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'Build Back Better' Isn't the Only Infrastructure Bill With Healthcare Provisions

— Smaller bill includes measures on single-dose drugs, Medicare rebate rule

MedpageToday
President Joe Biden, Vice President Kamala Harris, and senior staff clap after the infrastructure bill passes in the Senate

WASHINGTON -- What are the healthcare provisions in the two infrastructure bills making their way around Capitol Hill? If you think it's just about hearing coverage in Medicare and negotiating drug prices, think again.

The that passed the House last week actually contains several health-related provisions, including:

  • A requirement that manufacturers of certain single-dose drugs covered under Medicare Part B provide refunds for any drug product left over after a vial is used up. Proponents of this provision "will argue that the size of the vial is larger than it needs to be -- and therefore the payment for the drug is higher -- and there's this excess that happens after you administer it to the patient," Matthew Kazan, MPP, principal at Avalere, a healthcare consulting firm here, said in August when the bill was being discussed. "The intent of the provision is to try to recoup some of those savings," with the Congressional Budget Office (CBO) estimating that the provision will save about $3 billion over the next 10 years, he said.
  • A 3-year delay in implementation of a rule relating to prescription drug rebates. Currently, under an exception to the Stark anti-kickback laws, rebates paid by drug companies under the Part D program go to pharmacy benefit managers, which use them to decrease Part D premiums. The rebate rule, finalized by the Trump administration, would have forced the rebates to go directly to consumers.

That second provision is nothing more than an accounting gimmick to raise revenue to pay for the $1.2 trillion bill, according to several industry analysts. "The drug rule is a policy that this administration (and probably the last one) was not going to implement, since it cost the Medicare program billions by removing the incentive for Part D prescription drug plans to negotiate lower drug prices," said Marsha Simon, PhD, an independent drug industry analyst, in an email. She called the provision "particularly meaningless" and added that "it is a revenue-raiser thanks to arcane 'scoring' rules."

Thomas Miller, JD, resident fellow at the American Enterprise Institute, a right-leaning think tank here, concurred. "While efforts flag to curb 'pay for delay' practices by prescription drug patent holders, a different sort of 'pay for delay' was cashed in within this first somewhat more conventional infrastructure law -- delaying the poorly crafted Trump-era drug rebate rule an extra 3 years produced a modest 'revenue' gain on paper through the magic of CBO scoring," he said in an email.

The provision on refunds for leftover drug products drew mixed reviews. Simon said that provision "has more merit and some urgency. Manufacturers follow the practice to earn higher reimbursement from Medicare (nearly $1 billion for discarded medicine in 2019). Another consequence of the practice is the misuse of injectable anti-viral, pain, and cancer care drugs as doses intended for one patient are split among patients."

Requiring manufacturers to refund money for unused medication "is a win for the patient (as it removes the incentive to split a dose), the physician (as it lowers drug costs) and the Medicare program (as it saves the program more than $1 billion per year and the provision directs the savings to the [Medicare] trust fund)," she continued. "It is the biggest win for those patients, especially in pain clinics, according to the CDC, where , [which has] resulted in potentially fatal infections and diseases such as meningitis."

But Miller was not enthusiastic. "Like other lesser provisions, whatever rings the budget savings register is open for inclusion," he said. "It's nothing major, but provides more loose change from the pharma sofa cushion. You might think of it as a reverse twist on the much older practice of 'No deposit, no return' in which some customers (such as purchasers of bottled soft drinks) paid a little extra up front, and then could get it back as a refund when they returned 'clean and empty' bottles."

"In this case, Congress would just cut out the middlemen customers and collect the extra money from the manufacturer," he added. "Very secondary stuff, much further down the food chain, but every semi-imaginary 'saving' counts when you are dialing for dollars."

Since the bill has already been passed by the Senate, it now heads to President Biden for his signature; that is expected to happen soon. A larger infrastructure bill known as the "Build Back Better" bill, currently valued at around $1.75 trillion to $2 trillion, is still being debated in both houses of Congress. It is that larger bill for which provisions such as hearing aid coverage for Medicare beneficiaries and having Medicare negotiate drug prices are being considered.

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    Joyce Frieden oversees ľֱ’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy.