On Wednesday, May 9, 2012, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced new regulations that would allow hospitals to expand their definition of “medical staff” to allow nonphysician practitioners, including pharmacists, to have privileges like other medical staff members.

The rule revises the Medicare Conditions of Participation for hospitals and critical access hospitals.

Under the new regulation, hospitals would have the flexibility to grant other practitioners—such as pharmacists, advanced practice nurses, and physician assistants—the power to perform the duties they are trained for and allowed to do within their scope of practice and state law.

Accordingly, the new regulations would only apply in states that already permit pharmacists to enter into collaborative practice agreements.

The rule requires that the medical staff examine the credentials of all eligible candidates (as defined by the hospital governing body) and then make recommendations for privileges and medical staff membership to the governing body.

These steps are intended to help achieve the key goal of President Obama’s regulatory reform initiative to reduce unnecessary burdens on business and save almost $1.1 billion across the health care system in the first year and more than $5 billion in 5 years.

According to the Centers for Medicare & Medicaid Services (CMS), the rule is written to encourage physicians and hospitals to enlist qualified nonphysician practitioners to fully assist them in taking on the work of overseeing and protecting the health and safety of patients. This applies not only to the “work” of the medical staff—such as quality innovation and improvement, best practices application, and establishment of professional standards—but also to the everyday duties of caring for patients.

The rule reaffirms the agency’s belief that an interdisciplinary team approach to patient care is the best model for patients and states that physicians must be the leaders in overall care delivery for hospital patients.

The rule also establishes new provisions that would allow a hospital to use preprinted and electronic standing orders, order sets, and protocols for patient orders. Under these provisions, the nursing and pharmacy leadership of a hospital would be full partners in approving preprinted and electronic standing orders, order sets, and protocols and in ensuring that these orders are periodically reviewed to determine the continuing usefulness and safety of the orders and protocols.

Areas Not Addressed in the Final Rule

The rule does not address the issue of payment for services. Under the new regulations, hospitals would have the authority to grant privileges to pharmacists; however, this does not establish a pathway for pharmacists to bill directly for their services.

The agency stated that any expansion of Medicare Part B coverage was outside the scope of the proposed rule and would not be considered part of this rulemaking process.

The agency declined to act on requests to change the rule to require that the professional responsible for the patient or the person who ordered the medications also receive the report regarding pharmaceutical drug error, adverse event, or incompatibility issues. It also noted comments that the hospital pharmacy department should be included in the development of criteria for pharmacist privileging decisions.

The agency considered these requests outside the scope of the proposed rule, so it would make no changes to this provision; however, the agency stated that it might consider these comments when undertaking future rulemaking.

Click here to read the HHS Press Release on the Final Rule.
Click here to view the Final Rule in full.

Senator Franken Highlights Pharmacist-Provided Patient Care

In a letter to CMS Acting Administrator Marilyn Tavenner, Senator Al Franken (D-MN) highlighted quality interventions delivered by pharmacists that dramatically reduced medication errors when patients were discharged from hospitals.

The senator called for regulations regarding stage 2 meaningful use of health information technology to include a requirement that pharmacists deliver medication reconciliation services to patients.

The letter cited two Minnesota-based studies showing that pharmacist-led medication reconciliation resulted in improved clinical outcomes and reduced medication errors.

A study from the Hennepin County Medical Center found that although the implementation of a system of medication reconciliation at point of discharge using electronic health records (EHRs) reduced the error rate from 92% to 70%, the rate was reduced to zero when pharmacists were assigned to review medication orders.

A study from the Mayo Clinic found pharmacists working as part of a multidisciplinary medication reconciliation pilot to be an “outstanding resource” for reducing the number and severity of medication errors. The Mayo Clinic has since expanded the role of pharmacists coordinating with the discharge team and has updated its electronic medical records to improve medication reconciliation upon discharge.

The stage 2 meaningful use proposed rule already recognizes that medication reconciliation can reduce medication errors; that discharge from a hospital is an important setting for a quality intervention; and that quality intervention at hospital discharge should include targeting medication errors. Senator Franken called on CMS to consider these three areas opportunities to require pharmacist-provided medication reconciliation at hospital discharge.

The senator went on to identify three areas in which the proposed rule should be strengthened:

• Requiring medication reconciliation at hospital discharge as well as hospital admission (the proposed rule requires only medication reconciliation on admission)
• Requiring hospitals to check the summary of care record for medication errors at discharge (the proposed rule requires only the collection of the summary of care record)
• Requiring medication reconciliation as part of e-prescribing at discharge and engaging pharmacists in the medication reconciliation process as part of e-prescribing technology, including certifying e-prescribing technology that allows the pharmacist to communicate back with the hospital to correct medication errors in real time

The senator also acknowledged that the financial incentives in the traditional fee-for-service health care model actually discourage hospitals from using this intervention nationwide.

The senator later highlighted the value of pharmacist-led medication reconciliation at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing on health care delivery reform, held on May 16.

Click here to read Senator Franken’s letter.

About Health Information Technology Meaningful Use

The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology.

CMS is offering up to $44,000 over 5 years from Medicare, or $63,750 over 6 years from Medicaid, to eligible health professionals who adopt EHRs and use them in a meaningful way. The agency has developed performance measures to define meaningful use criteria. Stage 1 rules were implemented in 2011, and stage 2 objectives will be required for early EHR adopters starting in 2014.

Click here to read the stage 2 meaningful use proposed rule.

Support ACCP-PAC!

Against a backdrop of congressional stalemate and Supreme Court uncertainty over the future of the Affordable Care Act (ACA), the expansion of the definition of Medicare nonphysician practitioners and Senator Franken’s letter calling for pharmacists to deliver medication reconciliation services to Medicare and Medicaid patients serve as examples of positive, incremental, public policy progress for clinical pharmacy.

Regardless of the outcome of the November elections or the outcome of the Supreme Court’s ruling on the ACA, health delivery will continue to evolve. ACCP’s efforts in Washington remain focused on developing, advancing, and positioning clinical pharmacists through a variety of public and private initiatives, including the Patient-Centered Primary Care Collaborative (PCPCC).

To achieve our goals, it is vital that we help elect congressional leaders who understand and value the role of clinical pharmacists as integral members of patient-centered, interdisciplinary teams. ACCP has the only PAC dedicated to advancing the practice of clinical pharmacists. Political contributions are an essential component of a comprehensive advocacy strategy. With more than 12,000 members eligible to contribute, ACCP-PAC is in a position to become one of the most prominent pharmacy PACs, thereby influencing future advances in pharmacy practice. To do this, we need YOUR SUPPORT!

If each ACCP member contributed just $25, ACCP-PAC would raise $300,000. Please consider donating at least $25 to ACCP-PAC.

CLICK HERE to support clinical pharmacy through your PAC contribution today!

For more information, please visit our Web site (www.accpaction.org), or contact John McGlew, Associate Director, Government Affairs, at (202) 621-1820 or [email protected].