Please join Husch Blackwell as we go virtual with our Health Law Conference. The series will include a range of important topics relevant to the healthcare industry. The webinar programs will be offered every Thursday from October 1 through November 19.

Our first session will include a panel discussion on a potential COVID-19 vaccine. The

Many colleges and universities offer on-campus healthcare clinic services to their students. These student health clinics are typically staffed by a physician or advanced practice provider such as a nurse practitioner. In addition to providing professional services, these providers may on occasion prescribe medications to students. Some of our clients have asked whether it is also permissible for the providers to actually dispense these medications on-site, even though the clinic is not licensed as a pharmacy.
Continue Reading Dispensing Medications at Student Health Clinics

After the U.S. Department of Health and Human Services (“HHS”) automatically distributed $30 billion to providers as Tranche #1 Relief Fund payments based on 2019 Medicare fee-for-service payment data, HHS subsequently released a new formula that was based on 2018 “program service revenue” and intended to calculate providers’ payments under Relief Fund Tranches #1 and #2 cumulatively.  For providers whose Tranche #1 payments alone exceeded their expected payment under the new “program service revenue” formula, there have been ongoing questions about whether such providers were “overpaid” and needed to reject and return their Tranche #1 payments.
Continue Reading CARES Act Provider Relief Fund: Connecting HHS’s Dots on Whether Your Tranche #1 Payment Is An Overpayment

Background

 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.”  In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and  Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.
Continue Reading HHS Clarification on PREP Act Impact on State Licensing Laws: What it Means for Pharmacists’ COVID-19 Testing Capabilities

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.
Continue Reading CMS Doubles Payment for Diagnostic Lab COVID-19 Testing

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.
Continue Reading OCR to Waive Penalties for Community-Based COVID-19 Testing Sites

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:
Continue Reading HHS Expands COVID-19 Testing Capabilities by Allowing Pharmacists to Test