IN THIS ISSUE

November 30, 2022


  • COVID-19 Updates
  • Upcoming Events
  • OIG Telehealth Fraud Concerns
  • Pharmacy Times: Wellness is the Future of Pharmacy But is the Profession Prepared?
  • FDA Guidance on Compounding Certain Beta-Lactam Products
  • Indiana Regulatory Update
  • Federal Regulatory Update
COVID-19 UPDATES

Top Headlines

HHS Likely to extend Public Health Emergency Through Mid-April 2023

Though a formal announcement has yet to be made, HHS will likely extend the COVID-19 Public Health Emergency through mid-April 2023. HHS had previously extended the public health emergency through January 12. While HHS previously promised to give 60 days’ notice before ending the PHE, this time frame passed on November 11. The Administration has previously extended the public health emergency in 90-day increments, indicating that the PHE will likely be extended at least until mid-April.





Upcoming Events
All times ET

Business, Healthcare, And The Economy: Outlook For 2023


December 6, 2022, 12:15 p.m.

Register



T-Cell Engagers & Emerging Targets In Prostate Cancer


December 7, 2022, 12 p.m.

Register

Save the Date!


IPA Legislative Day

Tuesday, January 24, 2023

Statehouse


Registration opening in December

Donate to the Pharmacy Education Foundation

on Amazon Smile


Do your Christmas shopping using Amazon Smile, Amazon donates to PEF at no cost to you!

OIG Telehealth Fraud Concerns

In September 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) put out a report1 on program integrity risks concerning Medicare telehealth services during the first year of the COVID-19 pandemic. The OIG states that in the first year of the pandemic, more than 28 million Medicare beneficiaries (roughly 2 in 5) used telehealth - amounting to a dramatic 88-fold increase from the previous year. Because of this, the OIG wanted to find out if providers were appropriately billing telehealth services, while looking to identify the best way to further protect the Medicare program and beneficiaries from fraud, waste, and abuse (FWA).


Read the full article here.

Pharmacy Times: Wellness is the Future of Pharmacy But is the Profession Prepared?

The topic of wellness has been exponentially growing across different industries as health care becomes more complex and expensive to navigate. The article takes a dive into how wellness may become a big part of the pharmacist profession and the numbers of wellness services pharmacists can potentially provide for their patients. Read the article here!

FDA Guidance on Compounding Certain Beta-Lactam Products

 The FDA released a final guidance document stipulating minimum steps compounders who compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

 

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

 

The final guidance states:

“FDA’s insanitary conditions guidance describes the processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products as an example of an insanitary condition the Agency has observed. However, during the time that beta-lactam antibiotic powder for oral suspension products are on the FDA shortage list … compounders under section 503A of the FD&C Act that prepare beta lactam oral antibiotic suspension products that appear on FDA’s shortage list without complete and comprehensive separation from non-beta-lactam products should take at least the following minimum steps to mitigate the potential risk of cross-contamination and reduce risk to patients.”

 

The guidance adds that the agency will “prioritize its regulatory and enforcement actions” if the nine prescribed steps “are not all followed when preparing beta-lactam oral antibiotic suspension products that appear on FDA’s shortage list.”

Indiana Regulatory Update

BT2022102 – IHCP announces pharmacy reimbursement updates for COVID-19 vaccine administration


BT2022101 – IHCP adds coverage for COVID-19 booster vaccines and administration


The Indiana Board of Pharmacy has officially amended its immunization rule to permit technicians to administer any vaccine a pharmacist can administer. The rule previously limited this authority to the COVID-19 and influenza vaccines.

Federal Regulatory Update

FDA Announces Temporary Enforcement Discretion for Clozapine REMS Requirements

FDA is temporarily exercising additional enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine recently discharged from an inpatient setting. For details, see here.


USP Publishes Final Compounding Chapters <795> and <797>

USP has published the final versions of compounding chapters <795> and <797> in the USP-NF 2023, Issue 1. For FAQs and fact sheets on the chapters, see here


Physician Fee Schedule Updates Vaccine Administration Payment for 2023

CMS issued the final physician fee schedule for CY 2023, which updates vaccine payment information. The CY 2023 payment amount for influenza, pneumococcal, and HBV vaccine administration is $31.14. This amount will be geographically adjusted based upon the fee schedule area where the preventive vaccine is administered. With regard to COVID-19 vaccine administration, for CY 2023 the payment amount is $41.52. This differential will remain in place until the end of the calendar year in which the current Emergency Use Authorization declaration for drugs and biologicals with respect to COVID-19 ends. Thereafter, the payment amount for COVID-19 vaccine administration will be adjusted to align with the payment rate for the other Medicare Part B preventive vaccines.


CMS will also continue the in-home additional payment for the administration of COVID-19 vaccines. For CY 2023 the in-home additional payment amount for COVID-19 vaccine administration described by HCPCS code M0201 is $36.85, and payment for these services will be adjusted for geographic cost differences.


For CMS’ fact sheet, click here. For CMS’ press release, click here. For the final rule, click here.

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