CMS Plans to Regulate Pharmacy Benefit Manager DIR Fees [Weekly Roundup]

 News and notes from around the interweb:

  • DIR charges from PBM increased by 91,500% in just 9 years. The probe by the Centers for Medicare and Medicaid Services (CMS) will center on huge increases in direct and indirect remuneration fees that PBMs charge pharmacies on Medicare prescriptions. These DIR fees were implemented as a way to incentivize U.S. pharmacies collecting millions of Medicare dollars to do more than simply push pills. But the assessment — charged well after a prescription drug sale is supposedly complete — evolved into a system that today offers pharmacies only penalties through higher and higher fees, even if every PBM performance standard is achieved. The fees now total $11.2 billion a year, up from $200 million in 2013.
  • Join the Movement!

    Documents reveal the secrecy of America’s drug pricing matrix. Several people who work in the industry, who asked not to be named due to the confidential nature of coalitions, said most employers, regardless of how big they are, have no idea what they’re giving up when they enter coalitions. Once employers are locked into the coalition, they can’t get a full second opinion on the drug prices they pay, experts said.

  • The Consolidated Appropriations Act Introduces Broker Compensation TransparencyEffective December 27, 2021, brokers and consultants of ERISA covered group health plans, regardless of size, will be required to execute a written contract with a responsible plan fiduciary which includes a description of the services to be provided, a description of all direct compensation the broker expects to receive, and a description of all expected indirect compensation including vendor incentive payments. 
  • CMS Plans to Regulate Pharmacy Benefit Manager DIR FeesOn Dec. 14, 2021, the Centers for Medicare and Medicaid Services (CMS) unexpectedly issued a letter to U.S. Senator Ron Widen (D-OR)[1] indicating that CMS plans to use its “administrative authority to issue proposed rulemaking” addressing price concessions and direct and indirect remuneration (DIR) fees that pharmacy benefit managers (PBMs) have increasingly charged to specialty and retail pharmacy providers in Medicare and other pharmacy benefit programs in recent years. CMS’s letter is welcome news to pharmacy providers around the country and could result in substantial disruption to a multi-billion-dollar line of fees that PBMs have previously realized.
The Certified Pharmacy Benefits Specialist (CPBS) educational offering includes knowledge that is critical to effective management of the pharmacy and medical drug benefit. If you want to learn more, click here.

Tip of the Week: Copay Accumulator Programs are Bad for Business

How’s that for the first blog post of year? Bang, copay accumulator programs are bad for business! Hear me out. Due to a technical glitch that caused scheduled payments to be conducted twice, Santander Bank last week accidentally paid out $175 million to thousands of its customers. The glitch that impacted over 75,000 transactions has affected over 2,000 commercial and corporate accounts. Although the glitch has since been identified and rectified, many people received a Christmas bonus that they were not expecting at all.
 
The transactions included both, regular payments such as wages as well as one-off payments made to clients that ended up being duplicated due to the glitch. According to CNN Business, wages were paid in duplicate over a period of two days. The second payment, however, was not made from the accounts of the customers but from the reserves, leaving the bank poorer by this amount due to a computer glitch. 

US patients are being left poorer, not by an accident or computer glitch, but by intentional acts. The primary difference between the aforementioned bank scenario and copay accumulators is that no one is policing copay accumulator programs. PBMs are free to pocket greenbacks that were never intended for them without fear of reprisal. Those bank customers will have to return those funds or pay a price. 

Below is an example of a historical payment model for medication versus an accumulator model. For this example, the patient has a $2,000 deductible, 20% coinsurance, and a $4,000 out of pocket max. The drug in this example is $2,000 per month:

Source: National Infusion Center Organization

A copay accumulator – or accumulator adjustment program – is a strategy used by insurance companies and pharmacy benefit managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two costs: 1) the deductible and 2) the maximum out-of-pocket spending. Bank customers should not keep money that was never intended for them. Likewise, PBMs should not profit from cost-sharing assistance programs that are intended solely to benefit patients. 

Drug manufacturers have made it clear their cost-sharing assistance programs were not created to drive profit for PBMs. As drug manufacturers attempt to create programs to subsidize out-of-pocket cost for patients, the payers reduce the value of these programs by exhausting such funds while also requiring the patients to pay their deductibles and coinsurance up to their out-of-pockets to obtain their medications. I’m not alone on the position I’ve taken.

It just doesn’t make sense to me that PBMs, insurers, and third-party payers (e.g. self-insured employers) point the finger at manufacturers of high-cost medications only to turnaround and siphon the cost-sharing assistance that the manufacturer provided to the patient away from counting toward deductibles or out-of-pocket maximums. This is especially harmful when there is no low-cost therapeutic alternative for high-cost formulary drugs. 

Anyone who purports that copay accumulator programs are a good thing either works for a specialty pharmacy or has been influenced by someone who works for a specialty pharmacySure accumulator programs save employers money, but the bulk of the savings accumulated (no pun intended) through slick spreadsheeting and contract wordplay goes to the PBMs and insurers who enforce these programs. That’s just wrong.

DIR fees from PBMs increased by 91,500% in just 9 years [Weekly Roundup]

 News and notes from around the interweb:

  • DIR charges from PBM increased by 91,500% in just 9 years. The probe by the Centers for Medicare and Medicaid Services (CMS) will center on huge increases in direct and indirect remuneration fees that PBMs charge pharmacies on Medicare prescriptions. These DIR fees were implemented as a way to incentivize U.S. pharmacies collecting millions of Medicare dollars to do more than simply push pills. But the assessment — charged well after a prescription drug sale is supposedly complete — evolved into a system that today offers pharmacies only penalties through higher and higher fees, even if every PBM performance standard is achieved. The fees now total $11.2 billion a year, up from $200 million in 2013.
  • Join the Movement!

    Documents reveal the secrecy of America’s drug pricing matrix. Several people who work in the industry, who asked not to be named due to the confidential nature of coalitions, said most employers, regardless of how big they are, have no idea what they’re giving up when they enter coalitions. Once employers are locked into the coalition, they can’t get a full second opinion on the drug prices they pay, experts said.

  • The Consolidated Appropriations Act Introduces Broker Compensation TransparencyEffective December 27, 2021, brokers and consultants of ERISA covered group health plans, regardless of size, will be required to execute a written contract with a responsible plan fiduciary which includes a description of the services to be provided, a description of all direct compensation the broker expects to receive, and a description of all expected indirect compensation including vendor incentive payments. 
  • ERISA Preemption of State Laws Requiring Employers to Report or Disclose Benefit Plan Information to EmployeesOne reaction to the Rutledge decision was a sense that the scope of ERISA preemption was perhaps narrower than once thought and a state’s ability to indirectly regulate ERISA plans perhaps broader than once thought. This article will address whether that is an accurate assumption by applying the Court’s holdings in Rutledge and two if its other key ERISA preemption cases to determine whether the recently enacted Illinois Consumer Coverage Disclosure Act (Public Act 102-0630) may be preempted.
The Certified Pharmacy Benefits Specialist (CPBS) educational offering includes knowledge that is critical to effective management of the pharmacy and medical drug benefit. If you want to learn more, click here.

The Untold Truth: How Pharmacy Benefit Managers Make Money [Free Webinar]

How many businesses do you know want to cut their revenues in half? That’s why traditional pharmacy benefit managers don’t offer a fiduciary standard and instead opt for hidden cash flow opportunities such as rebate masking. Want to learn more?

Here is what some participants have said about the webinar.

Thank you Tyrone. Nice job, good information.” David Stoots, AVP

“Thank you! Awesome presentation.” Mallory Nelson, PharmD

“Thank you Tyrone for this informative meeting.” David Wachtel, VP

“…Great presentation! I had our two partners on the presentation as well. Very informative.” Nolan Waterfall, Agent/Benefits Specialist


A snapshot of what you will learn during this 30 minute webinar:

  • Hidden cash flows in the PBM Industry
  • Basic to intermediate level PBM terminologies
  • Specialty pharmacy cost-containment strategies
  • Examples of drugs that you might be covering that are costing you
  • The #1 metric to measure when evaluating PBM proposals

Sincerely,
TransparentRx
Tyrone D. Squires, MBA  
10845 Griffith Peak Drive, Suite 200  
Las Vegas, NV 89135 
Office: (866) 499-1940
Mobile: (702) 803-4154


P.S.  Yes, it’s recorded. I know you’re busy … so register now and we’ll send you the link to the session recording as soon as it’s ready.   

The Consolidated Appropriations Act (CAA) Introduces Broker Compensation Transparency [Weekly Roundup]

 News and notes from around the interweb:

  • Survey on Outcomes-Based Contracts Shows Mixed Results for Novel Therapies. Avalere Health’s fifth annual survey of outcomes-based contracts (OBC) for novel therapies showed varied results in overall participation and across specific therapies. OBCs center on “high-cost novel treatments and other types of products” and “typically include an agreement between health plans and drug or device manufacturers that ties product reimbursement to specific clinical, quality, or utilization outcomes.” John Neal, an Avalere managing director notes: “These products come with big price tags. Payers want to make sure the outcomes are what was indicated in clinical trials.”

  • Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers. Over time, PBMs have found ways to take advantage of a lack of transparency and oversight to increase their profit, said Sally Greenberg, executive director of the National Consumers League. This report showcases not only the many ways they do this but also just how much money they’re making from these tactics. We must find policy solutions to bring that money — those savings — back to consumers as intended.
  • Join the Movement!

    Documents reveal the secrecy of America’s drug pricing matrix. Several people who work in the industry, who asked not to be named due to the confidential nature of coalitions, said most employers, regardless of how big they are, have no idea what they’re giving up when they enter coalitions. Once employers are locked into the coalition, they can’t get a full second opinion on the drug prices they pay, experts said.

  • The Consolidated Appropriations Act Introduces Broker Compensation TransparencyEffective December 27, 2021, brokers and consultants of ERISA covered group health plans, regardless of size, will be required to execute a written contract with a responsible plan fiduciary which includes a description of the services to be provided, a description of all direct compensation the broker expects to receive, and a description of all expected indirect compensation including vendor incentive payments. 
  • 340B Program, PAPs Help Ensure SP Rx SuccessBut those 340B savings don’t magically appear, Dr. Mitchell stressed. His specialty pharmacy has clinical pharmacists embedded in clinics who make sure that orders for specialty medications sent to the internal specialty pharmacy are eligible for 340B savings. They also are responsible for ensuring that orders patients choose to have filled at external pharmacies—or that payors mandate be sent to a specialty pharmacy—still remain in the health system’s contract pharmacy network.
The Certified Pharmacy Benefits Specialist (CPBS) educational offering includes knowledge that is critical to effective management of the pharmacy and medical drug benefit. If you want to learn more, click here.

Tip of the Week: Think Twice Before Joining a PBM Drug Pricing Coalition (rerun)

Documents provided to Axios reveal a new layer of secrecy within the maze of American drug pricing — one in which firms that manage drug coverage for hundreds of employers, representing millions of workers, obscure the details of their work and make it difficult to figure out whether they’re actually providing a good deal. 

How it works: Employers hire pharmacy benefit managers to handle the drug coverage in their workers’ health insurance plans. PBMs negotiate prices with drug manufacturers and decide which drugs get preferential treatment.
Big consulting firms work with PBMs to organize drug pricing coalitions, pulling Fortune 500 companies and other large employers into purchasing agreements that, in theory, maximize negotiating power. But it can be difficult for employers to determine the financial upside of these arrangements. So what are employers not seeing within coalitions? The data on prices, and understanding whether those prices are a good deal.

Tyrone’s Commentary:

I’m not opposed to coalitions per se. I am, however, opposed to information asymmetry in health care. Information Asymmetry or “Information Failure” is a term that refers to when one party in a business transaction is in possession of more information or knowledge than the other (see figure 1). In certain transactions, sellers might take advantage of buyers because information asymmetry exists whereby the seller has more knowledge of the good or service being sold than the buyer. The best proponent of transparency is informed and sophisticated purchasers of PBM services. If a coalition is engaging in information asymmetry, employers in that coalition are leaving money on the table.

Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers [Weekly Roundup]

 News and notes from around the interweb:

  • Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers. Over time, PBMs have found ways to take advantage of a lack of transparency and oversight to increase their profit, said Sally Greenberg, executive director of the National Consumers League. This report showcases not only the many ways they do this but also just how much money they’re making from these tactics. We must find policy solutions to bring that money — those savings — back to consumers as intended.
  • Documents reveal the secrecy of America’s drug pricing matrix. Several people who work in the industry, who asked not to be named due to the confidential nature of coalitions, said most employers, regardless of how big they are, have no idea what they’re giving up when they enter coalitions. Once employers are locked into the coalition, they can’t get a full second opinion on the drug prices they pay, experts said.
Join the Movement!
  • Pharma Grapples With Best Price Accumulator. A new CMS policy, issued in December 2020 with an effective date of Jan. 1, 2023, requires pharmaceutical manufacturers to “ensure” the benefit of copay assistance programs goes only to patients to maintain the exclusion from best price reporting. If a coupon’s full value doesn’t accrue to the patient, the pharmaceutical manufacturer must count it as a discount to the drug’s Medicaid price.
  • 13 million Americans skip prescription drugs due to costThe report, based on a national survey of U.S. households, outlined the range of obstacles that Americans face in affording needed medications. According to the report, more than 2.3 million elderly Medicare beneficiaries and 3.8 million privately insured working-age adults reported skipping needed treatments because of costs in both 2018 and 2019. 
  • 340B Program, PAPs Help Ensure SP Rx SuccessBut those 340B savings don’t magically appear, Dr. Mitchell stressed. His specialty pharmacy has clinical pharmacists embedded in clinics who make sure that orders for specialty medications sent to the internal specialty pharmacy are eligible for 340B savings. They also are responsible for ensuring that orders patients choose to have filled at external pharmacies—or that payors mandate be sent to a specialty pharmacy—still remain in the health system’s contract pharmacy network.
The Certified Pharmacy Benefits Specialist (CPBS) educational offering includes knowledge that is critical to effective management of the pharmacy and medical drug benefit. If you want to learn more, click here.

Tip of the Week: Think Twice Before Joining a PBM Drug Pricing Coalition

Documents provided to Axios reveal a new layer of secrecy within the maze of American drug pricing — one in which firms that manage drug coverage for hundreds of employers, representing millions of workers, obscure the details of their work and make it difficult to figure out whether they’re actually providing a good deal. 

Figure 1: Explanation for coalitions withholding data


How it works: Employers hire pharmacy benefit managers to handle the drug coverage in their workers’ health insurance plans. PBMs negotiate prices with drug manufacturers and decide which drugs get preferential treatment.
Big consulting firms work with PBMs to organize drug pricing coalitions, pulling Fortune 500 companies and other large employers into purchasing agreements that, in theory, maximize negotiating power. But it can be difficult for employers to determine the financial upside of these arrangements. So what are employers not seeing within coalitions? The data on prices, and understanding whether those prices are a good deal.

Tyrone’s Commentary:

I’m not opposed to coalitions per se. I am, however, opposed to information asymmetry in health care. Information Asymmetry or “Information Failure” is a term that refers to when one party in a business transaction is in possession of more information or knowledge than the other (see figure 1). In certain transactions, sellers might take advantage of buyers because information asymmetry exists whereby the seller has more knowledge of the good or service being sold than the buyer. The best proponent of transparency is informed and sophisticated purchasers of PBM services. If a coalition is engaging in information asymmetry, employers in that coalition are leaving money on the table.

Pharmacy Benefit Managers are Outwitting Attempts at Accountability, Tougher Rules [Weekly Roundup]

 News and notes from around the interweb:

  • The case for “unbundling” self-funded health benefit programs. They [employers] can unbundle their plan and choose a fully transparent PBM that makes sure all of the rebate dollars get back to the plan within certain time frames and their contractual obligations are potentially different than they might have been within the bundled plan. That unbundling could save the employer a significant amount of money without negatively affecting the services provided to plan participants.
  • Key Drugs in Specialty Pharmacy Slated to Launch in 2022. Ray Tancredi, RPh, MBA, divisional VP of specialty pharmacy development and brand Rx/vaccine purchasing at Walgreens, addresses key drugs in development that are slated to launch in 2022, key drugs in development that are slated to launch in the future of note, and some of the promising and unique medications to keep an eye on that are expected to be approved in the specialty pharmacy space.
Join the Movement!
  • Pharma Grapples With Best Price Accumulator. A new CMS policy, issued in December 2020 with an effective date of Jan. 1, 2023, requires pharmaceutical manufacturers to “ensure” the benefit of copay assistance programs goes only to patients to maintain the exclusion from best price reporting. If a coupon’s full value doesn’t accrue to the patient, the pharmaceutical manufacturer must count it as a discount to the drug’s Medicaid price.
  • Pharmacy and PBM Leader Deloitte Consulting: Specialty Drugs Rely on Personalization for Optimal OutcomesThe high cost of specialty drugs makes it important to use companion diagnostics and other tests to make sure the drug is going to the right patient, said George Van Antwerp, MBA, managing director, Deloitte Consulting. When we look at the cost of specialty drugs, and especially some of the cell and gene therapy drugs, which are really all about precision medicine, those costs mean they have to work. They have to be focused on and personalized to the individual.
The Certified Pharmacy Benefits Specialist (CPBS) educational offering includes knowledge that is critical to effective management of the pharmacy and medical drug benefit. If you want to learn more, click here.

Tip of the Week: Don’t Opt-Out of Step Therapy Programs

Step therapy is a process that requires physicians to prescribe more costly drugs, usually brand drugs, only after a less costly drug treatment has been tried and failed with a patient. Step therapy is just one tool in the drug utilization management (DUM) toolkit which includes drug utilization review, quantity limits, prior authorization, refill too soon, and mandatory generic enforcement programs just to name a few. Step therapy programs evoke strong emotions in both support and opposition.

Click to Enlarge
Positions in Opposition of Step Therapy Programs

Coalition of State Rheumatology Organizations: Step therapy can lead to serious negative patient outcomes and increased costs if not carefully managed. Step therapy needs to be regulated by nationally recognized clinical practice guidelines. Physicians should have the authority to override step therapy protocols based on a patient’s medical history. Override protocols should be clear and abbreviated.

Patient Rising: Step therapy prevents patients from accessing treatments prescribed by their doctor, and instead mandates a course of treatment mandated by their insurance carrier. Patients start with older, cheaper treatments, and if they are not effective, patients “step” to another treatment. Some patients suffer terribly during this process, becoming sicker when denied prescribed treatments. For this reason, it becomes abundantly clear why patients across the country have another description for step therapy: “fail first.” When a patient has to fail first on a drug before being allowed to take the medication originally prescribed, the patient, physician and public health suffers.

National Psoriasis Foundation: Because of the rise in costs of conventional medical treatments, many patients nowadays are beguiled by their health insurance companies into undergoing considerably less expensive options such as step therapy. This “wealth before health” kind of thinking is actually futile and unwise, at best, since step therapy is never a good option in treating life-threatening diseases.

According to a new study, led by researchers at Tufts University, tracked the application of step therapy protocols across 17 payers. Across those insurers, 38.9% of coverage policies deployed some kind of step therapy protocol. On average, insurers required 1.5 steps in their protocols, with 66.6% of policies requiring a single step. Of the remaining policies, 22.7% required two steps, 7.6% were three steps and 3.1% included four or more steps, according to the study. 

Here’s the part few opponents talk about

Before I owned a mail-order pharmacy and fiduciary-model PBM, I was a pharmaceutical sales representative. Yes, whatever you’ve heard about drug sales reps it is likely true. It was a good gig with a great company. Eli Lilly and Company had a big sales force and effective marketing machine behind it. It took me 1.5 years but I took a territory ranked something like 600 out of 612 to #12 in the country. 
I did it by asking doctors to prescribe a new brand oral antidiabetic, Actos, as a first line drug therapy or in combination with metformin. It wasn’t any more complicated than that.  
Looking back, there were thousands of prescriptions written for an expensive brand drug when the “old” tried and true generic metformin would have been as efficacious at 1/100 the cost. Multiply that by the tens of thousands of other drug sales reps across the country doing exactly the same thing. I’ll dig deeper into direct-to-consumer advertising as a key sales driver in a separate post. But don’t kid yourself. A lot of people see a TV ad then go into the doctor’s office and say, “I want to try that.” Simply put, pharmacy benefit managers deploy step therapy as a tool to manage drug costs.
Step therapy programs are not created equally. Some PBMs run better, more efficient step therapy programs than others. That said, no PBM wants to put patients in harms way. Opponents of step therapy programs aren’t cutting the checks which cover the high costs of biologics, cell or gene therapies. Sure, health plan sponsors can opt out of step therapy programs but in doing so you expose your company to massive FWA