Price Transparency
Hospital Price Transparency Rule Finalized; Health Plan Transparency Rule Proposed
The Centers for Medicare and Medicaid Services (CMS) has issued a final rule to require every hospital licensed in the United State to make public a robust set of standard charges for every item or service that the hospital bills. In addition, CMS and other agencies have issued a proposed rule to require group health plans and health insurance issuers to: (1) disclose in-network negotiated rates and out-of-network allowed amounts for every health care item or service; and (2) offer a real-time tool to provide a plan enrollee with an estimate of cost-sharing and out-of-pocket expenses associated with plan covered items and services. The hospital price disclosure rule is effective January 1, 2021. Hospitals and hospital trade associations have stated that they will bring a legal challenge against the final rule as exceeding CMS’ legal authority. The rule will require every licensed hospital to provide two separate sets of standard charge lists: (1) a list of standard charges for at least 300 “shoppable” hospitals services that a consumer can schedule in advance; and (2) a comprehensive list of standard charges for all items and services for which the hospital establishes a charge. Both lists must be updated at least annually and placed on a publicly-accessible website. Only hospitals are regulated under the final rule; ambulatory surgery centers or other clinics or facilities that may provide items and services that are also performed in hospitals are not required to report pricing. For the comprehensive charge list the hospital must report seven data elements for each item or service: (1) description; (2) code used to bill the item or service; (3) hospital’s gross charge; (4) negotiated rate with every third party payer (linked by name to the third party payer and plan); (5) highest charge the hospital has negotiated with any third party payer; (6) lowest charge the hospital has negotiated with any third party payer; and (7) charge applicable to an individual who pays cash. The “shoppable” charge list must include similar data elements, with the addition of the hospital location(s) at which the “shoppable” service is provided. The resulting report will be an exceedingly dense data set of hundreds of thousands of line items for a typical hospital. The biggest change the final rule would effect is that payment rates that a hospital negotiates with third party payers would no longer be confidential or proprietary, and would in fact be public information under the final rule. CMS made clear that a hospital must report data on all items or services the hospital provides and charges, including the professional services of its employed physicians or other clinicians. This appears to apply only to the hospital itself (presumably identified by NPIs associated with the hospital) and not to separate corporate entities, formed for the purpose of operating physician group, that do not operate the hospital but may be owned by the same entity (or corporate affiliate) that operates the hospital. The health plan proposed rule would require every group health plan or health insurance issuers to make available on a website a negotiated rate file that lists: (1) the name and Employer Identification Number (EIN) or Health Insurance Oversight System (HIOS) identifier for each plan option or coverage offered; (2) codes and plan language description for each item or service; and (3) negotiated rate for each item or service furnished by every in-network provider (linked by National Provider Identifier (NPI) to each in-network provider) along with the last date of contract term for that rate. A separate file that lists out-of-network allowed amounts for each items or service furnished by out-of-network providers must also be posted. These lists must be updated monthly under the proposed rule. In addition, health plans must offer a tool to allow plan enrollees to obtain real-time information about cost-sharing information with regard to specific items or services. Unless halted by courts, hospitals will need to begin the considerable work of compiling and formatting the data files required under the final rule. And, although it is unclear how the hospital pricing data will be analyzed and used (and by whom), hospitals should analyze their own pricing data and begin anticipating and preparing for the questions and critiques that will arise.
November 20, 2019
by Ross C. D'Emanuele
Price Transparency
CMS Proposed Rule to Require Drug Pricing Transparency
On October 18, 2018, the Centers for Medicare and Medicaid Services (“CMS”) proposed a new rule (“Proposal”) that would require direct-to-consumer (“DTC”) television advertisements of prescription drugs paid for by Medicare or Medicaid to include the drug’s wholesale acquisition cost (“List Price”). The Proposal comes as part of the current administration’s promise and attempt to both lower the cost and increase the transparency of prescription drug prices. As the Proposal notes, prescription drug prices have seen a dramatic increase over the past decade due to factors such as lack of competition and lack of relevant product information. The Proposal aims to address these factors in an attempt to improve the efficient administration of the Medicare and Medicaid programs and lower the cost of prescription drugs. Prescription drug prices are variable and largely unknown to everyday consumers. Typically, a consumer knows the price of a product before making an informed decision on purchasing that product. That is not the case with prescription drugs where the consumer often makes purchase decisions without knowing much, if any, information about the drug’s price. By mandating the inclusion of a prescription drug’s List Price, CMS hopes to make prescription drug prices more transparent in a fashion similar to the “sticker” price on a new car. The List Price is the price set by drug manufacturers. It can play a major role in price negotiations between payors (e.g., an employer providing a prescription drug benefit plan to its employees or the government providing Medicare and Medicaid coverage), pharmacy benefit managers, and manufacturers. These negotiations impact a benefit plan’s cost sharing and the ultimate drug price paid by the consumer. The price paid by the consumer for prescription drugs can vary widely based on these individual negotiations, but the underlying element of every price is the static List Price. Currently, there is no market pressure for manufacturers or pharmaceutical companies to compete based on the List Price, but the Proposal argues that mandating its inclusion in DTC television advertising will eventually lead to lower prices through increased competition and consumer knowledge. There are at least three main critiques with this Proposal, all of which are pre-emptively addressed by the Proposal: The first is that the Proposal will not lower drug prices but rather make the market for prescription drugs more confusing to consumers. The argument is that since the List Price is rarely the price paid by consumers (in fact, it is largely only paid by those without any coverage), advertising a high List Price will only deter potential consumers instead of create competition. The Proposal states that even though the List Price is typically not the price paid, it is a basic piece of factual information that the consumer should know in order to have at least one metric for comparison shopping. The second critique is that the Proposal will not withstand First Amendment scrutiny; namely, that this mandate is unreasonably compelled speech by the government. The Proposal states that the List Price is simply a required disclosure of factual information in a commercial speech setting, thus requiring a lower level of First Amendment scrutiny. The third main critique is that the Proposal lacks an enforcement mechanism. If a prescription drug advertiser violates the Proposal, their name is only added to a list of violators on the CMS website. The Proposal assumes that enforcement will come from private actions for false or misleading advertising under the federal Lanham Act. In order to better address the critiques outlined above, CMS is accepting comments on the Proposal until December 17th, 2018. In addition to the above critiques, CMS is seeking comments regarding the requirements of the price disclosure among other specific aspects of the Proposal. If you would like to submit comments, one of the authors or your regular Dorsey attorney would be happy to assist you.
October 19, 2018
by Randall Hanson and Neal N. Peterson