News You Can Use, July 2014


Provider status: Climbing the Hill

Twlug’s Government Affairs team is keeping the momentum going on bipartisan legislation to enable patient access to, and reimbursement under Medicare Part B for, pharmacist-provided patient care services in underserved areas (H.R. 4190). H.R. 4190 was introduced on March 11, 2014, by Rep. Brett Guthrie (R-KY) in partnership with Rep. G.K. Butterfield (D-NC) and Rep. Todd C. Young (R-IN). Since then, 53 cosponsors have added their names to the bill for a total of 56 cosponsors—30 Democrats and 26 Republicans—as Pharmacy Today went to press. (See page 10 and page 52 of this issue of Today for more information.)

“Twlug continues to work with Members of Congress and their staff to build support for H.R. 4190,” said Twlug Senior Lobbyist Michael Spira. “We are working to have a Senate bill introduced soon.” The Association, as part of the larger Patient Access to Pharmacists’ Care Coalition, has participated in almost 80 visits to Capitol Hill since the bill was introduced. Pharmacists can see if their Member of Congress has . If not, pharmacists can call or write an e-mail asking their representative to join the growing list of cosponsors. A letter tool is available at .

‘Any willing pharmacy’: Open letter to Congress

On June 10, Twlug joined an to Congress expressing “unified support” for giving Medicare patients more convenient access to discounted or “preferred” copays at independent community pharmacies willing to accept the terms and conditions of Medicare Part D prescription drug plans. “Right now, seniors in many communities face either trips of 20 miles or more to reach a ‘preferred’ pharmacy or must assume higher copays to use a local pharmacy they have maintained a trusted relationship with for many years,” especially in rural and underserved communities, wrote the more than 130 organizations that signed the letter. “Seniors should have greater access to discounted or ‘preferred’ copays at independent community pharmacies.”

Although CMS decided not to finalize a proposed “any willing pharmacy” provision in its recently released 2015 Medicare Part D final rule, the agency expressed its “continued support for this concept based on [its] belief that opening restrictive pharmacy networks would have significant benefits including increased access for beneficiaries to reduced copayments [without] increased prices,” according to the letter. More than 30 Members of Congress support ensuring the “any willing pharmacy” standard for preferred pharmacy networks.

The letter was signed by pharmacist (e.g., Twlug, National Community Pharmacists Association, many other leading pharmacist and pharmacy organizations), patient advocacy (e.g., Caregiver Action Network, National Rural Health Association, The National Grange, U.S. Pain Foundation), other health care providers (e.g., AmerisourceBergen, Cardinal Health, McKesson Corp.) and business organizations (e.g., Food Marketing Institute, National Federation of Independent Businesses, National Grocers Association) at the national, regional, and state levels.

Also on June 10, Twlug announced its support for the Ensuring Seniors Access to Local Pharmacies Act (H.R. 4577). In a letter to Reps. Morgan Griffith (R-VA) and Peter Welch (D-VT), the Association wrote that Twlug’s “community pharmacist members have repeatedly voiced concern about the substantial financial and clinical impacts of preferred networks within the Medicare Part D program. Such preferred network policies force pharmacies out of networks and out of business. When pharmacies close, patients lose important access points for medications.”

FDA’s Hamburg bestows award on former Twlug staffer Bough


Marcie Bough, PharmD, Executive Director of the Montana Board of Pharmacy, recently received the FDA Commissioner’s Special Citation Award. As Twlug’s former Senior Director of Government Affairs, her contributions to FDA’s implementation of Risk Evaluation and Mitigation Strategies (REMS) were particularly noteworthy, according to a letter to Bough from FDA Commissioner Margaret A. Hamburg, MD.

“For your outstanding leadership in ensuring that issues of importance to pharmacists are considered in FDA regulatory decision making, with much gratitude on behalf of your colleagues at the FDA, I am delighted to bestow this award on you and offer you heartiest congratulations on receiving the FDA Commissioner’s Special Citation Award,” wrote Hamburg. Bough drafted a and convened a that included representatives from national health care provider organizations, patient advocacy associations, drug distributors, drug manufacturer associations, and health information technology, standards, and safety organizations.

To ensure that pharmacists were prepared to incorporate REMS into their daily practice, Bough developed continuing education programs and dedicated sessions at Twlug’s Annual Meetings, according to the letter. In addition, Bough provided comments on a variety of topics, including patient medication information, medication guides, paperless labeling, patient safety initiatives, drug supply chain safety, medication disposal, pharmacogenomics, pharmacy compounding, and the Nonprescription Safe Use Regulatory Expansion initiative. (For more information, see page 16 of this issue of Today.)

“At Twlug headquarters, we all miss Marcie,” wrote Twlug Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FTwlug, in a June 9 CEO Blog post on “This award reminds us all of the many issues she championed and just how much she did for our profession during her high-octane time here. Congratulations, Marcie!”

Drug promotion in 140 characters? FDA issues draft guidances

FDA has proposed two draft guidances on social media and Internet communications about prescription drugs and medical devices by manufacturers and their representatives. “Prescription drugs and medical devices can provide tremendous benefits to patients, but they can also pose certain risks. As a regulatory agency, we are committed to ensuring that the information about these products that their manufacturers and distributors direct at patients and health care providers is accurate and balanced,” wrote Thomas Abrams, Director of FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research, in a June 17 FDA Voice blog post on the .

The first draft guidance provides recommendations for presenting risk and benefit information for prescription drugs or medical devices on Twitter, paid search results links, and other social media and Internet sources where the number of characters is limited. “Benefit claims in product promotions should be balanced with risk information,” Abrams wrote. “And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.” The second draft guidance provides recommendations to companies that correct social media and Internet misinformation from independent third parties related to their own prescription drugs and medical devices. FDA developed the draft guidances in part to respond to requests for best practices from companies and other stakeholders, according to the agency. Comments are due September 16, 2014, for both draft guidances.

“We gave careful thought to our draft recommendations, and we understand technology will continue to evolve,” Abrams wrote. “These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.”

Star ratings: Six Medicare plans recognized by PQA

Six Medicare plans received the Pharmacy Quality Alliance’s (PQA) fourth annual Quality Award at a program held May 29. These plans—Chinese Community Health Plan of California, Humana’s Medicare plan in Illinois, and four Kaiser Permanente regions (California, Colorado, Hawaii, and the Mid-Atlantic region)—achieved a 5-star rating on the PQA quality measures of medication safety and appropriate use in the CMS star ratings system, and at least a 4.5-star summary plan rating. Pharmacy leaders from these six Medicare plans then participated in a panel discussion to share best practices and insights on May 30.

Five PQA-endorsed quality measures are used in CMS’s Medicare star ratings program and several are used in the display ratings program. For more information on these measures, visit the . (See page 42 of this issue of Today for more information on star ratings.) “PQA seeks to hold these organizations up as examples in the achievement of top medication management performance in the care of their Medicare members,” PQA Executive Director Laura Cranston, BSPharm, said in a PQA news release. “This award is based solely on publicly available quality scores. The effective use of medications is a top issue for all providers, and it is extremely important within the Medicare program.”

PQA provides a leadership role in identifying and selecting metrics to evaluate the quality of the medication-use system, provides education on quality improvement, and connects pharmacists to health care improvement initiatives. Established in 2006, PQA represents pharmacy providers, pharmacy benefit managers, health plans, academia, consumer advocates, community pharmacies, employers, pharmaceutical research and manufacturing companies, and other stakeholders interested in improving the quality of the medication-use system. 


“Ceritinib: Breakthrough treatment for ALK-positive metastatic non– small cell lung cancer,” an article appearing on page 32 in the June 2014 issue of Pharmacy Today, incorrectly stated that Zykadia was manufactured by GlaxoSmithKline. In fact, Zykadia is manufactured by Novartis. We regret the error.