Tag: Drug & Device

Categories
Health Law Highlights

Ozempic’s Success Treating Other Ailments Is Bad News for Rivals

From Bloomberg Law, by Madison Muller:

  • Ozempic, and other GLP-1 receptor agonists, are diabetes medications that have become popular for weight loss.
  • Now, there is evidence that they have other more far-reaching benefits too:
    • They may have a protective effect on the heart, liver and kidneys.
    • They may combat substance abuse or even Alzheimer’s disease.
    • Wegovy has been shown to reduce the risk of heart attacks and strokes by 20% in overweight people with a history of heart issues.
  • As a result, these medications may disrupt many different industries.
  • For example, when the manufacturer of Ozempic announced on Oct. 10 that its effectiveness in kidney disease was so conclusive that it was stopping a trial early, it sparked a $3.6 billion selloff in shares of dialysis providers Fresenius Medical Care AG and DaVita Inc.
  • These drugs may also disrupt the health insurance market. Even if approved for new uses, these drugs are very expensivThe list price for Ozempic is about $900 a month, and for Wegovy it’s more than $1,000.
Categories
Alert

Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).

Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a medical practitioner to conduct at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. There are seven exceptions, one of which is during a public health emergency.

For the past three years, many telehealth providers have become accustomed to prescribing controlled substances following a telehealth visit, without first conducting an in-person exam.

With the PHE coming to an end in May, an in-person exam will be required. However, the Drug Enforcement Agency (DEA) has proposed rules to that will create additional flexibilities on the timing and manner for obtaining an in-person exam.

Federal Register

Categories
Highlight

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

As the title implies, this final rule clarifies and amends the discount safe harbor at 42 C.F.R. § 1001.925(h) under the federal Anti-kickback statute (AKS) such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe harbor. The rule also adds a new safe harbor for point-of-sale reductions in price that are passed on directly to a buyer (a defined term under the rule) and an additional safe harbor for “legitimate” service fees paid to PBMs by drug manufacturers.

Source: OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

Categories
Alert

Unapproved and Misbranded COVID Treatments Get FDA Attention

There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got the FDA’s attention, but rather the claims of treatment, recovery, and cure. The FDA gave the pharmacy 48 hours to correct the misleading claims.

Source: Warning Letter – Pharmacy Plus, Inc. dba Vital Care Compounder