CMS Issues Long-Awaited Draft Guidance for Hospital Co-Location with Other Hospitals or Healthcare Facilities

By Michael Paddock, Erica Kraus and Theresa Thompson on May 9, 2019 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On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain circumstances.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

By Jordan Grushkin, Matthew Goldman and Melissa Gertler on May 6, 2019 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

By Erica Kraus, Theresa Thompson and Keeley A. McCarty on May 3, 2019 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

By Christine Clements and Samuel Gilkeson on April 26, 2019 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

By Kenneth Yood and Melissa Gertler on April 24, 2019 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

By Matthew Goldman and Melissa Gertler on April 23, 2019 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

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton and Kenneth Yood on April 22, 2019 Posted in FDA

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance. Continue Reading

Overview of Proposed Rule from the Centers for Medicare & Medicaid Services Regarding Interoperability and Patient Access to Data

By Lynsey Mitchel on April 19, 2019 Posted in Federal Healthcare Legislation, Healthcare Information

On March 4, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a wide-ranging proposed rule (“Proposed Rule”)[1] with the intent to “move the health care ecosystem in the direction of interoperability” in alignment with the objectives set out in the 21^st Century Cures Act (“Cures Act”)[2] and Executive Order 13813.[3] According to CMS, this Proposed Rule is a key step in putting patients at the center of their health care and ensuring that they have access to their health information – attempting to solve the problem of accessing complete health information from different providers and payors. CMS believes patients should have the “ability to move from health plan to health plan, provider to provider, and have both their clinical and administrative information travel with them throughout their journey.”[4] A twin goal is that health IT should not “detract from the clinician-patient relationship… or from the quality of work life for physicians, nurses, and other health care professionals.”[5] Continue Reading

Notes from the 2019 Health Evolution Summit: Promoting Quality Healthcare and a Quality Healthcare Experience

By Eric Klein and Aytan Dahukey on April 18, 2019 Posted in Health Systems, Healthcare Industry News, Healthcare Information

Laguna Niguel, California. Another wild year in healthcare is upon us and another insightful and inspiring week of discussions at the 2019 Health Evolution Summit (HES) has just wrapped up in California. HES, which many refer to as “Baby JP Morgan” (a reference to the annual JP Morgan Healthcare Conference in San Francisco, California), brings together some of the most influential minds and leaders in healthcare in an intimate setting offering the opportunity to participate in frank and detailed discussions regarding the healthcare industry, what we’re doing right, what we can do better, and what we envision for the future. Healthcare thought-leaders focused on disruptive technologies and Artificial Intelligence (“AI”), managed care, legislation and policy and virtually all other aspects of the healthcare system all participated in lively discussions throughout the week and we were privileged to join the fun.

Health, Not Healthcare. There was a true focus on consumerism, patient experience, and the delivery of “health, not healthcare” at the conference with an interesting dichotomy among companies focused on engagement of the portion of the population that does not take an active role in managing their own health (i.e., healthy people) and companies focused on those suffering from chronic conditions that require more hands-on involvement to manage a completely different set of challenges. Continue Reading

CMS Expands Telehealth Benefits under Medicare Advantage

By Matthew Shatzkes and Susan Ingargiola on April 10, 2019 Posted in Federal Healthcare Legislation, Medicare Advantage

On Friday, April 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced that it had finalized policies allowing Medicare Advantage plans (“MA Plans”) to include additional telehealth benefits in their basic benefit packages starting in 2020. The final rule implementing the changes (the “Final Rule”) will be published in the Federal Register on April 16, 2019. An advance copy of the Final Rule is available here. Continue Reading

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