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Healthcare Blog

Holland & Knight's Healthcare Blog provides insights and analysis on important issues and new developments in healthcare law. We cover a wide variety of topics including fraud and abuse, technology, health plans, facility operations, long-term care, life sciences and public policy.

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The Centers for Medicare & Medicaid Services (CMS) on July 12, 2018, published the CY 2019 Proposed Rule for the Medicare Physician Fee Schedule (PFS). While in previous years regulations for the Quality Payment Program (QPP) were released independently, the 2019 Medicare PFS proposed rule includes proposals related to Medicare physician payment as well as the QPP.
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July 20, 2018
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On July 19, 2018, The Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would revise the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2019, and would update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI).
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July 19, 2018
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The Department of Justice (DOJ) recently announced the creation of a Task Force on Market Integrity and Consumer Fraud. Relevant to the contracting and healthcare community, the task force is designed to strengthen the government's efforts to investigate and prosecute crimes of fraud committed against the U.S. Government. The task force will also focus on combating fraud against consumers, and in particular the elderly, service members and veterans.
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July 18, 2018
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Healthcare attorney Melissa Wong wrote an article about the role of healthcare in natural disaster response and recovery efforts. The article was published in July 2018 issue of The American Health Lawyers Association (AHLA) Connections magazine.
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July 2018
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The Centers for Medicare & Medicaid Services (CMS) on June 25, 2018, published a Request for Information (RFI) seeking "input from the public on how to address any undue regulatory impact and burden of the physician self-referral law."
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June 27, 2018
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The U.S. Department of Labor (DOL) announced a final rule on June 19, 2018, regarding association health plans (AHPs). The final rule was published in the Federal Register on June 21, 2018.
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June 22, 2018
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In May 2018, the U.S. Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially available since the 1940s, the FDA did not begin to regulate them until 1978. Since then, the FDA has published a handful of rules governing the marketing of sunscreens.
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June 20, 2018
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A three-judge panel of the U.S. Court of Appeals for the Federal Circuit on June 14, 2018, reversed the ruling of a U.S. Court of Federal Claims judge against the U.S. Department of Health and Human Services (HHS) in a lawsuit regarding the Patient Protection and Affordable Care Act's (ACA) Risk Corridor Program. The decision deals a blow to health insurers seeking payment under the program.
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June 19, 2018
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On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers" (Guidance). The Guidance pertains to communications by medical product manufacturers, packers, distributors, and their representatives (Manufacturers) to payors (1) of health care economic information (HCEI) regarding approved drugs and approved/cleared devices (Approved Products); and 2) of information about unapproved drugs/devices (Unapproved Products) and unapproved uses of approved/cleared medical products (Unapproved Uses).
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The Health Resources and Services Administration announced that the January 2017 340B Drug Pricing Program final rule will again be delayed.
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June 11, 2018
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On May 30, 2018, President Donald Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients with life-threatening diseases who have exhausted approved treatment options and are unable to participate in a clinical trial involving the drug. Similar legislation has been enacted in 40 states.

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June 8, 2018
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On June 4, 2018, the U.S. Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19 review divisions.
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June 7, 2018
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With all of the regulatory obligations that hospitals and other healthcare facilities need to comply with, it might be easy to overlook an environmental law that can lead to significant trouble. Hospitals may find themselves in the U.S. Environmental Protection Agency's (EPA) sights over handling of hazardous waste. Operators of healthcare facilities are encouraged to include this topic in their risk assessments, and to consider environmental compliance audits.
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June 1, 2018
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On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 18-02 regarding the provision of sample ostomy products to patients by a device distributor (the Arrangement).
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Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The health sector is one of 16 Critical Infrastructure (CI) sectors as defined by the U.S. Department of Homeland Security (DHS).
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May 21, 2018
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On May 17, 2018, the U.S. Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to “improv[e] transparency about this and other gaming tactics that delay the generic competition Congress intended."
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May 18, 2018
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"American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs," released on May 11, 2018, outlines the much-anticipated set of actions that the Administration proposes to take to lower prescription drug prices.
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May 15, 2018
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Under HIPAA, patients have a right to information about certain disclosures, referred to as an accounting. Under the current iteration of the regulations, covered entities and business associates need not account for disclosures for treatment, payment, and health care operations purposes.
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Most practitioners are aware that the statute of limitations under the False Claims Act (FCA) is six years after the date on which the violation is committed. 31 U.S.C. § 3731(b)(1).
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May 2, 2018
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On April 24, 2018, the Centers for Medicare and Medicaid Services (CMS) issued for comment a 1883-page proposed rule (CMS-1694-P) that aims, among other goals, to increase transparency relating to pricing and electronic medical records at Medicare-participating hospitals. Specifically, the Proposed Rule requires hospitals to post their pricing lists online, accessible to patients in a "consumer-friendly" way, so that "patients understand what their potential financial liability might be for the services they obtain at the hospital, and to enable patients to compare charges for similar services across hospitals."
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April 27, 2018
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