As we previously reported, the House Energy and Commerce Health Subcommittee held a hearing on May 21, 2019 on improving drug pricing transparency and lowering prices for consumers. The subcommittee considered seven bills, each of which is intended to reform the drug supply chain, and to ensure that drug prices are affordable. Several of the hearing witnesses lauded the intent of the bills, while also cautioning that they could have unintended negative consequences to patients.
Some witnesses were particularly concerned about a sample reporting provision in the Prescription Drug Sunshine, Transparency, Accountability and Reporting (“STAR”) Act. The STAR Act is intended to increase transparency and public reporting of information in the prescription drug market. One provision requires manufacturers to annually report to the Center for Medicare and Medicaid Services (“CMS”) the monetary value of samples provided to certain recipients each year. This data will be made available to the public in the Open Payments Database.
Madelaine Feldman, MD, a New Orleans rheumatologist and the President of the Coalition of State Rheumatology Organizations, testified at the hearing on behalf of the Alliance of Specialty Medicine about the importance of samples to patient care. She noted that because of aggressive utilization management, patients often “wait weeks to over a month before getting final approval and then actually getting the prescribed medicine,” but that in cases of “progressive, irreversible disease[s] like rheumatoid arthritis, patients do not have the luxury of time.” As a result, healthcare providers need to have samples on hand to give to patients to fill in this time gap until patients can get their prescriptions filled. Feldman also voiced her concern that requiring public disclosure of the monetary value of samples could cause a “chilling effect of manufacturers’ willingness” to provide samples because of the potential for “shame campaigns against physicians and manufacturers by Twitter experts, bloggers, and the like.” Instead, Feldman advocated for following a June 2017 MedPAC recommendation that would require manufacturers to report information on free drug samples to oversight agencies, researchers, payers and health plans. This information would be available to the enumerated entities only, not the public, and would be subject to confidentiality and data use agreements.
Another bill causing concern is the Fair Accountability and Innovative Research (“FAIR”) Drug Pricing Act. The FAIR Act requires certain drug manufacturers to alert the Department of Health and Human Services (“HHS”) 30 days prior to increasing the price of a drug, as well as to justify the price increase. HHS will publish this information, unless it is considered a trade secret and confidential.
Lisa Joldersma, Senior Vice President for Insurance and State Issues at the Pharmaceutical Research and Manufacturers of America (“PhRMA”), testified at the hearing about the potential impact of the FAIR Act 60-day notification requirement. She noted that this requirement could lead to market distortions, such as bulk purchasing and stockpiling. Joldersma also cautioned against “overly broad policies that may seem designed to ‘shame’ manufacturers while doing little to make prescriptions more affordable for patients.”