Historic Drug Legislation Passed: What It Means for Employers and American Workers
August 18th, 2022
The landmark drug pricing reforms passed by Congress and signed into law by President Biden on August 16 will provide needed relief from the burden of prescription medication costs for many Americans by enabling Medicare to negotiate prices for certain high-cost drugs and limit further price increases.
This was an historic step in curbing what most Americans agree is an issue that Congress has long needed to address. Unfortunately, based on arcane Senate rules, the drug price provisions in the Inflation Reduction Act will not extend protections to the 180 million Americans with commercial health coverage.
Here, a look at what the law will and won’t do, and the steps large private employers and public purchasers of health care can take to help mitigate rising drug costs in the wake of legislation, that at least for now left them behind.
What the Law Accomplishes
The new law includes a provision that will enable the Centers for Medicare and Medicaid Services (CMS) to begin negotiating prices in Medicare starting in 2026 for a limited number of high-cost drugs that lack generic or biosimilar competition.
This marks a significant break from the existing prohibition on negotiation, which was a condition for drug manufacturers’ support for the creation of Medicare Part D nearly 20 years ago. That prohibition, combined with the market exclusivity for new drugs granted under the Hatch-Waxman framework, has allowed drug companies to set prices without competition or negotiation. This law begins to pierce the monopolies drug companies have long enjoyed, an important first step in pursuing further legislative action. CMS previously estimated that an earlier version of the negotiation proposal could reduce Medicare enrollee cost-sharing expenses by more than $102 billion by 2029.
Two other key provisions of the law include a $2,000 cap on out-of-pocket spending for Part D enrollees and a reduction in Medicare beneficiaries’ portion of total drug costs below the $2,000 out-of-pocket cost threshold from 25% to 23%.
Further, the bill requires manufacturers to pay rebates to CMS if drug prices charged to Medicare increase faster than the rate of inflation. This will apply to all drugs over $100 covered by Medicare Part D and single-source drugs and biologics covered by Part B. The penalty is expected to discourage drug makers from raising prices in Medicare, thereby reducing out-of-pocket costs for Medicare beneficiaries and constraining Part D premium increases.
What the Law Does Not Do
While this legislation is step in the right direction toward controlling prescription drug prices, it does not protect the 180 million Americans who get their health insurance coverage either through their employer or on the private market. Therefore, large employers and public purchasers that provide coverage to working Americans must remain vigilant and be ready to call attention to any adverse effects of this new law once it is implemented, including the potential of dramatic increases in the launch prices of new drugs and for existing medications, which would indicate manufacturers are charging high prices to make up for lost Medicare revenue.
We have seen this kind of cost-shifting before in the hospital sector, with ample evidence demonstrating that large private employers and public purchasers pay an average 224% more than Medicare for the same services. PBGH and its members will be watching prescription drug prices for evidence of cost-shifting to make up for lost Medicare revenue. This could lead to future opportunities for additional policy changes.
6 Steps Large Health Care Purchasers Can Take to Mitigate Cost Increases
In the absence of further policy changes, PBGH recommends six steps employers and purchasers can take to address the exceedingly high-cost burden of prescription drugs:
- Engage in a detailed negotiations with pharmacy benefit managers (PBMs) related to rebates and insist that all earned rebate dollars are passed back to you as the employer/purchaser.
- Take your PBM out to bid at the end of every contract cycle and consider working with new market entrants that have adopted a more innovative, transparent approach aligned with the needs of employers and American workers.
- Scrutinize your PBM contract and ensure you have access to the data ownership and audit rights you need to evaluate and optimize your pharmacy benefit.
- Look at total manufacturer revenue, not just rebates, and push for a guarantee of a major percentage of all manufacturer revenues, or the higher of, the guaranteed rebate amount or actual manufacturer rebates earned.
- Ensure your PBM contract has contractual terms clearly defined in an all-inclusive Definitions section, using the readily accessible industry standards as the source, and include a clause dictating that the terms and their definitions are only available once.
- Use your purchasing power to ensure your PBM is consistently working in you and your employees’ best interests.
You can learn more about how to evaluate the drug supply chain and your PBM performance here.
6 Things Every Employer Should Know About Their Pharmacy Benefit Manager
May 11th, 2022
Pharmacy benefit managers (PBMs) ostensibly work on behalf of self-insured employers to manage drug spending and ensure employee access to preventive and curative medications. But an industrywide lack of transparency, coupled with complex and often-confusing policies and contract terms, has opened the door to PBM profiteering. Large, self-insured employers – and their employees – are the ones paying the price.
Here are six things employers should keep in mind when evaluating the drug supply chain and PBMs:
1. The higher the drug price, the more money the PBM makes. Like drug manufacturers and wholesalers, PBMs are paid a percentage of retail drug prices. They’re incentivized to exclude lower-cost drugs and promote higher-cost medications in their approved drug lists or formularies. This means employers often end up paying higher drug prices for branded medications when clinically equivalent generic drugs exist. Branded drugs will at times, be needed, knowing that, every employer should engage in a detailed negotiation related to rebates and insist that all earned rebate dollars are passed back to the employer.
2. Industry consolidation is contributing to reduced transparency and higher costs. The three leading PBMs are controlled by national health care enterprises, managing nearly 90% of prescription claims in the U.S. These consolidations create potential conflicts of interest between business units and make it nearly impossible to trace the flow of funds surrounding prescription drug costs. Every employer should take their PBM out to bid at the end of every contract cycle and consider working with new market entrants that have adopted a more innovative, transparent approach, aligned with the needs of employers and their employees.
3. The big three PBMs are adding cost and opacity by layering on new organizations that contract directly with drug manufacturers. The three leading PBMs all have group purchasing organizations (GPOs) to serve as intermediaries between drug manufacturers and their respective PBM operations. Even though it’s not clear what, if any, value the GPOs will create, research suggests they’re expected to extract an added 5-8% in fees from the drug supply chain. Additionally, because they’re replacing PBMs as the organizations that contract directly with drug manufacturers, the GPOs will help insulate PBM operations from audits and potential legislative cost remedies, including new transparency requirements of the Consolidated Appropriations Act. Every employer should scrutinize their PBM contract and ensure they have access to the data ownership and audit rights they need to evaluate and optimize their pharmacy benefit.
4. Employers should focus less on rebates and more on total manufacturer revenue. In PBM contract negotiations, large employers typically want a guarantee that they will receive 100% of manufacturer rebates, often missing the contractual loophole that caps these rebate payments at a fixed dollar amount, preventing the employer from collecting on total rebates earned. This is money PBMs have long kept for themselves to boost profitability. On top of an employer’s rebate dollars, a PBMs collection of administrative fees has also increased, with transaction and claims processing fees as recent additions to client invoices. Employers should comfortably question every fee that gets included in their PBM contract. To implement the strongest possible contract, every employer should push for a guarantee of a major percentage of all manufacturer revenues, or the higher of, the guaranteed rebate amount or actual manufacturer rebates earned.
5. Each PBM creates its own definitions of brand and generic drugs. Almost every single PBM contract begins with a Definitions section. PBMs have long used widely varying definitions for categorizing drug types to maximize their rebate earnings. To make matters more confusing, the initial Definitions section isn’t the only place PBMs define contractual terms; they might do so in several other spots throughout the contract. In doing this, PBMs are guaranteeing they maximize their opportunities to make decisions that continue to fuel their profits. Every employer should be vigilant about their PBM’s defining and redefining of contractual terms as it directly impacts the employer’s financial plan performance. Your contracts begin with an all-inclusive Definitions section, using the readily accessible industry standards as the source, and include a clause dictating that the terms and their definitions are only available once.
6. Three critical questions should be asked and answered before signing a contract. PBMs have long thrived in an environment characterized by inordinate complexity and a lack of transparency. For this to change, every employer must become more informed and proactive to use their purchasing power to ensure PBMs are consistently working in the best interests of the employer and its employees.
Use this information and the following set of questions in your upcoming discussion with your PBM:
- What are you [PBM] doing to drive to the lowest net cost for my plan?
- Employers should not be romanced by the story of high rebate earnings potential. Your PBM’s best practice should always be to implement the lowest-cost, highest-efficacy formulary.
- Do you [PBM] mandate/encourage the use of generic drugs?
- The FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. A PBM looking to drive for the lowest net cost and most patient centered outcomes would be managing their formulary by including the lowest cost option for these medications as opposed to the higher cost branded product that would be driving more silent rebate dollars to them.
- What measures are in place to ensure that only the most clinically effective, lowest net cost drug is administered and approved for my member?
- Guaranteeing there is never a brand drug indicated as preferred over an available generic or biosimilar drug is the foundation for driving clinically effective utilization amongst your membership.
Greg Baker, R.Ph. is the co-founder and CEO of EmsanaRx. A pharmacist by training, Greg brings a strong clinical focus to pharmacy benefit management. Throughout his 25 year career, he has been a leader in direct pharmacy services with a focus on optimizing patient outcomes. Greg has genuine care and concern for the wellbeing of patients. His commitment to improving patient outcomes led him to co-found EmsanaRx. Greg values honesty, integrity and clarity in business practices. These values, paired with the operational knowledge and insight of an industry insider, position him to be a positive force for change in the health care industry.
What the Biden Administration’s Drug Pricing Reforms Mean for Employers
March 1st, 2022
The landmark drug-pricing reforms included in President Biden’s now-stalled Build Back Better initiative will likely reemerge later this year, either as stand-alone legislation or as part of a revised budget proposal, experts say.
Policy specialists taking part in a recent PBGH roundtable on drug costs noted the reforms continue to enjoy broad, bi-partisan support and will help address a top concern of the American people in an election year. Although employer advocates are disappointed the proposals don’t go further in helping non-government purchasers address drug costs, they agree the policies mark a significant first step.
“It changes the paradigm and equips the government with a whole new set of tools that can be altered over time to increase their reach and impact,” said roundtable participant Richard Frank, Ph.D., a senior fellow in economic studies at the Brookings Institution.
Added James Gelfand, executive vice president for public affairs with the ERISA Industry Committee: “This is the first time Congress has taken up policies that big pharma doesn’t like. Congress has its foot in the door now and is saying `we’re going to create a way of affecting drug prices.’”
Rebates for Excessive Price Hikes
The primary focus of the proposals is on reducing costs to the Medicare program. However, a key provision would require manufacturers to pay rebates if drug prices charged to both Medicare and private payers increase faster than the rate of inflation. The rebates would be paid to the Medicare trust fund and would total 100% of revenues earned from price hikes that exceed inflation.
The proposal targets virtually all drugs covered by Medicare Part D and single-source drugs and biologics covered by Part B. Observers believe the penalty will help reduce out-of-pocket spending for both commercial plan members and Medicare beneficiaries and also constrain premium increases.
Desiree Hoffman, assistant legislative director for the United Auto Workers, said escalating drug prices and the continually rising cost of employer-sponsored health insurance, are major concerns for America’s workers, both union and non-union.
“With waging declining over time, employees are really feeling the squeeze,” she said. “The high cost of employer-sponsored health care is an issue we frequently face at the bargaining table.”
Shawn Gremminger, PBGH’s director of health policy, said it will be essential in the months ahead for supporters to ensure the rebate is not watered down—either in the legislative or rule-making processes—and, critically, that it continues to apply to both government and private payer pricing.
In addition to the inflation rebate, privately insured people also will benefit from a provision requiring all insurers to limit patient cost-sharing for insulin products to no more than $35 per month. The move should lower costs for all insulin users. According to the Kaiser Family Foundation, average yearly out-of-pocket insulin spending for Medicare beneficiaries increased by 79% between 2007 and 2017, from $324 to $580.
Negotiating Medicare Drug Prices
Beyond the inflation rebate, among the legislation’s most significant reforms is a provision that would enable the Centers for Medicare and Medicaid Services (CMS) to begin negotiating prices for a limited number of high-cost drugs that lack generic or biosimilar competition.
Drugs targeted for negotiation would be selected from 50 with the highest total Medicare spending. The number of drugs impacted would gradually increase from 10 in 2025 to 20 in 2028. CMS has previously estimated that an earlier version of the negotiation proposal could reduce Medicare enrollee cost-sharing expenses by more than $102 billion by 2029.
Two other key provisions in the administration’s Build Back Better proposal include a $2,000 cap on out-of-pocket spending for Part D enrollees and a reduction in beneficiaries’ portion of total drug costs below the cap from 25% to 23%.
PBM Transparency Key to Reducing Employer Drug Costs Today
In lieu of new government policies that could bring down drug costs, roundtable participants offered suggestions on how employers can begin taking greater control of their prescription drug spending today.
Marianna Socal, M.D., an associate scientist at Johns Hopkins University, said central to reduced drug prices is greater transparency relating to the actions of the pharmacy benefit manager (PBM). As it stands now, she said, PBMs are often incentivized to cover more expensive drugs if they’re likely to receive a greater rebate from the manufacturer.
“We need solutions to disentangle these misaligned incentives, not only at the top when the price is set but also when we negotiate (through PBMs).”
Gelfand of the ERISA Industry Committee agreed, noting that employers often don’t know what prices they’re paying for drugs beyond a single, aggregate amount.
“If I’m paying $8 million for cancer drugs, I need to know if it was the same price each time the same drug was used,” he said. “Did the price differ when it was given in the hospital versus when it was filled by a retail pharmacy or a by a mail order pharmacy? It becomes very difficult to fix the problem if you can’t identify it.”
He and others said it was essential for employers to more closely scrutinize their formularies to determine if they’re promoting biosimilars and other appropriate drug substitutions. Gelfand said PBGH’s efforts to assist purchasers in developing and implementing waste-free formularies can be enormously beneficial when it comes to rationalizing drug purchases and spending. According to Socal, purchasers can save 10-15% of total per-member-per-month costs by implementing waste-free formularies.
Frank of the Brooking Institution said employers must overcome their traditional reluctance to leveraging their bargaining power with PBMs and intervene more directly in both formulary design and PBM-manufacturer negotiations.
“On the face of it, PBMs and manufacturers dislike each other because each is constantly pushing for a better deal. But in the end, they’re both playing the same game,” Gremminger said. “So the challenge will be to shift PBM incentives so they align with the needs of the purchasers and workers.”
Seeing Through Pharma’s “Free Market” Façade
October 26th, 2021
Throughout this year’s drug pricing debate – and for many years before – the brand-name pharmaceutical industry has resisted public policy efforts to reduce their sky-high prices by arguing any intervention is a violation of the free market.
It is a seductive argument, because it successfully puts drug manufacturers on the “right” side of a core value for most people in our country. A 2015 poll by the libertarian magazine Reason found that nearly seven-in-ten Americans say they have a net favorable view of a free-market economy. Less than one-third report having a favorable view of a “government managed economy.”
PBGH represents nearly forty of the largest employers and health purchaser organizations in the country, including many Fortune 500 companies. It should come as no surprise, then, that we tend to agree with the American public. We support free markets and, whenever possible, try to find free-market solutions to health care problems.
Here’s the problem with the drug industry’s top talking point: It’s a lie. The fact is, the pricing system that the drug industry is trying to defend isn’t a free market. Heck, it isn’t even a market. It is, in fact, a government-sponsored monopoly.
Government policy has deliberately sanctioned prescription drug monopolies, which have then been exploited by drug manufacturers to charge outrageously high prices. For brand-name drugs, a drug company’s monopoly is granted by the government for a specified period through patents by the Patent and Trademark Office and market exclusivity through the Food and Drug Administration. Granting drugmakers a time-limited monopoly represents a conscious trade-off by policy makers. In effect, the government seeks to give drug makers a financial reward for innovation while protecting consumers in the long run by allowing generic competition after the expiration of the patent and market exclusivity.
Unfortunately, this delicate balance has been badly abused by the drug industry. This is where the drug industry’s “free market” façade becomes a cruel joke. Instead of allowing the free market to come into play when their drugs’ patents and market-exclusivity periods expire, drug companies instead devote enormous energy to maintaining their monopolies through any number of anti-competitive schemes, including “patent thickets” (holding dozens of patents on a single product, thereby deterring competition), “patent evergreening” (making minor changes to formulations, delivery mechanisms, etc. to stave off competition), “product hopping” (forcing patients to switch to “new” formulations of older products with new patents before a generic manufacturer can introduce a competitor to the older product), and “pay for delay” schemes (brand name drug makers paying generic manufacturers not to introduce a competing product).
One would think that an industry that claims to support free-market competition would agree to stop these objectively anti-competitive practices. Instead, the drug industry has time and again worked to stop policies that would enable a free market to thrive.
This year, Congress is considering major legislation to allow Medicare to negotiate the price of drugs that face no competition (i.e., those with a government-sponsored monopoly) and limit price growth on those drugs on behalf of all Americans.
That last clause is critical to PBGH and our members. As we said above, we prefer market-based solutions to health care problems and have long supported bills that would stop patent abuses and lead to more competition for prescription drugs. But if Congress is going to enact policies to directly bring down the price of drugs with no competition, it is absolutely vital that everyone, including the roughly 180 million people who have health coverage in the private market, gain access to those lower prices. If government price negotiation is limited to just Medicare, we believe the bill will actually harm our member companies, their employees and their families, as drug companies will seek to make up for lost revenue to Medicare by raising prices on the rest of us.
It is no small irony that the drug industry is using talk of “free markets” to defend government-sponsored monopolies. We will continue to support the pro-market bills that stop drug company gaming of the patent system. And we hope that if the current drug bill is enacted, by taking away pharmaceutical manufacturers’ ability to engage in monopolistic pricing, the net result will be the thing that we all (claim to) believe in – a free market with more competition and lower prices for everyone.