We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. Client Alert

Impacted industries must immediately comply with the nationwide ban on the sewering of hazardous waste pharmaceuticals as of the August 21st effective date. 

The Centers for Medicare and Medicaid Services (“CMS”) issued on April 2, 2018, an advanced copy of the final rule title “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” (“Final Rule”). This Final Rule will

On November 1, 2017, the Centers for Medicare & Medicaid Service (“CMS”) released the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) final rule (“Final Rule”), finalizing a Medicare payment reduction from Average Sales Price (“ASP”) + 6% to ASP – 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the

On May 19th, the FDA again postponed publication of the Final Rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” to April 2017 (the “Final Rule”).  On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes

CMS announced on February 13  (and to be published in a Federal Register notice this week) that despite the general guideline that final rules be issued within 3 years of a proposed or interim final rule, CMS will be taking an additional year to finalize the “Medicare Program; Reporting and Returning of Overpayments” final rule.   

Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

  • President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 (“the IMPACT Act”) into law;
  • The Centers

On March 9, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule that modifies several of the durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) supplier standards. Most notably, the final rule modifies restrictions on the “direct solicitation” of Medicare beneficiaries by DMEPOS suppliers. CMS stated in the final rule that

by Shawn M. Gilman and Julia E. Loyd

On February 14, 2012, a final rule implementing Section 2715 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, regarding the requirements for group health plans and health insurance issuers to provide a summary of benefits and coverage (“SBC”) to