The Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2018 that updates physician fee schedule (PFS) payments for calendar year (CY) 2019 and finalizes several policies. The final rule includes amendments to the regulations promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) intended to increase the number of clinical laboratories that qualify as an “applicable laboratory” for reporting purposes; specifically (1) removal of payments received from Medicare Advantage (MA) Plans for determining ...
Clinical laboratories need to review how they compensate sales personnel following the passage of the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (Section 8122 of the SUPPORT Act) which is effective as of October 24, 2018. The SUPPORT Act is a combination of more than 70 bills aimed at fighting the opioid epidemic, with EKRA intended to address patient brokering in exchange for kickbacks of individuals with substance abuse disorders. However, as written, EKRA is far more expansive.
EKRA adds an all payor (public and private) anti-kickback rule to the health care fraud ...
The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)) (the “Ryan Haight Act” or “Act”) expanded the federal Controlled Substances Act to define appropriate internet usage in the dispensing and prescribing of schedule drugs, and in doing so effectively banned the issuance of prescriptions via telemedicine services for any controlled substances unless the ordering physician has conducted at least one in-person evaluation of the patient. The Act includes multiple exceptions that permit prescribing of controlled substances ...
The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”). The OIG concluded that although the Proposed Arrangement could potentially generate prohibited ...
The Florida State Legislature has decided to eliminate its state licensure requirement for clinical laboratories. Effective July 1, 2018, Florida’s recent legislation (SB 622) repeals the entirety of Chapter 483, Part I of the Florida statutes, and in doing so removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and therefore, in tow, eliminates section 59A-7.024(1) and as well as all other ...
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Recent Updates
- Federal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?
- HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived
- Medical Clinic’s Use of NDAs to Suppress Negative Online Reviews Violates Federal Consumer Review Fairness Act, Washington Federal Judge Finds
- Breaking Down the Legal Challenges Surrounding State Licensure Restrictions for Telehealth Providers