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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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President Trump’s budget was released yesterday as the fiscal year (FY) 2020 appropriations process ramps up. The FY 2020 budget requests $87.1 billion in discretionary funding for the Health and Human Services (HHS) Department, down 11.9 percent from fiscal year (FY) 2019.
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March 13, 2019
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When the 2018 Farm Bill was signed into law last December, there was a good deal of excitement about the legalization of industrial hemp production. However, as we have noted before (see Holland & Knight's alert, "The Road Ahead for Cannabis-Derived Goods," Jan. 28, 2019), a number of open questions would need to be resolved before growers could begin cultivating hemp, and the timeline was uncertain at best.
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With the start of the 2019 Florida Legislative Session, several proposed bills could have significant impact on the healthcare landscape in the state. The following are brief highlights of some of the bills that have been introduced and under consideration for the 2019 Session.
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March 6, 2019
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FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products.
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The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), on Feb. 11, 2019, released separate but related rules addressing interoperability, information blocking, patient access to data and electronic health record (EHR) certification criteria.
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The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. See 40 C.F.R. Part 266, Subpart P. The rule, published on Feb. 22, 2019, is the result of policy discussions between EPA and the pharmaceutical industry that date back to 1981.
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Senate Finance Committee Chairman Charles Grassley (R-Iowa) has launched a new review of nonprofit hospitals, continuing a longstanding oversight in the sector.
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On Jan. 31, 2019, the U.S. Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects rebates currently negotiated between pharmaceutical manufacturers and Medicare Part D prescription drug plans and Medicaid plans. In its place, the agency would create two new "safe harbor" exemptions.
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February 5, 2019
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On Jan. 29, 2019, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and its first guidance on Digital Medicine (DM) technology as part of a patient assistance program. This favorable opinion demonstrates that, with proper safeguards in place, the OIG shows its willingness to support low-income patients with technologies that can enhance patient care.
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February 1, 2019
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The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back to work and will receive back pay.
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On Jan. 15, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene therapy product development. According to Gottlieb and Marks, FDA is seeing a surge of cell and gene therapy products enter early stages of development, and the agency expects a jump in product approvals in the near future.
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January 28, 2019
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As the federal government shutdown enters its fifth week, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb released new estimates on Jan. 18 suggesting that 31 percent of the FDA's total staff is in furlough status. Gottlieb also said an additional 32 percent of the staff is in some form of alternate pay status, such as partially paid and excepted (non-paid but working) status.
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In December 2018, the U.S. Department of Justice (DOJ) statistics for its civil False Claims Act (FCA) and fraud cases from the fiscal year ending Sept. 30, 2018 (Fiscal Year 2018). The DOJ reports it recovered $2.8 billion in settlements and judgments for Fiscal Year 2018.
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Cybersecurity risks to the healthcare sector have been growing exponentially in the last five years and, over time, have come to include not only data security and privacy risks but also operational and systemic risks that could affect the health and safety of patients.
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With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC) – less than 0.3 percent on a dry weight basis – are no longer illegal substances under the Controlled Substances Act. While this means that these products can be legally produced and marketed in the United States, it does not mean that marijuana is legal or that the U.S. Food and Drug Administration (FDA) no longer has regulatory authority over hemp and other cannabis-derived products
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January 4, 2019
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On Dec. 28, 2018, the U.S. Department of Health and Human Services (HHS) announced the release of voluntary cybersecurity practices and tools for the healthcare industry. The documents were the result of Section 405(d) of the Cybersecurity Act of 2015, and developed by a task group of 103 members and tested by more than 120 stakeholders, including clinicians and IT professionals.
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The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and reminding manufacturers about the parameters of its current compliance and enforcement policy for certain human cell, tissue, or cellular or tissue based products (HCT/Ps).
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The HHS Office of Inspector General issued OIG Advisory Opinion No. 18-11, addressing the breadth of the Eligible Managed Care Organization (EMCO) safe harbor.
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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and others. He made these remarks at the Food and Drug Law Institute's Enforcement, Litigation and Compliance Conference.
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December 14, 2018
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The Department of Health and Human Services' Office for Civil Rights (OCR) has issued a Request for Information, which is scheduled for publication in the Federal Register on Dec. 14, 2018. OCR is asking the public to provide input on ways that the HIPAA privacy and security rules could be modified to improve coordinated care.
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December 12, 2018
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