Provider groups are pressuring HCFA to allow public comment on a revived regulatory proposal to use cost-effectiveness in determining whether Medicare will pay for a procedure or treatment.
And the reasons some provider groups now are asking for an opportunity to comment are much the same as those they used when objecting to a proposed cost-effectiveness regulation published in 1989. Provider groups said the proposal could lead Medicare to refuse to pay for appropriate treatments for beneficiaries.
Under existing law, Medicare does not pay for any medical devices or services that are not "reasonable and necessary for the diagnosis and treatment of illness or injury." HCFA recently dusted off the 1989 proposed rule that included the words "cost-effective" in its definition of "reasonable and necessary" procedures.
HCFA's wants to clarify that proposal to define a "reasonable and necessary" treatment as one that is "cost-effective when compared with an equivalent Medicare-covered service" (April 29, p. 70).
HCFA officials say the rule is necessary to make clear for beneficiaries and providers what treatment technologies Medicare will cover.
But HCFA has stumbled into some opposition. A coalition of provider groups-including the American Medical Association, Health Industry Manufacturers Association and the Pharmaceutical Research and Manufacturers of America-objects to the proposal because the changes in the healthcare market since 1989 have created a different context for coverage decisions.
They also questioned whether cost-effectiveness analyses are accurate.
Providers fear implementation of the cost-effectiveness criterion could lead to rationing or denial of appropriate care.
The provider coalition, in a September letter to HCFA Administrator Bruce Vladeck, used that same justification when it objected to HCFA's apparent intent to publish the revised cost-effectiveness definition as a final rule rather than as new proposed rule.
The provider group coalition said publishing a final rule without public comment "could inappropriately deprive Medicare beneficiaries of access to life-saving, life-enhancing medical technology."
In its objection, the provider coalition is joined by two dozen members of Congress who said publication of the rule in its final form would be a violation of the federal Administrative Procedures Act, which established opportunity for public input into regulatory rulemaking. Because the public comment on the original proposed rule closed in March 1989, publishing a final rule without another comment period "flouts the very reason" Congress passed the administrative procedures law, the members wrote.
HCFA officials now say they are considering publishing at least the disputed part of the revision as a proposed rule again.
Kathleen Buto, HCFA's associate administrator for policy, however, said she believed the provider groups were "responding about what they think might come out in the final rule," which nobody has seen yet.
She added that providers ought to welcome the rule because it merely will write into law what HCFA currently does "on a day-to-day basis."