Recent Joint Commission Guidance Recommends Steps for Health Care Organizations to Reduce Workplace Violence

Workplace violence is a risk at any health care workplace. Whether from patients, residents, clients, or employees. The Occupational Safety and Health Administration (“OSHA”) estimates that three quarters of all workplace assaults reported annually – approximately 19,000 – occurred in health care and social service settings.

While OSHA does not have any specific regulations addressing violence in the workplace, OSHA’s General Duty Clause applies to covered employers and requires they provide their employees with a place of employment that is “free from recognized hazards that are causing or are likely to cause death or serious harm.” It is OSHA’s position that the General Duty Clause imposes a legal obligation upon an employer to provide a workplace free of conditions or activities “that either the employer or industry recognizes as hazardous and that cause, or are likely to cause, death or serious physical harm to employees when there is a feasible method to abate the hazard.”

In recent years, OSHA has published guidelines to the health care community – Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers – with specific recommendations to prevent violence in health care workplaces. OSHA also has a webpage dedicated to workplace violence, which provides helpful guidance and training materials.

In an effort to further assist health care organizations better prevent and address violence in their workplaces, in April the Joint Commission released a Sentinel Event Alert addressing physical and verbal violence against health care workers. The Joint Commission accredits and certifies health care organizations and programs in the United States.

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Massachusetts Files Suit Against Connecticut-Based Purdue Pharma for Opioid Related Harms

On June 13, 2018, Attorney General Maura Healey filed a complaint in Massachusetts Superior Court on behalf of the Commonwealth against Purdue Pharma Inc. and Purdue Pharma L.P., Connecticut-based drug companies that manufacture and market OxyContin.  The lawsuit also names sixteen individual defendants, including current and former CEOs and certain members of the board of Purdue Pharma Inc. This is not the first time a Purdue Pharma company has been accused of wrongdoing with respect to the marketing of opioids. In 2007, Purdue Frederick Company (an affiliate of Purdue Pharma L.P.) paid nearly $700 million dollars in fines and plead guilty to criminal charges, admitting that, with the intent to defraud or mislead, it marketed and promoted  its drugs as less addictive and less subject to abuse. Continue Reading

Connecticut Enacts Legislation to Address Hospital-Insurer Network Conflicts

On June 6, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-115 “An Act Concerning Disputes Between Health Carriers and Participating Providers That Are Hospitals” (PA 18-115). This legislation updates state laws concerning the departure or removal of a hospital from an insurance carrier’s provider network. PA 18-115 takes effect July 1, 2018. Continue Reading

Connecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

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

Connecticut Legislature Revises DSS Provider Audit Processes

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

HHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)

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

OIG Posts Telemedicine Advisory Opinion

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

Medicare Appeals Settlement Program Expanded

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

Connecticut Legislature Operationalizes New Health Oversight Agency: The Office of Health Strategy

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

DOJ Enters Into Largest-Ever Civil Settlement with Hospital for Drug Diversion

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.

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