CMS delays controversial demand for the best price for drug producers

The Biden administration has delayed a portion of a rule of the Trump era demanding that they include the discounts they offer patients when calculating the “best price” for drugs in the Medicaid drug reimbursement program, according to a proposed rule in March.

Drugs were supposed to start reporting some better prices starting January 1, but CMS delayed the requirements until July 1, 2022. The agency said additional time would allow the healthcare industry. to address concerns about patient access and quality of care before the new requirements take effect.

“The primary reason for the original delay, and the proposed new delay, is to provide more time for CMS, states and manufacturers to make the complex system changes needed to implement the new best price and program (value-based payment). ) (e) dedicate resources to the public health emergency, ”the rule says.

CMS also proposed delaying the inclusion of some U.S. territories in the Medicaid definitions of “states” and “United States” of Medicaid. The changes are expected to take effect on April 1.

Drug producers sued the federal government last week forcing them to present multiple better prices, arguing that CMS did not have the power to issue the rule and apparently reversed the course on the agency’s lengthy interpretation of the law.

The Trump administration approved the new rule in December, hoping it will make it easier for private insurers, state Medicaid programs and prescription drug manufacturers to create value-based payment agreements linked to clinical outcomes. .

But hospitals, insurers, drug companies, medical schools and Medicaid directors argued last summer that CMS precipitated the rule. They warned that they needed more time to understand, since the agency did not look at how it could influence states and the healthcare industry or say how it would ensure the rule would work as planned.

Drugs were concerned that the regulation could lower the price they are allowed to charge in hospitals under the 340B drug discount program. And others are concerned that it will create administrative problems and costs for suppliers, states and insurers.

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