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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] According to the American Pharmacists Association, "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." [3] [4] 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] [4]
As of 2016, PBMs managed pharmacy benefits for 266 million Americans. In 2017, the largest PBMs had higher revenue than the largest pharmaceutical manufacturers, indicating their increasingly large role in healthcare in the United States. [5] However, in 2016 there were fewer than 30 major PBM companies in this category in the US, [1] and three major PBMs (Express Scripts, CVS Caremark, and OptumRx of UnitedHealth Group) comprise 78% of the market and cover 180 million enrollees. [1] [6]
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. [7]
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. [8] This practice is known as "spread pricing". [9] Savings are generally considered trade secrets. [10] 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. [11]
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. [12] Pharmaceutical manufacturers say that in order to cover the cost of these rebates, they are forced to raise the price of drugs. For example, the president of Eli Lilly and Company claims the cost of discounts and rebates accounts for 75% of the list price of insulin. PBMs such as Express Scripts claim rebates are a response to rising list prices, and are not the cause of them. [13]
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". [14] 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. [15] Since 2017, six states have passed legislation making such "gag clauses" illegal. [16] This has recently been followed by a federal bans on gag orders [17] for private insurance effective Oct 2018, [18] and for Medicare effective Jan 2020. [19]
Overall, the PBM industry claims to provide significant cost savings for end users. For example, in 2015, CVS Caremark said that it reduced its plan members' prescription drug spending to 5%, down from 11.8% in 2014. [20] However, such conclusions can be controversial. A 2013 investigation of PBM marketing from Fortune Magazine showed: Drug pricing is difficult to untangle and customers have no way of knowing how much they are saving. [21]
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". [22] : 34
By the late 1980s, PBMs had become a major force "as health care and prescription costs were escalating". [23] 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). [24] : 304 [25] After SmithKline Beecham acquired DPS in 1994, Diversified played a pivotal role in its Healthcare Service division and by 1999 UnitedHealth Group accounted for 44% of Diversified Pharmaceutical Services's total membership. [25] Express Scripts acquired Diversified in April 1999 and consolidated itself as a leading PBM for managed care organizations. [25]
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. [26]
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", [22] : 34 negotiating "drug discounts with pharmaceutical manufacturers", [22] : 34 and providing "drug utilization reviews and disease management". [22] : 34 PBMs also created a formulary to encourage or even require "health plan participants to use preferred formulary products to treat their conditions". [22] : 34 In 2012, Express Scripts and CVS Caremark transitioned from using tiered formularies, to those that excluded drugs from their formulary. [1] [27]
As of 2004, the Federal Trade Commission found PBMs operated in a marketplace with "vigorous competition". [28] And as of 2013, in the United States, a majority of the large managed prescription drug benefit expenditures were conducted by about 60 PBMs. [29] Few PBMs are independently owned and operated. PBM's 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] [4] However, in 2016 fewer than 30 major PBM companies were in this category in the US, [1] and only three major PBMs (Express Scripts, CVS Health, and OptumRx of UnitedHealth Group) comprised 78% of the market, covering 180 million enrollees. [1] [6]
In 2015, the three largest public PBMs were Express Scripts, CVS Health (formerly CVS Caremark) and United Health/OptumRx/Catamaran. [30] [31] [32] As of 2018, the three largest PBMs controlled more than 80% of the market. [33]
In 2012 Express Scripts acquired rival Medco Health Solutions for $29.1 billion and became "a powerhouse in managing prescription drug benefits". [34] As of 2015, Express Scripts Holding Company was the largest pharmacy benefit management organization in the United States. [35] with 2013 revenues of $104.62 billion. [36]
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. [35]
In 1994, CVS launched PharmaCare, a pharmacy benefit management company providing a wide range of services to employers, managed care organizations, insurance companies, unions and government agencies. [37] By 2002 CVS' specialty pharmacy ProCare, the "largest integrated retail/mail provider of specialty pharmacy services" in the United States, [38] : 10 was consolidated with their pharmacy benefit management company, PharmaCare. [38] [39] : 4 Caremark Rx was founded as a unit of Baxter International and in 1992 spun off from Baxter as a publicly traded company. In March 2007, CVS Corporation acquired Caremark to create CVS Caremark, later re-branded as CVS Health. [40]
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. [41]
OptumRx, one of the Optum businesses of UnitedHealth Group Inc, has been a leading PBM. [42] In March 2015 UnitedHealth Group acquired Catamaran Corporation for about $12.8 billion to extend this PBM business. [43] [44]
Many Pharmacy benefit managers are represented by the trade association the Pharmaceutical Care Management Association.
PBMs have been strong proponents in the creation of a U.S. Food and Drug Administration pathway to approve biosimilar versions of expensive specialty drugs which treat conditions like Alzheimer's, rheumatoid arthritis and multiple sclerosis. [45] PBM's support so-called biosimilar legislation which does not grant brand name drug manufacturers monopoly pricing power. [46] In 2015 the Federal Trade Commission 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. [47]
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. [23]
In 2004, litigation added to the uncertainty about PBM practices. [41] [48] In 2015, there were seven lawsuits against PBMs involving fraud, deception, or antitrust claims. [1] [6]
State legislatures have been using "transparency," "fiduciary," and "disclosure" provisions to improve the business practices of PBMs. [48] In 2011, the Mississippi Board of Pharmacy formed a new division of the Pharmacy Benefit Managers, with a mandate to license and regulate PBMs. [49]
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. [50]
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". [51]
In 2017, the Los Angeles times wrote that PBMs cause an inflation in drug costs, especially within the area of diabetes drugs. [52]
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." [53]
On January 31, 2019, Health and Human Services released a proposed rule to remove Anti-kickback Statute, safe harbor protections for PBMs and other plan sponsors, that previously allowed PBMs to seek rebates from drug manufacturers. [54]
Ron Wyden said 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. [55]
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.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
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.
AdvancePCS Inc. was a large prescription benefit plan administrator from the United States, also known as a PBM.
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 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 largest healthcare company, and its headquarters are in Woonsocket, Rhode Island.
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.
A drug coupon is a coupon intended to help consumers save money on pharmaceutical drugs. They are offered by drug companies or distributed to consumers via doctors and pharmacists, and most can be obtained online. There are drug coupons for drugs from many categories such as cholesterol, acne, migraine, allergies, etc.
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 his/her 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.
Universal American is a Fortune 500 company with offices throughout the United States, and headquarters in Rye Brook, New York. The company offered health insurance, and also deals in Medicare managed care plans, and Medicare prescription drug benefits. Its CEO is Richard A. Barasch.
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.
Surescripts is an American information technology company based in Arlington, Virginia that supports e-prescription, the electronic transmission of prescriptions between health care organizations and pharmacies, as well as general health information exchange (HIE) of medical records.
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.
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."
Optum, Inc. is an American healthcare services provider with business interests encompassing technology and related services, pharmacy care services and various direct healthcare services. It has been a subsidiary of UnitedHealth Group since 2011. UHG formed Optum by merging its existing pharmacy and care delivery services into the single Optum brand, comprising three main businesses: OptumHealth, OptumInsight and OptumRx. In 2017, Optum accounted for 44 percent of UnitedHealth Group's profits and as of 2019, Optum's revenues have surpassed $100 billion. Also in early 2019, Optum gained significant media attention regarding a trade secrets lawsuit that the company filed against former executive David William Smith, after Smith left Optum to join Haven, the joint healthcare venture of Amazon, JPMorgan Chase, and Berkshire Hathaway.
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