The United States District Court for the District of Arizona ruled that a court, not an arbitrator, should decide whether a plaintiff’s claims against a company must be sent to arbitration, including pharmacy disputes with a PBM. PBM arbitration is costly for pharmacies and takes away legal protections for pharmacies if they could have gone through the court system. The other aspect of this case, whether PBM penalties for Medicare Part D prescriptions on pharmacies, known as direct and indirect remuneration fees, are legal, has yet to be settled.
The American Diabetes Association (ADA) has issued a statement reflecting the organization's standpoint on the use of compounded glucagon-like peptide 1 receptor agonists (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA therapies. Demand for compounded versions of the drugs, which treat type 2 diabetes and obesity, has thrived due to a shortage of the approved formulations. The supply crunch is easing, but ADA warns that safety, efficacy, and quality concerns associated with compounded GLP 1 and GIP/GLP 1 RAs remain. The statement notes that widespread marketing and use of non-FDA-cleared incretin-based products are particularly alarming. Importantly, these are not identical to the approved counterparts; compounded versions have been linked to clinically relevant dosing errors and adverse events. There is also a risk of receiving counterfeit products. If an approved incretin medication is in tight supply, the association recommends temporarily switching to another sanctioned drug rather than using an unregulated and potentially unsafe compounded product. If the decision is made to use a non-FDA-approved compounded drug anyway, the ADA urges patients to have a discussion with their healthcare provider first. They also should confirm that the compounding pharmacy is registered with the FDA or licensed with a state board of pharmacy, avoid online sources not registered with the agency, receive instruction on appropriate dosing and administration, report adverse events, and notify their providers when they start or stop using a compounded product, as the change will affect overall diabetes management. See more...
Compounders have been permitted to compound GLP-1 diabetic/weight loss medication because of manufacturer shortages.
On December 18th, the FDA announced the manufacturers who have patents for these drugs have changed their drug availability to "Available". This automatically stopped the emergence authorization for sterile and non-sterile compounding GLP-1 compounds. Non-sterile compounders must cease dispensing by 18 Feb. Sterile compounders must stop by March 19th.
What solutions do you have for patients to select the best overall Part C/Part D Plan? Pharmacies are generally at the mercy of Medicare.gov, Amplicare, or Prescribe Wellness to guide their patients to the best plan. You may be able to help your patients and have an additional revenue stream by becoming an ACA Marketplace Insurance Broker. The process can take four to six months, so now would be the time to think about it.
First, the ACA Marketplace insurance broker must be in a separate corporation from the pharmacy. Second, HHS has a Quick-start guide: 5 steps to start selling Marketplace health and dental plans. Brokers make at least $250.00 per patient who signs up for any marketplace plan. Pharmacy technicians are perfect for training and performing these tasks but must be paid through a non-pharmacy company.
We continue to consider the input received carefully and are working to promulgate a final set of telemedicine regulations. However, with the end of 2024 quickly approaching, DEA, jointly with HHS, has extended current telemedicine flexibilities through December 31, 2025. The full text of the extension, entitled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”, was submitted to the Federal Register jointly with HHS on November 15, 2024. View Federal Register
Effective January 1, 2025, the annual deductible for all Medicare Part B beneficiaries is $257.00, an increase of $17 from the annual deductible of $240 in 2024. Please remember to collect the reimbursable fee when you dispense Medicare Part B DMEPOS products and pharmaceuticals. 2025 Medicare Parts A & B Premiums and Deductibles | CMS
Regardless of whether you are billing through your computer system or submitting a claim manually, we strongly recommend that you collect this deductible within the month of January. It does not matter whom the patient sees, the patient must pay the deductible. If you collect over the patient’s deductible, you simply refund the patient’s over-payment. Dual-eligible patients fall under the individual state Medicaid requirements, which vary from state to state.
Representatives from four health systems in Rochester, NY, work together to prevent pharmacy deserts in their region. This is a good read for thinking outside the box. Read more…
The Corporate Transparency Act went into effect with little information. You are exempt from this new law if you have 21 or more full-time employees. However, if you have 20 or fewer employees, then annual reporting is required. All companies formed before January 1, 2024, have one year to report. Part II, Company Applicants, only applies if the company is registered as a sole proprietor. This is NOT an easy online application to complete. https://www.fincen.gov/boi
*Revision* Alert: Impact of Ongoing Litigation – Deadline Stay – Voluntary Submission OnlyWe continue to field calls from our clients about Opioid Treatment plans where the physician refuses to complete the specific form sent by the pharmacy. We recommend that you provide the following support information to the physician when this occurs, starting with the podcast.
References with the Compliance Portal®:
If you have a change in ownership due to a sale or an owner passing away; please be sure to notify your Project Manager. Most states require notification within 30 days to amend licensure, Additionally, DEA, Medicare, Medicaid and NCPDP have timeframes in which they need to be notified depending how the change of ownership has occurred.
In the even your facility receives a Corrective Action or Medicare Request please inform your Project Manager immediately. We will do our best to assist but can not guarantee completion of work when not given adequate time or when not given the correct or necessary documents. We reserve the right to apply additional charges for work requested outside of the scope of agreements or for expedited involvement.
R.J. Hedges & Associates is having a Moving Sale for our Hazardous Drug Spill Kits. These kits can be used for Hazardous Drugs, Hazardous Chemicals, and Bio-Hazards containment and cleanup. Get yours while they last for $65.00 + shipping. Email sales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies.
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