These entities include drug  wholesalers, independent pharmacies, PSAOs, and third-party payers  and their PBMs. These sales accounted for almost 17 percent of the  $266 billion in prescription drug sales in the United States in 2010. Third-party payers include private and public health plans  such as those offered by large corporations and the federal government  through Medicare and the FEHBP, many of which use PBMs to help them  manage their prescription drug benefits. 1 for a diagram  of the network of entities in the distribution of and payment for  pharmaceuticals.) At Least 22 PSAOs Contracted with over 20,000 Pharmacies in 2011 or 2012, the Majority of Which Were Independent Pharmacies

At least 22 PSAOs, which varied in the number and location of  pharmacies to which they provided services, were in operation in 2011 or  2012. In total, depending on different data sources, these 22 PSAOs  represented or provided other services to between 20,275 and 28,343  pharmacies in 2011 or 2012. The number of pharmacies  contracted with each PSAO across these sources ranged from 24 to  5,000 pharmacies; however, according to NCPDP data most contracted  with fewer than 1,000 pharmacies. Some PSAOs contracted primarily with pharmacies  located in a particular region. These PSAOs generally represented fewer  pharmacies than PSAOs representing pharmacies across the United  States. PSAOs Provide Independent Pharmacies with a Range of Services Intended to Achieve Administrative Efficiencies, and Most PSAOs Are Paid a Monthly Fee for These Services

PSAOs provide a broad range of services to independent pharmacies  including negotiating contractual agreements and providing  communication and help-desk services. Both the HHS OIG and an industry  study reported that small businesses such as independent pharmacies  generally lack the legal expertise and time to adequately review and  negotiate third-party payer or PBM contracts, which can be lengthy and  complex.independent pharmacies that we reviewed indicated, and all of the  PSAOs we spoke with stated, that the PSAO was explicitly authorized to  negotiate and enter into contracts with third-party payers on behalf of  member pharmacies. All of the model agreements between PSAOs and  PSAOs we spoke with had different processes for negotiating and  entering into contracts with third-party payers or their PBMs. In addition to  communicating contractual requirements, PSAOs may also communicate  applicable federal and state regulatory updates. PSAOs may  provide such assistance by means of a help-desk (or customer service  department) or a dedicated staff person. For example, PSAOs  may provide services that help the pharmacy with payment from a third- party payer or its PBM, comply with third-party payer requirements, or  develop services that make the pharmacy more appealing to third-party  payers or their PBMs. PSAOs Provide Services Intended to Achieve Administrative Efficiencies for Independent Pharmacies and Third- Party Payers or Their PBMs

PSAOs provide services intended to achieve administrative efficiencies  for both independent pharmacies and third-party payers or their PBMs. Most PSAOs Charge a Monthly Fee for Bundled Services and Additional Fees for Other Services

Although PSAOs’ charges to member pharmacies for their services may  vary depending on how the services are provided, 8 of the 10 PSAOs we  spoke with charged a monthly fee for a bundled set of services. Virtually all of the fees for PSAO services are paid for by member  pharmacies. Wholesalers and Independent Pharmacy Cooperatives Owned the Majority of PSAOs; Requirements to Use Non-PSAO Services Varied by Owner

The majority of PSAOs in operation in 2011 or 2012 were owned by  wholesalers and independent pharmacy cooperatives.PSAO owners varied as to whether they require member pharmacies to  also use the non-PSAO services they offer. Specifically, of the   22 PSAOs we identified, 9 PSAOs were owned by wholesalers, 6 were  owned by independent pharmacy cooperatives (“member-owned”),   4 were owned by group purchasing organizations, and 3 were stand- alone PSAOs owned by other private entities. PSAO owners may operate PSAOs for a number of reasons, including to  benefit another, non-PSAO line of their business. Other  types of PSAO owners also provided a number of reasons for providing  PSAO services, for instance, a number of these owners stated that they  began offering PSAO services as a market-driven response to the growth  of third-party payers and PBMs. PSAO Owners Vary As to Whether They Require Member Pharmacies to Use Their Non-PSAO Services

The owners of PSAOs we spoke with varied as to whether they require  PSAO member pharmacies to also use services from a separate non- PSAO line of their business. Of the remaining  three, one wholesaler-owned PSAO limited its offer of services to  pharmacies that were existing customers of its drug distribution line of  business, while two member-owned PSAOs reported requiring their  PSAO member pharmacies to join their group purchasing organizations. In this case, a pharmacy must contract and pay for  PSAO and other services separately.
Why GAO Did This Study

Independent pharmacies dispensed about 17 percent of all prescription drugs in the United States in 2010. To obtain, distribute, and collect payment for drugs dispensed, pharmacies interact with a network of entities, including drug wholesalers and third-party payers. With limited time and resources, independent pharmacies may need assistance in interacting with these entities, particularly with third-party payers that include large private and public health plans. Most use a PSAO to interact on their behalf. PSAOs develop networks of pharmacies by signing contractual agreements with each pharmacy that authorizes them to interact with third-party payers on the pharmacy's behalf by, for example, negotiating contracts. While specific services provided by PSAOs may vary, PSAOs can be identified and distinguished from other entities in the pharmaceutical distribution and payment system by their provision of intermediary or other services to assist pharmacies with third-party payers.
GAO was asked to review the role of PSAOs. In this report, GAO describes: (1) how many PSAOs are in operation and how many pharmacies contract with PSAOs for services; (2) the services PSAOs offer and how they are paid for these services; and (3) entities that own PSAOs and the types of relationships that exists between owners and the pharmacies they represent. GAO analyzed data on PSAOs in operation in 2011 and 2012, reviewed literature on PSAOs and model agreements from 8 PSAOs, and interviewed federal agencies and entities in the pharmaceutical industry.

What GAO Found

At least 22 pharmacy services administrative organizations (PSAO), which varied in the number and location of the pharmacies to which they provided services, were in operation in 2011 or 2012. In total, depending on different data sources, these PSAOs represented or provided other services to between 20,275 and 28,343 pharmacies in 2011 or 2012, most of which were independent pharmacies. While the number of pharmacies with which each PSAO contracted ranged from 24 to 5,000 pharmacies, most PSAOs represented or provided other services to fewer than 1,000 pharmacies. Additionally, some PSAOs contracted with pharmacies primarily located in a particular region rather than contracting with pharmacies located across the United States.
While PSAOs provide a broad range of services to independent pharmacies, and vary in how they offer these services, PSAOs consistently provide contract negotiation, communication, and help-desk services. All of the model agreements between PSAOs and independent pharmacies that GAO reviewed stated that the PSAO will negotiate and enter into contracts with third-party payers on behalf of member pharmacies. PSAOs may also contract with pharmacy benefit managers (PBM), which many third-party payers use to manage their prescription drug benefit. In addition to contracting, PSAOs also communicate information to members regarding contractual and regulatory requirements, and provide general and claims-specific assistance to members by means of a help-desk or a dedicated staff person. They may also provide other services to help member pharmacies interact with third-party payers or their PBMs, such as managing and analyzing payment and drug-dispensing data to identify claims unpaid or incorrectly paid by a third-party payer. PSAO services are intended to achieve administrative efficiencies, including contract and payment efficiencies for both independent pharmacies and third-party payers or their PBMs. Most PSAOs charge a monthly fee for a bundle of services and may charge additional fees for other services provided to its member pharmacies. Virtually all of the fees paid for PSAO services are paid by member pharmacies, with PSAOs receiving no administrative fees from other entities such as third-party payers or their PBMs.
The majority of PSAOs in operation in 2011 or 2012 were owned by drug wholesalers and independent pharmacy cooperatives. Of the 22 PSAOs we identified, 9 PSAOs were owned by wholesalers, 6 were owned by independent pharmacy cooperatives, 4 were owned by group purchasing organizations, and 3 were stand-alone PSAOs owned by other private entities. These owners varied in their requirements for PSAO member pharmacies to also use services from their separate, non-PSAO line of business. Three PSAO owners GAO spoke with required PSAO members to also use their non-PSAO services. For example, one wholesaler-owned PSAO limited its offer of PSAO services to existing customers of its drug distribution line of business. All but one PSAO owner GAO spoke with reported that their PSAO line of business earned little to no profit. However, PSAO owners may operate PSAOs for a number of reasons, including helping pharmacies gain access to third-party payer contracts and to provide benefits to the owner's non-PSAO line of business.