Health Care Counsel Blog

In recent years, the US health care system has experienced unprecedented challenges, an increasing pace of change, and ever-growing complexity.

Following up on the recent New York State Executive Order the New York City Department of Health and Mental Hygiene issued an alert advising providers that all point-of-care COVID-19 test results must be reported electronically via the New York State Electronic Clinical Laboratory Reporting.

Headlines that Matter for Companies and Executives in Regulated Industries

The Centers for Medicare and Medicaid Services (CMS) has withdrawn its proposed Medicaid Fiscal Accountability Regulation (MFAR), according to a September 14, 2020, announcement via Twitter by Administrator Seema Verma.

Multiple members of Congress issued a letter to HHS Secretary Alex Azar on September 14, 2020, urging him to use his authority to compel pharmaceutical manufacturers to comply with the laws and regulations governing the 340B Drug Pricing Program.

The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for prescription drugs under both the Medicare Part B and Medicare Part D program

The FCC’s Connected Care Pilot Program is poised to defray eligible health care providers’ costs of providing certain telehealth services. On September 3, 2020, the FCC issued additional information and guidance for potential applicants.

Since the pandemic began, associations and their members have had to manage tighter budgets and virtual gatherings. With pandemic-related litigation already blooming, as we reported in May and August, managing liability risks is critical.

Medical providers treating patients covered by ERISA-governed health plans on an out-of-network basis can assert state-law claims to hold plans to their payment promises without running afoul of ERISA’s preemption provision (ERISA § 514(a), 29 U.S.C. § 1144(a)).

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and its related agencies must follow when issuing guidance to the public or regul

Headlines that Matter for Companies and Executives in Regulated Industries

CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.

Headlines that Matter for Companies and Executives in Regulated Industries

Due to the broader spread of COVID-19 in California, the Department of Consumer Affairs (DCA) has extended numerous professional licensing waivers to facilitate the delivery of patient care during the state of emergency.

On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Guidance Memorandum (Guidance) setting forth revised state survey agency priorities as well as providing information regarding the resumption of enforcement activities and resolution of open enforcement cases.

On August 17, 2020, CMS encouraged State Survey Agencies to resume some of their normal enforcement activities.

Headlines that Matter for Companies and Executives in Regulated Industries

After a four-month hold, CMS announced on August 6 that it would resume Medicare Fee-For Service (FFS) medical reviews.

Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods.

Headlines that Matter for Companies and Executives in Regulated Industries

On July 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced new initiatives designed to protect nursing home residents from the novel coronavirus (COVID-19).

Headlines that Matter for Companies and Executives in Regulated Industries

The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.”