Published June 17, 2010 PHARMACY LAW Health Care Reform Legislation: Part II—Opportunities Jesse C. Vivian, RPh, JD Professor, Department of Pharmacy Practice College of Pharmacy and Health Sciences Wayne State University Detroit, Michigan US Pharm. 2010;35(6):58-60. Many of the pharmacy benefits and other provisions of the federal “Health Care Reform Legislation” were addressed in last month’s edition of this column.1 Here, the legislative impact on the pharmacy profession will be expanded to include some additional programs not previously discussed. At the outset, one projected outcome is that by 2016, when the majority of the reform measures will have been implemented, 141 million more prescriptions will be dispensed over current levels.2 This is a tremendous increase in pharmacy volume. Opportunities abound! The keystone of pharmacy advances included in the legislation has been set, but realization of the potential for success is still a long way from being achieved. No doubt, many congressional members were impressed by the pharmacy lobbyists who presented concrete evidence that an estimated $290 million is wasted annually because patients fail to take medications as prescribed.3 The opportunity to reach these savings depends on pharmacy efforts. Pharmacists must recognize that we are not the only professionals who are seeking expanded roles for nonphysicians in the health care reform packages. Nurses, physician assistants, and allied health providers are all looking for their piece of the pie as well.4 Pharmacists have to demonstrate their worth not only to Congress but also to the third-party payers of health benefits and the consuming public. While drug utilization review programs have been a normal part of pharmacy practice for many years, taking blood pressures, monitoring glucose levels, and other activities could evolve into the mainstream of professional activities. Don’t let these opportunities slip away to others. Perhaps the most significant provisions were in the Patient Protection and Affordable Care Act of 2010.5 The law includes a series of health care delivery reforms to promote coordination among health care providers and several important changes to Medicare Part D benefits.6 Benefits will only be achieved if pharmacy takes advantage of the opportunities that the reforms embody. Medication Therapy Management Specifically, the legislation establishes a stand-alone grant program to ensure pharmacist-provided medication therapy management (MTM) services as defined by the pharmacy profession’s consensus definition on the core elements of an MTM program. This program provides mechanisms for the testing of practice and care delivery models, such as patient-centered self-management programs that improve patient outcomes through team-based collaborations between prescribers and, hopefully, pharmacists. Here is an opportunity for pharmacy. The Department of Health and Human Services (HHS) is launching a Patient Safety Research Center as part of the Agency for Healthcare Research and Quality (AHRQ) to provide, in part, grants and/or contracts to fund pilot projects implementing pharmacist-provided MTM services.7 While the funding of this project is not mandated, it will be administered by the Center for Medicare and Medicaid Services (CMS) Innovation Group that will be charged with testing payment and service-delivery models.8 Here is another opportunity for pharmacy. The services offered by this program are intended to target patients who take four or more prescribed drugs or any high-risk medications, have two or more chronic diseases, or are at high risk of developing medication-related problems. Recipients of money under this program are required to submit outcomes reports to HHS at specified periods, and HHS is to provide an annual report to Congress regarding progress made utilizing these services. HHS also has the authority to develop performance metrics to determine the effectiveness of MTM activities by providers, which may or may not include pharmacists. More opportunities for pharmacy. Beginning in 2013, sponsors of MTM services under Medicare Part D will be required to provide annual comprehensive medication reviews and interventions as necessary. While the law does not indicate who is required to offer that intervention, it does require a pharmacist or other qualified provider to undertake the medication review directly with the Part D enrollee in person or through the use of specified communication technologies. Enrollees must be given a written or printed summary of the medication review. Another opportunity for pharmacy. Integrated-Care Models for Patient-Centered Medical Homes Another provision of the law is intended to ensure that providers with expertise in pharmacotherapy, including pharmacists, are fully engaged in integrated, collaborative, team-based approaches to delivering care, such as medical homes, accountable care organizations, community health teams, and home-based chronic care programs.9 This project, also to be administered by HHS, will include grants and/or contracts with state-based groups and Native American tribes with a focus on community-based health providers whose purpose is to support primary care practices using the patient-centered medical homes model.10 There is a clause in this section of the law that would include new payments for the additional components of patient-centered care that should include pharmacists as members of the team approach envisioned in this project. Part of the reason that pharmacists should be included it that the newly created teams must, under the law, enable local primary care providers to give their patients access to pharmacist-delivered MTM services, including medication reconciliation. The teams must also provide a 24-hour transitional care program that includes medication reconciliation on admission to and discharge from hospitals, nursing homes, and other institutional settings, another area where pharmacist participation is crucial to positive patient outcomes. Unfortunately, there is no time period specified in the law for the implementation of these programs. Practically an ordained opportunity for pharmacy. Independence at Home HHS is required to conduct a demonstration program for Medicare to test a payment-incentive and service-delivery model in which physicians and nurse practitioners direct home-based primary care teams. Pharmacists are to be part of these teams. All team members must have experience providing home-based primary care, make in-home visits, and be available 24 hours a day, 7 days a week, to carry out a Medicare beneficiary’s plan of care. HHS must start this program by 2012. A shining opportunity for pharmacy. New Definition for AMP Between 2007 and now, pharmaceutical manufacturers have calculated their average manufacturer price (AMP) for drugs based on the prices paid by wholesalers that sell to community and mail order pharmacies. Under the Health Care Reform Legislation, the federal government will use AMP as the basis of payments to pharmacies for Medicaid-covered generic medications. Starting October 1, 2010, AMP will be based on the average price paid by wholesalers for drugs distributed to “retail community pharmacies”—defined as independent, chain, supermarket, and mass-merchandiser pharmacies—and by these pharmacies when they buy directly from the manufacturer. Manufacturers will exclude from their calculations customary prompt-pay discounts and certain rebates and discounts. This should provide a more realistic calculation of what community pharmacies actually pay for drug supplies. A positive opportunity for pharmacy. Workforce Monitoring and Development A new National Health Care Workforce Commission will be established and charged to annually assess the nation’s supply and distribution of health care workers, including pharmacists, and project demand for the next 10 and 25 years. Another goal is to assess the implications of the government’s Medicare and Medicaid graduate medical education policies. Findings and recommendations will have to be reported annually to Congress and the executive branch. As part of this initiative, HHS will give career-incentive awards to pharmacists and others who are pursuing an advanced degree in geriatrics or a related field at an accredited health professions school. In addition, HHS will establish the United States Public Health Sciences Track at selected academic health centers to grant advanced degrees emphasizing team-based service, public health, epidemiology, and emergency preparedness and response. One of the stated goals is to graduate at least 50 pharmacy students annually in this program. What a great opportunity for pharmacy. Waste Reduction in Medicare Part D HHS will be required to survey pharmacists and other health care providers on methods aimed at decreasing the amount of outpatient prescription medication that goes to waste at long-term care facilities. The primary issue targeted by this provision is the customary 30-day prescription refills for medications covered by Part D. Sponsors of the prescription drug plans must begin to make changes suggested by this program by 2012. Here is another opportunity for pharmacy. DMEPOS Accreditation for Part B Pharmacies do not need to apply for or receive accreditation in 2010 to provide durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) under Medicare Part B. However, starting in 2011, pharmacies providing DMEPOS will need accreditation unless they meet certain criteria including: 1) annual billings of those items and services under Part B are less than 5% of the pharmacy’s total sales, 2) the pharmacy has been in good standing as a Part B supplier for at least 5 years, and 3) the pharmacy agrees to submit material in support of an HHS-initiated audit. One more opportunity for pharmacy. The Future Most of the various interest groups representing pharmacies and pharmacists have applauded the inclusion of all or parts of the above provisions.11 What happens next, however, is up to the profession of pharmacy. The Health Care Reform Legislation could be the best opportunity ever for pharmacists to demonstrate our worth and value-added services to federal and state governments. It lays the groundwork for letting pharmacy evolve into what we all dream about—the cornerstone of patient care and well-being. But it will require a great deal of work and ongoing efforts to make sure pharmacy is at the forefront of the core elements for patient-centered care initiatives. That will not happen without the involvement of every segment of the profession. To quote Steve Anderson, CEO of National Association of Chain Drug Stores (NACDS), “This in many ways is still the early stage of our campaign to advance pharmacy’s value and viability as the face of neighborhood health care.”12 No pharmacist anywhere in the country should feel that he or she has too small a voice or no ability to effect positive changes in the delivery of pharmacy services. The time for activating or increasing your involvement with local, state, or national pharmacy organizations is now. Do not let opportunities for the growth and development of our profession pass you by. Please give your active and enthusiastic support. REFERENCES 1. Vivian JC. Health care reform legislation: part I. US Pharm. 2010;35(5):51-53. 2. Q&A: Anderson keeps NACDS focused on what matters. Chain Drug Review. April 26, 2010. www.chaindrugreview.com/ inside-this-issue/news/04-26- 2010/qa-anderson-keeps-nacds- focused-on-what-matters. Accessed May 25, 2010. 3. Frederick J. With health-reform bill passage, NACDS hails ‘impact’ of March lobbying push. Drugstore News. April 19, 2010. www.drugstorenews.com/story. aspx?id=136493. Accessed April 30, 2010. 4. Smith T. Health reform may expand non-physician roles. Richmond Times-Dispatch. April 26, 2010. www2.timesdispatch.com/rtd/ business/health_med_fit/ article/HEAL26_20100425- 221405/340020/. Accessed April 30, 2010. 5. HR 3590. March 23, 2010. To read the MTM provisions of the Act, see Note 11, infra. 6. Health reform bill becomes law: includes key clinical pharmacy provisions. American College of Clinical Pharmacy. March 2010. www.accp.com/announcements/ healthreform.aspx. Accessed April 30, 2010. 7. Thompson C. New health care laws will bring changes for pharmacists. AJHP News. May 1, 2010. www.ashp.org/import/news/ HealthSystemPharmacyNews/ newsarticle.aspx?id=3318. Accessed April 30, 2010. 8. Agency for Healthcare Research and Quality. Funding opportunities. www.ahrq.gov/fund. Accessed May 26, 2010. 9. See Note 5, supra. 10. See Note 6, supra. 11. Health care reform pharmacy stakeholders coalition letter to AHRQ Director Clancy. March 3, 2010. www.amcp.org/data/legislative/ analysis/HCR%20Pharmacy% 20Stakeholders%20MTM%20Grant% 20Program.pdf. Accessed April 30, 2010. 12. Walden G. NACDS backs pro-pharmacy elements of health reform. Chain Drug Review. April 5, 2010. www.chaindrugreview.com/ inside-this-issue/news/04-05- 2010/nacds-backs-propharmacy- elements-of-health-reform. Accessed April 30, 2010. To comment on this article, contact rdavidson@uspharmacist.com.