Pharmacy & Therapeutics - February 2009 - (Page 79)

COMMENTARY: Pushing an Expanded Role for Pharmacists gram. That is where Section 176 of the MIPPA came in. It cancelled the six categories—because dual eligibles are no longer coming into Part D—and set up a new process whereby the secretary of the Department of Health and Human Services (DHHS) designates drug classes that meet two conditions: 1. Restricted access to drugs in the category or class would have major or life-threatening clinical consequences for individuals who have a disease or disorder treated by the drugs in such a category or class. 2. These individuals must have access to multiple drugs within a category or class because of unique chemical actions and pharmacological effects of medications within the category or class, such as those used to treat cancer. Formularies would have to provide all available drugs in each of those categories, although exceptions could be made. The DHHS secretary could designate as many categories as applicable, and the hope of drug companies and patient groups is that the number would be much higher than six. Among those who have had second thoughts about some provisions in the MIPPA is Senator Max Baucus (D-Mont.), chairman of the Senate Finance Committee. He wrote a “technical corrections” bill that would make some ostensibly minor changes, including eliminating Section 176. The Baucus bill would simply reinstate the CMS guidance. But groups such as the Academy of Managed Care Pharmacy (AMCP) oppose both Section 176 and the CMS guidance. Judith A. Cahill, AMCP’s Executive Director, said: We would suggest that the appropriate ‘corrective’ action that should be taken by the Congress is to repeal Section 176 [and replace it] with language that reaffirms the independent, evidencebased Part D formulary decision-making process that is applicable for all therapeutic drug classes.” The AMCP has produced a study showing that the regulations requiring Medicare’s Part D prescription drug plans (PDPs) to include all drugs in the six designated classes could be costing U.S. taxpayers an additional $511 million per year. The upcoming Medicare reform bill will also be the venue for a full-court press from pharmacy groups for direct payment to pharmacists for expanded MTM services. The Medicare Modernization Act (MMA) of 2003, which established the Part D drug benefit, defined MTM services very narrowly and dictated that PDPs had to offer them only to a small subset of beneficiaries, as follows: (1) those with multiple chronic conditions, (2) those who take multiple medications, and (3) those with drug costs expected to exceed $4,000 per year. For those patients, MTM services can be provided by anyone, not just the pharmacist at the point of prescription delivery. Services can be provided via a telephone call that can be made by any type of health care professional. Medicare reimbursement for MTM services is not dictated either; it is part of the administrative fee that Medicare pays for a particular PDP. The plan then decides how much to pay whichever professional delivers the service. The American Pharmacists Association (APhA) is part of a broad coalition called the Leadership for Medication Management. The coalition has developed an MTM legislative agenda that includes payment to pharmacists for activities outside the current scope narrowly defined by the MMA. Payments to pharmacists could be approved for such things as collaboration with the physician to provide feedback on drug therapy and development and implementation of a medication management plan, in collaboration with the caregiver and others. But questions have been raised about the effectiveness of MTM services. MedPac, the group that advises Congress on Medicare policy, issued a report on November 6, 2008, noting no data existed to indicate that MTM services are effective. MedPac recommended some actions that Medicare could take, such as setting minimum standards for MTM programs and requiring outcomes reporting. Both those ideas leave the APhA queasy. “We are concerned that a minimum could become the maximum and could remove the discretion of the health care providers, working with patients, to determine the needs of an individual patient,” says John A. Gans, PharmD, Executive Vice President and APhA’s Chief Executive Officer. Any legislation expanding MTM services and payments would have to be negotiated with Tom Daschle, the new secretary of DHHS. The former leader of Senate Democrats, who has been out of Congress for a few years, was a leading supporter of federal negotiation with drug companies over Part D prices and, as an analogy to that, development of a national Medicare formulary. Besides wrestling with Medicare reform efforts, though, he will confront congressional efforts to toughen up regulation of the drug industry by the FDA, which is part of DHHS. As for FDA oversight and legislation, the House has a new drug czar, Representative Henry Waxman (D-Calif.). He replaces Representative John Dingell (D-Mich.) as chairman of the House Energy and Commerce Committee, which has considerable authority over health policy. Mr. Dingell, who remains at the committee, is “an old bull,” the longest-serving member of the House, a bit crotchety and better known these past few years for his dyspeptic questioning of committee testifiers than for getting bills passed. Henry Waxman is a ball of energy. Moreover, he has been a pesky antagonist of the brand-name drug industry, constantly investigating its drug pricing policies and highlighting questionable aspects. In 2008, as chairman of the House Oversight and Investigations Committee, he had no legislative authority. In 2009, he has more legislative authority than almost anyone in the House, and he is closer to House Speaker Representative Nancy Pelosi (D-Calif.) than John Dingell is. The flip side of Mr. Waxman’s antipathy to the brand-name industry is his support for greater use of generic drugs. It was Waxman who last year teamed up with Senator Charles Schumer (D-N.Y.) to introduce a bill (the Access to LifeSaving Medicine Act) that created a pathway at the FDA for approving generic versions of the most advanced types of biotechnology drugs, such as various interferons. The point is that the Waxman bill is considerably more progeneric than a rival bill that actually passed a Senate committee last June—the Biologics Price Competition and Innovation Act. Its chief sponsor is Senator Edward Kennedy (D-Mass.). continued on page 104 Vol. 34 No. 2 • February 2009 • P&T® 79

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - February 2009

Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

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