Blockchain and Healthcare Innovation: A City, Academia, and Technology Firms Join Forces to find Blockchain Solutions to Address Public Health Challenges

Samuel GilkesonJohn TiltonBy Samuel Gilkeson and John Tilton on Posted in Blockchain

As the excitement around blockchain technology continues to grow in the healthcare sector, there is an increasing realization that blockchain has the capability of addressing many of the data and information-related challenges that the healthcare world has been focused on for years – such as providing access to comprehensive interoperable electronic health records and ensuring data continuity for patients who receive treatment in multiple healthcare settings. As this realization has taken hold, healthcare stakeholders and constituents are seemingly trying to “make up for lost time” with new blockchain initiatives being announced on a regular basis seeking to turn theoretical applications into real-world blockchain solutions.[1] Continue Reading

SCOTUS Rejects CMS DSH Policy, Calls CMS Guidance Practices Into Question

Christine ClementsErica KrausBy Christine Clements and Erica Kraus on Posted in Hospitals, Medicare

Earlier this week, the Supreme Court upheld a D.C. Circuit Court decision vacating a policy of the Centers for Medicare and Medicaid Services (“CMS”) that would have “dramatically – and retroactively – reduced payments to hospitals serving low-income patients.” Azar v. Allina Health Services, 587 U.S. __ at 1 (2019). The Supreme Court’s Allina opinion (“Op.” or the “Decision”) is critically important for hospitals that rely on Medicare disproportionate share (“DSH”) payments and has broader implications for the way that CMS issues the voluminous guidance that the agency applies to Medicare-participating providers and suppliers and other CMS-contracted entities. Continue Reading

Supreme Court Addresses False Claims Act Statute of Limitations

Bryce ChadwickDavid T. FischerBy Bryce Chadwick and David T. Fischer on Posted in False Claims Act

On May 14, 2019, the Supreme Court issued a decision in the case of Cochise Consultancy, Inc. v. United States ex rel. Hunt, No. 18-315, 2019 WL 2078086 (U.S. May 13, 2019). In its decision, the Supreme Court essentially added four years on the time available for private suits to be brought by whistleblowers/relators under the False Claims Act (“FCA”), regardless of whether the Government decides to intervene. As a result of this decision, entities that submit claims to the Government for payment – including Medicare, Medicaid and other Federal healthcare program-participating providers and suppliers – may find themselves facing a private whistleblower complaint more than six years after the alleged conduct took place. As described in the following article, “Supreme Court Addresses False Claims Act Statute of Limitations,” that was previously posted on the Sheppard Mullin False Claims Act Defense Blog on May 14, 2019, the Court decision now allows for the possibility that a whistleblower could inform an appropriate U.S. official of material facts relating to an alleged FCA violation after the whistleblower’s own six-year statute of limitations has already tolled, so long as the action is brought within 10 years of the alleged violation. Continue Reading

Recent Activity in Medicare Audit Programs: CMS Announces Increase in Audit Contractor Oversight

Kenneth YoodSamuel GilkesonMelissa GertlerBy Kenneth Yood, Samuel Gilkeson and Melissa Gertler on Posted in Medicare

The Centers for Medicare and Medicaid Services (“CMS”) healthcare audit programs – including the Unified Program Integrity Contractors (“UPICs”) audit program, the Recovery Audit Contractor (“RAC”) program, the Comprehensive Error Rate Testing (“CERT”) program, etc. – have been the subject of regular complaints and calls-for-action by the Medicare/Medicaid provider community for many years. Continue Reading

CMS Issues Long-Awaited Draft Guidance for Hospital Co-Location with Other Hospitals or Healthcare Facilities

Michael PaddockErica KrausTheresa ThompsonBy Michael Paddock, Erica Kraus and Theresa Thompson on Posted in Centers for Medicare and Medicaid Services ("CMS"), Medicare

On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain circumstances.

In welcome news for the industry – particularly for hospitals that co-locate provider-based space with non-provider-based facilities – CMS has proposed that hospitals may co-locate with other hospitals or healthcare entities on the same campus or in the same building, either in its entirety or only in part, sharing certain space, staff, and/or services. To date, some industry participants have struggled with whether and/or to what extent a hospital is able to co-locate with other health care facilities – indeed, the CMS Chicago Regional Office once issued a letter denying off-campus provider-based status to a hospital because, in part, that location merely shared common areas with another health care facility. In the Guidance, CMS delineates its proposed expectations and requirements for how hospitals must operate when they co-locate, addressing (1) space sharing, (2) contracted services, and (3) emergency services. Continue Reading

Update to Texas v. United States: DOJ Files a Brief in Support of Eliminating the ACA

Jordan GrushkinMatthew GoldmanMelissa GertlerBy Jordan Grushkin, Matthew Goldman and Melissa Gertler on Posted in Affordable Care Act (ACA), Healthcare Reform

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

The Military Health Care Fraud and Abuse Prevention Program: The Department of Defense Issues Proposed Regulations regarding TRICARE and Civil Monetary Penalties

Erica KrausTheresa ThompsonKeeley A. McCartyBy Erica Kraus, Theresa Thompson and Keeley A. McCarty on Posted in Federal Healthcare Legislation

The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated, affordable, and high quality health service to all DOD beneficiaries” and to be “a responsible steward of taxpayer dollars.” Noting that the Department of Justice (“DOJ”) has limited resources to prosecute those who commit fraud and abuse against the TRICARE program, the DOD now seeks to step in and ramp up enforcement. Continue Reading

Arkansas and Kentucky Halt Medicaid Work Requirements

Christine ClementsSamuel GilkesonBy Christine Clements and Samuel Gilkeson on Posted in Healthcare Law, Medicaid

On April 10, 2019, the Department of Justice filed notices[1] appealing two District Court rulings that struck down Medicaid work requirements in both Kentucky[2] and Arkansas[3] to the U.S. Court of Appeals for the District of Columbia Circuit. The rulings, issued on March 27, 2019, by Judge James E. Boasberg of the Federal District Court for the District of Columbia, held that the U.S. Department of Health and Human Services (“HHS”) acted arbitrarily and capriciously in violation of the Administrative Procedure Act (“APA”) when it approved the Arkansas Works Amendments and Kentucky HEALTH programs. Arkansas and Kentucky halted the programs, pending resolution of the appeals. Continue Reading

Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the 340B Program

Kenneth YoodMelissa GertlerBy Kenneth Yood and Melissa Gertler on Posted in Healthcare Industry News, Healthcare Law

If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services (“HRSA”) finally updated the Office of Pharmacy Affairs 340B Information System website (the “340B Website”) to allow 340B Drug Pricing Program (the “340B Program”) providers – including 340B Program-eligible hospitals and other eligible healthcare providers– to use the 340B Website to verify the accuracy of the ceiling prices that they are being charged by manufacturers of 340B Program-covered drugs. Continue Reading

CMS Announces New Initiative for Value-Based Transformation of Primary Care

Matthew GoldmanMelissa GertlerBy Matthew Goldman and Melissa Gertler on Posted in Federal Healthcare Legislation

On April 22, 2019, the U.S. Department of Health and Human Services (“HHS”) and Centers for Medicare & Medicaid Services (“CMS”) announced the CMS Primary Cares Initiative (the “Initiative”), which consists of new payment models that seek to transform primary care in order to deliver better value for patients. The Initiative aims to improve quality and patient experience of care while reducing administrative burdens and lowering overall healthcare costs. The Initiative consists of five (5) payment model options in two broad paths: (1) Primary Care First and (2) Direct Contracting. Continue Reading

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