The Secretary of the U.S. Department of Health and Human Services announced on May 8, 2019 a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. The final rule will go into effect 60 days after it was published in the Federal Register.
Up until now, drug companies were required to disclose the major side effects a drug can have—but not the effect that buying the drug could have on your wallet. List prices matter to patients, many of whom either pay the list price or prices based on the list price. For the 47% of Americans who have high-deductible health insurance plans, the price they see in ads essentially is the price they pay, until they meet their deductible. All seniors on Medicare Part D have coinsurance for certain types of drugs, which means their out-of-pocket expenses are calculated as a share of list price. List prices are also what patients pay if a drug is not on their insurance formulary.
The 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy.
If a manufacturer simply includes price information in a direct-to-consumer advertisement as required by § 403.1202, that information in the advertisement will not require review by the FDA Office of Prescription Drug Promotion (ODPD). OPDP does not review price information in prescription drug advertisements and does not intend to do so in the future, unless the price information explicitly or implicitly incorporates safety or efficacy information about the drug, or makes express or implied claims about the safety or efficacy of the drug.
In announcing the final rule, the Secretary of HHS stated: “Requiring the inclusion of drugs’ list prices in TV ads is the single most significant step any administration has taken toward a simple commitment: American patients deserve to know the prices of the healthcare they receive. Patients who are struggling with high drug costs are in that position because of the high list prices that drug companies set. Making those prices more transparent is a significant step in President Trump’s efforts to reform our prescription drug markets and put patients in charge of their own healthcare.”
The CMS Administrator stated in reference to the final rule: “Patients have the right to know the prices of healthcare services, and CMS is serious about empowering patients with this information across-the-board. Today’s final rule is an important step toward achieving President Trump’s vision for lowering prescription drug prices by bringing much-needed pricing transparency to the convoluted market for prescription drugs. Equipped with information on prescription drug prices, patients will be better able to make informed decisions and demand value from pharmaceutical companies.”
If you or a loved one suffered injuries (or worse) as a result of a bad drug/defective drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.
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