As surges in various respiratory illnesses – including COVID-19 – loom over holiday gatherings, the Centers for Medicare & Medicaid Services (“CMS”) held an Open Door Forum for skilled nursing facility (“SNF”) providers addressing their obligations to offer/provide COVID-19 vaccinations, vaccination education and COVID-19 treatments, and gave providers the opportunity to bring up questions about obstacles they are facing in achieving compliance with the federal requirements.

Continue Reading Long Term Care Update: As Winter Arrives, CMS Renews its Emphasis on COVID-19 Vaccinations, Bivalent Boosters and Timely Therapeutic Treatments

Overall, healthcare professionals are 10-15% more likely to develop substance abuse issues than the general population.[1] As addiction to prescription medication has reached nation-wide epidemic proportions, it has become a major driver of drug diversion. Drug diversion occurs when prescription medicines are obtained or used illegally. Healthcare practitioners and facilities are the gatekeepers tasked with safeguarding prescription controlled substances. The failure of a facility to effectively prevent drug diversion leads to substandard care, the denial of essential pain medication or therapy, risk of infection, and even death. 

Continue Reading Don’t Let Drugs Bring You Down: The Importance of an Effective Drug Diversion Program

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.[1] EMTALA, which was enacted in 1986 to address concerns about patient dumping, went unnoticed for many years, but has garnered heightened attention as a result of the COVID-19 pandemic, and more recently, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (Dobbs).[2]

Continue Reading EMTALA in the Post-Dobbs World

On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program (“340B Program”).

Continue Reading Supreme Court Saves Hospitals from $1.6B Cut to 340B Program

In its December Hospital Flash Report, Kaufman Hall identified and reviewed the continued, negative impact of COVID-19 on hospital operating margins. After a dramatic drop in hospital margins during the height of the pandemic in 2020 and early 2021, hospitals experienced a fluctuation of decreasing and increasing margins in the latter-half of the year. Overall, hospital margins remain significantly narrower than they were in 2019, before the pandemic. As a result, the industry may see an increase in hospital transactions in 2022 to offset the operational and financial hardships that continue to burden the health care system, as described in greater detail below.

Continue Reading COVID-19 Impacts and Outcomes on Hospital Margins in 2021: Increased Activity in Hospital Transactions in 2022?

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies.

Continue Reading 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation

On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed Rule”). The Proposed Rule, if enacted, would eliminate the requirement from the Hospital IPPS and LTCH Final Rule for 2021 (“IPPS Final Rule for 2021”), as discussed in our September 11, 2020 blog post, that hospitals report the median payer-specific negotiated charge with Medicare Advantage (“MA”) payers, by MS-DRG, on its Medicare cost reports for cost reporting periods ending on or after January 1, 2021. CMS estimates that this will reduce the administrative burden on hospitals by approximately 64,000 hours.
Continue Reading CMS Proposes Repeal of Certain Cost Reporting Requirements from the IPPS Final Rule for 2021

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies