OIG calls for diagnosis information on prescriptions

March 15, 2012

Prescriptions could take on a new look if the Office of the Inspector General gets its way.

Prescriptions could take on a new look if the Office of the Inspector General (OIG) for the Department of Health and Human Services gets its way. An OIG report issued late last year renewed earlier recommendations to include diagnosis information on prescriptions as a way to reduce inappropriate payments for Medicare Part D claims.

The Centers for Medicare and Medicaid Services (CMS) rejected the idea. The American Pharmacists Association (APhA) said that including diagnosis information makes sense. It could help curtail inappropriate reimbursement and increase patient safety. But APhA isn't expecting quick changes.

"We would like to have diagnosis information on the prescription," said Brian Gallagher, RPh, JD, APhA senior vice president for government affairs. "But as CMS points out, this is something that is under the purview of the states, not the federal government. CMS could get creative in its regulatory authority, but would medicine approve?"

"The OIG didn't bring patient safety into the discussion, but the report clearly highlights the current limits of claims information," said Marcie Bough, PharmD, senior director of government affairs for APhA.

A prior OIG report on the use of antipsychotic drugs covered by Part D for older nursing home residents found that half of the claims for atypical antipsychotic drugs were paid in error because the uses were inappropriate (Drug Topics, July 2011).

For drugs to qualify for Part D reimbursement, they must be used for medically accepted indications. That means either the uses for which the agent was approved by FDA or off-label uses supported by at least 1 of 3 major compendia specified by the Social Security Act: the American Hospital Formulary Service drug information; the United States Pharmacopeia drug information or its successor publications; and the Drugdex information system.

The OIG found that without a diagnosis, it is difficult, if not impossible, for PDP sponsors to determine whether a Part D claim is medically appropriate.

"In our previous evaluation, we recommended that CMS facilitate PDP sponsors' access to information necessary to ensure accurate reimbursement of Part D claims," the OIG wrote in its report. "CMS did not concur with this recommendation. This report provides further evidence to support the prior recommendation."

CMS requires PDP sponsors to maintain fraud and abuse plans as part of their general Part D compliance program, but does not suggest any strategies to ensure that Part D drug payments are limited to medically accepted indications. Most plans rely on prepayment edits, prior authorization, or postpayment reviews.

Prior authorization requires diagnosis information, but requiring prior authorization on all Part D claims is not a practical solution. And pharmacists do not want to be put in the position of policing off-label use, Bough said.

The other 2 strategies, prepayment edits or postpayment reviews, require diagnosis information that is not required on Part D claims. One obvious solution is to require diagnosis information on Part D claims.

"CMS does not have the statutory authority to require physicians to include diagnosis information on prescriptions, which are generally governed by state law," wrote then-CMS administrator Donald Berwick, MD, in response to the report. "Absent diagnosis information on the prescription, pharmacies would have no ability to comply with a requirement to include diagnoses on the claims submitted to Part D sponsors."

But putting the diagnosis on every prescription could do wonders for patient safety, said Michael R. Cohen, RPh, MS, ScD, FASHP, president of the Institute for Safe Medication Practices.

"Pharmacists are working without enough information," Cohen said. "If we're going to get serious about 100,000 being hospitalized, billions of dollars wasted every year from medication errors, pharmacists need access to lab values, to patient health information, to diagnoses. It is a serious weakness in our health system."