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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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Partner Morris Miller discusses why the provisions of healthcare services via telemedicine or telehealth are increasingly viewed as an important means of controlling healthcare costs and improving access to healthcare services.
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September 11, 2018
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Among the notable developments in healthcare law is a rule proposed by the Centers for Medicare & Medicaid Services (CMS) that covers a number of topics that could affect providers, including telemedicine. Other recent healthcare matters include an advisory opinion related to group purchasing organizations (GPOs), as well as decisions involving allegations under the Anti-Kickback Statute (AKS) and False Claims Act (FCA), claims of kickbacks in medical expense reimbursements, hospital antitrust claims, class action lawsuits filed under the Fair Debt Collection Practices Act (FDCPA) and Florida telemedicine legislation.
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The Centers for Medicare & Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D sponsors to customize their formularies based not just on drug, but also based on the drug’s indication, or the patient condition that the drug is intended to treat.
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August 30, 2018
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On Aug. 24, 2018, the Office of Inspector General (OIG) issued a request for information (RFI) regarding the Anti-Kickback Statute (AKS) and Beneficiary Inducement provisions of the Civil Monetary Penalty (CMP) law.
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August 28, 2018
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On Aug. 7, 2018, the U.S. Court of Appeals for the Eleventh Circuit affirmed the dismissal of a whistleblower case brought under the federal False Claims Act. The principal grounds for affirmance was a finding that the employee exemption to the Anti-Kickback Statute (AKS) applied to payments that the defendant, the AIDS Healthcare Foundation (the Foundation), made to employees (Linkage Coordinators) to refer HIV patients to healthcare services offered by the Foundation.
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August 23, 2018
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On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released proposed policy and payment updates affecting the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for the calendar year (CY) 2019.
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August 15, 2018
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On Aug. 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would update the Medicare Shared Savings Program (MSSP). Called "Pathways to Success," the proposal significantly alters the Accountable Care Organization (ACO) program. CMS estimates that these changes will save the federal government $2.24 billion over the next ten years, primarily due to a $2.17 billion reduction in ACO net earnings.
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August 13, 2018
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On Aug. 1, 2018, the Departments of Health and Human Services (HHS), Labor and Treasury jointly issued the Short-Term, Limited-Duration Insurance Final Rule. The rule is the second of three regulations resulting from President Donald Trump's October 2017 executive order seeking to reshape the Affordable Care Act (ACA) through the regulatory process. The administration released a final rule earlier this year to expand access to association health plans (AHPs), which allow employers to form groups to purchase health coverage for their employees collectively. The administration has yet to release the third proposal expected to expand the use of health reimbursement arrangements (HRAs).
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August 7, 2018
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The Emergency Medical Treatment & Labor Act (EMTALA) requires a hospital with an emergency department (ED) to provide "an appropriate medical screening examination" when an individual comes to the ED and a request is made on behalf of the individual for examination or treatment for a medical condition.
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The Centers for Medicare & Medicaid Services (CMS) is proposing a redesign of incentives under the Merit-Based Incentive Payment System (MIPS) as part of the 2019 Updates to the Quality Payment Program (QPP). This affects Medicare eligible clinicians participating in the “Promoting Interoperability” (formerly Advancing Care Information) performance category of the MIPS.
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July 31, 2018
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A perfect storm is brewing in the area of healthcare litigation. The advent of consumer-driven healthcare is forcing providers to engage in more advertising and promotion than ever before and to explore new and more aggressive ways to reach patients. At the same time, medical malpractice caps are being enacted throughout the country limiting the damages that may be awarded for malpractice.
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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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