Included in this newsletter
- Centers for Medicare & Medicaid Services (CMS) Changes COVID-19 Requirements for Healthcare Employees
- DMEPOS Competitive Bidding Program: Temporary Gap Period
- House Committee Hearing Held Regarding Pharmacy Benefit Managers (PBM)
- FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
- Cybersecurity Attack Against Amazon-Owned Online Pharmacy Pillpack Exposed User Health Data
- Enforcement
- Updated and New Forms
- Updated and New Policies & Procedures
Centers for Medicare & Medicaid Services (CMS) Changes COVID-19 Requirements for Healthcare Employees
CMS has removed the mandatory requirements for COVID-19 vaccination for all healthcare workers. CMS maintains their position that COVID-19 vaccines are safe and encourages healthcare workers to maintain their COVID-19 vaccinations.
Federal Register, June 5, 2023 Click Here
DMEPOS Competitive Bidding Program: Temporary Gap Period
Starting January 1, 2024, there will be a temporary gap period for the DMEPOS Competitive Bidding Program (CBP). CMS will start bidding for the next round of the DMEPOS CBP after they:
- Complete the formal public notice and comment rulemaking process
- Implement necessary DMEPOS CBP changes to:
- Establish sustainable prices
- Save money for Medicare patients and taxpayers
- Help limit fraud, waste, and abuse in the Medicare Program
- Ensure patient access to quality items and services
During the temporary gap period, Medicare-enrolled DMEPOS suppliers may furnish DMEPOS items and services to patients. Review Details…
House Committee Hearing Held Regarding Pharmacy Benefit Managers (PBM)
The U.S. House Committee on Oversight and Accountability Chairman James Comer (R-KY) held a hearing titled, “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part I: Self-Interest or Health Care?” on May 23, 2023. View it here.
Two of the panelists were pharmacists who provided real world examples of how PBMs impact their pharmacy and patients.
There was bi-partisan agreement that Congress needs legislation to address PBMs aka "Pharmacy Benefit Mis-managers" or "Pretty Big Markup" as they were referred to by lawmakers. Rep. Katie Porter's questioning of the independent pharmacist made news, watch clip.
FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
The U.S. Food and Drug Administration (FDA) has approved the oral antiviral nirmatrelvir/ritonavir (Paxlovid—Pfizer) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. The drug is the fourth approved by FDA to treat COVID-19 in adults and it is the first approved oral antiviral. The drug's efficacy was mainly supported by the final results of the EPIC-HR clinical trial, a randomized, double-blind, placebo-controlled clinical study intended to evaluate the antiviral for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. See more…
Cybersecurity Attack Against Amazon-Owned Online Pharmacy Pillpack Exposed User Health Data
Amazon-owned PillPack reported a cybersecurity attack affecting the accounts of nearly 20,000 customers.
An unauthorized person used customer emails and passwords to log into PillPack customer accounts, over 3,000 of which contained prescription information. Social Security numbers and payment information were not involved in the attack, according to the online pharmacy.
PillPack’s internal investigation confirmed that the emails and passwords in question were not taken from its website. While PillPack is a subsidiary of Amazon, the company stated that only PillPack’s website was impacted. Read more…
Enforcement
- Owner of Northeast Philadelphia Pharmacy Charged with Conspiracy to Distribute Oxycodone and Fraud
- Pharmacy Owners Charged with $26 Million Health Care Fraud Scheme
- Justice Department Announces Nationwide Coordinated Law Enforcement Action to Combat COVID-19 Health Care Fraud
- Podiatrist and patient recruiter convicted for $8.5M compounding fraud scheme
- Pharmacist Sentenced for $1M Prescription Drug Fraud Scheme
New and Updated Forms
- Pharmacy
- Quality Assurance Officer Designation
- Compounding
- Compounder Designation
- DEA
- Power of Attorney for DEA Forms 222 and Electronic Orders
- Amphetamine Treatment Plan Request Form
New and Updated Policies and Procedures
- DEA
- Counterfeit Suspect or Illegitimate Drugs
- Securing and Handling of Controlled Substances
