing National Coverage Determination (NCD) prohibiting Medicare payment for transsexual surgery (now known as gender reassignment surgery).
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04.30.2014Theft of Unencrypted Laptops Leads to Two HHS Settlements Totaling Nearly $2 MillionUpdatesOn April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA). Through these latest settlements, HHS is reiterating its message to covered entities and business associates that laptops and similar devices containing electronic protected health information (ePHI) should be encrypted.
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08.22.2013Oregon Settlement Expands Disclosure Obligations of Physicians Receiving Payments From Drug and Device ManufacturersUpdatesAs of August 1, 2013, pharmaceutical companies and medical device manufacturers are required to report to the federal government payments made to physicians under the Physician Payment Sunshine Act (PPSA).
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08.08.2013CMS Adopts New “2 Midnights” Presumption for Inpatient Hospital AdmissionsUpdatesOn August 2, 2013, the Centers for Medicare and Medicaid Services (CMS) issued an advance copy of its final rulemaking that adopts a new approach to evaluating the medical necessity of inpatient hospital admissions.
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03.20.2013Hospitals Provided Temporary Relief in Medicare Rebilling PolicyUpdatesThe Centers for Medicare & Medicaid Services (CMS) released a ruling and an interim rule that, effective immediately, will allow hospitals to rebill certain inpatient hospital services as outpatient services for one year after the date of service.
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01.25.2013U.S. Supreme Court Holds Equitable Tolling Doctrine Does Not Apply to Administrative Appeal DeadlineUpdatesOn January 22, 2013, the U.S. Supreme Court issued a unanimous decision in Sebelius v. Auburn Regional Medical Center, 568 U.S. _____ (2013), holding that hospitals cannot appeal Medicare inpatient reimbursement determinations to the Provider Reimbursement Review Board if it has been more than three years since the issuance of a Notice of Program Reimbursement from a Medicare fiscal intermediary.
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01.04.2013Takeaways From HHS Report On CMS E-Records ProgramArticles
Law360
Joel Levin, David Robbins and Jerica Peters published an article discussing the government's use of monetary incentives to encourage Medicare providers to make meaningful use of electronic health records (EHR). The article focuses on a recent report by the Department of Health and Human Services Office of Inspector General that criticizes the government's oversight of the EHR incentive program. -
12.07.2012HHS OIG Takes Aim at CMS’ Oversight of Electronic Health Records Incentive ProgramUpdatesOn November 29, 2012, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report raising concerns about the Centers for Medicare and Medicaid Services’ (CMS) oversight of the Medicare electronic health record (EHR) incentive program. The report was based on a review of healthcare professionals’ and hospitals’ meaningful use of certified EHR technology (i.e., the computerized systems that store health-related patient information) from May to December 2011.
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12.06.2012In Landmark Decision, Second Circuit Reverses Conviction for Off-Label PromotionUpdatesOn December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of the federal Food, Drug and Cosmetic Act (FDCA). A majority of the court held on First Amendment grounds that the misbranding provisions of the FDCA do not “prohibit[] and criminaliz[e] the truthful off-label promotion of FDA-approved prescription drugs.”
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10.15.2012Sixth Circuit Rebukes Government’s Reliance on Profit Motive to Prove False ClaimUpdatesOn October 5, 2012, the Sixth Circuit reversed an $82.6 million award in a False Claims Act (FCA) lawsuit against Fresenius Medical Care Holdings (Fresenius) and granted partial summary judgment in favor of the defendants.
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04.19.2012HIPAA Enforcement Comes to Small Providers: $100,000 and Heightened Compliance ObligationsUpdatesA small cardiac surgery practice (two owners; currently five physicians) is the latest covered entity to enter into a settlement agreement and Corrective Action Plan (CAP) with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), to resolve alleged violations of the HIPAA privacy and security regulations. In announcing the $100,000 settlement OCR Director Leon Rodriguez stated, "OCR expects full compliance no matter the size of a covered entity."
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03.13.2012Washington Medicaid Fraud False Claims Act Awaits Governor’s SignatureUpdatesIn the final hours of its regular session, the Washington Legislature enacted the Washington Medicaid Fraud False Claims Act.
Presentations
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11.03.2018Fraud and Abuse UpdateSpeaking Engagements
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20162016 Fraud and Abuse UpdateSpeaking EngagementsWashington State Society of Healthcare Attorneys / Vancouver, British Columbia
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2016Fraud Enforcement: Recent Trends and Lessons LearnedSpeaking EngagementsOregon Medical Association / Portland, OR
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2009Fraud & Abuse UpdateSpeaking EngagementsWashington State Society of Healthcare Attorneys / Vancouver, B.C.
