U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar by finalizing a rule that will compel pharmaceutical manufacturers to disclose the list prices of their products in television advertisements. The rule is not without controversy, and finalization of the rule likely sets up a conflict with manufacturers that see the move as overstepping the authority of the Centers for Medicare & Medicaid Services (CMS) and infringing on First Amendment rights to free speech.
On May 8, HHS Secretary Azar announced finalization of a rule requiring direct-to-consumer (DTC) television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price — the Wholesale Acquisition Cost (WAC) — if the price is equal to or greater than $35 for a month’s supply or the usual course of therapy. The rule will go into effect on July 9, 2019, which is 60 days from its planned publication in the Federal Register on May 10, 2019.
This is the first major step in furtherance of the “American Patients First” blueprint, which, among other goals, aims to increase patient transparency and bring down prescription drug costs. The blueprint laid out four strategies to achieve its goals: (1) increasing competition, (2) enhancing negotiation, (3) creating incentives for lower list prices, and (4) bringing down out-of-pocket costs. The inclusion of list prices in DTC television advertising is one effort to incentivize manufacturers to lower list prices according to HHS Secretary Azar. Azar said, “If we want to have a real market for drugs, why not have [companies] disclose their prices in the ads, too? Consumers would have much more balanced information, and companies would have a very different set of incentives for setting their prices.”1
According to HHS, the rule highlights the importance of patients’ understanding of drug prices, as many patients either pay the list price or pay a discounted price that is based on the list price. For example, list prices are what patients pay if a drug is not on their insurance formulary, and many Americans with high-deductible health insurance plans (including some Medicare Part D plans) will pay the price they will see in television ads until they meet their deductible. Secretary Azar believes that, “Putting prices in TV ads may be the most significant single step any administration has ever taken toward this very clear commitment: Patients have a right to know the price of the healthcare they receive, before they receive it.”2
This rule is not without controversy. Multiple manufacturers have objected to the rule, raising the following issues and concerns:
Notably, PhRMA has previously announced enhancements to its voluntary DTC principles, which were expanded in October 2018 to recommend that “All DTC television advertising that identifies a medicine by name should include direction as to where patients can find information about the cost of the medicine, such as a company-developed website, including the list price and average, estimated, or typical patient out-of-pocket costs, or other context about the potential cost of the medicine.”10
Following publication of these voluntary principles, many pharmaceutical manufacturers began including links in their TV advertisements directing consumers to detailed pricing information. Recently, at least one large drug manufacturer announced an effort to build on the support for the PhRMA-revised advertising principles to include list prices and potential out-of-pocket costs in its DTC TV advertisements.
It will be interesting to see whether other drug manufacturers choose to publicize their list prices and comply with the rule or decide to challenge the constitutionality and enforcement of the rule.
1 CMS Drug Pricing Transparency Fact Sheet (May 8, 2019), https://www.hhs.gov/about/news/2019/05/08/cms-drug-pricing-transparency-fact-sheet.html.
2 Remarks on Requiring List Prices in Drug Ads, HHS Secretary Alex M. Azar (May 8, 2019), https://www.hhs.gov/about/leadership/secretary/speeches/2019-speeches/remarks-on-requiring-list-prices-in-drug-ads.html.
3 SSA §§ 1102(a) (authorizes the Secretary of HHS to issue regulations that are “not inconsistent with this Act” that are “necessary to the efficient administration of the functions with which [the Secretary] is charged under this Act” ); 1871(a) (authorizes the Secretary of HHS to “prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title”).
4 83 Fed. Reg. 52789, 52791 (Oct. 18, 2018).
5 See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984); Colo. River Indian Tribes v. Nat’l Indian Gaming Comm’n, 466 F.3d 134 (D.C. Cir. 2006) (striking down regulations promulgated by the National Indian Gaming Commission as exceeding the authority delegated by Congress under the Indian Gaming Regulatory Act).
6 To support their position, the manufacturers rely on the recent Supreme Court decision in National Institute of Family & Life Advocates v. Becerra, 138 S. Ct. 2361 (2018), as well as Sorrell v. IMS Health Inc., 546 U.S. 552 (2011) and Riley v. Nat’l Fed’n of the Blind of N. Carolina, Inc., 487 U.S. 781 (1988), which outline the circumstances under which the heightened scrutiny test will be applied.
7 CMS relies on Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985), which sets forth the parameters for First Amendment review of required disclosures in the context of commercial speech.
8 42 CFR 403 [CMS-4187-F] (Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency).
9 42 CFR 403 [CMS-4187-F] (Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency).
10 PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines (Revised Oct. 2018).
Hyung Steele is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Suzanne Forbis Mack and Scott Robinson are associates in the Health Sciences Department.
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.