On October 3, the U.S. Supreme Court will hold a hearing in a case from California that’s about access to care for Medicaid patients. We know many states are under budgetary pressure to cut Medicaid reimbursement to pharmacies and other health care providers. Yet when reimbursement rates are too low, pharmacies are forced out of Medicaid. This reduces patient access to pharmacy and our services.

APhA, the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations filed a friend-of-the-court brief on August 4 with the Supreme Court in the case of Douglas v Independent Living Center of Southern California. We supported the initial lawsuit filed by California pharmacies and other health care providers to challenge a 10% Medicaid reimbursement cut in that state. We argued that states can be sued for actions that may deprive patients of access to medications and pharmacist services. In particular, these proposed cuts violate a federal patient access law. State actions must be consistent with federal laws.

The state of California says that it cannot be sued for Medicaid cuts, and the National Governors Association and the Obama administration are siding with the states. But key Democratic leaders in Congress and former federal health officials have filed separate friend-of-the-court briefs agreeing with us in spite of the administration’s position.

This is an important case. APhA and our colleague pharmacy organizations are watching it closely.

Last week, the White House Office of National Drug Control Policy (ONDCP), U.S. Department of Health and Human Services, FDA, and DEA released the Obama administration’s comprehensive action plan to address the national prescription drug abuse epidemic, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” The plan provides a national framework for reducing prescription drug diversion and abuse by focusing on education, prescription drug monitoring programs, medication disposal, and enforcement on pill mills and doctor shopping.

Marcie Bough, our Senior Director of Government Affairs, attended the press conference on April 19 during which ONCDP also announced efforts to pursue legislation to amend the Controlled Substances Act by requiring prescriber education upon DEA registration and reregistration. We should expect to see such legislation introduced in a month or so.

As part of this coordinated intergovernmental effort, FDA also announced the final Risk Evaluation and Mitigation Strategies (REMS) for long-acting and extended-release opioid medications as one step in addressing prescription drug abuse and better ensuring safe use of opioids. FDA expects the REMS to become effective in 2012.

The opioid REMS will require manufacturer-developed prescriber education that addresses proper pain management, patient selection and education, and information on proper storage and disposal; Medication Guides for patients; and assessment of prescriber education and patient access. The prescriber education component will be voluntary at this time. A future mandatory hook is tied to DEA registration.

FDA had reached out to us in advance of the announcement to provide us with some background. I was pleased to join Marcie on that call with FDA Center for Drug Evaluation and Research (CDER) Deputy Director Doug Throckmorton, MD. He focused on how REMS fits into the overall action plan, which we support. He specifically expressed FDA’s appreciation for all the work that APhA has done on the REMS issue and in helping FDA better understand the impact of REMS on pharmacy. Marcie does a nice job of managing this relationship.

On a final note, FDA also held a stakeholder call to further discuss the REMS. When asked by a caller about the REMS not requiring pharmacist education, Marcie reports that CDER Director Janet Woodcock, MD, said that at FDA they already think that pharmacists are the most educated on these medications and that this program is focused on the prescribers. Then she said that FDA fully supports the role of pharmacists in counseling patients and in discussing proper storage and disposal of all medications. This was a good plug for pharmacists!