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CVS Health is Changing the Way it Prices Prescription Drugs Using a New Cost-Plus Model

New ‘simple’ pricing scheme will provide transparency and value to all stakeholders, says company’s Chief Pharmacy Officer

Woonsocket, R.I.-based CVS Health (NYSE:CVS) is planning to scrap what it says is an old-school prescription reimbursement model and turn to a new way to price prescription medications at its 9,000 CVS pharmacies nationwide. Why is this relevant for clinical laboratory and pathology managers? It shows the disruption that is ongoing in healthcare.

Like clinical laboratories, retail pharmacies have significant reimbursement, competition, and labor challenges to address. But unique to retail pharmacies is the emergence of pharmacy benefit management (PBM) companies that work between health insurance plans and drug makers.

“National pharmacy chains found themselves disintermediated from providing prescriptions to patients by pharmacy benefit management (PBM) companies. By 2021, PBMs had captured $484 billion of the total prescription drug spending of $576.9 billion. That meant PBMs controlled 84% of the prescription drug market! That caused retail pharmacies to look for new sources of revenue,” noted Dark Daily’s sister publication The Dark Report.

This arrangement may be motivating retail pharmacy companies to seek ways to recover the volume lost to PBMs.

CVS’ new CostVantage model will work with a formula based on how much CVS paid for the drug, a set markup over those costs, and a fee for pharmacy services to fill the prescription, according to a news release. Some experts and publications have compared the change to the approach used by the Mark Cuban Cost Plus Drug Company.

CVS Health expects to start CostVantage in 2024 before introducing it to PBMs for commercial payers in 2025.

CVS is “committed to lowering drug pricing,” CVS Health Chief Executive Officer Karen Lynch (above), CVS Health’s President and Chief Executive Officer, told CNBC. “What this (the new model) does is it essentially aligns the economics of our pricing for drugs to what consumers will pay at the pharmacy counter,” she added. Clinical laboratory managers and pathologists should understand that this new pricing strategy may be an attempt by CVS to win back prescription business lost to pharmacy benefit management companies. (Photo copyright: Rick Burn/Wikipedia.)

CVS Aims for Value and Transparency

CVS Health’s leaders believe it is time for a change in how the company’s pharmacies are reimbursed by PBMs and other payers.

Prem Shah, PharmD, Executive Vice President and Chief Pharmacy Officer, CVS Health, explained during a CVS Health Corporation Investor Day presentation some of the challenges of current pharmacy reimbursement:

  • Generic drugs dispensed in CVS pharmacies reached 90%. “That limits the capacity or the amount of value remaining through the higher levels of generic dispensing,” he said.
  • Also branded drugs have risen in price about 40% since 2019, leading to “higher costs for patients, our customers’ plans, and PBM plan sponsors.”

“This model has reached an inflection point that is just ripe for change,” Shah said. “We’re changing this outdated reimbursement model that made sense for the last decade, but no longer works today or in the future. We’re introducing a new simple model that provides value for all stakeholders across the supply chain in a much more simple, transparent, and comprehensive way,” he continued.

Cost-Plus Plans versus Retail Drug Prices 

Fierce Healthcare compared CVS CostVantage to the Mark Cuban Cost Plus Drug Company, which claims it offers prescription drugs at prices below traditional pharmacies and openly shares with customers the “15% markup over its cost, plus pharmacy fees.”

Some examples on the company’s website include: Abiraterone acetate (generic for Zytiga), a prostate cancer treatment. It is priced at $33.50, compared to $1,093 retail. Cost Plus Drug Company says its costs are:

  • Manufacturing: $24.60
  • 15% markup: $3.90
  • Pharmacy labor fee: $5.00

Another drug offered is canagliflozin (generic for Invokana), a type 2 diabetes medication, which sells for $245.92, compared to $676.14 retail. Cost Plus Drug Company says its costs are:

  • Manufacturing: $209.50
  • 15% markup: $31.42
  • Pharmacy labor fee: $5

Expert Sees More Cost-Plus Plans

In a column he penned for Drug Channels titled, “What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices,” Adam Fein, PhD, President of the Drug Channels Institute, a pharmaceutical research firm, wrote “Mark Cuban should be flattered but not fearful.”

Fein predicts there will be more cost-plus models by retail pharmacies. “Other large pharmacies will likely follow CVS with attempts to force payers and PBMs to accept some form of cost-plus reimbursement,” he wrote.

Fein noted pharmacies prefer cost-plus models for reasons including the “stripping away of complexity and hidden cross-subsidies. … For a pharmacy, the same PBM would pay the same price for the same prescription regardless of the PBM’s arrangement with different plan sponsors.”

Turbulent Retail Pharmacy Market

CVS has also been dealing with limited growth, pharmacist labor relations issues, and a decline in COVID-19 testing, Healthcare Dive reported.

Meanwhile, pharmacies have been closing store sites and affiliated physician practices. CVS announced plans to close 900 stores between 2022 and 2024, according to a news release.

Rite Aid Corporation, Philadelphia, announced last year that it had filed for bankruptcy and may eventually close 400 to 500 of its 2,100 stores. 

Walgreens Boots Alliance, Deerfield, Ill., intends to close 150 US and 300 United Kingdom locations, according to its former Chief Financial Officer James Kehoe’s remarks in a third quarter 2023 earnings call transcribed by Motley Fool.

The turbulence in the retail pharmacy market is another sign of ongoing disruption in healthcare. Long-established sectors are experiencing market shifts that are eroding their access to patients and ability to generate adequate profits.

Understanding how pharmacies approach these issues may help medical laboratory and pathology managers develop strategies for adding value to their relationships with healthcare providers and insurance plans.

—Donna Marie Pocius

Related Information:

CVS Health Highlights Path to Accelerating Long-Term Growth through Building a World of Health Around Every Consumer

CVS to Change How it Prices Prescription Drugs with New Pharmacy Reimbursement Model

CVS Health Corporation Investor Day

Navigating CVS’s New Pricing Models: What to Know about CVS CostVantage and CVS Caremark TrueCost

CVS Health Revamps Pharmacy Reimbursement Model Amid Scrutiny on High Drug Prices

What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices

CVS Health Announces Steps to Accelerate Omnichannel Health

CVS Overhauls How Its Retail Pharmacies Charge for Prescription Drugs

Walgreens to Close 60 VillageMD Locations

Bankruptcies and Store Closings are Signs of Tough Times Ahead for US Retail Pharmacy Chains

Group of Transparent Pharmacy Benefit Managers Form Transparency-Rx to Advocate for Clarity and Reform in Pricing of Prescription Drugs

Coalition is pushing for action among 43 pharmaceutical pricing bills currently before Congress

Increased transparency that lets consumers see prices charged by hospitals, physicians, and clinical laboratories in advance of service is an important goal of healthcare policymakers and self-insured employers. But greater transparency has yet to affect how prescription drugs are first priced, marked up, and charged to the final purchasers.

Now a group within the pharmaceutical industry has issued a call for greater transparency in the pricing of prescription drugs. A number of smaller Pharmacy Benefit Managers (PBMs) have formed a coalition against the often confusing and overly complex pricing of prescription drugs in hopes that their efforts will give healthcare consumers more clarity when it comes to comparison shopping for pharmaceuticals.

Calling itself Transparency-Rx, the newly-formed coalition “will push for changes to the PBM model … [such as] a ban on spread pricing as well as reforms to the rebate model that include the impact of group purchasing organizations,” Fierce Healthcare reported.

Traditional PBMs act as a third-party to connect pharmacies and drug companies with healthcare payers. This new alliance of “Transparent” PBMs claims that traditional PBMs need to be reformed, and that is what Transparency-Rx is advocating.

According to a press release, Transparency-Rx is working with both political parties in Congress and the current administration to bring “critical reforms to a costly and misaligned drug pricing market.”

The group is seeking:

  • A 100% pass-through model.
  • A ban on spread pricing.
  • National reporting and disclosure requirements for the industry and its consultants.
  • Delinking provisions that will require PBMs to be paid by a flat, disclosed fee.
  • Rebate reform, inclusive of “group purchasing organizations” (GPOs).
  • Technology that empowers actionable data and information to be shared with patients, plans, pharmacists, and physicians, throughout the drug supply-chain.

“In an industry that has opposed meaningful drug reform, Transparency-Rx seeks to inject common-sense, change, and clarity into a complex environment,” the coalition stated in its press release.

This is consistent with the wider goal of healthcare policymakers to achieve fully-transparent prices for all healthcare services so that buyers—self-insured employers, patients, and others—can easily compare prices of prescription drugs.

“The notion that transparency is a dangerous idea, to us is sort of a little absurd—it’s already working,” Transparency-Rx founder, President, and Managing Director Joseph Shields, JD, (above) told Fierce Healthcare. “The question is, can Congress help empower it and take it to scale for a variety of different plans?” (Photo copyright: Transparency-Rx.)

Transparency-Rx Members

In a press release announcing S.4293—the Pharmacy Benefit Manager Transparency Act of 2022—Senator Chuck Grassley stated, “Today, three PBMs control nearly 80% of the prescription drug market. They serve as middlemen, managing every aspect of the prescription drug benefits process for health insurance companies, self-insured employers, unions, and government programs. They operate out of the view of regulators and consumers—setting prescription costs, deciding what drugs are covered by insurance plans and how they are dispensed—pocketing unknown sums that might otherwise be passed along as savings to consumers and undercutting local independent pharmacies. This lack of transparency makes it impossible to fully understand if and how PBMs might be manipulating the prescription drug market to increase profits and drive-up drug costs for consumers.”

The act was reintroduced as S.127 to the next Congress in 2023.

According to PharmaNewsIntelligence, “Vertical integration within the market has resulted in most PBMs being owned by the largest insurers in the country. The ACMA [Accreditation Council for Medical Affairs] estimates that CVS Caremark, Express Scripts, and OptumRx control approximately 89% of the market share.”

Transparency-Rx represents more than 14 million people in all 50 states, the press release notes. Founding transparent PBM members include:

“The founding members are companies that are looking to have a voice in the drug pricing debates and reform efforts,” Joseph Shields, JD, founder, President, and Managing Director of Transparency-Rx, told Fierce Healthcare.

Transparency-Rx’s efforts will “likely ruffle feathers at the industry’s biggest companies,” Fierce Healthcare surmised.

“As a counterweight to the status-quo, Transparency-Rx confronts stale and dated ideas, takes on corporate monopolies, and especially big PBMs and the insurance lobby,” Transparency-Rx states on its website. “For too long, these special interests have been the lone and loudest voice fighting against real policy changes on drug pricing and health care, protecting a broken system which hides profits and inflates prescription costs, harming the interests of diverse communities, working families, and seniors.”

Transparent PBMs Focus on Congress

“Congress should know patients, employers, and plans can thrive in a transparent, competitive, and efficient PBM market,” LeAnn Boyd, PharmD, CEO and founding partner at Liviniti, told Fierce Healthcare. “We embrace critical reforms to a costly and misaligned drug pricing market. In fact, most of these reforms are already reflected in the business and innovations of transparent PBMs.”

Clinical laboratory managers and pathologists may be surprised to learn that 43 bills are currently pending in Congress. Each of these bills focuses on changing the prescription pricing policy for both public and commercial healthcare sectors. The number of pending bills on this topic signals that many in Congress consider the long-standing and complex pricing structure of prescription drugs to be a major issue that needs a solution.

“The coalition is working with lawmakers on both sides of the aisle as well as with the Biden administration, according to the announcement,” Fierce Healthcare reported.

“Just as transparency offers a better way to managing prescription drug benefits, Transparency-Rx represents a step forward to sound policy solutions, galvanizing true affordable prices,” Transparency-Rx claims.

“We’re not naive in terms of where we are in the conversation. We’re looking to scale up and play a meaningful role,” Shields told Fierce Healthcare.

Transparency-Rx’s progress is worth following because it’s a group of smaller PBMs forming a coalition to advocate for more transparency in the prices of prescription drugs. Currently, it’s nearly impossible to understand the way drugs are priced and how rebates are passed along the reimbursement chain. That complexity is what is causing transparent PBMs to organize.

How big is this problem? For 2022, prescription drug spending was $405.5 billion, according to government data. That is about four times the amount spent annually in the United States for clinical laboratory and anatomic pathology testing.

—Kristin Althea O’Connor

Related Information:

Transparent PBMs Form Coalition to Advance Industry Reforms

New Coalition of Transparent PBM Companies Seeks to Fix Nation’s Broken Drug Pricing System

A Unique Approach: Transparent PBMs

Exploring Pharmacy Benefit Manager Reforms: Transparency

Spread Pricing 101

S.127-Pharmacy Benefit Manager Transparency Act of 2023

S.4293-Pharmacy Benefit Manager Transparency Act of 2022

Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

By partnering with drug manufacturers to connect customers with clinical trials, the retail pharmacy chain believes this new venture will be the company’s “next growth engine.”

Walgreens is launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giants’ growing menu of healthcare services. This new venture might also mean additional test orders for clinical laboratories and pathology groups in areas that serve Walgreens customers.

In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” Dark Daily’s sister publication, The Dark Report, reported on Walgreens’ goal of building 1,000 primary care clinics at its retail pharmacies by 2027, a move which mimics the rollout of CVS Pharmacy MinuteClinic and Walmart Health primary care clinics in their retail locations.

Now, Walgreens is attempting to further redefine the patient experience by partnering with pharmaceutical companies to find participants for clinical trials, a business that could result in more Americans from underrepresented racial and ethnic populations enrolling in drug-development trials. With 9,021 retail pharmacies in all 50 states, it is well-positioned to know which of its customers would be candidates for different clinical trials.

“Walgreens’ trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, in a press release.

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, believes Walgreens can play a role in solving the issues of diversity and declining enrollment in clinical trials. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve,” she said in a press release. (Photo copyright: Walgreens.)

Serving the Socially Vulnerable

In an interview with Fierce Healthcare, Tandon described the clinical trials business as Walgreens’ “next growth engine” of consumer-centric healthcare solutions.

According to the company press release, “Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person.”

Walgreens notes that more than half of its roughly 9,000 U.S.-based stores are in “socially vulnerable areas.”

According to the Washington Examiner, a US Food and Drug Administration (FDA) study revealed that 75% of patients who participate in clinical trials are white, while just 11% are Hispanic and fewer than 10% are Asian or black. In addition, participation in clinical trials has been declining, with 80% of trials failing to attract enough participants on time.

Tandon maintains that making the process of participating in clinical trials easier is another key to increasing diversity and participation in clinical trials.

“During the clinical trial journey, we know it’s a burden for patients to visit sites. We also know that 78% of patient-consumers in the US live within five miles of a Walgreens,” she told PharmaVoice. “If a patient can complete much of the up-front clinical trial requirements at a local Walgreens, or conduct some of the visits digitally, it would make the whole clinical trial experience that much more positive and, maybe, encourage the patient to participate in new clinical trials going forward.”

Walgreens also plans to use its treasure-trove of customer data to find potential patients for its trials business.

“Understanding this detail of customer preference and segmentation can be quite useful particularly in clinical trials, for example, to create better protocols,” Tandon told PharmaVoice. “We are sitting on so much information, but we can, and need to, do a better job of using these insights in a real-world setting, which can be translated to pharma R/D or brand management organizations. We’re all about patient-centric drug development.”

FDA Seeks Diversity in Clinical Trails

Walgreens is in discussions with several drug manufacturers as it looks to launch this new venture.

“We are working very closely with them to understand their business needs and create the solution that’s going to be sort of bespoke to their specific trial needs,” Tandon told Fierce Healthcare. “Our goal is to move that needle and start to see a larger number of US patients participating and highly diverse participants that are coming into clinical trials.”

In April, an FDA press release announced new draft guidance aimed at “developing plans to enroll more participants from underrepresented racial and ethnic populations in the US into clinical trials.”

“Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research,” the FDA stated. “Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.”

Disintermediation of Retail Pharmacies

“Walgreens has a significant opportunity to create an interconnected healthcare ecosystem where we can use the physical assets of Walgreens and connect with patients and consumers at a local level to better support healthcare and healthcare equality,” Tandon said in PharmaVoice.

This is the latest example of a billion-dollar retail pharmacy chain diversifying away from simply filling prescriptions. Two types of competitors are driving the disintermediation of retail pharmacies because they end up directing patients away from the pharmacy:

  • Amazon.com acquired PillPack and now sends, via mail, prescriptions to patients’ homes.
  • Pharmacy benefit management (PBM) companies with a business model that encourage patients to get 90 days of prescriptions at once, mailed to their home.

In both cases, retail pharmacies lose access to patients. This is what is motivating several national pharmacy chains to offer primary care within their retail pharmacies (where following an office visit with a general practitioner, the patient simply crosses the store to the pharmacy to fill his/her prescription), as well as the clinical trial matching business.

As retail pharmacy chains become an increasingly disruptive force in healthcare, clinical laboratory managers and pathologists should be preparing new strategies to meet the testing needs of a changing primary care delivery model, which likely will include lab testing being offered in nontraditional medical locations.  

Andrea Downing Peck

Related Information:

Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience

Pharmacy Retail Giant Walgreens Looks to Disrupt Clinical Trials Business

By 2027, Walgreens Wants 1,000 Primary Care Clinics

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

Walgreens Opens First Clinical Trial Business to Achieve ‘Equitable’ Health Options

With Its Wealth of Patient Data, Walgreens Is Looking to Disrupt the Clinical Trial Space

New CMS Proposed Rule Encourages Value-Based Reimbursement Based on Patient Outcomes When Payers and Drug Manufacturers Negotiate Payment for Pricey Therapies

Clinical laboratories and anatomic pathology groups should consider this another example of how CMS is taking forward steps to encourage value-based payment arrangements throughout the health system

With the sky-high cost of many prescription drugs and gene therapies, it was only a matter of time before the Centers for Medicare and Medicaid Services (CMS) would seek to link reimbursement for them to patient outcomes.

A recent CMS proposed rule (CMS-2842-P) concerning value-based purchasing (VBP) for prescription drugs covered by Medicaid encourages payers to engage in Medicaid state value-based purchasing (aka, pay-for-performance) arrangements for expensive prescription drugs. This rule may have implications for medical laboratories and anatomic pathology groups if it were extended to cover companion diagnostics linked to expensive therapeutic drugs and gene therapies.

CMS also intents the proposed rule to help drug manufacturers ease roadblocks to contracting with payers—including Medicaid—a CMS fact sheet explained.

Federal officials are looking to reimburse healthcare providers for prescribing drugs that are shown to work best on patients that truly need them, while also incentivizing pharmaceutical manufacturers to created drugs “of high patient value,” stated Laffer Healthcare Intelligence, a Nashville, Tenn. healthcare investment firm, in an email to its intelligence service subscribers. 

In a press release announcing the proposed rule, Seema Verma, CMS Administrator, said “We are creating opportunities for drug manufacturers to have skin in the game through payment arrangements that challenge them to put their money where their mouth is.”

Old Regulations Don’t Address Value, Expensive Gene Therapies

According to CMS, for 30 years federal regulations have favored the “volume of drugs” sold over the “quality of drugs.” Simultaneously, during the past three years the US Food and Drug Administration (FDA) has approved four gene therapies with many more “in the development pipeline,” Verma wrote in the journal Health Affairs. “While the lifesaving impact of these often-curative therapies are profound, their costs are unprecedented,” she stated.

CMS’ new rule proposes to define value-based purchasing as “an arrangement or agreement intended to align pricing and/or payments to evidence-based measures and outcomes-based measures,” Verma added.

Companion Diagnostic: Molecular and Genetic Testing

For clinical laboratories, the case CMS makes for therapeutic drugs could be applied to expensive molecular diagnostics and genetic testing. CMS may base reimbursement on how accurately and how fast a lab test can enable a diagnosis. Also, payment could be linked to a lab’s report and guidance to the ordering provider in selecting a therapy that makes a difference in the patient’s outcome.

“This is exactly the concept of the companion diagnostic,” said Robert Michel, editor-in-chief of Dark Daily and its sister publication, The Dark Report. “Take, for example, a $5,000 genetic cancer test that that stages a $500,000 cancer prescription drug. Patients who will not benefit from the drug will not get it. And the $5,000 lab test may keep, say, 10 people from getting a drug that wouldn’t work for them. Thus, the $50,000 in lab tests could save $5 million in prescription drug costs,” he explained.

Deals That Focus on Gene Therapies

One gene therapy recently approved by the FDA is Zolgensma (trade name for Onasemnogene abeparvovec), a treatment for children with spinal muscular atrophy. It costs about $2 million for a one-time use, FDA Review reported.

For its part, Novartis, the Basel, Switzerland-based creator of Zolgensma, said the proposed CMS changes are “an important first step,” and helpful to the company’s “access strategy” in the US, BioPharma Dive reported.

Healthcare experts envision that deals struck under the new proposed CMS rule will focus on gene therapies and expensive drugs, MedPage Today reported.

Alexander Dworkowitz, Partner, Manatt Health
“Measuring outcomes is costly; it takes time, and everyone has to come up with a way to do it. So, if a drug costs $50, it’s not worth going to every single patient (in research). If the drug costs $500,000, maybe it’s worth it … figuring out if the drug worked. That’s why people talk about it in the context of gene therapies,” Alexander Dworkowitz (above), Partner, Manatt Health, New York, told MedPage Today. (Photo copyright: Manatt, Phelps and Phillips, LLP.)

Advancing Precision Medicine, Improving Patient Access

The CMS news release summarized potential benefits of the proposed rule (comments period ends July 20):

  • Support paying providers on improved patient outcomes instead of fees for services and volume.
  • Insurers could be in a better position to negotiate based on a drug’s effectiveness.
  • More clinical evidence about therapies may become available.
  • Providers and payers may see opportunities to use and offer medications and treatments in a precision medicine manner.
  • Patients may have greater access to new therapies.

Proposed Rule Names Pharmacy Benefit Managers, Opioids

According to the Laffer Healthcare Intelligence analysis email, CMS’ 137-page proposed rule is “very broad,” but focuses on three themes:

  •  “First, CMS wants to establish an official definition for VBP models to accelerate development of drug pay-per-value programs.
  • “Second, CMS want to restrict the amount of opioids doctors can prescribe.
  • “Third, very subtle changes are proposed that negatively affect the PBM (pharmacy benefit management) industry.”

CMS’ proposal also includes standards aimed at fighting opioid prescription fraud and misuse in Medicaid drug programs, noted Fierce Healthcare.

Transparent Drug Prices

Medical laboratory leaders may want to monitor the progress of this proposed rule. In addition to value-based payment, the rule advances price transparency by clearing the way to sharing prices of therapeutic drugs and how they improve patient care, while also lowering costs.

Meanwhile, a refresh of lab information technology to enable authorization of genetic and molecular tests by payer also may prove worthwhile.

—Donna Marie Pocius

Related Information:

Fact Sheet: Establishing Minimum Standards in Medicaid State Drug Utilization and Supporting Value-based Purchasing for Drugs in Medicaid, Revising Medicaid Drug Rebate and Third-Party Liability Requirements (CMS 2482-P)

CMS Issues Proposed Rule Empowering Commercial Plans and States to Negotiate Payment for Innovative New Therapies Based on Patient Outcomes

Federal Registry: Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-based Purchasing for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third-Party Liability Requirements (CMS 2482-P)

CMS’ Proposed Rule on Value-based Purchasing for Prescription Drugs: New Tools for Negotiating Prices for the Next Generation of Therapies

FDA Approves $2 Million Drug; Blame the Price on Excessive Regulation

With New Proposal, Trump Administration Tries to Encourage ‘Value-based’ Drug Deals

CMS Proposes Rule to Encourage ‘Value-based’ Drug Payments in Medicaid—Could Ease Access to Expensive Therapies, Experts Say

CMS Proposed Rule Aims to Foster More Medicaid Value-based Drug Agreements

Kroger Prescription Plans Partners with Myriad Genetics to Offer GeneSight Genetic Tests and Genetic Counseling in Kroger Pharmacies

Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances

In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.

As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.

Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.

“Depression is a leading cause of disability and lost productivity in the United States, and only 40% of people reach remission after their first antidepressant medication,” Colleen Lindholz (above), President of Kroger Health, told the Cincinnati Business Courier. “We are committed to helping people combat this debilitating disease, and we’re proud to launch this pilot program. This test can help patients escape the frustrating process of trying multiple medications in the hopes of finding one that works.” (Photo copyright: EatingWell.)

Kroger Not the Only Pharmacy to Offer Genetic Tests and Counseling

Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.

Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.

Participating locations include:

  • 21 Sav-On pharmacies at Albertsons in Boise, Idaho;
  • Five Jewel-Osco pharmacies in the Chicago area; and
  • Two Sav-On pharmacies at Acme supermarkets in the Philadelphia area.

The Albertsons-Genomind partnership is aimed at patients who may be struggling with a medication for depression, anxiety, obsessive-compulsive disorder, or other mental illnesses. Patients can receive counseling from “specially trained pharmacists” who work with referring clinicians to offer [Professional PGx], noted Supermarket News.

Pharmacists as Genetic Test Counselors?

Pathologists and medical laboratory leaders may be intrigued by the concept of putting pharmacists into the role of a genetic test counselor. However, pharmacists may need to increase their knowledge of pharmacogenomics, reported Drug Topics.

“The science advances in the field are just making it more critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics] into their training,” Kathleen Jaeger, National Association of Chain Drug Stores (NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug Topics.

However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.

Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.

“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.

“Additionally, pathologists are trained to understand the technical performance of clinical laboratory tests, such as whether the sample was of acceptable quality to produce a reliable result, whether the analyzer that produced a result was performing within specifications, and what factors should be considered in tandem with the lab test results when making a diagnosis,” he explained. “It is easy to see why the pathology profession would argue that pharmacists lack this depth of knowledge and experience when ordering and interpreting medical laboratory tests. How the pathology profession will respond to these developments involving pharmacists, interpretation of genetic test results, and counseling patients is not yet clear.”

Opportunities for Clinical Laboratories to Assist Pharmacies

This is not the first time Dark Daily has reported on genetic tests becoming popular as a corporate benefit. In “More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories,” we predicted that genetic test coverage by companies would expand and possibly drive new sources of revenue through increased lab test volume.

Additionally, we suggested, clinical laboratory leaders and pathologists could find opportunities helping others understand the results of the genetic tests.

The recent partnerships between genetic test companies and corporate retail pharmacies suggest that clinical laboratories could benefit from reaching out to pharmacists who are now at a point-of-care and who may be looking to improve their knowledge of pharmacogenomics.

—Donna Marie Pocius

Related Information:

Myriad Announces Coverage Decision by Kroger Prescription Plans for GeneSight

GeneSight GUIDED Study Published in the Journal of Psychiatric Research

Myriad Pushing Ahead with Payers on GeneSight as Data from Large Randomized Study is Published

Impact of Pharmacogenomics on Clinical Outcomes in Major Depressive Disorder in the GUIDED Trial: A Large Patient-and-Rater-Blinded, Randomized, Controlled Study

Albertsons Cos Pharmacies Offer Genetic Testing

Pharmacogenomics and the Future of Pharmacy

Consumer Genetic Testing Pharmacogenomics, a Potential Opportunity for Pharmacists

More Companies Pay for Employees to Have Genetic Tests in a Trend that Brings More Test Volume to Medical Laboratories

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