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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 Nov. 2, 2018, issued the Calendar Year (CY) 2019 Final Rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System. It is scheduled to be published in the Nov. 21, 2018, issue of the Federal Register and will become effective on Jan. 1, 2019.
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November 13, 2018
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Healthcare was a top voter priority in the 2018 midterm elections, with 41 percent of national voters stating that healthcare was their "most important" issue. Accordingly, the Democratic strategy to focus on healthcare opened opportunities in states the party likely wouldn't have dreamed of winning two years ago when the future of the Affordable Care Act (ACA) was in serious doubt. Ultimately, healthcare helped Democrats win control of the House, adding a nurse, dermatologist and a former U.S. Department of Health and Human Services (HHS) secretary as freshman representatives.
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November 12, 2018
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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2018, published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS). Although in previous years regulations for the Quality Payment Program (QPP) were released independently, the 2019 Medicare PFS Final Rule includes provisions related to Medicare physician payments as well as the QPP.
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November 7, 2018
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It has been almost impossible to exist in Washington, D.C., during the past several months without encountering the drug pricing debate. From fiery tweets to Rose Garden announcements and speeches, President Donald Trump, along with Secretary of Health and Human Services (HHS) Alex Azar and other Trump Administration officials, have adopted the issue of reduced drug prices as a major domestic policy priority. Masked by this and other discussions about drug development and marketing, however, has been the discussion about the development, approval and reimbursement of medical devices.
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October 29, 2018
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The Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Treasury released guidance relaxing a range of requirements for state waivers submitted under Section 1332 of the Affordable Care Act (ACA). Comments are due Dec. 23, 2018.
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October 23, 2018
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The U.S. Food and Drug Administration (FDA) is moving aggressively in October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft guidance on these risks, indicating that it will eventually supersede the cybersecurity guidance issued in 2014.
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October 18, 2018
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A recent dismissal of a qui tam action demonstrates there exists an affirmative approach for disposing of wasteful and meritless nonintervened qui tam claims without the time and expense of protracted litigation with relators.
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October 16, 2018
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Centers for Medicare & Medicaid Services (CMS) has published the list of 832 Acute Care Hospitals and 715 Physician Group Practices that will be participating in the Bundled Payments for Care Improvement – Advanced (BPCI Advanced) Model, which will run from Oct. 1, 2018, through Dec. 31, 2023, as well as the list of convener participants. Convener participants bring together multiple downstream entities, and bear and apportion financial risk under the model. This voluntary advanced payment model provides a single retrospective bundled payment as to of 32 bundled clinical episodes (29 inpatient/3 outpatient) with payment tied to performance on quality measures. Participants selected to participate in BPCI Advanced beginning on Oct. 1, 2018, must commit to be held accountable for one or more Clinical Episodes and may not add or drop such Clinical Episodes until Jan. 1, 2020.
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October 11, 2018
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The U.S. Department of Health and Human Services' Office of the Inspector General (HHS OIG) announced a new cybersecurity website on Oct. 9, 2018. The OIG stated that it has formed a Cybersecurity Team made up of "auditors, evaluators, investigators and attorneys focused on combatting cybersecurity threats within HHS and the healthcare industry."
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October 10, 2018
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Currently, U.S. Citizenship and Immigration Services (USCIS) defines a "public charge" as someone who is or is likely to become "primarily dependent on the government for subsistence, as demonstrated by either the receipt of public cash assistance for income maintenance, or institutionalization for long-term care at government expense." Existing federal policy dictates that a public charge may be denied permanent resident (green card) status or lawful entry into the United States.
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October 9, 2018
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Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security Act, passed in 2013, includes the Compounding Quality Act (Title I), and the Drug Supply Chain Security Act, or DSCSA (Title II). Manufacturers, wholesalers and dispensers must comply with a number of DSCSA deadlines.
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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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