Pharmacy Edge Magazin
Issue
Twenty One
Recent Legal Cases That Put Pharmacy Benefit Managers in a Bad Light
e
October - november 2018
Is There a Future for PBM Transparency? PBM Clawbacks
The Hidden Fees That Hurt Both Pharmacists and Patients
How Pharmacists Can Survive
Amazon
Darshan Kulkarni Pharm.D, MS, Esq.
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Pharmacy Edge 2018
Contents | October - November 2018
08 12 08
09
How Pharmacists Can Survive Amazon Darshan Kulkarni Pharm.D, MS, Esq. Is There a Future for PBM Transparency?
16 16
PBM Clawbacks The Hidden Fees That Hurt Both Pharmacists and Patients
18
Recent Legal Cases That Put Pharmacy Benefit Managers in a Bad Light
3
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How Pharmacists Can Survive Amazon Darshan Kulkarni Pharm.D, MS, Esq.
A
mazon has made several recent moves including hiring new health IT experts, and physicians to make a big foray into health1. Their recent disclosure that they want to enter the pharmacy world and their recent acquisition of PillPack2 makes pharmacists go - what does this mean for me? Will there be a reduced need for pharmacists?
As Global Positioning Satellites (GPS) became increasingly popular, the demand for traditional cartographers dropped significantly. Digital maps created and updated in real time compared an individual’s current location to their desired location and told the individual how to get to the final location. Traditional cartographers began to worry about their jobs and livelihood. Amazon’s overtures into pharmacy have similarly concerned pharmacists. However, since the concerns are similar, maybe the results will be too. There is a projection that between 2016 and 2026, the demand for cartographers will increase by 19%.3 This is attributed to an increased use of maps by government planning such organizations and the realization that there are some responsibilities that cannot be automated and delegated away.4 Similarly, pharmacists who hope to operate like they did 20 years ago are unlikely to survive. However, those who adapt, would likely be very much in demand. What Amazon taketh away, Amazon may also giveth Amazon has rarely been a manufacturer. Amazon typically connected businesses with potential clients and served as a marketplace. The marketplace originally
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started as being a place for them to sell their wares, but eventually expanded to become the Amazon Marketplace where anyone can use Amazon as a virtual store and sell their goods. As most know, goods sold by sellers on Amazon often compete against goods sold by Amazon itself, and the orders may often even be fulfilled by Amazon. Amazon has been happy to do this because they still make a profit with such an arrangement. So, one must wonder whether the pharmacy of the future will become a competitor to PillPack or will instead partner with them. Accordingly, pharmacists may be able to compete or deal with a post-PillPack pharmacy in one of the four following ways: 1) Amazon Marketplace Competing against PillPack in the near future will likely require demonstrating specialization and knowledge. Cartography grew because of the creation of Hyper-Local Communities (HLCs), These HLCs looked at the location of the nearest Dairy Queen but also looked for shops surrounding the Dairy Queen? This was unable to be achieved by large mapping companies. In the case of pharmacy, pharmacists could develop a specialization by connecting with unique providers or providing unique services or simply products
that cannot be easily mailed. This may include veterinary prescriptions, schedule II drugs, specialty drugs, emergency antibiotics, compounding or providing uniquely personalized care. 2) Delivering Services While Amazon has excelled at delivering goods, it has not demonstrated expertise in delivering services. As a result, CVS and Walgreens5 are looking to capitalize by partnering or hiring nurse practitioners or other mid level professionals and enabling them to engage with patients. Because these providers may be more likely to educate their patients at the pharmacy, diagnosed patients may find fulfilling their prescriptions on site to be more convenient. 3) New Partners Pharmacists traditionally think of Prescription Benefit Managers (PBMs)6 as their enemies. However, despite PBMs and Group Purchasing Organizations (GPOs) who are all supposed to theoretically help patients by keeping costs down, pharmacists feel squeezed and don’t have enough of a margin. With a new Amazon entrant, a pharmacy may now effectively assert that PBMs, GPOs and Pharmacies are likely to perish if they don’t survive together. Accordingly, this may enable better pricing opportunities and better opportunities for patients. 4) Branded Prescriptions Being a pharmacist in the Amazon Marketplace may enable prescription fulfillment across the state if not the country.
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Amazon Marketplace may enable a pharmacist sitting in New York City to sell a prescription to a patient in Albany. In some cases, the pharmacy itself may deliver to the new patient, or create a new category of “celebrity pharmacists” who simply are trusted to provide appropriate care, while a PillPack may do the actual fulfillment and delivery of the prescription. Concerns While Amazon’s entry may provide interesting partnering opportunities, it is important that pharmacists consider relevant laws. The stark, anti-kickback, False Claims Act and civil monetary penalties law will each come into play. Accordingly, pharmacists hoping to partner with other providers, but should be careful with such endeavors since it may expose them to potential legal liability. The Future It seems likely that a push by Amazon into pharmacy may impact individual pharmacists who may see a decrease in patient volumes. This is likely to scare pharmacies and pharmacists. However, it seems like this may be a temporary situation and lead to more opportunities in the future. If you are interested in hearing more about how Amazon affects pharmacists, the implications of an Amazon Pharmacy and patient centricity, or how Amazon’s Prime membership discounts might work with medications, search for the Pharmacy Podcast Network wherever you listen to your favorite podcasts or reach out to me directly on Twitter (@DarshanTalks). Amazon hires renowned Massachusetts General cardiologist Maulik Majmudar, MD, https://www.healthcarefinancenews.com/news/amazon-hires-renowned-massachusetts-general-cardiologist-maulikmajmudar- md It’s Official: Amazon Enters Pharmacy Business With PillPack Acquisition https://www.forbes.com/sites/brucejapsen/2018/06/28/its-official-amazon-enters-pharmacy-business-with-pillpackdeal/# e3721613fab1 3 Cartographers and Photogrammetrists, https://www.bls.gov/ooh/architecture-and-engineering/cartographers-andphotogrammetrists. htm 4 The Relevance of Cartography, http://www.esri.com/esri-news/arcnews/winter1314articles/the-relevance-of-cartography 5 Walgreens introduces new digital marketplace to compete with Amazon https://knightfoundation.org/articles/making-maps-essential-to-communities 6 What Your Pharmacist Can’t Tell You http://allianceforpatientaccess.org/what-your-pharmacist-cant-tell-you/ 1
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Is There a Future for PBM Transparency?
I
nsurance companies hire pharmacy benefit managers to manage drug benefit programs. They act as middlemen between drug manufacturers, insurers, and pharmacies. Part of their role is to help reduce the costs of drug acquisition and set more affordable patient copayments. But due to the lack of transparency in their methods and business model, it is difficult to prove if their claim of affordable prescription drugs is true or not. As it turns out, PBMs take advantage of their unique central role in the drug market and play a game where they profit from the transactions between the pharmacy, insurers, and patients. Thanks to the lack of transparency, PBMs get away with it all the time. Their contracts with pharmacies have gag clauses that prohibit pharmacists from disclosing the actual cost of a drug or to provide information about more affordable alternatives. 12
The only way that pharmacists can bypass the gag clause is when a patient directly asks them about the actual drug cost or a cheaper alternative. But, if a consumer doesn’t ask questions, pharmacists stay mum about that vital information. This is why many legislations are pushing for PBM transparency. According to 50-State Network, an organization focused on better health care for people living with and diagnosed with chronic illness, PBM transparency is vital for many reasons. • Helps confirm if a PBM is, in fact, securing low drug costs for the government, large corporations, and plan sponsors and payers. • Allows plan sponsors to verify that PBMs are actually sharing manufacturer rebates. • Allows plan sponsors to verify if a PBM is providing the service they’re hired to do which is negotiating the lowest possible cost for specific drugs.
It is clear that transparency is one way to help reduce copayment amounts and the cost of prescription drugs. What is the government doing to make this happen? How the Goal Was Set In a December 2017 report on Drug Topics, Senior Sales Executive for San Francisco-based PBM SmithRx, Derek Daggett, said that there is an increase in the number of transparent PBMs. “Within the last five years, transparent PBMs have gone from being an outlier in the industry to now representing 40% of contracts,” he said. Unfortunately, the number of contracts that are truly transparent, with “full disclosure of network contracts, no spread, and full pass through of rebates,” remain comparatively low. Still, it was a step in the right direction. There are several things that brought this on. • Large companies sought alternatives to bypass the traditional PBM model. They formed alliances with other organizations in order to purchase prescription drugs without going through pharmacy benefit managers. • Others chose to work with PBMs that generate revenue through a disclosed and fixed fee per member per month. • Some plan sponsors also chose to pay
Pharmacy Edge 2018
an administrative fee where they can see the true cost of the drug instead of not paying. This led to some PBMs to recognize the need for more transparent contract terms, said Doug Hoey, RPh, CEO of The National Community Pharmacists Association (NCPA). But unless the top-tier PBMs that hold the lion’s share of the marketplace become transparent, small PBM companies will have difficulty emphasizing transparency or ensuring transparency gets a larger foothold. But perhaps PBM transparency legislation can push for a bigger and wider change. Louisiana Leads Drug Pricing Transparency Legislation Last year, many states focused on the issue of pharmaceutical manufacturer pricing. As it turns out, focusing on just one part of the ecosystem only results in partial transparency. But the Bayou State in Louisiana understood that real pricing transparency should involve real transparency by all concerned to get the best outcome. This gave birth to two pieces of legislation that concern PBM transparency. Senate bill 283 This law requires PBMs to publish their rebate data in aggregate form on a public website. PBMs must “provide for internet
publication of formularies; to provide for transparency reporting; to provide for certain reportable aggregate data; to provide for internet publication of the transparency report; to provide for definitions; to provide for the duties of the commissioner of insurance relative thereto; to provide for confidentiality; and to provide for related matters.” Senate bill 282 This law requires PBMs to report “Excess Consumer Cost Burden” and its impact on the prices that patients pay at the pharmacy. Specifically, “an amount charged to an enrollee for a covered prescription drug that is greater than the amount that an enrollee’s health insurance issuer pays, or would pay absent the enrollee cost sharing, after accounting for rebates, or where an enrollee is subject to a paid for as medical care under any hospital or medical service policy or certificate, hospital or medical service plan contract, preferred provider organization, or health insurance organization offered by a health insurance issuer.” Other transparency legislations have been passed in other states. Connecticut passed the drug price transparency bill into legislature. According to Sen. Kevin Kelly, R-Stratford, Senate Republican chair of the Insurance and Real Estate Committee, prescription health pricing is one of the biggest drivers of drug cost and the bill will help curb expensive
prescription drug prices. “This bill is designed to bring transparency to that process and, armed with that information, we hope that we will be able to bring the cost of pharmaceuticals in Connecticut under control.” An April 2018 press release from the National Community Pharmacists Association also showed that pharmacy associations and community pharmacists are pressing Congress to support three priority bills, two of which is related to transparency—“The Improving Transparency and Accuracy in Medicare Part D Drug Spending Act” (S413/HR 1038) and “The Prescription Drug Price Transparency Act” (HR 1316).” The Future of PBM Transparency Is Now Just recently, the state of Ohio released a data that showed how much of the public money for pharmacy benefits for Medicaid was retained by pharmacy benefit managers. Out of the $2.5 billion, $223.7 million went to PBMs last year. Greg Moody, the director of the Ohio Department of Health Transformation, said that it is not whether the amount is too high or too low but that they now have the information they never had before and one that they can use to make their argument and carry out check and balances.
Sources: https://www.50statenetwork.org/all-issues/PBM-transparency/ http://www.drugtopics.com/PBM/new-goal-PBMs-transparency http://drugwonks.com/blog/PBM-transparency-legislation-how-s-bayou https://ctmirror.org/2018/05/09/drug-price-transparency-bill-passes-legislature-no-dissent/ https://www.specialtypharmacytimes.com/news/PBM-transparency-dir-fees-top-priorities-for-pharmacists-on-capitol-hill https://rx.trxade.com/PBM-transparency-PBMs-made-223-million-from-ohio-medicaid/
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PBM Clawbacks
The Hidden Fees That Hurt Both Pharmacists and Patients
A
recent study conducted by the University of Southern California Schaefer Center showed that, due to clawbacks, almost a quarter of patients are paying more than their prescription drugs’ full price under their insurance plan. The practice is also the basis of many federal lawsuits filed against insurance companies and PBMs. Lawsuits have been filed against Cigna, United Health, Humana, and Optum Rx, among others. The theories of liability include violations of the Racketeer Influenced
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and Corrupt Organizations (RICO) Act and the breach of fiduciary duty under the Employment Retirement Income Security Act (ERISA). What is a clawback? This occurs when patients purchasing drugs from pharmacies make copayments that exceed their prescription drugs’ price. The excess amounts paid are then clawed back from the pharmacies by the insurers and/or pharmacy benefit managers. For example, a patient filled a prescription for the drug Sprintec, a
medication used to treat severe acne and for contraceptive purposes. The copay for the drug was charged at $50 but the pharmacy only received $11.65. This means $38.35 was directed back to the pharmacy benefit manager of the patient’s insurance company. A clawback is basically the hidden fees that patients have to pay when drugs are dispensed at the pharmacy. Since patients don’t know the actual cost of their prescription drugs, they are unaware that there are less expensive options.
Pharmacy Edge 2018
A medication that can be purchased in cash for $92 will cost a patient $164 when purchased using insurance from the same pharmacy. Understanding the pharmacy business Unlike other retail stores, a pharmacy uses a business model where they don’t have complete control of the prices they charge for their services and products. Pharmacy benefit managers leverage several aspects of contracts, allowing them to indirectly manipulate the usual and customary price in pharmacies. Usual and customary price (U&C price) This refers to the price that a business charges for products and services. Pharmacies are required by pharmacy benefit managers to submit their U&C price. A typical contract between the pharmacy and the PBM stipulates that the latter will pay the lesser of the following: • The U&C price • Maximum allowable costs (MAC) plus a dispensing fee • Average wholesale price (AWP) plus a dispensing fee and a minus a percentage This means the pharmacy can’t lower its U&C price if they ever want
to stay in business. If they rely on MAC reimbursement, they can only expect a few pennies on the table because reimbursement costs are often so low. Their only recourse is to ensure that they are paid the full allowable amount of every claim, which involves inflating their U&C price so that MAC reimbursement for drug prescriptions are higher. Effects of clawbacks on the pharmacy business It can potentially damage the relationship between patients and pharmacies because consumers will associate excessive costs with the pharmacy. Unfortunately, pharmacists are not allowed to tell customers about cheaper alternatives. And they have to charge the patients more whenever a copay is required. Worse, the pharmacies receive a bad rep but they’re hardly earning enough to cover the costs of drug acquisition. It is basically a lose-lose situation for them. Effects of clawbacks on patients and consumers Clawbacks hit patients where it hurts the most—their pockets. With PBM-
negotiated rebates with pharmaceutical companies passed on to consumers, they are paying more than the actual price of the drug with their copay. A medication that can be purchased in cash for $92 will cost a patient $164 when purchased using insurance from the same pharmacy. Because pharmacy benefit managers frequently charge a copay that far exceeds the cash price for generic drugs. Many pharmacists reported feeling complicit in price gouging but they are tied by “gag clauses” in their contracts with PBMs that stipulate that they do not offer low-cost options or discuss clawback practices. The only exception is when a customer specifically asks for a lower price option. Only then can a pharmacist provide the consumers with the right answer. Therefore, as a patient, protect yourself against clawback by asking your pharmacist the best price for your medication. If the costs of paying in cash for your prescription medication is much cheaper than using insurance, go for it. Because, more often than not, your insurance could be costing you more money at the pharmacy.
Sources: https://www.erisapracticecenter.com/2018/05/clawbacks-recent-litigation-targeting-insurers-and-pharmacy-benefit-managers/ http://www.thethrivingpharmacist.com/2016/11/27/the-art-of-the-claw-back/ https://www.pbahealth.com/pbm-clawbacks-what-your-pharmacy-needs-to-know/ https://imedicare.com/articles/what-do-clawback-fees-mean-for-pharmacies-and-patients/ http://blog.needymeds.org/2017/10/18/what-is-a-clawback-how-its-affecting-your-prescription-copays/#.W2vxhOgzbcs
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Pharmacy Edge 2018
Recent Legal Cases That Put Pharmacy Benefit Managers in a Bad Light P
harmacy benefit managers (PBMs) are no longer the good guys they are supposed to be. The number of legal cases filed against them over the years proves that there are anomalies in the way they do business. If only PBM transparency was maintained in all and every transaction they have with patients, insurance providers, and the government, PBMs would have less opportunity to fatten their pockets and drive prescription drug costs through the roof. But, as it is, transparency is lacking. And that provided PBMs the cover they need to carry out their evil plans. Recent Legal Cases Filed Against PBMs Negron v. CIGNA Corporation On October 13, 2016, Kimberly Negron filed a complaint against CIGNA Corporation, Cigna Health and Life Insurance Company, alleging violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and the Employment Retirement Income Security Act (ERISA).
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A 2014 lawsuit made by an Aetna actuary whistleblower has been unsealed. The insurance company alleged that the pharmacy benefit manager, CVS Caremark, billed the government for prescription drugs at a greater price than what was being paid to pharmacies.
The class action lawsuit alleged that the defendants participated in a conspiracy to overcharge patients. The plaintiff alleged that CIGNA required the network pharmacies to charge patients with excessive and unauthorized amounts for prescription drugs even when they are insured. This helped the PBM company established the spread and illegal clawbacks. On March 12, 2018, a bid to dismiss the case was rejected by a Connecticut federal judge. US District Judge Warren W. Eginton found that the plaintiff’s allegations are true. “Taking the allegations to be true, the court cannot hold as a matter of law that plaintiffs have failed to allege that Cigna directly or indirectly participated in the alleged enterprises’ affairs through racketeering activity,” Judge Eginton wrote. As for the ERISA claims, there was no need for the plaintiff to exhaust administrative remedies because there are no procedures in place that will address the claims for overcharging. But the judge allowed most of the claims to survive because CIGNA was
Pharmacy Edge 2018
determined as fiduciaries who breached their fiduciary duty under ERISA. PBMs vs. Webb County, TX A suit filed in Webb County last January was recently absorbed into Ohio as a hefty lawsuit against pharmacy benefit managers. According to a report in STAT, the lawsuit alleged that PBMs have a role in allowing access to prescription opioids that are partly to blame for the severity of the opioid epidemic. PBMs are said to have driven the epidemic on the basis of increasing profits from the opioid drugs.
“We see them as an absolutely essential part of this scheme,” Webb County lawyer Joanne Cicala told STAT. “They made sure these drugs were dispensed and they controlled their flow out into the communities.” The suit is filed against the 3 largest PBMs—CVS, Express Scripts, and OptumRx, as well as Navitus Health Solutions and Prime Therapeutics, 2 smaller PBMs that operate in Texas. Legal experts say that it will be difficult to prove the role the PBMs played in overdose-related deaths and other consequences that stem from the opioid epidemic.
Nearly all of the accused have denied the allegations brought against them and cited examples where they started to mitigate abuse of opioid. PBMs and 4 other defendants vs. Missouri 1 city and 10 counties in Missouri have filed a civil suit in St. Louis Circuit Court by St. Louis Attorney Jeffrey J. Lowe against prescription benefit managers, pharmacies, distributors, manufacturers, and “pill mills.” The suit established two levels of liability—general misbranding of
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Pharmacy Edge 2018
opioid medications and the violation of both state and federal laws for failure to report to the Missouri State Pharmaceutical Board and Drug Enforcement Agency any suspicious orders of opioids. The first level claimed that the defendants made false claims about opioids, marketing it as a proper treatment for chronic pain, not addictive, more effective than nonsteroid anti-inflammatories, and have no withdrawal symptoms, among others. The second level is a violation of the law that requires entities that manufacture, prescribe, or sell opioids to report suspicious orders. Six criminal actions were specified in the suit: 1. Public nuisance 2. Negligence per se—illegal diversion 3. Negligence 4. Fraud in the omission 5. Fraud 6. Negligent misrepresentation Judgment, as requested by the plaintiffs, are listed as disgorgement, damages to
abate the nuisance, and restitution out-ofpocket costs, to name a few. Aetna vs. CVS Caremark A 2014 lawsuit made by an Aetna actuary whistleblower has been unsealed. The insurance company alleged that the pharmacy benefit manager, CVS Caremark, billed the government for prescription drugs at a greater price than what was being paid to pharmacies. The complaint brought by Sarah Behnke against the PBM and its affiliate Silverscript Insurance Company, stated that, since at least 2007, fraudulent Medicare Part D actual drug costs were submitted to CMS. During an investigation that Behnke conducted following an increase in the maximum allowable price of generic drugs that are utilized by party beneficiaries of Aetna, it was discovered that the drug prices Caremark charged were significantly higher than what was being charged by other Part D plan sponsors. For instance, Aetna’s price for Lisinopril 10 mg tablet was $4.69 while its competitors only charged between $1.84 dollars and $3.02.
As what the lawsuit said, “This arrangement benefits the Caremark defendants because in commercial contracts, they keep the difference, or the spread between the price Caremark has negotiated with the pharmacy and the price they charge their PBM customers, particularly under lock-in PBM agreements”. These are just some of the lawsuit filed against PBMs and more are likely to follow, especially now that Ohio Attorney General Mike Dewine has increased his efforts in investigating the costly practices of a pharmacy middleman. He has hired outside counsel to assist with a probe that he expects will lead to a litigation when proven that companies managing drug benefits for Medicaid and other tax-funded health insurance programs guilty. According to DeWine, “Today, I am putting PBMs (pharmacy benefit managers) on notice that their conduct is being heavily scrutinized, and any action that can be taken and proven in court will be filed to protect Ohio taxpayers and the millions of Ohioans who rely on the pharmacy benefits provided.”
Sources: http://www.PBMwatch.com/PBM-litigation-overview.html https://topclassactions.com/lawsuit-settlements/lawsuit-news/838748-cigna-prescription-overcharging-class-action-survives-motion-dismiss/ https://www.courtlistener.com/docket/4552511/negron-v-cigna-corporation/ https://www.ajpb.com/news/opioid-lawsuit-places-blame-on-pharmacy-benefit-managers https://dailyjournalonline.com/news/local/area-counties-join-lawsuit/article_4e40f642-28f8-558f-ae34-0484a8c95e3f.html https://www.healthcarefinancenews.com/news/aetna-whistleblower-accuses-cvs-healths-caremark-fraud-medicare-part-d-drug-prices http://www.dispatch.com/news/20180723/dewine-tells-ohios-pharmacy-middlemen-hes-ready-to-sue-them
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