On June 1, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act 18-77 “An Act Limiting Auto Refills of Prescription Drugs Covered Under the Medicaid Program and Requiring the Commissioner of Social Services to Provide CHIP Data to the Health Information Technology Officer” (PA 18-77). This legislation allows the Department of Social Services (DSS) to prohibit pharmacies from automatically refilling certain prescription drugs for Medicaid beneficiaries and prohibits DSS from paying for refills of such drugs unless it receives a request for payment from the beneficiary or his or her legal representative. Continue Reading
On June 1, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-76 “An Act Concerning Audits of Medical Assistance Providers” (PA 18-76), which makes several changes to the Medicaid provider audit process conducted by or on behalf of the Connecticut Department of Social Services (DSS). PA 18-76 is effective July 1, 2018. Continue Reading
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil monetary penalties (Final Rule). Enforcement on the Final Rule is delayed to July 1, 2019. Continue Reading
The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items and services to a clinic run by a county Department of Health (County Clinic), that would facilitate telemedicine encounters (the Arrangement). Although the OIG found that the Arrangement could potentially implicate the anti-kickback statute (AKS), the OIG concluded that it would not impose administrative sanctions. Continue Reading
The Office of Medicare Hearings and Appeals (OMHA) has announced the expansion of their Settlement Conference Facilitation (SCF) program. SCF is a dispute resolution process for Medicare appeals that provides for payments as percentage of the Medicare approved amount. The percentage is negotiated during a telephone settlement conference utilizing a mediation facilitator. Utilizing dispute resolution processes such as SCF will be very important in helping to reduce a very significant backlog of Medicare appeals, which the government estimates would take OMHA at least eleven years to process. Continue Reading
On May 14, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-91 “An Act Concerning the Office of Health Strategy” (PA 18-91), a bill that operationalizes the Office of Health Strategy (OHS), a new health oversight agency in Connecticut. OHS is a division of the Department of Public Health (DPH) “for administrative purposes only” that was provisionally established by the Connecticut General Assembly within the budget implementer bill passed in a special session in late 2017 and accorded responsibility for developing and implementing a health care vision for Connecticut, among other things. PA 18-91 operationalizes OHS by assigning responsibility for administration of Connecticut’s certificate of need (CON) process to a newly created unit within OHS that succeeds the Office of Health Care Access (OHCA), as well as by clarifying and increasing OHS’s statutory health oversight duties.
PA 18-91 took effect from passage on May 14, 2018, except as noted below. Continue Reading
On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million dollars. The settlement with a Georgia hospital resolves allegations that the hospital “failed to provide effective controls and procedures to guard against theft and loss of controlled substances” that resulted in tens of thousands of 30mg oxycodone tablets being unaccounted for and believed to have been diverted for illegal uses over a four year period.
The settlement resolves an investigation commenced by the Drug Enforcement Administration (DEA) in 2017 after it received reports of diversion at the hospital. In addition to alleging that the hospital failed to meet its obligations under the Controlled Substances Act (CSA) to securely maintain its controlled substances, DEA alleged that the hospital failed to notify DEA of the suspected diversion within the requisite time period. In connection with this settlement, the hospital agreed to enter into to a performance improvement plan with DEA to improve its handling of controlled substances, which will include quarterly internal accountability audits and requirements for tracking controlled substances within the hospital.
The announcement of this settlement references the recent creation by the Attorney General of the Department of Justice Prescription Interdiction & Litigation Task Force for combatting the prescription opioid crisis. The announcement also notes that the Department of Justice will use all available remedies under the CSA against providers, pharmacies, and others that violate federal drug laws. It therefore may be the case that this settlement portends heightened federal scrutiny of providers involved in the prescribing and dispensing of opioid drugs.
The Department of Justice (DOJ), recently intervened in a civil False Claims Act (FCA) case filed against Insys Therapeutics, Inc. (Insys) in the Central District of California that alleges FCA violations arising from the payment of kickbacks in violation of the Anti-Kickback Statute (AKS) as well as other fraudulent activities. Insys is an embattled Arizona-based pharmaceutical manufacturer of a highly-addictive sublingual opioid spray known as Subsys, and is currently the subject of a number of criminal and civil suits ongoing across the country (certain of which were consolidated into this case in connection with DOJ’s intervention). Continue Reading
On May 7, 2018, the Health and Human Services Office of Inspector General (OIG) issued a favorable Advisory Opinion in which it permitted a medical device company (Requestor) to provide free sample ostomy products and conduct follow-up customer satisfaction surveys (Arrangement). Continue Reading
On April 27, 2018, the United States District Court for the District of New Jersey held that the Medical Executive Committee (“MEC”) of a hospital, which is comprised of doctors that decide who is given privileges within the hospital, can sue and be sued. Nahas v. Shore Med. Ctr., 2018 U.S. Dist. LEXIS 70785. Continue Reading