Disclaimer

This Blog/Web Site ("Blog") does not provide specific legal advice. It is for educational purposes only. Use of the Blog does not create any attorney-client relationship between you and Holland & Knight LLP or the author(s) of any posts. The Blog does not constitute legal advice and is not a substitute for competent legal advice from a licensed attorney in your state. Any links from another site to the Blog are beyond the control of Holland & Knight LLP and do not convey their approval, support or any relationship to any site or organization.

Find News & Knowledge

Healthcare Law Blog Topics

Affordable Care Act    OCR

HIPAA   FDA    HHS

Compliance   Medicare

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.

Showing 1-20 of 211 results
Sort By:
 
Next
In In re: Amendments to the Florida Evidence Code, No. SC19-107 (Fla. May 23, 2019), the Florida Supreme Court used its exclusive rulemaking authority to adopt the Daubert standard governing the admission of expert testimony, replacing the outdated and more lenient Frye standard.
Read more »
Whistleblowers now have more time in which to bring their qui tam suits following the much-anticipated U.S. Supreme Court decision in Cochise Consultancy, Inc. et al. v. United States ex rel. Hunt, No. 18-315, 587 U.S. __ (May 13, 2019).
Read more »
May 14, 2019
|
The U.S. Department of Justice (DOJ) recently updated its guidance to Criminal Division prosecutors in evaluating a corporation's compliance program when making charging decisions (Guidance). Unlike previous DOJ guidance documents that were limited in scope – e.g., to Fraud Section prosecutors, corporate monitor assessments, Foreign Corrupt Practices Act (FCPA) investigations, etc. – the new Guidance provides all federal prosecutors with a sweeping mandate, regardless of the type of industry, activities or misconduct at issue, to assess and evaluate the state of a corporation's compliance program both at the time of the misconduct and at the time of the charging decision following a period of investigation and remediation.
Read more »
The U.S. Department of Justice (DOJ) released guidelines for evaluating self-disclosures and awarding cooperation credit in False Claims Act (FCA) cases. As expected, these guidelines set forth several key factors anticipated in our previous blog post, Cooperation Credit in False Claims Act Cases. The guidelines, which are codified in DOJ's Justice Manual, 4-4.11, Guidelines for Taking Disclosures, Cooperation, and Remediation into Account in False Claims Act matters (2019), provide a comprehensive list of activities and factors that may qualify for cooperation credit and identifies the types of benefits DOJ is willing to offer in exchange. In short, an entity or individual seeking to earn maximum credit should generally undertake a timely self-disclosure that includes identifying all individuals substantially involved in or responsible for the misconduct, provide full cooperation with the government's investigation and take remedial steps designed to prevent and detect similar wrongdoing in the future.
Read more »
May 9, 2019
|
As new healthcare delivery models evolve, we may see an increase in hospitals that share space with other hospitals or healthcare entities. On May 3, 2019, CMS issued draft guidance for its state survey agency directors regarding co-located hospitals.
Read more »
The Centers for Medicare & Medicaid Services (CMS) on April 23, 2019, released the Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. The proposed rule will affect discharges occurring on or after Oct. 1, 2019. It is scheduled to be published in the Federal Register on May 3, 2019. Comments on the proposed rule are due by June 24, 2019.
Read more »
May 1, 2019
|
The Centers for Medicare & Medicaid Services (CMS) announced five new, voluntary value-based payment models for primary care: Primary Care First and Direct Contracting. Applications are expected to open shortly, and both models will begin in January 2020 for five years. Both are expected to qualify as advanced alternative payment models (APMs). Included in the announcement was a request for information regarding a geographic risk model, where participants would assume financial and clinical accountability for a broader patient population.
Read more »
April 29, 2019
|
Doctors, hospitals and others in the healthcare space should take to heart the increasingly aggressive position the U.S. Department of Justice (DOJ) is taking, including through an expansive application of state bribery laws under the Travel Act, in bringing federal healthcare prosecutions.
Read more »
Companies facing liability under the False Claims Act (FCA) often desire early resolution with the Department of Justice (DOJ) through settlement. Hand in hand with the decision to settle comes the decision of whether or not to cooperate.
Read more »
April 25, 2019
|
The federal Department of Health and Human Services' Office for Civil Rights (OCR), which enforces HIPAA, maintains a website with very helpful "frequently asked questions" (FAQs) regarding the HIPAA Privacy Rule and Security Rule. On April 18, 2019, OCR published five new FAQs discussing aspects of HIPAA that are important for medical app developers.
Read more »
As we have previously written (see Holland & Knight's alerts, "Legalized Industrial Hemp Production Is Coming (But It's Not Here Yet)," March 11, 2019, and "The Road Ahead for Cannabis-Derived Goods," Jan. 28, 2019), the 2018 Farm Bill included a provision from Senate Majority Leader Mitch McConnell (R-Ky.) that was designed to legalize industrial hemp on a broad scale. Fittingly, the current status of the much-anticipated legal hemp and cannabidiol (CBD) market can be described through lyrics from the popular Grateful Dead song: Though there's more than a "Touch of Grey," there's also more than enough of an underlying regulatory framework for industry to proclaim, "We will get by."
Read more »
Legislation revising the Florida's Continuing Care Retirement Community (CCRC) statutes are now pending in final committee stops in the Florida House of Representatives and Senate. House Bill 1033 and its Senate counterpart, Senate Bill 1070, were unanimously approved in their respective committee meetings.
Read more »
April 15, 2019
|
The Centers for Medicare & Medicaid Services (CMS) announced on April 5, 2019, a new Medicare Part D demonstration to address the potential implementation of the recent proposed rule issued by the U.S. Department of Health and Human Services' Office of Inspector General (OIG) that would exclude from anti-kickback safe harbor protection pharmaceutical manufacturer rebates paid to Part D sponsors, Medicaid managed care organizations and their contracted pharmacy benefit managers (the Proposed Rule). If OIG were to finalize the rule to take effect during the 2020 plan year, CMS would then allow Part D sponsors to apply for and participate in the voluntary, two-year demonstration.
Read more »
April 9, 2019
|
On April 2, 2019, the Federal Food and Drug Administration (FDA) outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction with a public hearing notice, FDA said it is aware of both Congress and the public's interest in cannabis and cannabis-derived products, and the Agency is actively considering the proper regulatory framework for the lawful marketing of these products.
Read more »
Healthcare & Life Sciences Partner Shannon Hartsfield published an article on The Florida Bar Health Law Section Newsletter discussing how healthcare clinics and healthcare clinic establishments are two separate permits.
Read more »
The United States Supreme Court heard oral arguments in the case mentioned in our prior blog post, Cochise Consultancy v. United States, ex rel. Hunt, 887 F. 3d 1081 (11th Cir. 2018). The main question before the Supreme Court was "whether a relator in a False Claims Act (FCA) qui tam action may ultimately rely on the statute of limitations provision in 31 U.S.C. § 3731(b), when the United States has declined to intervene in the lawsuit and, if so, whether the relator constitutes an 'official of the United States' for purposes of section 3731(b)(2)."
Read more »
March 27, 2019
|
When a surveyor cites "immediate jeopardy" at a provider, supplier or laboratory's location, it can lead to serious consequences, including potential fines and termination from federal healthcare programs.
Read more »
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.
Read more »
March 13, 2019
|
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.
Read more »
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.
Read more »
March 6, 2019
|
Next