The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have important real-world effects and encourage efforts on the federal stage. Over the past twelve months a number of regulatory trends have played out that define the current operating environment for pharmacies, many of which are anticipated to continue in 2019.
Continue Reading Recent Developments in State Pharmacy Law & Regulation: Looking Back at 2018 and What to Expect in 2019
HHS proposes moving up the enforcement of 340B penalties to January 1, 2019
On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed.
Continue Reading HHS proposes moving up the enforcement of 340B penalties to January 1, 2019
FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies
On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products. See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states.
Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies
Need a Lift? Uber Enters the Healthcare Arena
Earlier this month, Uber released its new program, Uber Health. In a nutshell, Uber Health is a program that facilitates patient transportation to and from appointments with healthcare providers. This post expands on a previous post regarding patient ridesharing programs.
Continue Reading Need a Lift? Uber Enters the Healthcare Arena
Value-based payments are heading for physicians
In a 92-8 vote on April 14, 2015, the Senate passed a bipartisan measure to repeal the Medicare payment formula known as the Sustainable Growth Rate (“SGR”). The legislation also included a new payment system that rewards providers for the quality and efficiency of care they provide.
Continue Reading Value-based payments are heading for physicians
Healthcare providers should consider effects of loss of tax-exempt status
The LA Times reported on March 18, 2015, that one of California’s biggest health insurers, Blue Shield of California, had lost its tax-exempt status. The report came after California’s Franchise Tax Board quietly revoked Blue Shield’s state tax-exempt status back in August 2014. One of the biggest reasons for doing so was because of Blue Shield’s huge financial reserves.
Continue Reading Healthcare providers should consider effects of loss of tax-exempt status
Don’t let research on ‘little’ subjects get you in big trouble
Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.
Continue Reading Don’t let research on ‘little’ subjects get you in big trouble
UPDATE: FTC victory creates challenge for physician acquisitions
The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which the Federal Trade Commission (“FTC”) litigated through trial a challenge to a physician acquisition.
Continue Reading UPDATE: FTC victory creates challenge for physician acquisitions
HHS makes moves toward value-based payments
On Jan. 26, 2015, Secretary Sylvia M. Burwell announced the goals and a timeline of the U. S. Department of Health & Human Services (“HHS”) to move the Medicare program, and the healthcare system at large, toward paying providers based on quality, rather than quantity, of care they give to patients.
Continue Reading HHS makes moves toward value-based payments
New White Paper On Avoiding Liability with EHR Systems Now Available
In the Electronic Health Records (EHR) space, unconnected and competing systems carry the potential for organizational train wrecks.
Until robust, efficient, and mandatory interoperability standards emerge, providers should consider linking systems through other means, as failure to do so may lead to malpractice and regulatory compliance issues.