The Columbus Dispatch
Dr. Stephanie Ott’s eyes tell the story of Americans’ frustrating struggles to obtain essential prescription drugs.
They moisten above her multi-hued mask almost to the point of tears as she describes a patient with crippling rheumatoid arthritis taking her first steps in years after successful drug treatment.
"I'll never forget. She was sitting in an (examination) room one against the wall and I didn't see a wheelchair. I thought, 'Well, I guess somebody took it out, right?'" Ott recalls.
"She says 'I want to give you a hug.' And I said, 'OK, I'll come right over.'
"And she says, 'Oh no, I'm coming to you.' And she got up and she walked across the room ...
"To this day, I get chills when I think about it. She's like, 'I can hold my grandkids!' She was so proud to tell me how she had swept her front porch."
But the doctor's eyes fill with anger as she relates how a Lupus patient was denied insurance coverage for a drug Ott prescribed, wound up in the hospital and remains on dialysis to this day.
And the Lancaster physician's visage hardens even more while diagnosing the cause of this mess: Multibillion-dollar pharmacy benefit managers and health insurers making decisions about which drugs should be covered by insurance based on what she says is corporate greed rather than medical need.
“It’s not that (a drug) didn’t work. It’s just that somebody’s profits got in the way. That's what I call practicing profit medicine instead of real medicine, because I’m trained to practice evidence-based medicine,” said Ott, who has been president of the Ohio Association of Rheumatology since 2011.
She is talking about a rapidly growing practice by pharmacy benefit managers, often known as PBMs, and health insurers to use something called "formulary exclusions." That sounds complicated, but it’s actually quite simple.
Formulary is a fancy name for the list of prescription drugs that a PBM says should be covered by health insurers. However, in the past several years, PBMs have come up with a separate list of drugs they say should not be covered by health insurance. Thus, they are excluded from the formulary, and known collectively as formulary exclusions.
The Perfect 'Lose Lose' for Patients
Because America’s health-care system is increasingly consolidated, the formulary decisions of just three pharmacy benefit managers essentially dictate the entire U.S. market, since they handle nearly 80% of the country's prescription drugs. All three PBMs also are corporately joined with major health insurers, magnifying the consolidation.
Since 2014, the number of drugs excluded from the trio's’ formularies has skyrocketed tenfold, to more than 1,300. Continue Reading
The Columbus Dispatch
Dave Dillahunt has been forced to watch the same bad movie time after time: An Ohioan receives the crushing news that they have cancer, learns about a medication that can help, but then must wait weeks to get it.
Unfortunately, that's true life for many in Ohio because pharmacy benefit managers require patients to receive their medication through the mail — often from specialty pharmacies run by the PBM — as a requirement for insurance to cover the usually expensive drugs. It may arrive within a couple of days, but horror stories abound of cancer victims who have had to wait much longer.
“People aren’t getting treated in time,” says Dillahunt, executive director of the Ohio Hematology Oncology Society.
“In many cases, the more delay you have, the worse the outcome is going to be.”
All that would change under a bill introduced this week in the Ohio General Assembly by a bipartisan duo of House members: Scott Lipps, a Republican from Warren County northeast of Cincinnati, and Thomas West, a Democrat from Canton.
Instead of waiting a month or more for potentially life-saving medication to treat the newly diagnosed cancer, Ohio
..Dillahunt said the Ohio measure is patterned after laws in several states, including Texas and Georgia.
House Bill 336 also would:
• Forbid PBMs and insurers from requiring pharmacies to obtain accreditation from outside entities, which can cost several thousand dollars.
• Bar health insurers from ordering or directing a consumer to use an affiliated pharmacy, or charging consumers more if they use a pharmacy not tied to the insurer.
• Trim the ability of PBMs to assess big charges for even minor errors during audits of pharmacies, and banning compensation of auditors based on the quantity of violations found.
Read the Full Article
Ohio Capital Journal
One of two federal agencies tasked with policing anticompetitive behavior among corporations last week said it has a lot more work to do when it comes to the prescription-drug supply chain.
One of the members of the Federal Trade Commission went even further. He suggested the agency has abdicated its responsibility as drug prices have risen, taking an ever-larger bite out of family budgets even as generic drugs flood the marketplace.
“Drug prices are out of control, and too many players in the pharmaceutical industry have failed to follow the law. There is a growing consensus that the Federal Trade Commission’s approach to overseeing the pharmaceutical industry is not working,” Commissioner Rohit Chopra said in a May 28 statement.
“For example, I am unable to identify an instance where the FTC has filed a lawsuit in federal court to block a merger of pharmaceutical companies,” he added. “In addition, the FTC largely stood by as the pharmacy benefits manager (PBM) industry consolidated to three main giants and even took steps to undermine state legislation.”
That last sentence is significant.
The letter accompanied a six-page report requested by Congress that discussed the system of rebates drug manufacturers give drug middlemen, or PBMs, in exchange for PBMs covering brand-name medicines and giving them preferred treatment. But the report focused almost exclusively on ways drugmakers might use rebates to shut down competition with other drugmakers.
Referring to one, it described how a drugmaker might threaten to stop paying rebates to a PBM if a cheaper rival is placed on a PBM’s “formulary,” its list of drugs that it will cover. That could force up drug prices in a number of ways, the report said.
It seems only logical to assume that when a drug is absurdly expensive, the company that makes it is to blame. But that ignores the complexity of the drug-supply chain — and possibly the relative bargaining power of the players in it.
Drugmakers need PBMs and insurance companies just as insurers and middlemen need manufacturers. The insurers and middlemen contract to handle millions of “covered lives” and if the maker of a patented drug wants access to them through a PBM’s formulary, it often has to offer rebates.
Supply chain analyst Adam Fein has shown for many patented drugs, net prices have been falling while list prices have been rising to accommodate those ever-bigger rebates.
PBMs insist they force down drug prices. But Chopra, the FTC commissioner, referred to possible downsides of non-transparent rebates in his letter.
Drug “manufacturers may pay for the rebate by increasing list prices of their drugs,” he wrote. “This raises the question of whether PBMs are incentivized to select higher list price drugs instead of lower list price drugs for their formularies in order to collect a higher rebate.”
The relative size of the corporations that make drugs might also suggest something about who has the upper hand when they negotiate with PBMs and insurers. Continue Reading
Congress is beginning to take notice as corporations become increasingly dominant in one or more marketplaces.
It’s investigating whether Amazon, Google, Apple and Facebook are engaging in anticompetitive practices. And Sen. Amy Klobuchar, D-Minn., just published a book about the need to revive the government’s antitrust powers.
But if this is to be a new era of trust-busting, advocates say, prescription drugs should be a top priority.
With bipartisan support, Sens. Chuck Grassley, R-Iowa, and Maria Cantwell, D-Wash., in April introduced a bill that would require the Federal Trade Commission to launch such an investigation. It would look at whether the healthcare giants that own the biggest pharmacy middlemen are using their market power to drive up the cost of drugs and diminish access to care by driving out competing pharmacies.
The middlemen, known as pharmacy benefit managers, or PBMs, control more than 77% of the prescription marketplace in the U.S. That gives them great power to decide which drugs are covered, the size of rebates manufacturers grant them and how much pharmacies will be reimbursed if those pharmacies want access to the millions of patients the PBMs represent.
The largest PBM, CVS Caremark, is owned by a company that also owns the largest retail chain, CVS Pharmacy. So as a PBM, it’s determining how much its own stores and its competitors will be reimbursed when they supply drugs to CVS Caremark’s clients.
CVS maintains that it doesn’t advantage its own pharmacies when determining reimbursements. But The Columbus Dispatch obtained confidential documents showing that in 2017, CVS Caremark reimbursed CVS pharmacies far more for generic Medicaid drugs than it did large competitors such as Walmart.
In addition, the Arkansas Insurance Department last year published an analysis showing that the big three PBMs — CVS Caremark, OptumRx and Express Scripts — reimbursed national pharmacy chains at substantially higher rates than they did regional chains and independent pharmacies. The smaller chains and independents are often in underserved areas and if they go out of business, it could create “pharmacy deserts.”
In another possible instance of abuse, CVS Caremark in late 2017 slashed reimbursements under the Ohio Medicaid program. Then it sent letters to struggling independent pharmacists acknowledging that reimbursements were down and saying that CVS wanted to buy their pharmacies.
Meanwhile, each of the PBMs has combined with a major health insurer since 2014. CVS owns Aetna. OptumRx is owned by UnitedHealth. And Express Scripts is owned by Cigna.
The companies say they maintain firewalls between their business units to keep one from unfairly advantaging the others. But suspicions abound.
Alabama, Tennessee, Texas and West Virginia have passed laws in recent months banning the companies from using their insurance or PBM operations to steer clients to certain pharmacies. They were passed after residents offered testimony such as, “‘I got a prescription filled at Joe’s pharmacy and when I got home there’s a message on my voicemail saying, ‘We know you just got prescription X filled. You can go to the CVS down the street and get it filled at a better rate, a better copay,’” Anne Cassity, Vice President of Federal and State Government Affairs for the National Community Pharmacists Association, said Friday.
CVS didn’t respond to a request for comment.
A group representing the PBM industry, the Pharmacy Care Management Association, earlier this month said it had no problem with a Federal Trade Commission antitrust investigation.
“The core mission for PBMs is to advocate on behalf of patients to increase access to affordable prescription drugs,” PCMA spokesman Greg Lopes said. “We look forward to working with Sens. Grassley and Cantwell on real solutions to lowering drug costs.”
Sens. Marsha Blackburn, R-Tenn., Richard Blumenthal, D-Conn., Thom Tillis, R-N.C., and Joni Ernst, R-Iowa, have signed onto the bill requiring an investigation, but it’s unclear how many others in Congress have tuned in.
Cassity, of the community pharmacists association, said her group and others need to work to explain an admittedly complex matter to lawmakers.
“I think it’s a little early and there’s been so much focus on pharmaceutical manufacturers since January,” she said. “I think there’s an opportunity here. It’s very complicated and many members of Congress don’t understand it the way they need to, but a lot of them do.”
She added, “There has been more understanding, but there needs to be more education. And frankly, antitrust, a lot of folks hear that and they back off if they’re not intimately involved with it in their committee.”
NBC Oklahoma News4
Legislators are set to enter their final week of session at the Oklahoma State Capitol.
With the budget passing through the Oklahoma State Senate late last week and being signed by the governor, all the major tasks look to be taken care of but there are some loose ends to tie up.
One of them, will there be a veto override on Senate Bill 821?
“Senate Bill 821 allows an individual in Oklahoma to choose their pharmacy. That’s as basic as the bill is,” said Greg Piatt, of the Oklahoma Pharmacist Association.
Oklahoma independent pharmacists were out in force at the Oklahoma Capitol last week, singing the bill’s praises.
They say currently some pharmacy benefit managers are telling their customers to go to large chains.
Reportedly, the average Oklahoman pays the same price but, they say, the manager makes a large payment, sometimes 10 times the cost of the meds, to the chain pharmacy on the side.
They say it will ultimately put independent pharmacies out of business and limit availability for Oklahomans
“That’s important for Oklahomans, especially in rural areas where access to health care and pharmacists can be 40 to 50 miles away,” said Piatt.
The bill passed easily through the Oklahoma House and Senate. But late last month, Governor Kevin Stitt vetoed the measure.
Stitt says larger employers that are self-insured would face too much red tape.
In a statement, the governor said that the bill “places an undo burden on employers.” He added that the “cost of this burden would be passed on to Oklahoma employees.”
Some members of the Legislature agree with the chief executive.
“They want PBM’s transparency. They don’t want to hurt the small pharmacy, that is not their intent,” said Rep. Marilyn Stark.
Some say the bill restricts mail-order prescription drugs too much, hurting Oklahomans.
“If our goal is to lower health care costs, why are we specifically preventing discounts being offered?” said Sen. Julie Daniels.
The bill passed both chambers with veto proof majorities, but will it be put to a vote to override the governor?
Bill supporters are expected to lobby lawmakers this week to try to make it happen.
“This isn’t about forcing anyone to go anywhere, they can choose. The companies that are on the other side of this are so large and have so many resources. At some point, we need to start doing what’s right for Oklahomans.”
KFOR talked to the bill’s author. He says he has requested a veto override vote in the Senate but is unsure if it will actually happen in the last week legislators are scheduled to be at the Capitol.
To Watch This News Piece on Oklahoma News4 Click Here
A group of independent pharmacists plans to raise concerns over UnitedHealth Group’s [NYSE:UNH] planned acquisition of Change Healthcare [NASDAQ:CHNG] with the Department of Justice, said M. Scott Newman, president of Pharmacists United for Truth and Transparency (PUTT).
PUTT, a nonprofit industry watchdog group that specifically advocates around what it believes are harmful practices by pharmacy benefit managers, plans to send a letter to the agency outlining how the merger between UnitedHealth’s software and analytics business OptumInsight and health care technology company Change is likely to cause harmful anticompetitive effects for rivals, consumers and firms in adjacent markets, Newman said. These include the small and independent community pharmacies in PUTT’s membership and the patients they serve, he said.
Other groups and possibly state pharmacist associations are expected to help develop and co-sign the letter, Newman added.
There is widespread industry concern that the deal would further entrench the market dominance of UnitedHealth, one of the largest vertically integrated managed care and insurance conglomerates, Newman said. The merger would likely restrain other firms’ ability to compete in multiple healthcare sectors and potentially reduce UnitedHealth’s incentives to protect private patient data, he said.
OptumInsight is part of UnitedHealth’s pharmacy benefit manager and care services division Optum. In a statement to this news service, Optum said the combined company’s “distinct and complementary capabilities” will “help health care providers and payers better serve patients by more effectively connecting and simplifying key clinical, administrative and payment processes to the bene t of the health system and the people we serve.”
Last January, Optum announced its proposed acquisition of Change for USD 13bn including debt. According to the merger agreement, the parties are committed to divesting assets that account for up to USD 650m in annual revenues from the past 12-month period in order to obtain antitrust approvals. The deal is expected to close in 2H21, though its termination date can be extended to 5 April 2022. The parties, which pulled and refiled their premerger notification in February, received a second request for more information from the DOJ on 24 March, according to SEC filings.
In their deal announcement, the companies said the addition of Change Healthcare’s solutions for payment and revenue management, along with its clinical and administrative information exchange technologies, will accelerate innovation and efficiencies.
Both companies also offer services for Medicaid and state employee health plans. The Wall Street Journal reported earlier this month that multiple states are investigating possible overpayments to UnitedHealth’s PBM business. Change Healthcare provides claims administration/processing and healthcare management services to state Medicaid programs so the acquisition would potentially port those contracts into OptumInsight's business while PBM services are provided to those same customers with OptumRx.
Two industry analysts told this news service that the combined company would also have a significant presence in healthcare clearinghouses, which act as intermediaries between providers and insurers. Both agreed that the deal could legitimately threaten the degree of competition in this space, given that the market is “somewhat esoteric” with very few big players.
The companies’ combined market share in the clearinghouse sector would exceed 50%, one of the analysts said, citing Bellevue, Washington-based Edifecs, as an independent competitor. Change Healthcare’s current clearinghouse capability was established through its combination with certain assets of McKesson [NYSE:MCK] in a deal that closed in 2017, he said.
PUTT’s concerns echo issues recently raised in letters to the DOJ from the American Hospital Association (AHA) and American Antitrust Institute (AAI) in March and May, respectively, as evidence for the need for the agency to conduct a thorough antitrust review. PUTT agrees with the doubts raised by these groups that the DOJ could address the transaction’s competitive harms by imposing behavioral remedies or ordering divestitures, Newman said.
Newman, AHA and AAI argue that the removal of Change Healthcare as a head-to-head competitor with OptumInsight’s data analytics and information exchange solutions raises horizontal competition concerns.
The second healthcare analyst agreed, adding that many physicians rely on one of these two platforms for their artificial intelligence and clinical decision-making support capabilities. These are sophisticated businesses without an overwhelming number of competitors, the analyst said. While Change Healthcare and UnitedHealth are two of the largest providers, other existing data analytics solutions providers include Experian [LON:EXPN], Health Catalyst [NASDAQ:HCAT], AllScripts Healthcare Solutions [NASDAQ:MDRX] and Ingenius Med, he said.
There are also vertical competition issues, according to Newman, AHA and AAI. For example, with the addition of Change Healthcare’s data and data analytics capabilities, Optum would likely be equipped and incentivized to advantage UnitedHealth over rival insurers, as the aggregation of private patient data further entrenches the company’s dominance across the markets in which it operates.
An independent healthcare provider speaking to this news service expressed concerns that the deal could potentially provide UnitedHealth access to other types of data – fee scheduling and pricing information from other payors – which could be used anticompetitively, to inform its health insurance reimbursement rates.
Newman said commitments to anonymize that data or keep it appropriately siloed with firewalls to prevent its misuse are difficult to enforce, especially considering how strong the incentives are for the companies to find a workaround. AHA and AAI made similar arguments.
UnitedHealth’s dominance over the interconnected healthcare markets it serves, even without the acquisition, warrants a breakup of the company’s businesses, so a divestiture remedy for this merger would likely fall short of what would be necessary to restore competition, Newman said.
In recent years, UnitedHealth has become one of the industry’s most active consolidators in various verticals. Deals include UnitedHealth’s acquisition of Surgical Care Affiliates in 2017, which expanded its ambulatory surgery center provider services, its purchase of Advisory Board’s healthcare division the same year, and its acquisition of DaVita Medical Group in 2019, which expanded its physician network.
Some of UnitedHealth’s previous transactions have received complaints from third parties but all were eventually approved, in some cases with conditions.
The DOJ declined to comment. Change Healthcare did not respond to a request for comment.
by Christopher Kane in Washington, DC and Yiqin Shen in New York
Wall Street Journal
Several states are investigating pharmacy benefit managers, with some saying they are focused on whether the companies fully disclosed details about their business and potentially received overpayments under state contracts, according to state officials and documents.
States including Ohio, Oklahoma, Georgia, New Mexico, Kansas, Arkansas and Mississippi, as well as the District of Columbia, are scrutinizing PBMs, according to the offices of state attorneys general and auditors, as well as public documents including state contracts and securities filings.
Details about the investigations’ focus are typically not public. Officials with some states said they were looking at companies in their Medicaid programs and state-employee plans. Among the companies under scrutiny are units of Centene Corp. , UnitedHealth Group Inc. and CVS Health Corp.
“I’m aware of many states that are looking at this,” said Ohio Attorney General Dave Yost, a Republican, whose office recently sued Centene, alleging it had misled the state’s Medicaid program about its pharmacy-related costs, resulting in overpayments by the state. States are at various stages of examining PBMs, he said, but he expects a couple of new suits to be filed this summer, and “before this is all done, I will be surprised if we don’t have a dozen or more states” bringing complaints against PBMs.
A Centene spokeswoman said it “provides pharmacy benefit programs for Medicaid and Medicare according to the regulations, laws and contractual guidelines issued by state agencies.” The Ohio suit’s claims are “unfounded and will be vigorously defended in court,” she said. Continue Reading
Newswires: The Daily Inter Lake
A bill that would give Montana officials the power to license and regulate pharmacy benefit managers — the middlemen that negotiate drug prices and determine which medications are covered by health insurers — is headed to Gov. Greg Gianforte's desk.
Proponents say the measure would shine a light on a powerful yet obscure part of the health-care industry and create opportunities to address skyrocketing drug prices.
Troy Downing, Montana's state auditor and commissioner of securities and insurance, held lengthy discussions and led the drafting of Senate Bill 395 after the U.S. Supreme Court clarified late last year that states can regulate pharmacy benefit managers. The proposal had unanimous support in the Senate and cleared the House on a 98-2 vote.
In an interview with the Daily Inter Lake, Downing said the Supreme Court decision, which stemmed from a similar legislative proposal in Arkansas, "opened a floodgate of possibilities" for Montana to pursue its own regulations.
Pharmacy benefit managers develop the "formularies" that list which drugs health plans will cover; they also negotiate wholesale prices and facilitate reimbursements to pharmacies for drugs they dispense. Those formularies can have huge implications for a drug's profitability, so manufacturers offer rebates and other incentives to pharmacy benefit managers to include their products on the lists.
But without financial data, regulators can't know how much money is being exchanged in the middle ground between drug makers and pharmacies — or if any of those cost savings are being passed on to consumers.
"For the most part, it's a black box and we're trying to peer inside of it," said Downing, a Republican.
Cautionary tale: Plan sponsors losing manufacturer rebate dollars to PBMs through rebate aggregators
Pharmacy benefit managers (PBMs) have created opaque manufacturer rebate arrangements, either directly or through wholly owned subsidiaries. These subsidiaries, known as “rebate aggregators,” cost plan sponsors, beneficiaries and taxpayers staggering sums of money. A growing number of examples of PBMs causing economic harm to plan sponsors through rebate aggregators is publicly emerging.
Related: Vetting your contract: How to know what your PBM is really offering
In one such example, Lehigh County’s audit report revealed a typical one-sided PBM contract term that has caused many plans to lose rebate revenue. Information asymmetry is to the advantage of PBM Rebate Aggregators and to the detriment of plan sponsors. Plans should be aware of rebate arrangements and learn from Lehigh’s audit experience. PBMs generally offer two manufacturer rebate models. In a “pass-through” model, PBMs purport to relay 100% of rebates PBMs received back to the Plan, but in reality, PBM-owned rebate aggregators are known to retain a significant amount of manufacturer rebates.
Under a “fixed model,” PBMs pay plans a guaranteed fixed-dollar amount per brand claim regardless of the actual amount of manufacturer rebates PBMs collect. While the fixed rebate model provides minimum rebate guarantees, it may also cap manufacturer rebates that could have significantly lowered a plan sponsor’s drug spend. Well-educated plan sponsors can avoid unfair contract terms by actively negotiating the rebate provision of the PBM Agreement.
Lehigh County’s contract was opaque and strongly favorable to the PBM. The Lehigh County’s audit report concluded, among other things, that the county could have received in excess of $700,000 in manufacturer rebates during the calendar year (“CY”) 2019, had it not chosen the “fixed rebate” model. The report further notes that if the County had been allowed the option of receiving the higher of actual rebates earned versus a fixed rebate, the total rebate savings for CYs 2017 through 2020 would have been $1.6 million. Also, the County identified 200 cheaper prescription drugs for a total potential savings of over $650,000.
Plan sponsors can learn a great deal from Lehigh County’s losses.
Why would the county agree to a fixed rebate arrangement? One likely scenario is that a non-fiduciary benefits broker “facilitated” the PBM favored terms and conditions. When a broker that is not a “fiduciary” represents a plan sponsor in a Request For Proposal (RFP) process, the resulting contract will likely advantage the PBM, and disfavor the plan. Continue Reading
Pharmacy benefit managers (PBMs) should consider the implications of a model law making its way through the National Association of Insurance Commissioners (NAIC) that would establish a licensure requirement and rules of conduct for these participants in the health care marketplace. A number of states have already adopted their own PBM laws, and an NAIC model would be likely to motivate others to do so.
On April 12, 2021, the NAIC’s Health Insurance and Managed Care Committee, meeting by videoconference at the NAIC’s Spring National Meeting, briefly discussed the PBM Model Act, agreeing to defer action until further consideration of additional features of PBM activities. This alert summarizes the principal features of the Model Act in its current form, minfdul that the NAIC may impose additional requirements on PBM conduct as the Model Act undergoes further consideration.
The Model Act defines “pharmacy benefit manager” as an entity, “including a wholly or partially owned or controlled subsidiary” of a PBM, that provides “claims processing services” or “other prescription drug or device services” (each defined below) to covered persons (generally, health plan enrollees or dependents) who are residents of the adopting state, for health benefit plans.
For purposes of this definition: