Proposed EHR rule offers ‘breathing room’


Important developments that could have an impact on urology practices include an attempt by the Centers for Medicare & Medicaid Services to provide more flexibility for providers in how they use certified EHR technology to meet meaningful use requirements and be eligible for program payments as well as proposed revisions to the FDA's “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.”

Bob Gatty
Bob Gatty,

Washington-The dog days of summer have descended on Washington, with typical heat, humidity, and the doldrums when it comes to hot political activity. In August, Congress takes a month-long break and in the federal agencies, many bureaucrats head for the beach or, at least, the hills.

Nevertheless, there are important developments percolating here that can have an impact on urology practices.

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One such action involves an attempt by the Centers for Medicare & Medicaid Services to provide more flexibility for providers in how they use certified EHR technology to meet meaningful use requirements and be eligible for program payments.

Another involves the FDA’s revised “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.” Those guidelines can affect physicians who seek to use drug products or medical devices off label, according to their best judgment.

AUA addresses proposed rule

In late May, CMS published its proposed EHR rule designed to provide a little breathing room. On June 17, in a “Policy & Advocacy Brief,” the AUA made note of this, saying that CMS and the Office of the National Coordinator for Health Information Technology “acknowledge the difficulty that some eligible health care providers have had in updating their EHR software to comply with standards originally required for the second stage of meaningful use.”

Under the proposed rule, eligible professionals may continue to use software certified under 2011 standards for the 2014 reporting period. If finalized, the AUA noted that the proposed rule would allow meaningful use participants who began their attestations in 2011 or 2012 an additional year under Stage 2, rather than having to meet more stringent Stage 3 standards following 2 years of Stage 2 attestations.

The AUA said it intended to submit comments in support of the proposed rule. The comments were due by mid-July.


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New FDA off-label guidance

Regarding the new recommended practices on unapproved new uses of medical products, the FDA’s intent was to clarify how a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature does not conform to the product’s FDA-approved uses.

The FDA, in its guidance, said that if a manufacturer who chooses to distribute scientific or medical journal articles that include information on unapproved/uncleared uses of its products complies with the new guidance, the FDA will not use that distribution as evidence of the manufacturer’s intent that the products be used for an unapproved new use.

The guidelines establish a checklist of requirements for journals, which should be peer reviewed, and articles, which should be distributed in unabridged form and be “scientifically sound.” FDA-approved labeling should be disseminated along with the literature, and the literature cannot be funded by a company with financial interest in the product.

In addition, the guidelines also cover clinical practice guidelines (CPGs), statements that include recommendations intended to help clinicians make decisions for individual patient care, including in circumstances where there are few or no approved drugs or devices indicated for the patient’s condition or in cases where approved therapies have not proven successful for the individual.

CPGs, the FDA guidelines state, should be based on an explicit and publicly accessible process, provide a clear explanation of the logical relationships between alternative care options and health outcomes, provide clearly articulated recommendations in standardized form, and provide ratings of both quality of evidence and strength of recommendations.

They also must be reconsidered and revised when important new evidence warrants modifications of recommendations.

CPGs must be distributed separately

The guidance recommends that manufacturers should distribute the CPG to a physician separately from promotional information.

“For example, if a sales representative delivers a CPG to a physician in his or her office, the CPG should not be attached to any promotional material the sales representative uses or delivers during the office visit,” the recommendations state.

The manufacturer should also ensure that the CPG contains a prominently displayed and permanently affixed statement identifying the distributing manufacturer and disclosing that some of the uses of drugs and/or devices described in the CPG might not be approved or cleared by the FDA.

In a letter to the FDA regarding the proposed guidelines, the Alliance of Specialty Medicine, which includes the AUA, noted that the FDA has long recognized that physicians may use products off label, even if manufacturers cannot promote those same uses.

“However, disseminating truthful, non-misleading scientific information on the medically accepted alternative uses of approved medical products is not viewed as promotional by our organizations,” the Alliance said.

Provided there is prominent disclosure that the FDA does not approve such use, limitations on communications should only be related to patient risk based on such factors as the approval status of the medicine, general medical acceptance of the treatment, and the “level of scientific sophistication of the audience,” the group added.

“Toward that end,” the Alliance stated, “we urge the FDA to ensure that access to scientific information from manufacturers on the safe and effective approved and unapproved use of medical products is not disrupted when the guidance is finalized.”UT

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