On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing “high throughput technologies.” The reimbursement under Medicare Part B for these laboratory tests will be raised from about $51 per test to $100 per test. This increase will begin with tests performed on or after March 18, 2020 and end when the national emergency is over.
OCR to Waive Penalties for Community-Based COVID-19 Testing Sites
On April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to order and administer COVID-19 tests. Immediately following this guidance, on April 9, 2020, the HHS Office of Civil Rights (OCR) announced that it will exercise its enforcement discretion and will refrain from imposing penalties for violations of HIPAA for covered entities or business associates participating, in good faith, in the operation of COVID-19 Community-Based Testing Sites (CBTS) during the nationwide public health emergency. The guidance regarding pharmacists testing for COVID-19 and the notice related to the relaxation of HIPAA rules comes on the heels of pharmacies, such as CVS and Walgreens, taking on a more active and critical role in the fight against the COVID-19 pandemic.
HHS Expands COVID-19 Testing Capabilities by Allowing Pharmacists to Test
On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.” HHS noted that it recognized that most Americans are relatively close to a retail pharmacy and they interact with pharmacists more frequently than other healthcare professionals. Allowing pharmacists to administer the tests should reduce travel to testing locations – an important mitigation step. HHS Secretary Alex Azar issued the following statement:
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.
Recent Regulatory Updates Aimed at Pharmacy (and Retail) Compliance with RCRA
On September 12, 2016, the EPA issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework (Strategy Document), which addresses growing concerns about the application of federal hazardous waste regulations to pharmacies and retail operations. The Strategy Document takes into account practices common to pharmacies (e.g., reverse distribution) that present unique compliance issues
Potential Legislation Could Change the Way Compound Pharmacies Do Business
In response to the deadly incidents with a compounding pharmacy in Massachusetts that is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths, potential federal legislation has been introduced in the U.S. House of Representatives. Two bills have been introduced in the U.S. House of Representative that