In the United States, a pharmacy benefit manager (PBM) is a third-party administrator 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] PBMs operate inside of integrated healthcare systems (e.g., Kaiser Permanente or Veterans Health Administration), as part of retail pharmacies (e.g., CVS Pharmacy), and as part of insurance companies (e.g., UnitedHealth Group). [1]
The role of pharmacy benefit managers includes managing formularies, maintaining a pharmacy network, setting up rebate payments to pharmacies, processing prescription drug claims, providing mail order services, and managing drug use. PBMs play a role as the middlemen between pharmacies, drug manufacturers, wholesalers, and health insurance plan companies. [3]
As of 2023, PBMs managed pharmacy benefits for 275 million Americans. As of 2023, the three largest PBMs in the US, CVS Caremark, Cigna Express Scripts, and UnitedHealth Group’s Optum Rx, make up about 80% of the market share and cover approximately 270 million people. [4] [5]
This consolidation and concentration has led to lawsuits and bipartisan criticism for unfair business practices. [6] [7] In 2024, The New York Times , [8] Federal Trade Commission, [9] [10] and many states Attorneys General [11] [12] accused pharmacy benefit managers of unfairly raising prices on drugs.
Additionally, several states have created regulations and policies concerning PBM business practices, however, more research must be conducted on how these regulations will affect patient outcomes. [13]
In the United States, health insurance providers often hire an outside company to handle price negotiations, insurance claims, and distribution of prescription drugs. Providers which use such pharmacy benefit managers include commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. [1] PBMs are designed to aggregate the collective buying power of enrollees through their client health plans, enabling plan sponsors and individuals to obtain lower prices for their prescription drugs. PBMs negotiate price discounts from retail pharmacies, rebates from pharmaceutical manufacturers, and mail-service pharmacies which home-deliver prescriptions without consulting face-to-face with a pharmacist. [14]
Pharmacy benefit management companies can make revenue in several ways. First, they collect administrative and service fees from the original insurance plan. They can also collect rebates from the manufacturer. Traditional PBMs do not disclose the negotiated net price of the prescription drugs, allowing them to resell drugs at a public list price (also known as a sticker price) which is higher than the net price they negotiate with the manufacturer. [15] This practice is known as "spread pricing". [16] The industry argues that savings are trade secrets. [17] Pharmacies and insurance companies are often prohibited by the PBM from discussing costs and reimbursements. This leads to lack of transparency. Therefore, states are often unaware of how much money they lose due to spread pricing, and the extent to which drug rebates are passed on to enrollees of Medicare plans. In response, states like Ohio, West Virginia, and Louisiana have taken action to regulate PBMs within their Medicaid programs. For instance, they have created new contracts that require all discounts and rebates to be reported to the states. In return, Medicaid pays PBMs a flat administrative fee. [18]
PBMs advise their clients on ways to "structure drug benefits" and offer complex selections at a variety of price rates from which clients choose. This happens by constructing a "formulary" or list of specific drugs that will be covered by the healthcare plan. The formulary is usually divided into several "tiers" of preference, with low tiers being assigned a higher copay to incentivize consumers to buy drugs on a preferred tier. Drugs which do not appear on the formulary at all mean consumers must pay the full list price. To get drugs listed on the formulary, manufacturers are usually required to pay the PBM a manufacturer's rebate, which lowers the net price of the drug, while keeping the list price the same. [19]
The complex pricing structure of the formulary can have unexpected consequences. When filing an insurance claim, patients usually are charged an insurance copayment which is based on the public list price, and not the confidential net price. Around a quarter of the time, the cost of the insurance copayment on the list price is more than the entire price of the drug bought directly in cash. The PBM can then pocket the difference, in a practice known as a "clawback". [20] Consumers can choose to buy the drug in cash, but in their contracts with pharmacies, PBMs would forbid pharmacists from telling consumers about the possibility of buying their medication for a cheaper price without an insurance claim, unless consumers directly ask about it. [21] Since 2017, six states have passed legislation making such "gag clauses" illegal. [22] This has recently been followed by a federal bans on gag orders [23] for private insurance effective Oct 2018, [24] and for Medicare effective Jan 2020. [25]
TheNew York Times, [8] Federal Trade Commission, [26] [27] and many states' Attorneys General [11] [12] argue pharmacy benefit managers unfairly raise prices on drugs.
A report by House Committee on Oversight and Accountability chairman, Kentucky Rep. James Comer, found that PBMs use utilization schemes to increase pricing for payers and health plans. [28]
PBMs regulate how much community pharmacies are reimbursed by drug companies and health insurance plans for the drugs they sell. PBMs are not required to share how these rebate rates are calculated and this can result in local pharmacies being paid back less or the same as the sticker prices of the drugs themselves. [29]
Vertical integration of PBMs can lead to a preference for PBM-affiliated pharmacies compared to unaffiliated pharmacies. Some PBMs may increase the reimbursement rates for affiliated pharmacies compared to nonaffiliated pharmacies. Because of this, nonaffiliated pharmacies compete with affiliated pharmacies in the dispensing of drugs. [30] For example, the vertical integration of the three largest PBMs, CVS Caremark, Cigna Express Scripts, and UnitedHealth Group’s Optum Rx, in which each owns their own insurance companies and pharmacies, allows PBMs to divert patients away from nonaffiliated independent pharmacies and toward their affiliated pharmacies. [29]
Clint Hopkins, joint owner of Pucci's Pharmacy in Sacramento, reports regularly turning away customers rather than lose money on high-end prescriptions. [31]
In 1968, the first PBM was founded when Pharmaceutical Card System Inc. (PCS, later AdvancePCS) invented the plastic benefit card. [1] By the "1970s, [they] serve[d] as fiscal intermediaries by adjudicating prescription drug claims by paper and then, in the 1980s, electronically". [32]
By the late 1980s, PBMs had become a major force "as health care and prescription costs were escalating". [33] Diversified Pharmaceutical Services was one of the earliest examples of a PBM which came from within a national health maintenance organization United HealthCare (now United HealthGroup). [34]
In August 2002, the Wall Street Journal wrote that while PBMs had "steered 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 marketing expensive brand name drugs. [35] [ clarification needed ]
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", [32] negotiating "drug discounts with pharmaceutical manufacturers", [32] and providing "drug utilization reviews and disease management". [32] PBMs also created a formulary to encourage or even require "health plan participants to use preferred formulary products to treat their conditions". [32] In 2012, Express Scripts and CVS Caremark transitioned from using tiered formularies, to those that excluded drugs from their formulary. [1]
As of 2013, in the United States, a majority of the large managed prescription drug benefit expenditures were conducted by about 60 PBMs. [36] Few PBMs are independently owned and operated. PBMs operate inside of integrated healthcare systems (e.g., Kaiser Permanente or Veterans Health Administration), as part of retail pharmacies, major chain drug stores (e.g., CVS Pharmacy or Rite-Aid), and as subsidiaries of managed care plans or insurance companies (e.g., UnitedHealth Group). [1] [37]
As of 2015, the three largest public PBMs were Express Scripts, CVS Health (formerly CVS Caremark) and United Health/OptumRx/Catamaran. [38] [39] [40]
As of 2022, Caremark Rx, Express Scripts, OptumRx, Humana, Prime Therapeutics, and MedImpact Healthcare Systems were the six largest public PBMs that control 95% of the market, while the top three control 80% of the market. [41]
In 2012 Express Scripts acquired rival Medco Health Solutions for $29.1 billion and became "a powerhouse in managing prescription drug benefits". [42] As of 2015, Express Scripts Holding Company was the largest pharmacy benefit management organization in the United States. [43]
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. These reviews resulted from investigations into "questionable practices" at Valeant Pharmaceuticals International Inc's partner pharmacy, Philidor Rx Services. [43]
In 2011 Caremark Rx was the nation's second-largest PBM. Caremark Rx was subject to a class action lawsuit in Tennessee, which 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. [44]
In March 2015 UnitedHealth Group acquired Catamaran Corporation for about $12.8 billion to extend grow its PBM business. [45]
PBMs have recently been subject to scrutiny mainly due to their lack of transparency regarding their complex drug pricing strategies and multiple facets of their business practices that contribute to rising drug pricing. [46]
In 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 was questioned. [33] [ non-primary source needed ]
In 2004, litigation added to the uncertainty about PBM practices. [44] [47] In 2015, there were seven lawsuits against PBMs involving fraud, deception, or antitrust claims. [1] [48]
State legislatures have been using "transparency," "fiduciary," and "disclosure" provisions to improve the business practices of PBMs. [47]
A 2013 Centers for Medicare & Medicaid Services study found negotiated prices at mail order pharmacy to be up to 83% higher than the negotiated prices at community pharmacies. [49] [ non-primary source needed ]
A 2014 ERISA (Employee Retirement Income Security Act of 1974) hearing 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". [50] [ non-primary source needed ]
In 2017, the Los Angeles Times wrote that PBMs cause an inflation in drug costs, especially within the area of diabetes drugs. [51]
United States Secretary of Health and Human Services Alex Azar stated regarding PBMs, "Everybody wins when list prices rise, except for the patient. It’s rather a startling and perverse system that has evolved over time." [52]
On January 31, 2019, Health and Human Services released a proposed rule to remove the Anti-kickback Statute, safe harbor protections for PBMs and other plan sponsors, that previously allowed PBMs to seek rebates from drug manufacturers. [53] [ needs update ][ non-primary source needed ]
Ron Wyden stated in April 2019 that they were as “clear a middleman rip-off as you are going to find”, because they make more money when they pick a higher-priced drug over a lower-priced drug. [54]
In June 2024, the New York Times released its first article in a series critiquing pharmacy benefit managers for artificially raising drug prices. [8]
In July 2024, the Federal Trade Commission released an interim report on its 2-year investigation into pharmacy benefit managers, many of which it accuses of raising drug prices due to conflicts of interest, consolidation, and other factors. [26] [27] It looks likely to sue as soon as August 2024. [12] As of July 2024, states that have already filed suits against PBMs include Vermont, California, Kentucky, Ohio, and Hawaii. [6]
Bill Head, assistant vice president at the Pharmaceutical Care Management Association (PCMA), claims that “[Pharmacy benefits managers] are the only entity in the drug-supply chain that exert downward pressure on drug prices by negotiating rebates and discounts with manufacturers". [29]
Since September 2024, brand name drugs Ozempic and Wegovy, two common weight loss and anti-diabetic drugs, have been experiencing increased list prices. [55] [56] On a Tuesday in late September, a senate hearing was held where Lars Fruergaard Jørgensen, the CEO of Novo Nordisk, the Danish pharmaceutical company that owns these two drugs, expressed his concerns to several congressional leaders, including Vermont Senator Bernie Sanders, stating that PBMs are the reason for Novo Nordisk not being able to lower the list prices since PBMs may take the drug off their list if the pieces become too low decreasing access to the drug for everyone. However, this was not the case as written commitments by all three major PBMs (Caremark, Express Scripts, and Optum Rx) promised not to withdraw coverage should Novo Nordisk decide to reduce their prices. [55] [56] Following the hearing the Senate Health, Education, Labor, and Pensions Committee submitted a report on the drug pricing strategies of Novo Nordisk, from which it can be concluded that PBMs were not the cause of high prices of these drugs. [55]
More recently, federal lawmakers have become more critical of the business practices in the PBM industry. [13] For example, gag clauses between PBMs and pharmacies regarding pricing plans were banned on a nationwide scale following the enactment of both the Patient Right to Know Drug Prices Act and the Know the Lowest Price Act in 2018. [13] [57]
Much of the controversy surrounding PBM practices has to do with how PBMs are incentivized by profits to raise drug costs. Due to this, regulators are mainly concerned with managing drug costs and pharmacy reimbursement rates. [13]
Many states have their own way of regulating PBM activities. These relate to different areas of PBM practice from managing reimbursement rates to increasing transparency about PBM business practices. In a 2022 web search conducted by Mattingly et al. it was found that "A total of 45 states implemented policies on pharmacy operations, 41 states on pricing and reimbursement, 36 states on licensure and registration, 26 on reporting requirements, and 25 on pharmacy networks". [13]
These are some ways in which states regulate drug pricing and pharmacy reimbursement funds: maximum allowable cost (MAC) lists, timely payment for pharmacy services, prevention of spread pricing, adjudication fee limit, and calculations for drug price reimbursement. [13]
The Knox-Keene Health Care Service Plan Act of 1975 is a set of Californian laws that regulate Healthcare Service Plans. Under these laws, pharmacy benefit managers with contracts to Health care service plans are required by law to be registered with the Department of Managed Health Care to disclose information. [58]
SB 966: Pharmacy benefits
SB 966: Pharmacy benefits is a California state bill written by state senators Aisha Wahab and Scott Weiner. It is currently in the process of becoming law. Adding on to the Knox Knee Act, SB 966 requires all PBMs to acquire licensure under the California Department of Insurance and file annual business reports disclosing information about revenue and purchaser-specific benefits. [58] SB 966 also prohibits pharmacy benefit managers from discriminating against nonaffiliated pharmacies and requiring customers to purchase from affiliated pharmacies. [29]
According to Assemblymember Devon Mathis, co-author of the bill, this would effectively reduce drug prices for consumers. [31] Additionally, the National Community Pharmacists Association reported that health insurance premiums increased by a nationwide average of 16.66% between 2015 and 2019. In states with licensing regulations, the increase in premiums was 0.3% lower than the national average, while in states without these regulations, it was 0.4% above the average. [31]
However, PBMs argue that enforcing this regulation will only drive up drug costs and increase coverage premiums for all parties. [31] The Pharmaceutical Care Management Association believes that this bill only favors community pharmacies over chain pharmacies and that all it will do is make it harder for PBMs to effectively negotiate lower drug prices with manufacturing companies. [31]
The Pharmacy Benefit Manager Transparency Act of 2023, Introduced on January 26, 2023, states that pharmacy benefit managers cannot unfairly lower rebate payments to pharmacies, claw back reimbursement payments, or charge arbitrary fees. If PBMs pass all discounts to the health plan and provide them with pricing information about their services, they will be exempt from these prohibitions. Under this act, PBMs would also need to disclose information about payments from health plans to the Federal Trade Commission (FTC) through annual reports. [59]
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
CVS Pharmacy Inc. is an American retail corporation. A subsidiary of CVS Health, it is headquartered in Woonsocket, Rhode Island. Originally named the Consumer Value Stores, it was founded in Lowell, Massachusetts, in 1963.
Longs Drugs is an American chain owned by parent company CVS Health with approximately 70 drugstores throughout the state of Hawaii and formerly in the Continental US.
Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Under the program, drug benefits are provided by private insurance plans that receive premiums from both enrollees and the government. Part D plans typically pay most of the cost for prescriptions filled by their enrollees. However, plans are later reimbursed for much of this cost through rebates paid by manufacturers and pharmacies.
Express Scripts Holding Company is a pharmacy benefit management (PBM) organization. In 2017 it was the 22nd-largest company in the United States by total revenue as well as the largest pharmacy benefit management (PBM) organization in the United States. Express Scripts had 2016 revenues of $100.752 billion. Since December 20, 2018, the company has been a direct subsidiary of Bloomfield, Connecticut-based Cigna.
CVS Caremark is the pharmacy benefit management subsidiary of CVS Health, headquartered in Woonsocket, Rhode Island.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health products.
CVS Health Corporation is an American for-profit healthcare company that owns CVS Pharmacy, a retail pharmacy chain; CVS Caremark, a pharmacy benefits manager; and Aetna, a health insurance provider, among many other brands. The company is the world's second largest healthcare company, behind UnitedHealth Group. In 2023, the company was ranked 64th in the Forbes Global 2000.
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication. Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
Electronic prescription is the computer-based electronic generation, transmission, and filling of a medical prescription, taking the place of paper and faxed prescriptions. E-prescribing allows a physician, physician assistant, pharmacist, or nurse practitioner to use digital prescription software to electronically transmit a new prescription or renewal authorization to a community or mail-order pharmacy. It outlines the ability to send error-free, accurate, and understandable prescriptions electronically from the healthcare provider to the pharmacy. E-prescribing is meant to reduce the risks associated with traditional prescription script writing. It is also one of the major reasons for the push for electronic medical records. By sharing medical prescription information, e-prescribing seeks to connect the patient's team of healthcare providers to facilitate knowledgeable decision making.
Based on the National Council for Prescription Drug Programs standard, all pharmacy software systems contain information fields for both a primary and secondary insurer to pay for patient's prescription. The co-pay card appeared in 2005 as a means by which pharmaceutical marketers could, by offering an instantaneous rebate to patients, combat their challenges to prescription pharmaceuticals, including generic competition, lack of patient compliance and persistency, and an access to the physician population. As of January 2017, in the United States, coupon cards for more than 600 prescription medications are available.
Catamaran Corporation is the former name of a company that now operates within UnitedHealth Group's OptumRX division. It sells pharmacy benefit management and medical record keeping services to businesses in the United States and to a broad client portfolio, including health plans and employers. Working independently of the government and insurance companies allowed it to operate as a third party verifier; the RxCLAIM online claim processing system allowed for prescription drug claims to be processed online if the customer lived in and filled their prescription in the United States. SXC had three separate but interrelated business segments which dealt with prescription drug programs. For 2013, 23% of company revenue came from Cigna Corporation.
Linda Cahn is the founder and president of a nationwide consulting firm, Pharmacy Benefit Consultants. The firm assists corporations, unions, government entities and insurance companies in improving their prescription coverage benefits and decreasing their prescription coverage costs.
Larry J. Merlo is the former president and CEO of CVS Health.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, around five years later nearly 30, by 2008 200, and by 2015 300.
Philidor Rx Services is a Pennsylvania-licensed specialty online pharmacy, which mainly sold Valeant Pharmaceuticals International Inc drugs directly to patients and handled insurance claims on the customers' behalf.
Specialty pharmacy refers to distribution channels designed to handle specialty drugs — pharmaceutical therapies that are either high cost, high complexity and/or high touch. High touch refers to higher degree of complexity in terms of distribution, administration, or patient management which drives up the cost of the drugs. In the early years specialty pharmacy providers attached "high-touch services to their overall price tags" arguing that patients who receive specialty pharmaceuticals "need high levels of ancillary and follow-up care to ensure that the drug spend is not wasted on them." An example of a specialty drug that would only be available through specialty pharmacy is interferon beta-1a (Avonex), a treatment for MS that requires a refrigerated chain of distribution and costs $17,000 a year. Some specialty pharmacies deal in pharmaceuticals that treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease (IBD) or Hepatitis C. "Specialty pharmacies are seen as a reliable distribution channel for expensive drugs, offering patients convenience and lower costs while maximizing insurance reimbursements from those companies that cover the drug. Patients typically pay the same co-payments whether or not their insurers cover the drug." As the market demanded specialization in drug distribution and clinical management of complex therapies, specialized pharma (SP) evolved. Specialty pharmacies may handle therapies that are biologics, and are injectable or infused. By 2008 the pharmacy benefit management dominated the specialty pharmacies market having acquired smaller specialty pharmacies. PBMs administer specialty pharmacies in their network and can "negotiate better prices and frequently offer a complete menu of specialty pharmaceuticals and related services to serve as an attractive 'one-stop shop' for health plans and employers."
GoodRx Holdings, Inc., is an American healthcare company that operates a telemedicine platform and free-to-use website and mobile app that track prescription drug prices in the United States and provide drug coupons for discounts on medications. GoodRx checks drug prices at more than seventy-five thousand pharmacies in the United States. The platform allows individuals to consult with a doctor online and obtain a prescription for certain types of medications at a cost of US$20, regardless of insurance status. Medical testing services, which vary in price, are also offered through the platform.
Optum, Inc. is an American healthcare company that provides technology services, pharmacy care services and various direct healthcare services.
J. David Joyner is an American business executive. He is the president and chief executive officer of CVS Health, and the former president of CVS Caremark.
{{cite journal}}
: CS1 maint: multiple names: authors list (link)