This article focuses on selected highlights of the 2010 laws that reform the U.S.

Transcription

1 REVIEWS APhA pharmacy law matters 2010: Focus on selected provisions of the Affordable Care Act American Pharmacists Association This article focuses on selected highlights of the 2010 laws that reform the U.S. health care system (Patient Protection and Affordable Care Act [PPACA; PL ], enacted March 23, 2010, and the Health Care and Education Reconciliation Act of 2010 [HCERA; PL ], enacted March 31, 2010). Collectively these laws are known as the Affordable Care Act (ACA). Selected provisions that affect pharmacists are discussed. In addition, this article provides a brief overview of other recent federal legislative and regulatory developments. Some provisions of this law have already gone into effect, and others will take years to implement. Ongoing implementation efforts will shape how the law ultimately affects patients, as well as pharmacists roles in patient care. In addition, new legislative and regulatory activities will continue to shape the practice of pharmacy. Pharmacists should continue to monitor developments and advocate on behalf of their profession and the patients that they serve. Advisory board: Jay Campbell, BPharm, JD, Executive Director, North Carolina Board of Pharmacy, Chapel Hill. Daniel Kennedy, BPharm, FAPhA, Outpatient Pharmacy Operations Manager, Oregon Health & Science University, Portland. This publication was prepared by Judy Crespi Lofton, MS, of JCL Communications, Schwenksville, PA, in consultation with APhA s government affairs staff on behalf of the American Pharmacists Association. Correspondence: To contact APhA s Government Affairs team, gvtaff@ aphanet.org. Affordable Care Act The year 2010 was a momentous one for developments in laws and regulations affecting the practice of pharmacy. Several decades of discussion about health care reform culminated in the passage of two laws in March 2010 that will reshape the delivery of health care in the United States. Accreditation Information Provider: American Pharmacists Association Target audience: Pharmacists and pharmacy technicians Release date: December 15, 2010 Expiration date: December 15, 2013 Learning level: 1 ACPE numbers: H03-P and H03-T CPE credit hours: 2.0 hours (0.2 CEUs) ACPE activity type: Knowledge-based Fee: There is no fee associated with this activity for members of the American Pharmacists Association. There is a $15 fee for nonmembers. The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Numbers assigned to this activity by the accredited provider are H03-P and H03-T. Development: This home-study CPE activity was developed by the American Pharmacists Association. Disclosure: Jay Campbell, BPharm, JD, and Daniel Kennedy, BPharm, FAPhA, declare no conflicts of interest or financial interests in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. APhA s editorial and government affairs staff declare no conflicts of interest or financial interests in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. Learning objectives At the completion of this activity, the pharmacist and pharmacy technician will be able to: n Describe provisions of the Affordable Care Act (ACA) that affect aspects of Medicare Part D, including the coverage gap discount program, changes to drugs excluded from the program, and new requirements for medication therapy management (MTM) services. (pharmacist, technician) n List the requirements of the MTM grant program of ACA. (pharmacist, technician) n Discuss potential roles for pharmacists in integrated care models such as medical homes and community care teams. (pharmacist) n Discuss provisions of the law that affect transition-of-care activities, including medication reconciliation. (pharmacist, technician) n State the impact of ACA on payments for hospital-acquired conditions. (pharmacist, technician) n Locate additional information and resources about the implementation of ACA and other legal and regulatory developments affecting pharmacy practice. (pharmacist, technician) 72 PHARMACY TODAY DECEMBER

2 PROVISIONS OF ACA AFFECTING PHARMACY REVIEWS Pretest questions Take a moment to answer the following questions pertaining to provisions of the Affordable Care Act. After reading the article, you ll see these questions again as part of the CPE exam. 1. Which group of Medicare beneficiaries received a $250 rebate check in 2010? a. Only those enrolled in a Medicare Advantage plan. b. Only those who had drug expenditures of greater than $5,000. c. All beneficiaries enrolled in a Medicare Part D prescription drug plan. d. Those who entered the coverage gap who did not qualify for low-income subsidies. 2. Which of the following statements about medication therapy management (MTM) requirements for Medicare Part D plans is true? a. All programs must provide for comprehensive medication reviews on a quarterly basis. b. Targeted beneficiaries are automatically enrolled in the program and may choose to opt out. c. Pharmacists must obtain preauthorization for providing followup interventions. d. Each plan will develop a plan-specific format for a written medication summary and action plan. 3. When are transition-of-care activities, including medication reconciliation, required by ACA? a. For all patients with hospital-acquired conditions. b. For all patients who receive MTM through Medicare Part D. c. For patients receiving care from health teams who are admitted to or discharged from hospitals, nursing homes, or other institutional settings. d. When Medicare or Medicaid beneficiaries switch primary care providers. Table 1. Affordable Care Act areas of interest to pharmacists Access to products and services, including durable medical equipment, the 340B program, and biosimilars Antidiscrimination Comparative effectiveness research Drug information Fraud, waste, and abuse Generics Health information technology Health plan benefits (including creation of exchanges ) Hospital-acquired conditions Immunizations Indian Health Integrated care models Long-term care waste Medicaid and Medicare Pain care Prevention and wellness Quality Transitions of care Transparency Value-based purchasing Workforce development Throughout the legislative process leading up to the enactment of health care reform, pharmacy organizations worked to educate lawmakers so that the value of pharmacists contributions to patient care could be optimized. In 2008, APhA cochaired a stakeholder group of national pharmacy organizations to define pharmacy principles for health care reform. These principles called for health care reform to address quality and safety, infrastructure, and health information technology. 1 Building on these principles during the next year and a half, APhA and others continued to advocate for legislation that would increase patient access to pharmacist clinical services such as MTM, ensure patient access to needed medications and products, and ensure a viable pharmacy infrastructure. The work of the stakeholders is reflected throughout the new law. On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PL ), a lengthy comprehensive bill. 2 On March 30, President Obama signed into law the reconciliation bill, the Health Care and Education Reconciliation Act of 2010 (PL ), which was a much smaller bill that amended the Patient Protection and Affordable Care Act. 3 The enactment of the reconciliation bill was the last major step in the legislative phase of health care reform. Collectively, these laws are referred to as the Affordable Care Act (ACA). The law aims to improve the quality, safety, and cost effectiveness of health care. Many provisions focus on access to and use of medications and will influence the practice of pharmacy (Table 1). Although pharmacists may not be named specifically in all sections that address the medication use process, roles may exist for pharmacists in achieving the goals of quality, safety, and cost effectiveness. Several provisions of ACA have already begun to affect the pharmacy profession, and others are likely to further stimulate transformation of pharmacy to a patient care centered practice as they are fully implemented in coming years. However, an important challenge with the law is that many provisions are not funded. These sections will not be implemented until funding is secured through the appropriations process (Table 2). The provisions selected for discussion here include those that update the Medicare Part D prescription drug benefit, affect the implementation and delivery of medication therapy management (MTM) services, support integrated care models, and address transitions of care and hospital-acquired conditions. The final law is more than 900 pages long and is arranged into 10 titles, which contain subtitles, which contain parts, which contain sections. This article includes the section numbers for the provisions that are discussed to aid readers who seek to identify the actual language for each provision. A comprehensive summary of provisions affecting pharmacists, as well as information about regulations and other efforts surrounding the implementation of these provisions, is available at APhA s government affairs webpage ( GA) and Health Care Reform Hub ( DECEMBER 2010 PHARMACY TODAY 73

3 REVIEWS PROVISIONS OF ACA AFFECTING PHARMACY Table 2. Implementation dates and funding for selected sections of the Affordable Care Act Section Implementation date(s) Funding Section 3301: Medicare coverage gap discount program July 1, 2010, through 2020 Yes (partially funded by pharmaceutical manufacturers) Section 2502: Elimination of exclusion of coverage of certain drugs January 1, 2014 NA Section 10328: Improvements to Medicare Part D MTM January 1, 2013 Yes Section 3503: MTM grant program Effective May 1, 2010 No (appropriations needed) Section 3502: Establishing community health teams to support the Effective March 23, 2010 No (appropriations needed) patient-centered medical home Section 3022: Medicare shared-savings program No later than January 1, 2012 Yes Section 3024: Independence at home demonstration program No later than January 1, 2012 Yes Section 3021: Establishment of Center for Medicare and Medicaid Innovation within CMS No later than January 1, 2011 Yes Section 3025: Hospital readmissions reduction program Fiscal years beginning on or after Yes October 1, 2012 Section 3026: Community-based care transitions team January 1, 2011 Yes Sections 2702 and 3008: Health care acquired conditions July 1, 2011 NA Abbreviation used: NA, not applicable. Medicare Part D updates Among the changes that ACA made to the Medicare Part D prescription drug program are the addition of a coverage gap discount program, elimination of the exclusion of certain drugs in the program, and new requirements for MTM services provided through Medicare Part D. Medicare Part D coverage gap discount program (section 3301). When Medicare Part D became effective in January 2006, it created a prescription drug benefit structure that included the following 4 : An annual deductible ($310 in 2010) 25% coninsurance up to an initial coverage limit ($2,830 in 2010) A gap in coverage during which beneficiaries pay 100% of the prescription drug costs until they reach the catastrophic threshold ($4,550 in 2010) Catastrophic coverage during which beneficiaries pay 5% of their prescription drug costs for the rest of the year More generous prescription drug subsidies are provided for low-income beneficiaries. Section 3301 of ACA creates a Medicare Part D discount program. Manufacturers must discount certain drugs for beneficiaries who fall into the coverage gap but who are not eligible for low-income subsidies. Approximately 14% of all enrollees (3.4 million beneficiaries) reached the coverage gap in This provision is being implemented in several phases and will completely eliminate the coverage gap by The law also reduces the catastrophic coverage threshold. During the first step of the program, in 2010, beneficiaries who enter the coverage gap will receive a one-time, tax-free $250 rebate check from Medicare. Checks were mailed monthly as beneficiaries reached the coverage gap (the first checks were mailed in June 2010). Beginning January 1, 2011, beneficiaries will receive a 50% discount from manufacturers on brand-name and some 74 PHARMACY TODAY DECEMBER 2010 generic prescription drugs in the coverage gap. CMS also will gradually phase in subsidies for generic drugs (beginning in 2011) and brand-name drugs (beginning in 2013). By 2020, enrollees will be responsible for 25% of the cost of brand and generic drugs in the coverage gap. 5,6 Between 2014 and 2019, the out-of-pocket amount that qualifies a beneficiary for catastrophic coverage will be reduced. In 2020, the catastrophic coverage threshold level will revert to the pre-2014 threshold level (Figure 1). 5 These discounts will be provided at the point of sale (POS) in the pharmacy. Medicare Part D plan sponsors will be responsible for determining whether beneficiaries are eligible for a discount and whether the drugs are discountable drugs, calculating the discount amounts for claims in the coverage gap, and including that information in adjudicated claim response messages to the pharmacies at POS. 7 Pharmacists will only receive the copay amount in the adjudicated claims response message; the amount of the discount will not be available at POS. Beneficiaries who wish to know the discounted amount may contact their Part D plan and/or review the monthly explanation of benefits that they receive from their Part D plan. 8 The pharmacy will be reimbursed by the plans for the difference between the negotiated and discounted price. Plans must reimburse pharmacies for the discounts within the same time frame as Medicare Part D claims 14 days if submitted electronically and 30 days if submitted otherwise. 7 Drug manufacturers must pay the plans for the discounts after the claim is adjudicated. Manufacturers who do not participate in the gap discount program will not have their products covered by Medicare Part D. Manufacturers were required to sign agreements for participation in 2011 by September 1, CMS has prepared a tip sheet ( for pharmacists that provides additional information about the program.

4 PROVISIONS OF ACA AFFECTING PHARMACY REVIEWS Without health reform With health reform 5% paid by enrollee 15% paid by plan; 80% paid by Medicare Catastrophic coverage 5% paid by enrollee 15% paid by plan; 80% paid by Medicare Catastrophic coverage 100% paid by enrollee Coverage gap 25% paid by enrollee Brands: 50% discount 25% paid by plan Generics: 75% paid by plan 25% paid by enrollee 75% paid by plan Initial coverage limit 25% paid by enrollee 75% paid by plan Initial coverage limit 100% paid by enrollee Deductible 100% paid by enrollee Deductible Figure 1. The Medicare Part D standard prescription drug benefit in 2020 Reprinted with permission from the Henry J. Kaiser Family Foundation. The Kaiser Family Foundation is a nonprofit private operating foundation, based in Menlo Park, CA, dedicated to producing and communicating the best possible analysis and information on health issues. Altered with permission of the Henry J. Kaiser Family Foundation. Source: Reference 5. Consider this... Do you feel prepared to educate your patients who are Medicare Part D beneficiaries about the changes to the coverage gap? If not, consider the patient education resources from CMS at health-and-drugs/coverage-gap-information.aspx. Elimination of exclusion of coverage of certain drugs (section 2502). When Medicare Part D was created, specific medications and classes were specifically excluded from coverage by the program (Table 3). 10 ACA modified the Medicare Part D prescription drug benefit so that the following drugs or classes of drugs, or their medical uses, are included in coverage: Agents used to promote tobacco cessation, including those that are available OTC Barbiturates Benzodiazepines This provision of the law applies to services furnished on or after January 1, Improvements to Medicare Part D MTM (section 10328). ACA adds new required interventions to the Medicare Part D prescription drug benefit MTM program. (Many of these requirements are similar to those implemented by CMS for plan years beginning in 2010 through the 2010 Call Letter to plans [available online at and through final regulation published April 15, 2010 [75 FR 19726].) Starting in 2013, Part D plan sponsors must offer MTM services to targeted beneficiaries that include, at minimum, strategies to improve adherence to prescription medications or other goals. Services and strategies must include the following: An annual comprehensive medication review furnished person-to-person or using telehealth technologies (e.g., Table 3. Medications excluded from coverage under Medicare Part D Barbiturates a Benzodiazepines a Agents when used for anorexia, weight loss, or weight gain Agents when used to promote fertility For cosmetic purposes or hair growth Symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Nonprescription drugs b a Allowed starting in 2014 under Affordable Care Act. b Nonprescription drugs approved for tobacco cessation allowed starting in 2014 under Affordable Care Act. Source: Reference 10. telephones, videoconferencing) by a licensed pharmacist or other qualified provider. The comprehensive medication review must include the following: A review of the individual s medications. This review may result in the creation of a recommended medication action plan or other actions in consultation with the individual and with input from the prescriber to the extent necessary and practicable. A written or printed summary of the results of the review. CMS, in consultation with relevant stakeholders, will develop a standardized format for the action plan and the summary. Follow-up interventions as warranted based on the findings of the annual medication review or the targeted medication enrollment and that may be provided person-to-person or DECEMBER 2010 PHARMACY TODAY 75

5 REVIEWS PROVISIONS OF ACA AFFECTING PHARMACY using telehealth technologies. In addition, Medicare Part D plan sponsors must have a process to: Assess, at least on a quarterly basis, the medication use of individuals who are at risk but not enrolled in the MTM program, including individuals who have experienced a transition in care (e.g., a hospitalization or stay in a skilled nursing facility), if the prescription drug plan sponsor has access to that information. Automatically enroll targeted beneficiaries, including beneficiaries identified in the quarterly assessment. Permit beneficiaries to opt out of enrollment in the MTM program. This provision does not limit CMS authority to modify or broaden requirements for MTM under Medicare Part D or to study new models for MTM through the Center for Medicare and Medicaid Innovation. 76 PHARMACY TODAY DECEMBER 2010 MTM grant program (section 3503) Several sections of the law address the provision of MTM services to patients outside Medicare Part D and create important potential opportunities for pharmacists. One of the most notable provisions is the creation of an MTM grant program. This program, titled Medication Management Services in Treatment of Chronic Disease, will be administered through the newly created Patient Safety Research Center at the Agency for Healthcare Research & Quality (AHRQ). AHRQ is part of HHS. Its stated mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 11 Although the law directed the grant program to begin May 1, 2010, the program has not been funded and implementation has been delayed. APhA, in collaboration with other pharmacy organizations, is working with members of Congress to fund this section of the law through the appropriations process. 12 If and when funding becomes available, grants will be awarded through this program to implement MTM provided by pharmacists as part of a collaborative, multidisciplinary, interprofessional approach to the management of chronic disease. The services authorized for grant funding by the law are similar to the profession s MTM consensus definition. 13 The stated goal of the program is to improve quality of care and reduce overall cost in the treatment of chronic diseases. Specific requirements for grant recipients indicate that the program is designed to support robust services to a broad patient population of targeted individuals. For this section of the law, a targeted individual is a person who meets at least one of the following criteria: Takes four or more prescribed medications (including OTC medications and dietary supplements) Takes any high-risk medications Has two or more chronic diseases Has undergone a transition of care or other factors that are likely to create a high risk of medication-related problems The grant application process will require pharmacists (or other applicants) to provide information regarding their plans for providing services (as allowed by state law, including applicable collaborative pharmacy practice agreements). Applicants must: Provide a setting appropriate for MTM services. Submit a plan for achieving long-term financial sustainability. Where applicable, submit a plan for coordinating MTM services through local community health homes (established by section 3502). Submit a plan for performing the following activities: Performing or obtaining necessary assessments of the health and functional status of each patient receiving MTM services Formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber and patient (or caregiver or authorized representative of the patient) Selecting, initiating, modifying, and recommending changes to or administering medication therapy Monitoring, which may include access to, ordering, or performing laboratory assessments, and evaluating the response of the patient to therapy, including safety and effectiveness Performing (1) an initial comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events; (2) quarterly targeted medication reviews for ongoing monitoring; and 3) additional follow-up interventions on a schedule developed collaboratively with the prescriber Documenting the care delivered and communicating essential information about such care, including a summary of the medication review, and the recommendations of the pharmacist to other appropriate health care providers of the patient in a timely fashion Providing education and training designed to enhance the understanding and appropriate use of the medications by the patient, caregiver, and other authorized representative Providing information, support services, and resources and strategies designed to enhance patient adherence with therapeutic regimens Coordinating and integrating MTM services within the broader health care management services provided to the patient Other patient care services allowed under pharmacist scopes of practice in use in other federal programs that have implemented MTM services Consider this... If funding becomes available to implement the MTM grant program, what (if any) changes would you need to make to your practice to be eligible to apply for the program? Recipients of a grant or contract must submit a report to CMS that describes and evaluates the activities carried out under the grant or contract. This report must include the impact on quality measures that will be identified by CMS. CMS

6 PROVISIONS OF ACA AFFECTING PHARMACY REVIEWS in turn will report to Congress on the clinical effectiveness of pharmacist-provided services under the MTM services program compared with usual care. This report must: Include an evaluation of whether enrollees maintained better health with fewer hospitalizations and emergency department visits than similar patients not enrolled in the program. Assess changes in overall health care resource use by targeted individuals and assess patient and prescriber satisfaction with MTM services. Assess the impact of patient cost-sharing requirements on medication adherence and recommendations for modifications. Identify and evaluate other factors that may affect clinical and economic outcomes, including demographic characteristics, clinical characteristics, and health services use of the patient, as well as characteristics of the regimen, pharmacy benefit, and MTM services provided. Evaluate the extent to which participating pharmacists who maintain a dispensing role have a conflict of interest in the provision of MTM services and, if such conflict is found, provide recommendations on how such a conflict might be appropriately addressed. This report will likely contain important new information and could be used to guide future legislation to support expanded MTM services and roles for pharmacists. Understanding medical homes and accountable care organizations Medical homes (sometimes called patient-centered medical homes) and accountable care organizations (ACOs) have similar goals but important distinctions (Table 4). An ACO is a financing model, while a medical home is a care delivery model. Therefore, an entity could deliver care as a medical home and finance it as an ACO. However, an ACO could deliver care or a medical home could finance care in a myriad of other ways. In a medical home, care is coordinated by primary care providers across all elements of the health care system (e.g., specialty care, hospitals, home health agencies, nursing homes) and the patient s community (e.g., family, public and private community-based services). Care coordination among physically dispersed providers is facilitated by registries, information technology, health information exchanges, and other means to ensure that patients get the indicated care when and where they need and want it in a culturally and linguistically appropriate manner. 14 Providers are eligible to receive additional compensation for care coordination. In the medical home model, pharmacists can play integral roles in optimizing therapeutic outcomes and promoting safe, cost-effective medication use. 15,16 Pharmacists manage medication therapies for selected patients with chronic conditions in a more cost-effective manner than physicians and can share therapy recommendations with other care providers through the use of health information systems. 15 Before ACA was enacted, pharmacists already were working in roles in medical home settings, often focusing on collaborative drug therapy. 17 According to a recent article in Health Affairs, pharmacists perform comprehensive therapy reviews of prescribed and selfcare medications, resolve medication-related problems, optimize complex regimens, design adherence programs, and recommend cost-effective therapies. Pharmacists should play key roles as team members in medical homes and their potential to serve effectively in this role should be evaluated as part of medical home demonstration projects. 15 ACOs represent a financing model in which entities (e.g., provider groups) are accountable for the quality and cost of patient care. They share risk and year-end savings if quality and cost thresholds are met. ACOs largely will be based on physician practices and hospitals that, in turn, may be organized as patient-centered medical homes or may contract with a medical home to provide services. Many ACOs also will include hospitals, home health agencies, nursing homes, and perhaps other delivery organizations. Although pharmacists are unlikely to be part of ACO entities themselves, they can certainly play a valuable role in reducing the costs to the ACO. Thus, the entity may contract with pharmacists to support the ACO s achievement of cost and quality goals. Pharmacists roles in integrated care models A centerpiece of ACA is the emphasis on using integrated care models to improve the quality of care while managing costs. Accountable care organizations (ACOs), medical homes, community health teams, and home-based primary care teams are among the care models used by ACA. All of these models are structured to compensate providers through Medicare Part B fee-for-service payment. However, Medicare Part B does not currently cover pharmacist clinical services. Pharmacists likely will need to negotiate compensation for their services directly from medical homes and ACOs. Although nothing in the law precludes pharmacist participation in ACOs, which are a payment model, more opportunities may be available for pharmacists to engage in medical homes, which are a care delivery model. Pharmacists who have data demonstrating the return on investment from their services will be well positioned to negotiate contracts with these entities. The law establishes a program within HHS to provide grants or enter into contracts with eligible entities to established community-based interdisciplinary, interprofessional health teams to support primary care providers (sections 3502 and 10321). These health teams, which by definition may include pharmacists, must be designed to support patient-centered medical homes, which are defined as models of care that include the following: A primary care provider Whole-person orientation Coordinated and integrated care Safe and high-quality care (including evidence-based medicine, appropriate use of health information technology, and continuous quality improvement) Expanded access to care Payment that recognizes the added value of patient-centered care Health teams will help coordinate disease prevention, chronic disease management, and transitioning between health care providers and settings, with priority given to preventive services and health promotion. Health teams must provide support necessary for local primary care providers to provide access to pharmacist-delivered MTM services. Transitional care programs must provide medication reconciliation upon admission/discharge and ensure that postdischarge DECEMBER 2010 PHARMACY TODAY 77

7 REVIEWS PROVISIONS OF ACA AFFECTING PHARMACY Table 4. Medical homes versus ACOs Accountable care Medical homes organizations Type of model Team-based care mode Financing model Compensation Providers are eligible to receive additional compensation for care coordination Entities are accountable for the quality of care Pharmacists roles Pharmacists may be part of medical home teams Pharmacists are unlikely to be part of these entities; however, entities may contract with pharmacists to meet quality and cost goals plans include medication management. The law also creates an option for states to provide medical assistance (Medicaid) to individuals with chronic conditions through medical homes and specifies that these teams may include pharmacists (section 2703). Section 3022 of the law directs HHS to establish a Medicare shared-savings program that promotes accountability for a defined patient population, coordinates items and services under traditional Medicare Parts A and B, and encourages investment in infrastructure and redesigned care processes for high-quality and efficient service delivery by January Under this program, groups of providers meeting specific criteria may work together to manage and coordinate care for Medicare beneficiaries through an ACO. ACOs that meet certain quality and cost performance standards are eligible to receive payments in the form of shared savings (see understanding medical homes and accountable care organizations sidebar). These payments would be in addition to other payments that the providers receive under the original Medicare fee-for-service program (Medicare Parts A and B). CMS is currently working on developing its rule for establishing ACOs and has sought stakeholder input on a number of topics, including: Joint accountability among providers in the formation and use of ACOs. Cost and quality measures to assess performance. Risk adjustment. Attribution of Medicare beneficiaries to ACOs. Benchmarks for purposes of defining shared savings. Coordination with other value-based purchasing initiatives. Medicare beneficiary protections. CMS plans to propose a regulation for implementing this section. Final regulations are required no later than January 1, 2012, and will need to consider numerous factors, including how this provision of the law is affected by other laws, including antitrust laws, the physician self-referral prohibition, and federal anti-kickback statutes. 18 Consider this... Consider potential groups in your community that are forming or might be interested in forming an integrated care model (e.g., medical home, ACO). How could you work with these groups to provide your services? Establishment of Center for Medicare and Medicaid Innovation within CMS. Section 3021 of ACA establishes a Center for Medicare and Medicaid Innovation within CMS to test payment and service delivery models beginning January 1, The goal is to reduce program expenditures while preserving or enhancing quality of care. The center will research, develop, test, and expand innovative payment and delivery arrangements (e.g., medical homes, ACOs) to improve the quality and reduce the cost of care. Successful models can be expanded nationally. Dedicated funding is provided to allow for testing of models that require benefits not currently covered by Medicare. The program will involve two phases. In the first phase, the center will test payment and service delivery models and assess the impact of these modes. Of particular interest to pharmacists, the law specifically states that these models may include the use of MTM services, which may be provided by pharmacists. The center is an essential component of health care reform. It is therefore important that MTM is specifically listed as a model for the center to test. This inclusion will support efforts by pharmacists to obtain greater appreciation of the value of MTM services provided by pharmacists. Several other listed models, such as medical homes, address health care delivery reforms that also could involve pharmacists services, although neither pharmacists nor MTM are specifically mentioned in these models. Based on the impact of the model on quality of care and cost, CMS may expand the duration and scope of the model during phase 2 without going back to Congress for additional authority. Independence at home demonstration program. The purpose of section 3024 is to test a payment incentive and service delivery model that uses home-based primary care teams to provide services to applicable beneficiaries. The purpose of this model is to allow people to stay at home as long as possible while avoiding hospitalizations and nursing home admissions. Under this section, an independence at home medical practice is defined as either an individual or group of physicians or nurse practitioners who provide care as part of a team that includes physicians, nurses, physician assistants, pharmacists, and other staff as appropriate. Because pharmacists are explicitly listed in this section, their inclusion as part of any team in this demonstration is expected; however, exact roles have not been defined. This demonstration program is scheduled to begin no later than January 1, It will test whether this practice model can reduce preventable hospitalizations, hospital readmissions, emergency department visits, and costs. It also will assess the impact of this care model on patient health outcomes, the efficiency of care, and beneficiary and family caregiver satisfaction. In approving an independence at home medical practice, preference will be given to practices that (1) are located in high-cost areas of the country, (2) have experience in providing health care services to applicable beneficiaries in the home, and (3) use electronic medical records, health information technology, and individualized plans of care. 78 PHARMACY TODAY DECEMBER

8 PROVISIONS OF ACA AFFECTING PHARMACY REVIEWS Transitions of care activities The law recognizes that increased attention to managing transitions of care, including activities such as medication reconciliation, is important for improving quality of care. Several provisions specifically list medication reconciliation or activities that could include medication reconciliation provided by a pharmacist. Section 3025 establishes the hospital readmissions reduction program for Medicare payments. Hospitals with excess readmissions will have payments from Medicare reduced beginning in October Excess readmissions are defined by a formula that accounts for actual readmissions and expected readmissions. Section 3026 of the law establishes a community-based care transitions program to provide funding for improved care transition services to high-risk Medicare beneficiaries. Funds will be available to hospitals with high readmission rates and to community-based organizations that provide care transition services across a continuum of care. Care transition interventions include those that can be performed by pharmacists, such as conducting comprehensive medication reviews and management (including, if appropriate, counseling and self-management support). In addition, the law creates a quality improvement program to help hospitals improve readmission rates. Payments also will be reduced for hospitals with excessive readmissions for several conditions, including myocardial infarction, heart failure, and pneumonia. These provisions are likely to stimulate increased focus on robust discharge planning, including postdischarge medication reconciliation by pharmacists. The law also includes provisions (section 3013) that require quality measure development to address transition of care activities, including the management and coordination of health care across episodes of care and care transitions for patients across the continuum of providers, health care settings, and health plans. Finally, as noted earlier in the discussion of health teams, section 3502 calls for primary care providers to provide access to pharmacist-delivered medication management services, including medication reconciliation. Further, it requires teams to provide 24-hour care management and support during transitions in care settings, including (but not limited to) a transitional care program that includes medication reconciliation upon admission to and discharge from hospitals, nursing homes, or other institution settings. Health care acquired conditions (sections 2702 and 3008) Other provisions designed to stimulate focus on quality include sections 2702 and 3008, which address hospital/health care acquired conditions (HACs). HACs are specific, preventable adverse conditions that were not present when the patient was admitted to the hospital that could reasonably have been prevented through the application of evidence-based guidelines. 19 In October 2008, CMS stopped paying hospitals for the treatment of hospital-acquired conditions in Medicare patients. 19 Ten categories were identified at the time, including categories of events that could be prevented with appropriate medication management (e.g., certain manifestations of poor glycemic control such as diabetic ketoacidosis). 19 ACA expanded the impact of HACs on payments to hospitals by extending the program to state Medicaid and waiver programs beginning July 1, CMS also will study the potential application of HAC policies to other settings, including inpatient rehabilitation facilities, long-term care hospitals, hospital outpatient departments, skilled nursing facilities, ambulatory surgical centers, and health clinics. Although no specific activities for pharmacists are identified in the law, pharmacists may engage in efforts to address HACs. Manufacturer definitions may affect compounding Two sections of ACA include compounding in the definition of manufacturer. In section 3301 of the law, which addresses the prescription drug coverage gap in Medicare Part D, the definition includes entities that are engaged in the production, preparation, propagation, compounding conversion, or processing of prescription drug products. Although wholesale distributors and community pharmacies are specifically excluded from this definition, this limited exemption does not reflect the variety of practice settings in which pharmacists compound. Compounding also is included in the definition of manufactuer in section 6002 of the law, which addresses transparency of physician relationships with manufacturers. In this section, no exemption for pharmacy compounding appears. These definitions may have important implications for pharmacy compounding. Some parties have asserted that pharmacy compounding is manufacturing and therefore regulated by FDA. APhA is working with the International Academy of Compounding Pharmacists to address this issue to ensure that these two sections of the law are not construed to indicate that FDA now regulates traditional pharmacy compounding. (The Federal Food, Drug, and Cosmetic Act currently exempts pharmacy compounding if certain criteria are met.) Additional information on this issue is available at APhA s government affairs webpage ( Additional activities affecting pharmacy practice In addition to ACA, many other legal and regulatory issues affect the practice of pharmacy. Highlights of actions on selected issues are shown in Table 5. For in-depth analysis of these issues and as regular updates on issues of importance to pharmacists, visit APhA s government affairs webpage at www. pharmacist.com/ga and the Health Care Reform Hub. In addition, look for a review of recent activity regarding fraud, waste, and abuse in an upcoming issue of Pharmacy Today. Conclusion This activity provides a review of selected provisions of ACA that impact the practice of pharmacy. The inclusion of several provisions in the new law that promote pharmacists roles as providers of patient care is an important step forward for pharmacy. It indicates that policy makers recognize the value of the pharmacists to the health care system. Furthermore, support of pharmacists activities from stakeholders outside the profession has been seen throughout the process and represents growing understanding among broader constituencies. The implementation of the law is an ongoing and compli- DECEMBER 2010 PHARMACY TODAY 79

9 REVIEWS PROVISIONS OF ACA AFFECTING PHARMACY cated process that requires continuing education of decision makers. It will be important for pharmacists to continue to advocate for their profession, as well as to pursue new patient care opportunities created by the law. In addition to visiting www. pharmacist.com/ga and the Health Care Reform Hub for information about laws, regulations, and advocacy, pharmacists can visit the Pharmacy Practice section of pharmacist.com for more information about developing and implementing patient care services. Table 5. Selected pharmacy-related federal activities Issue Recent developments Description/key issues for pharmacists Drug disposal The Secure and Responsible Drug Disposal Act (PL ) became law October 12, This law amends the Controlled Substances Act to provide for take-back disposal of controlled substances in certain instances. It also authorizes longterm care facilities to dispose of controlled substances on behalf of users who reside in the facility. Products used to manufacture methamphetamine E-prescribing for controlled substances REMS Information on dispensing controlled substances in LTCFs 22 Patient medication information 23 The Combat Methamphetamine Enhancement Act (PL ) became law October 12, On March 24, 2010, DEA filed an interim final rule authorizing the electronic prescribing of controlled substances beginning June 1, In July 2010, FDA held public meetings to obtain input on issues and challenges associated with the development and implementation of REMS programs, and discussed issues surrounding a REMS for long-acting opioids. APhA has led several initiatives to work with stakeholders to discuss principles of REMS; implementation strategies; and opportunities to improve REMS, including design, communication, and evaluation. APhA s activities include the publication of a 2009 REMS white paper and hosting of stakeholder meetings in July 2009 and October DEA sought information on the dispensing of controlled substances to residents in LTCFs. DEA aims to make it easier for residents of LTCFs to receive controlled substances and is exploring whether revisions are needed and feasible on regulations implementing the Controlled Substances Act. FDA has sought input from stakeholders on the best strategies for communicating prescription drug information to patients through several avenues in recent years. Most recently, in September 2010, FDA held a public hearing to gather input on a potential new framework for patient medication information for prescription medications. Abbreviations used: LTCF, long-term care facility; REMS, risk evaluation and mitigation strategy. This law amends the Controlled Substances Act to require all regulated retail sellers, including pharmacies, of certain listed chemical products used to make methamphetamine to self-certify that they are compliant with certain requirements; prohibits distributors of listed chemical products from selling such products to individuals not registered with DEA; requires the Attorney General to develop a list of all self-certified individuals and make it publicly available on the DEA website; and imposes civil penalties for negligent failure to self-certify. Because substantial changes were made from the proposed rule issued in 2008, DEA sought feedback on the rule. APhA and other pharmacy organizations submitted comments, and additional changes may be needed. Although authorized, implementation logistics and criteria are still being worked on to facilitate the e-prescribing of controlled substances. 20 APhA has developed and communicated specific recommendations on improving the REMS program and highlighting the role that pharmacists can play in REMS. APhA continues to work with FDA and other stakeholders on ways to develop a standardized, system-based approach that minimizes the burden on the health care system and ensures patient access to medications. DEA will use comments received during the public comment period (which ended August 30, 2010) when evaluating whether revisions are needed. APhA supports FDA s efforts to create a single, easy-to-read document. As currently conceived, patient medication information would integrate information that is currently available through consumer medication information, patient package inserts, and medication guides. 80 PHARMACY TODAY DECEMBER

10 PROVISIONS OF ACA AFFECTING PHARMACY REVIEWS Resources n Agency for Healthcare Research and Quality: n APhA: Government affairs webpage, Health Care Reform Hub (in Pharmacy Today and at www. pharmacist.com/hcr) n American Society for Pharmacy Law: n CMS: n Thomas (legislative information from the Library of Congress): n U.S. Government Agency Regulations: n HHS: Affordable Care Act website, Spanish version, References 1. Academy of Managed Care Pharmacy, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, et al. Pharmacy principles for health care reform. Accessed at CONTENTID=18602&TEMPLATE=/CM/ContentDisplay.cfm, October 1, U.S. Government Printing Office. Public Law : Patient Protection and Affordable Care Act. Accessed at gov/fdsys/pkg/plaw-111publ148/pdf/plaw-111publ148.pdf, November 8, U.S. Government Printing Office. Public Law : Health Care and Education Reconciliation Act of Accessed at gov/fdsys/pkg/plaw-111publ152/pdf/plaw-111publ152.pdf, November 8, Marietta CS. Medicare coverage gap discount program to provide economic relief to Medicare Part D enrollees by closing the donut hole. Accessed at healthlaw/perspectives/2010/%28cm%29%20donuthole.pdf, September 15, Henry J. Kaiser Family Foundation. Explaining health care reform: key changes to the Medicare Part D drug benefit coverage gap. No Accessed at September 15, CMS. Medicare coverage gap discount program beginning in 2011: revised Part D sponsor guidance and responses to summary public comments on the draft guidance. Accessed at www. cms.gov/prescriptiondrugcovcontra/downloads/2011coverage GapDiscount_Revised%20Guidance% pdf, October 1, CMS. Medicare coverage gap discount program beginning in Accessed at Downloads/2011CoverageGapDiscount_043010v2.pdf, September 16, Yap D. Closing the doughnut hole in 2011 and beyond. Pharmacy Today. 2010;16(10): CMS. Medicare coverage gap discount program: manufacturer agreements. Accessed at CovGenIn/Downloads/CGDMemo_ pdf, September 15, Library of Congress. Medicare Prescription Drug, Improvement, and Modernization Act of 2003: H.R.1. Accessed at loc.gov/cgi-bin/query/z?c108:h.r.1:, September 16, Agency for Healthcare Research and Quality. AHRQ at a glance. Accessed at November 2, APhA. Letter to Senate & House Appropriations Subcommittee on funding for the MTM grant program. Accessed at TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=23123, September 15, Bluml BM. Definition of medication therapy management: development of professionwide consensus. J Am Pharm Assoc. 2005;45: American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Osteopathic Association. Joint principles of the patient centered medical home. Accessed at September 14, Smith M, Bates DW, Bodenheimer T, Cleary PD. Why pharmacists belong in the medical home. Health Aff. 2010;29: American College of Clinical Pharmacy. Integration of pharmacists clinical services in the patient-centered primary care medical home. Accessed at September 16, Worth T. Tick tock, tick tock: clock running out on Capitol Hill. Pharmacy Today. 2009;15(12): Federal Trade Commission, HHS. Medicare program: workshop regarding accountable care organizations, and implications regarding antitrust, physician self-referral, anti-kickback, and civil monetary penalty. Federal Register. 2010;75: CMS. Hospital-acquired conditions (present on admission indicator): overview. Accessed at www1.cms.gov/hospitalacqcond, September 14, APhA, American Society of Health-System Pharmacists, American Society of Consultant Pharmacists, National Community Pharmacists Association. Re: docket no. DEA-218I, electronic prescriptions for controlled substances, interim final rule with request for comment. Accessed at Template.cfm?Section=Issues&CONTENTID=23536&TEMPLA TE=/CM/ContentDisplay.cfm, September 17, APhA. White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system. J Am Pharm Assoc. 2009;49: DEA. Dispensing of controlled substances to residents at long term care facilities. Federal Register. 2010;75: APhA. Food and Drug Administration (FDA) public hearing and request for comment: development and distribution of patient medication information for prescription drugs. Accessed at CONTENTID=24204&TEMPLATE=/CM/ContentDisplay.cfm, September 16, DECEMBER 2010 PHARMACY TODAY 81