3:30 PM
Sep 12, 2018
 |  BC Extra  |  Politics & Policy

House votes to give public a say in local Medicare coverage decisions

The House of Representatives voted unanimously Wednesday in favor of legislation that would require Medicare contractors to consider public input and consult an expert panel before finalizing local coverage determinations, which govern whether Medicare will cover a drug or service within a certain geographical region.

Decisions on Medicare coverage of a drug can take one of two paths. In certain cases, CMS may develop a National Coverage Determination, which would apply to all beneficiaries regardless of region. In the absence of an NCD, Medicare coverage of a drug is left to the discretion of local contracted intermediaries or carriers, which make region-specific determinations based on patient demographics.

Companies often must tack on local coverage decisions one by one. This is not only time consuming, but also labor intensive, costly and difficult because different regional payers have different evidence requirements. These requirements can translate into the need for additional postmarket studies, which delay uptake (see "Second (Ex)act").

H.R.3635, titled the Local Coverage Determination Clarification Act of 2017, would inject public and expert input into the formation of local coverage decisions, and make the process more transparent.

Rep. Lynn Jenkins (R-Kan.), one of the bill's sponsors, said in a statement that the current process offers little opportunity for interested stakeholders to raise issues or offer alternatives.

"This bill will help ensure that Medicare coverage decisions are made by qualified health experts through a transparent process that is based on sound medical evidence," she said.

The legislation would require Medicare contractors to publish proposed local coverage determinations online, along with a written rationale and description of all evidence under consideration. Within 60 days, the contractor must hold at least one public meeting to review the draft, and secure the advice of a panel of qualified health experts. Public comments would be accepted up to 30 days after the meeting.

The bill would also establish a pathway by which parties can petition a contractor to reconsider a coverage determination.

The Senate version of the bill, S.794, includes several additional provisions to ensure local coverage decisions aren't copied from another region without due consideration. The bill would prevent a Medicare administrative contractor from adopting a local coverage determination developed for a different geographic area unless the contractor independently evaluated and considered the qualifying evidence supporting the determination as applicable to the local region.

The Senate's bill also would require a CMS to appoint a Medicare Reviews and Appeals Ombudsman. The Senate has not yet voted on the bill.

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