Pharmacy benefit management

In the United States, a pharmacy benefit manager (PBM) is a third-party administrator (TPA) of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans.[1][2][3]

According to the American Pharmacists Association (APhA), "PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims. For the most part, they work with self-insured companies and government programs striving to maintain or reduce the pharmacy expenditures of the plan while concurrently trying to improve health care outcomes."[4][5]

As of 2016, PBMs manage pharmacy benefits for 266 million Americans.[2] They operate inside of integrated healthcare systems (e.g., Kaiser or VA), as part of retail pharmacies (e.g., CVS Pharmacy or Rite-Aid), and as part of insurance companies (e.g., UnitedHealth Group).[1][5] There are fewer than 30 major companies in this category in the US.[1] The three major PBMs comprise 78% of the market, and cover 180 million enrollees.[1][6]

Scope of PBMs

PBMs aggregate the buying clout of enrollees through their client health plans, enabling plan sponsors and individuals to obtain lower prices for their prescription drugs through price discounts from retail pharmacies, rebates from pharmaceutical manufacturers, and the efficiencies of mail-service pharmacies.[7] As of 2015, CVS Caremark said that it reduced its plan members' prescription drug spend to 5%, down from 11.8% in 2014.[8] A 2014 ERISA hearing, however, noted that vertically-integrated PBMs may pose "conflicts of interest," and that PBMs' health plan sponsors "face considerable obstacles in...determin[ing] compliance with PBM contracts including direct and indirect PBM compensation contract terms."[9]

History of PBMs

The first PBM, Pharmaceutical Card System Inc. (PCS, later AdvancePCS) originated in 1968 with the invention of the plastic benefit card.[10] By the "1970s, [they] serve[d] as fiscal intermediaries by adjudicating prescription drug claims by paper and then, in the 1980s, electronically."[11]:34 By the late 1980s PBMs had become a major force "as health care and prescription costs were escalating."[12] Diversified Pharmaceutical Services (DPS) was one of the earliest examples of a PBM that entered the market from within a leading national Health maintenance organization (HMO) United HealthCare (now United HealthGroup).[13]:304[14] Diversified pioneered many cost containment strategies that are now core PBM services and became a recognized leader in clinical programs. After its acquisition by SmithKline Beecham in 1994, Diversified played a pivotal role in that company's Healthcare Service division. By 1999 UnitedHealth Group accounted for 44% of DPS's total membership.[14] Express Scripts acquired Diversified April 1, 1999 and consolidated its position as a leading PBM for managed care organizations.[14]

In 2007, when CVS acquired Caremark,[1] the function of PBMs changed "from simply processing prescription transactions to managing the pharmacy benefit for health plans,"[11]:34 negotiating "drug discounts with pharmaceutical manufacturers,"[11]:34 and providing "drug utilization reviews and disease management."[11]:34 PBMs also created a formulary that encouraged or even required "health plan participants to use preferred formulary products to treat their conditions."[11]:34 In 2012, Express Scripts and CVS Caremark transitioned from using tiered formularies, to ones that began excluding drugs from their formulary.[1][15]

2002 Marketing expensive brand name drugs

According to an article published in August 2002 in the Wall Street Journal, that while PBMs were "steering doctors to cheaper drugs, especially low-cost generic copies of branded drugs from big pharmaceutical companies" from 1992 through 2002, they had "quietly moved into a new business: helping those same big pharmaceutical companies market their expensive brand-name drugs."[16]

By 1998, PBMs were under investigation by Assistant U.S. Attorney James Sheehan of the federal Justice Department and their effectiveness in reducing prescription costs and saving clients money, were questioned.[12]

Major PBMs

In 2015,the three largest public PBMs were Express Scripts, CVS Health (formerly CVS Caremark) and United Health/OptumRx/Catamaran.[17][18][19] In 2015, the largest private PBM was Prime Therapeutics, a PBM owned by and operated for a collection of state Blue Cross Blue Shield plans.

Express Scripts

Express Scripts Holding Company is the largest pharmacy benefit management (PBM) organization in the United States,[20] with 2013 revenues of $104.62 billion.[21] In 2012 Express Scripts' $29.1 billion acquisition of rival Medco Health Solutions (once the nation's largest PBM) created "a powerhouse in managing prescription drug benefits."[22]

In October 2015 Express Scripts began reviewing pharmacy programs run by AbbVie Inc and Teva Pharmaceuticals Industries Ltd regarding the potential use of tactics that "can allow drugmakers to work around reimbursement restrictions" from Express Scripts and other insurers. Insurers like Express Scripts direct "patients to cheaper generic versions of widely-used medicines to save costs." These reviews resulted from investigations into "questionable practices" at Valeant Pharmaceuticals International Inc's partner pharmacy, Philidor Rx Services.[20]

CVS Health

In 1994, CVS launched PharmaCare, a pharmacy benefit management (PBM) company providing a wide range of services to employers, managed care organizations, insurance companies, unions and government agencies.[23] By 2002 CVS' specialty pharmacy ProCare, the "largest integrated retail/mail provider of specialty pharmacy services" in the United States,[24]:10 was consolidated with their pharmacy benefit management company, PharmaCare.[24][25]:4 Caremark Rx Caremark which was originally founded as a unit of Baxter International and was spun off from Baxter in 1992 as a publicly traded company. In March 2007, Caremark merged with CVS Corporation to create CVS Caremark, later re-branded as CVS Health.[26]

In 2011 Caremark Rx was the nation's second-largest PBM. Caremark Rx was subject to a class action lawsuit in Tennessee. The suit alleged that Caremark kept discounts from drug manufacturers instead of sharing them with member benefit plans, secretly negotiated rebates for drugs and kept the money, and provided plan members with more expensive drugs when less expensive alternatives were available. CVS Caremark paid $20 million to three states over fraud allegations.[27]

UnitedHealth Group

OptumRx, a leading PBM is one of the Optum businesses of UnitedHealth Group Inc.[28] – the largest single health carrier in the United States.[29] UnitedHealth Group — then-UnitedHealthCare Corporation — was created in 1977. UnitedHealthCare Corporation was renamed in 1998). UnitedHealthCare Corporation acquired Charter Med Incorporated in 1977. Charter Med Incorporated was founded in 1974. UnitedHealthCare Corporation had its origins in the development of the HMO.[30] In March 2015 UnitedHealth Group acquired Catamaran Corporation for about $12.8 billion to extend its PBM business.[31][32]

PBMs operate in a marketplace where competition has been described as "vigorous" by the Federal Trade Commission (FTC).[33] Currently, in the United States, a majority of the large managed prescription drug benefit expenditures are conducted by about 60 PBMs.[34] While many PBMs are independently owned and operated, some are subsidiaries of managed care plans, major chain drug stores, or other retail outlets. PBMs compete to win business by offering their clients administrative and clinically based services which manage drug spending by enhancing price competition and increasing the cost-effectiveness of medications.

PBM strategies and tools

All PBMs offer a core set of services to manage the cost and utilization of prescription drugs and improve the value of plan sponsors' drug benefits. Some offer additional tools, such as disease management, that can target specific clinical problems for intervention. It is up to the client of the PBM, however, to determine the extent to which these tools will be employed.

Such tools include:

In 1995 the US FDA found the temperature in a mail box in the sun could reach 136 °F (58 °C) while the ambient air temperature was 101 °F (38 °C).[36] One of the arguments for specialty pharmacies offered by PBMs included concerns about temperature-sensitive pharmaceuticals through regular mail and parcel post. PBMs use insulated shipping container and ship drugs by express mail and couriers to reduce transit time. This may involve delivery to the door, rather than a mail box. This reduces risks to drug safety and efficacy but increases cost.

Litigation over PBM practices

In 2004, litigation added to the uncertainty about PBM practices.[27][39] In 2015, there were seven lawsuits against PBMs involving fraud, deception, or antitrust claims.[1][6]

State responses

In 2011 a new division of the Pharmacy Benefit Managers (PBM's) was formed, with a mandate to license and regulate Pharmacy Benefit Managers (PBM's) under the Mississippi Board of Pharmacy.[40]

State legislatures are using "transparency," "fiduciary," and "disclosure" provisions to improve the business practices of PBMs.[39] The provisions require PBMs to disclose all rebate, discount, and revenue arrangements made with drug manufacturers, including all utilization information on covered individuals.

Fiduciary duty provisions have stirred the most controversy. They require PBMs to act in the best interest of health plans in a way that conflicts with PBMs' role as the intermediary, which is the foundation of the PBM industry. The Pharmaceutical care management association, the national trade association representing PBMs, starkly opposes legislation of this kind. The PCMA believes public disclosure of confidential contract terms would damage competition and ultimately harm private and public sector consumers. The association also argues that transparency already exists for clients that structure contracts to best suit their needs, including imposing audit rights.

Maine, South Dakota, and the District of Columbia have laws requiring PBM transparency. PCMA filed suit against Maine and the District of Columbia for their financial disclosure laws.

In the Maine lawsuit, PCMA v. Rowe, PCMA alleged the law:

PCMA won preliminary injunctions against the Maine law twice but was denied its motion for summary judgment. The judge agreed that financial disclosure was reasonable in relation to controlling the cost of prescription drugs. It was determined that the law was designed to create incentives within the market to curtail practices that are likely to unnecessarily increase costs without providing any corresponding benefit to those filling prescriptions. PCMA won an interim injunction against the D.C. law, with the judge ruling that it would be an "illegal taking" of private property.

Biosimilars

PBMs have been strong proponents in the creation of a U.S. Food and Drug Administration (FDA) pathway to approve similar versions of expensive specialty drug that treat conditions like Alzheimer's, rheumatoid arthritis and multiple sclerosis.[41] So-called biosimilar legislation that does not grant brand name drug manufacturers monopoly pricing power[42] is strongly supported by PBMs, AARP, AFL-CIO, the Ford Motor Company, and dozens of other consumer, labor, and employer organizations concerned about runaway health care costs in both the private and public sector. A recent Federal Trade Commission (FTC) found that patents for biologic products already provide enough incentives for innovation and that additional periods of exclusivity would "not spur the creation of a new biologic drug or indication" and "imperils" the benefits of the approval process.[43]

See also

References

  1. 1 2 3 4 5 6 7 Feldman, Brian S. "Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control". Quartz. Retrieved 2016-03-29.
  2. 1 2 Pharmaceutical Care Management Association (PCMA) (March 14, 2016), That's What PBMs Do, retrieved 2016-03-29
  3. ↑ Gryta, Thomas. "What is a 'Pharmacy Benefit Manager?'". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-03-29.
  4. ↑ "Pharmacy Benefit Management" (PDF). American Pharmacists Association. July 9, 2009. Retrieved November 4, 2015.
  5. 1 2 Danzon, Patricia (June 29, 2014). "2014 ERISA Advisory Council: PBM Compensation and Fee Disclosure" (PDF). Retrieved 2016-03-29.
  6. 1 2 Balto, David A. (November 17, 2015). "The State of Competition in the Pharmacy Benefits Manager and Pharmacy Marketplaces" (PDF). House Judiciary Subcommittee on Regulatory Reform, Commercial, and Antitrust Law. Retrieved 2016-03-29.
  7. ↑ "PCMA". www.spcma.org. Retrieved 2016-03-29.
  8. ↑ Health, CVS. "CVS Health Reports Dramatic Drop in Prescription Drug Trend to 5 Percent, Despite Rising Drug Prices". www.prnewswire.com. Retrieved 2016-03-29.
  9. ↑ "PBM Compensation and Fee Disclosure". www.dol.gov. Retrieved 2016-03-29.
  10. ↑ "Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control". Quartz. Retrieved 2016-03-29.
  11. 1 2 3 4 5 Allison Dabbs Garrett; Robert Garis (2007). "Leveling the Playing Field in the Pharmacy Benefit Management Industry". Valparaiso University Law Review 42 (1): 33–80. Retrieved October 31, 2015.
  12. 1 2 Brierton, Janet (December 24, 2003). "Pharmacy Benefit Managers". Hartford, CT: Connecticut General Assembly. Retrieved December 27, 2015.
  13. ↑ Peter Reid Kongstved (1995). Essentials of Managed Health Care. Barnes & Noble 1.
  14. 1 2 3 "Express Scripts to Acquire Diversified Pharmaceutical Services", PRNewswire (St. Louis), February 9, 1999, retrieved October 31, 2015
  15. ↑ "Drug Channels: Here Come the 2016 PBM Formulary Exclusion Lists!". www.drugchannels.net. Retrieved 2016-03-29.
  16. ↑ Martinez, Barbara (August 14, 2002). "Pharmacy-Benefit Managers at Times Toil for Drug Firms". The Wall Street Journal. Retrieved December 27, 2015.
  17. ↑ https://www.optumrx.com
  18. ↑ http://www.prnewswire.com/news-releases/catamaran-shareholders-approve-acquisition-by-unitedhealth-group-515064561.html
  19. ↑ http://blogs.wsj.com/briefly/2015/03/30/pharmacy-benefit-managers-the-short-answer/
  20. 1 2 Beasley, Deena (October 30, 2015). "Exclusive: Beyond Valeant, U.S. payers scrutinize other drugmaker ties to pharmacies". Los Angeles: Reuters. Retrieved November 1, 2015.
  21. ↑ "Express Scripts Holding Company FORM 10-K". 2013. Retrieved October 31, 2015.
  22. ↑ Sierra, Michelle (July 22, 2011). "Express Scripts takes $14 billion bridge loan". Reuters. Retrieved October 31, 2015.
  23. ↑ "CVS Caremark, Form 10-K, Annual Report, Filing Date Mar 29, 1995". secdatabase.com. Retrieved March 29, 2013.
  24. 1 2 "CVS Annual Report" (PDF). CVS. 2001. Retrieved October 17, 2015.
  25. ↑ "Overview of the Specialty Drug Trend" (PDF). IMS Health. 2014. p. 11. Retrieved October 5, 2015.
  26. ↑ "CVS Caremark, Form 8-K, Current Report, Filing Date Mar 23, 2007" (PDF). secdatabase.com. Retrieved March 29, 2013.
  27. 1 2 Pfeifer, Stuart (December 16, 2011). "Money & Company". Los Angeles Times. Retrieved January 17, 2014.
  28. ↑ New Optum Product Helps Companies Better Manage Pharmacy Costs, Irvine, California, October 18, 2012, retrieved October 31, 2015
  29. ↑ http://www.uhc.com/about_us.htm
  30. ↑ "United HealthCare Corporation History". Retrieved May 11, 2015.
  31. ↑ Trefis Team (April 1, 2015). "What The UnitedHealth-Catamaran Deal Means For Walgreens". Forbes. Retrieved October 31, 2015.
  32. ↑ "The Short Answer: Pharmacy-Benefit Managers". The Wall Street Journal. March 30, 2015. Retrieved October 31, 2015.
  33. ↑ US Federal Trade Commission & US Department of Justice Antitrust Division, "Improving Health Care: A Dose of Competition,” July 2004
  34. ↑ Shepherd, Joanna (July 2013). "Is More Information Always Better? Mandatory Disclosure Regulations in the Prescription Drug Market". Cornell Law Review Online 99. Retrieved October 31, 2015.
  35. ↑ http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/Downloads/Negotiated-Pricing-Between-General-Mail-Order-and-Retail-PharmaciesDec92013.pdf
  36. ↑ Black, J. C.; Layoff, T. "Summer of 1995 -Mailbox Temperature Excursions in St. Louis" (PDF). US FDA Division of Drug Analysis. Retrieved October 31, 2015.
  37. ↑ Perrone, M., "Electronic Prescribing Push Clicks with Congress," The Associated Press, June 3, 2008; Mathews, A.W. and Radnofsky, L., "E-Prescribing Gets Support in Congress," The Wall Street Journal, June 5, 2008.
  38. 1 2 Visante, "American Recovery and Reinvestment Act Will Save Billions and Reduce Medication Errors by Accelerating E-Prescribing," prepared for the Pharmaceutical Care Management Association, March 2009, http://www.pcmanet.org/wp-content/uploads/2009/03/final-arra-impact-on-eprescribing.pdf.
  39. 1 2 Stan Finkelstein; Peter Temin (2008). Reasonable Rx: Solving the Drug Price Crisis. FT Press (Upper Saddle River, New Jersey, USA). p. 208. ISBN 978-0-132344494.
  40. ↑ "Newsletter" (PDF), Mississippi Board of Pharmacy (Madison, MS), April 2012, retrieved October 31, 2015
  41. ↑ Schouten, F. (July 29, 2009), "Lobbyists battle over drug sales", USA Today, retrieved October 31, 2015
  42. ↑ "Our view on generic medications: Drugmakers seek excessive monopolies on ‘biologics’", USA Today, August 12, 2009, retrieved October 31, 2015
  43. ↑ "Follow-on Biologic Drug Competition", Federal Trade Commission, June 2009, retrieved October 31, 2015

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