The Pharmacy Benefit Management (PBM) industry is the Goliath of healthcare. PBMs have a huge impact on prescription healthcare that is little understood outside of the pharmacy industry. According to a November 2016 report, PBMs in the United States have revenues of $423 billion, they experienced 11-16% growth between 2011 and 2016, and they employ a workforce of at least 30,000. Additionally, Congressional testimony revealed that the top PBMs nearly doubled their profits over the past five years. The breadth and depth of the role that PBMs play in the lifecycle of a prescription drug is unequaled in healthcare. PBMs touch, in one aspect or another, nearly every drug dispensed nationally. But if you ask the average consumer who their particular PBM is, or even what a PBM does, few could answer those questions.
PBMs are middle men, “third-party administrators” that act as on behalf of private insurers to provide all of the services needed to manage a prescription benefit. PBMs provide drug plan design services, meaning that they assist insurers in designing and maintaining the formulary, which determines what medications are covered under a particular plan. PBMs also negotiate with drug manufacturers to obtain favorable drug prices and related manufacturer rebates. Once a drug program is implemented, PBMs are supposed to assist in controlling these drug costs. Through their mail order and retail pharmacy networks, PBMs determine the drug costs and dispensing fees paid by insurance companies and by beneficiaries through copays. PBMs also process and pay claims for virtually every prescription dispensed across the country every day. Companies that operate some of the largest PBMs (i.e., CVS Health and EnvisionRx), through related entities, also control huge swaths of the specialty, mail order, and retail pharmacy industry. These wholly-integrated PBMs control the entire prescription benefit process – from designing the drug programs to dispensing prescriptions.
Due to their historical involvement in commercial prescription benefit plans, PBMs play a central role in Medicare Part D, Medicaid, and other government-sponsored prescription drug programs. However, PBMs significantly impact both commercial and government-funded prescription programs, including Medicare Part D, Medicaid, prescription programs for state and federal employees, and healthcare benefits for our military, including Tricare.
Government agencies and private insurers are David to the PBM Goliaths. Identifying, quantifying, and controlling fraud, waste, and abuse in government-funded prescription drug programs, particularly as it relates to the PBM industry, is difficult at best. One of the greatest hurdles to prescription benefit oversight is the lack of transparency between the government agencies that fund drug benefits and PBMs that manage them.
Government agencies lack access to the PBM’s relationships with both drug manufacturers and their pharmacy networks, and significant related hidden income streams. One such income stream is related to the PBMs’ negotiations with drug manufactures to set drug prices paid by the PBM, as well as related volume-based rebates that are earned on specific drugs. PBMs share these rebates with drug benefit sponsors. A second income stream for PBMs results from the role PBMs play in setting drug costs and dispensing fees paid to the PBM’s network of retail, mail order and specialty pharmacies. When prescriptions are dispensed to beneficiaries, the PBM profits from the difference or “spread” between the price the PBM negotiates with drug manufactures and the price the PBM charges its network pharmacies.
The government also lacks access to the pharmacy claims data received by the PBM. It is unable to compare the pharmacy data to claims data that PBMs submit to insurance companies. In the Part D program, this same claims data is submitted to the Centers for Medicare and Medicaid Services, (“CMS”). This lack of transparency in PBM operations is an impediment to both identify and control pharmacy benefit overpayments, particularly in Medicare Part D.
Although there is a recognized need for transparency between the government and the public, on one side, and the PBM industry on the other, these efforts have yet to bear fruit. For example, even before the Part D program was added to Medicare in 2006, the General Accounting Office (GAO) highlighted the need for transparency and fairness should the Medicare drug benefit be outsourced to private insurers and PBMs. Ten years later, in January of 2013, the Office of Inspector General (OIG) called for CMS to amend Part D regulations to provide its auditors with direct access to information from pharmacies and PBMs. During September of 2015 hearings before the House Judiciary Committee on the State of Competition in the Pharmacy Benefits Manager and Pharmacy Marketplaces, witnesses addressed the concentration in the PBM industry, the ownership relationships between PBMs and retail pharmacies, and the lack of transparency in PBM operations negatively impacts competition and inures to the detriment of both health insurance plans and the ultimate consumer. One witness highlighted the lack of transparency in both rebates earned by PBMs and in prices that pharmacies were paying PBMs for drugs. Representatives of the PBM industry argued that transparency with regard to drug prices would result in price fixing.
In March of 2017, Senator Ron Wyden (D-Oregon) introduced S-637, “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act.” The bill is focused on just one aspect of PBM secrecy – the rebates paid by drug makers to PBMs. In response, the PBM industry has again argued that secrecy in rebate negotiations is essential to allow PBMs to obtain the best prices and to prevent manufacturers and pharmacies from colluding with competitors. Whether the C-THRU Act even makes it out of the Senate Finance Committee is yet to be determined.
The process to create legislation or regulations that require transparency in the PBM industry is a very long and uncertain one. In the near term, only an industry insider can identify conduct that results in overpayments in Part D and other government-funded prescription programs. Meanwhile, PBMs continue to control the pharmacy industry, operating unchallenged and largely in secret, to create gigantic profits.