Regulatory Developments

On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent from health care facilities to reverse distributors first be considered “disposed of,” regulated as solid waste and evaluated for hazardous classification at the health…… Continue reading this entry

President Trump just signed into law the “Special Registration for Telemedicine Act of 2018” (the Act), requiring the Drug Enforcement Administration (DEA) to activate a special registration allowing physicians and nurse practitioners to prescribe controlled substances via telemedicine without an in-person exam. The DEA has no more than one year to complete the task. Until…… Continue reading this entry

The Centers for Medicaid & Medicare Services (CMS) proposes to revise regulations issued pursuant to the Federal physician self-referrals Statute (Stark Law) to harmonize the regulations with the newly enacted Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted on February 9, 2018). Stark Law generally prohibits Medicare payment for claims resulting from physician referrals for…… Continue reading this entry

An ambitious California proposal to regulate health care rates and curb long-term health care spending was unveiled last week in Assembly Bill 3087 (Proposed Legislation).  The key concept in the Proposed Legislation is the establishment of an independent commission with the authority to set the rates paid for health care services in most commercial contexts. …… Continue reading this entry

While recent legislation impacting the Emergency Medical Services (EMS)/ambulance industry drew attention inside the industry for its reduction in Health and Human Services’ (HHS) spend on non-emergent dialysis transports and the five-year extension of the Medicare add-ons for the EMS industry, the legislation created a new forward-looking reporting obligation. Specifically, as part of the Continuing…… Continue reading this entry

The Tax Cuts and Jobs Act passed late last year and became effective as of January 1, 2018.  The Act includes a new provision that subjects certain “excess compensation” paid by exempt organizations (organizations exempt from income tax under section 501(a) of the Internal Revenue Code (the Code)) to the corporate income tax. Corporate Income…… Continue reading this entry

Congress passed a funding bill early this morning just after the February 8th deadline. The new legislation will make several changes to the Medicare program, delay cuts to disproportionate share hospitals, provide two years of funding for community health centers, and renew certain expired or expiring health care programs. The legislation increases government funding caps…… Continue reading this entry

New federal regulations published on January 3, 2018, clarify when lawful holders of substance-use disorder records may use and disclose patient identifying information for payment, health care operations, and audits and evaluations. The 2018 regulations address issues that were discussed, but not resolved, in last year’s final rule published on January 18, 2017. The 2017…… Continue reading this entry

New Jersey has a new telemedicine law, recently signed by Governor Chris Christie. The law cements the validity of telehealth services in the Garden State, establishes telemedicine practice standards, and imposes telehealth coverage requirements for New Jersey Medicaid, Medicaid managed care, commercial health plans, and other State-funded health insurance. After a year of debate in…… Continue reading this entry