apha pharmacy law matters2011 - library

APhA Pharmacy Law Matters

2011A continuing pharmacy education activity for pharmacists and pharmacy technicians.

Legal and Regulatory Developments Affecting Pharmacy in 2011

APhAmembers

only

Provider: American Pharmacists AssociationTargeT audiences: Pharmacists and Pharmacy Techniciansrelease daTe: December 15, 2011exPiraTion daTe: December 15, 2014acPe number (PharmacisTs): 202-000-11-287-H03-P acPe number (Technicians): 202-000-11-287-H03-T cPe crediT: 2 hours (0.2 CEUs)acPe acTiviTy TyPe: Knowledge-based learning level: IFee: There is no fee associated with this activity for APhA members.

PharmacisT and Technician learning objecTivesAt the completion of this activity, pharmacists and technicians will be able to:1. Describe new legal developments in 2011 that affect the

profession of pharmacy, including the Budget Control Act of 2011 and pending legislation concerning medication therapy management.

2. Explain activities that took place in 2011 by the Centers for Medicare and Medicaid Services to implement the Afford-able Care Act (ACA), including those pertaining to medical loss ratios, essential benefits, integrated care models, standardization of Medicare Part D forms, short-cycle dispensing, and public-private partnerships.

3. Discuss changes in ACA that apply to fraud, waste, and abuse laws.

4. Describe regulatory activities by the Food and Drug Admin-istration affecting pharmacists, including those pertaining to patient medication information, the Prescription Drug User Fee Act, counterfeit drugs and security, and drug shortages.

5. Describe regulatory activities by the Drug Enforcement Administration, including those pertaining to disposal of controlled substances and the electronic prescribing of controlled substances.

6. Discuss activities in 2011 that support the development of a national health information technology infrastructure.

7. Describe the outcome of Supreme Court rulings in 2011 that have a bearing on the practice of pharmacy.

advisory boardJay Campbell, BSPharm, JDExecutive DirectorNorth Carolina Board of PharmacyChapel Hill, North Carolina

Brian A. Gallagher, BSPharm, JDSenior Vice President, Government AffairsAmerican Pharmacists AssociationWashington, DC

accrediTaTion inFormaTionThe American Pharmacists Association is accred-ited 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 202-000-11-287-H03-P and 202-000-11-287-H03-T. To obtain 2 hours of CPE credit (0.2 CEUs) for this activity, complete the CPE exam and submit it online at www.pharmacist.com/education. A Statement of Credit will be awarded for a passing grade of 70% or better. You have two opportunities to successfully complete the CPE exam. Pharmacists and technicians who successfully complete this activity before December 15, 2014, can receive credit. Your statement of Credit will be available online immediately upon successful completion of the CPE exam.

develoPmenTThis home-study CPE activity was developed by the American Pharmacists Association as a benefit of APhA membership.

disclosuresJay Campbell, BSPharm, JD, and Brian A. Gallagher, BSPharm, JD, declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. APhA’s Government Affairs and editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. This publication was prepared by Judy Crespi Lofton, MS, of JCL Communications, in consultation with the Government Affairs staff, on behalf of the American Pharmacists Association.

©2011 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A.

Pharmacy Law Matters legal and regulaTory develoPmenTs aFFecTing Pharmacy in 2011A continuing pharmacy education activity for pharmacists and pharmacy technicians.

1APhA Pharmacy Law Matters 2011

INTroDUCTIoNWith the promulgation of several key

regulations governing various facets of the 2010 health care reform law, 2011 was a critical year for shaping the law’s implementation. Another important under-taking during the past year concerned efforts to address the nation’s budget deficit, which may have a substantial impact on future health care spending. These developments—along with other legislative, regulatory, and judicial ac-tivities—continue to redefine and shape certain aspects of pharmacy practice.

This monograph addresses a wide range of pharmacy practice issues, including federal health care programs, health information technology (HIT), anti-counterfeiting activities, patient safety, and drug disposal efforts. The American Pharmacists Association (APhA) has been integral in advocating on these issues to educate decision makers about the value of pharmacists’ services and the role of pharmacists on the health care team. Additionally, APhA has informed decision makers about actions and strategies that can optimize the benefits pharmacists can provide in managing medication use issues and improving patient care.

All topics in this monograph are current as of early December 2011, but are subject to change through legislative, regulatory, or judicial activity. It is vital that pharmacists regularly monitor legal and regulatory issues to ensure they stay informed of developments that affect the profession.

NEW FEDErAL LEGISLATIVE DEVELoPMENTS

New legislative developments af-fecting pharmacy in 2011 include those that address overall national spending, as well as those designed to improve medication therapy management (MTM) services within Medicare Part D.

efforts to control the Federal budget and the Potential impact on Pharmacy

Health care is one of the largest expenditures of the federal govern-

ment—Medicare, Medicaid, and the Children’s Health Insurance Program currently account for approximately 21% of the federal budget. Health care spending dwarfs most other programs such as transportation (3%), food stamps (less than 2%), and foreign aid (less than 1%).1 Moreover, health care expendi-tures are dramatically increasing at the same time that the U.S. government is facing intense pressure to reduce federal spending and debt levels. Given the current drive to reduce overall federal spending and debt levels, policy makers must explore strategies to control the government’s spending on health care–related programs.

The Budget Control Act of 2011 (Public Law 112-25), enacted August 2, 2011, raised the debt ceiling to allow the U.S. government to borrow more money to meet its current obligations. As part of the agreement to raise the debt ceiling, this law created a new Congressional Joint Select Committee on Deficit reduction, commonly known as the “super committee,” as one of several complex mechanisms for controlling spending.

The super committee was tasked with identifying a package of $1.2 tril-lion to $1.5 trillion in cuts over the next 10 years. Because health care costs (including Medicare and Medicaid) constitute such a large segment of the federal budget, they were considered for cuts. According to the agreement, any package had to be finalized by the super committee by November 23, 2011, and voted on by Congress by December 23, 2011.

The super committee was unable to reach agreement on a package to pres-ent to Congress. Thus, a mechanism called “the sequester” is scheduled to take effect. Under the sequester, the of-fice of Management and Budget will be charged with implementing across-the-board cuts beginning in January 2013. The Department of Defense and Medi-care are set to incur the lion’s share of cuts with Medicare provider reimburse-ments (but no other aspect of Medicare) reduced by 2%. Under the sequester,

Pretest Questions1. What is the purpose of the medical loss

ratio requirement in the affordable care act?a. Ensuring that individuals do not have to spend more than a certain percentage of their income on health insurance premiums.b. Ensuring that insurance policy holders receive value for the premiums that they pay.c. Protecting insurance companies against risk of overutilization of services.d. Minimizing the amount of money lost through waste, fraud, and abuse.

2. The purpose of the center for medicare and medicaid innovation is to:a. Expand access to patient care services.b. Perform cost-effectiveness research.c. Encourage states to adopt public health initiatives for underserved populations.d. Study new health care delivery and payment models and rapidly scale up successful models.

3. changes made in the final regulations for accountable care organizations that varied from the proposed regulations include which of the following items?a. Adding a requirement for the use of electronic health records (EHr).b. Eliminating medication reconciliation as a quality performance measure. c. Creating an advance payment model, in which the Centers for Medicare and Medicaid Services will advance a portion of future shared savings to increase participation. d. Increasing the number of quality performance measures.

4. The Food and drug administration is aiming to integrate which of the following topics into the 2012 reauthorization of the Prescription drug user Fee act?a. Standardization of requirements for risk evaluation and mitigation strategies.b. Patient medication information initiatives.c. The Safe Use Initiative.d. Track and trace requirements.

5. in stage 1 of the “meaningful use” criteria, what action must qualified health care pro-viders implement in 2011 to earn incentive payments for ehr? a. Issue at least 50% of all prescriptions electronically. b. Demonstrate quality improvement through the use of EHr.c. Provide patient access to self- management tools. d. Capture health information electronically and track key clinical conditions.

2 Visit www.pharmacist.com/GA for continually updated legislative and regulatory information

Medicaid and Social Security are exempt from cuts. Many of the required cuts could lead to undesirable outcomes and Congress is considering additional legislation to modify the mandatory cuts under the sequester.

Throughout the budgetary process, APhA has been leading efforts to edu-cate Congress on the value provided by pharmacists’ services, and advocating that increased investment in pharmacists’

patient care services, such as MTM, would result in long-term savings. A large and compelling body of evidence clearly demonstrates that such services improve patient outcomes while reducing overall health care costs—a primary goal of health care reform activities.2-4 As the de-bate about how to manage the national budget proceeds, APhA will continue to emphasize the value that pharmacists provide to the health care system.

Pending mTm legislation Congress is considering new

legislation that would increase patient access to MTM services. on March 3, 2011, the Medication Therapy Manage-ment Benefits Act of 2011 (H.r. 891) was introduced. (A companion bill, the Medication Therapy Management Empowerment Act of 2011 [S. 274], was introduced in the Senate.) Either bill would make several improvements to the Medicare Part D MTM program, including:1. require that annual comprehensive

medication reviews include creation of a personal medication record and

a recommended medication action plan in consultation with the patient.

2. require that MTM services include quarterly person-to-person targeted medication reviews furnished by a licensed pharmacist.

3. Increase the number of diseases and conditions for which beneficiaries may be targeted for MTM services.

4. require that prescription drug plans (PDPs) allow pharmacists or other qualified providers to identify nontargeted beneficiaries who are appropriate for MTM services.

5. require any MTM program to offer both comprehensive and targeted medication reviews to individuals dually eligible for Medicare and Medicaid, regardless of whether they are MTM-targeted beneficiaries.

6. require that PDPs offer any willing pharmacy in its network the opportu-nity to provide MTM services.

7. require that PDPs compensate phar-macists (and other MTM providers) based on the resources used and the time required to provide MTM services.

8. require development of performance measures for MTM and additional incentive payments for providers who achieve certain quality measures. APhA has been a leader in advocat-

ing for the passage of this legislation, which has the potential to significantly expand the ability of pharmacists to provide Medicare patients with MTM services and improve overall patient care while controlling costs.2-4

ACTIVITIES rELATED To THE IMPLEMENTATIoN oF THE AFForDABLE CArE ACT

In 2011, federal agencies proposed or finalized a number of regulations related to the implementation of the Affordable Care Act of 2010 (ACA; Public Law 111-148). The goals of the health care reform law are to expand coverage, improve quality, and control costs. ACA aims to achieve these goals through both reforming insurance and encouraging innovation. Insurance

reforms include requirements for medical loss ratios (MLr), individual health insur-ance coverage, and essential benefits. Innovations include activities driven by the Center for Medicare and Medicaid Innovation (CMMI). other activities that took place in 2011 included those from the Centers for Medicare and Medicaid Services (CMS) and increased activity to prevent fraud, waste, and abuse.

medical loss ratio, individual health insurance, and essential benefits

The MLr provision in ACA requires insurance companies to spend a certain percentage (i.e., 80% for small compa-nies and 85% for large companies) of premium dollars on medical care, health care quality improvement, and other benefits to patients instead of on admin-istrative costs and profits. This provision is intended to ensure that the majority of money contributed to insurance premiums is paid out in benefits so that policy holders receive value for the money they spend on premiums. While some costs (e.g., profits, salaries, overhead ex-penses) are clearly administrative costs, others are more ambiguous. Insurance companies want many of their expenses

Know the LingoThe sequester is a process in the

Budget Control Act of 2011 in which certain cuts will take effect

beginning in January 2013.

Know the LingoA targeted beneficiary is a patient who meets a PDP’s requirements for chronic

conditions and prescription use to qualify for MTM services.

A targeted MTM review addresses a specific medication-

related issue (in contrast to a com-prehensive medication review).

A targeted disease or condition is one used by a PDP to identify

patients for MTM services.


classified as health care expenses while consumer/patient groups considered many of those same expenses to be administrative costs. APhA has comment-ed to CMS to strongly encourage the inclusion of pharmacist-provided MTM services as medical costs in the calcula-tion of MLrs.5

The National Association of Insur-ance Commissioners (NAIC) was asked to advise the U.S. Department of Health and Human Services (HHS) on how to classify various costs. The NAIC’s report to HHS called for MTM-like services to be included in services that count toward the MLr. According to the NAIC, these services include “Medication and care compliance initiatives, such as checking that the insured is following a medically effective prescribed regimen for dealing with the specific disease/condition and incorporating feedback from the insured in the management program to effectively monitor compliance....”6 HHS released an interim final rule on MLr in December 2010 for the implementation of the MLr in 2011.7 APhA has noted that the language in this interim rule is ambiguous and has requested that HHS clarify the MLr regulation to clearly state that MTM services are counted as medical costs.5 The final rule was announced December 2, 2011, and takes effect January 1, 2012. MTM-like services were included in the final rule, however, additional clarification was not provided.8

Additionally, ACA requires individu-als to purchase health insurance that meets defined standards of coverage.

Certain insurance plans, including those participating in the state purchasing exchanges that will become available in 2014, cover a package of diagnostic, preventive, and therapeutic services and products that have been defined as “essential” by HHS. This package (i.e., the essential health benefits) constitutes a minimum set of benefits that the plans must cover, but insurers may offer additional benefits. ACA requires that these benefits be similar to those currently provided by a typical employer. It is important to note that the inclusion of MTM-like services in the MLr means that there is no incentive for insurance companies to fight MTM’s inclusion in the essential benefits.8

ACA contains a list of 10 categories of health services that must be included in the essential benefits package, includ-ing prescription drugs and prevention and wellness activities. ACA charged HHS with further defining what benefits should be included. To assist with this task, HHS invited the Institute of Medi-cine (IoM) to recommend a process for defining the benefits that should be included. The IoM released its essential benefit report in october 2011.9

The IoM report, Essential Health Benefits: Balancing Coverage and Cost, stresses the need for benefits to be sufficiently inclusive to enable access to essential services while also being affordable to allow as many individuals as possible to purchase the coverage.9 IoM encourages HHS to embrace a framework that incorporates the follow-

ing criteria and methods: • Considers the population’s health

needs as a whole.• Encourages better care by ensur-

ing good science is used to inform practice decisions.

• Emphasizes the judicious use of resources.

• Carefully uses economic tools to improve the value and performance. The list of essential benefits is ex-

pected to be released through a pro-posed rule at the end of 2011 or early in 2012. When the rule is proposed, APhA will work with its members and other pharmacy stakeholders to provide comments.

activities Within cms

Center for Medicare and Medicaid Innovation

CMMI, also known as the CMS Innovation Center, was funded by ACA and is directed to study new health care delivery and payment models, including MTM and other concepts. Correspond-ingly, CMMI is directed to rapidly scale up successful models.

Current programs include the Partner-ship for Patients, which is working to reduce preventable hospital-acquired conditions and decrease hospital readmissions, and the Health Care Inno- vation Challenge, which will invest up to $1 billion in support of local innovation in communities to improve quality of care and lower costs. APhA encourages pharmacists and academic researchers to engage with CMMI and seek oppor-tunities to partner on grant submissions. APhA is tracking the number and types of proposals pharmacists are submitting to CMMI.10 For more information on these initiatives, visit http://innovations.cms.gov or e-mail APhA Government Affairs staff at [email protected].

Medication Reconciliation and Transitions of Care

ACA provides opportunities for pharmacists in the areas of medication reconciliation and transitions of care. For example, ACA establishes a Medicare

Know the LingoThe medical loss ratio requires

insurance companies to pay out a certain percentage of premiums

as benefits to enrollees.

Know the LingoEssential health benefits com-prise the minimum package of benefits that certain insurers

must offer, including those that will participate in state exchanges

taking effect in 2014.


pilot program to evaluate the use of specific payment methods for hospitaliza-tions. The payment methodology that will be tested must embrace payment for certain services including medication reconciliation. The Partnership for Patients program aims to reduce hospital read-missions within 30 days and decrease iatrogenic occurrences including adverse drug reactions. Clearly, pharmacists can help reduce adverse drug reactions and play a key role on the health care team to decrease hospital readmissions by helping patients effectively take their medications as they transition from the hospital to the community.

ACA also created the Medicare Community-based Care Transitions Program (CCTP). CCTP aims to improve the quality of care transitions, reduce readmissions for high-risk Medicare beneficiaries, and document measur-able savings to the Medicare program by reducing unnecessary readmissions. CMS published a request for proposals for CCTP in the April 15, 2011, edition of the Federal Register and continues to work toward implementation of this program.11

Accountable Care Organizations Another mechanism that ACA uses

to support innovation is the creation of accountable care organizations (ACo). An ACo is a group of health care pro-viders that provides the full spectrum of care to a minimum of 5,000 Medicare patients and is accountable for the costs and quality of the care. The concept is that providers who provide high-quality care at lower costs can profit by shar-ing the savings (i.e., receiving bonuses based on the amount of savings) with the government and other payers. (Although the law is specific to Medicare, private health plans also are encouraged to contract with ACos.)

CMS released proposed ACo regu-lations in April 2011 and published final regulations in october 2011.12,13 The final regulations relaxed or waived many of the original requirements with the goal of increasing ACo participation.

The final regulations create an “ad-vance payment model,” which will test whether giving providers a portion of an ACo’s expected future shared savings in advance will increase participation. In addition, the final regulations reduce the financial risk that ACos will initially face as they start up and increase the percent-age of the savings they can keep. other administrative burdens also were allevi-ated, including reducing the number of quality measures from the originally pro-posed 65 measures to a more feasible 33 measures, with a longer phase-in time. Electronic health records (EHr) are no longer required for participation, but are considered for quality measure scor-ing. The first ACo agreements will go into effect April 1, 2012, and July 1, 2012, with an initial 18-month or 21-month performance period.13

Although the number of quality performance measures was reduced by almost half, the 33 measures that remain include several that allow pharmacists to contribute to ACos for achievement of positive outcomes.14

Pharmacists who contract with ACos can help address medication use issues, improve medication manage-ment activities, improve coordination of care activities, and provide medication reconciliation. Additionally, pharmacists can play an important role working with ACos to help increase quality measure performance.

Standardized Medicare Part D Forms for MTM

ACA also directed CMS to develop

a standardized format for documentation associated with comprehensive medica-tion reviews for targeted beneficiaries in the Medicare Part D MTM program. In March 2011, CMS released a draft for-mat for three components: a beneficiary cover letter, a medication action plan (MAP), and a personal medication list (PML). CMS notes that the format of the draft documents is consistent with MTM forms currently in use (i.e., those included in the core elements model from APhA and the National Association of Chain Drug Stores Foundation). For example, the PML is similar to the patient medica-tion record (PMr) described in the core elements model.15

CMS expects to finalize the stan-dardized format in 2012, and Medicare Part D plans will be required to use the format beginning January 1, 2013.16 APhA recommended that CMS use lan-guage and formatting that accounts for health literacy concerns and increases clarity regarding the appropriate manner for completing the forms. Additionally, APhA encourages CMS to develop an educational campaign to provide guid-ance to pharmacists for implementing the standardized materials to ensure that forms are used in an appropriate and consistent manner.17

Know the LingoAn accountable care

organization is a financial arrangement in which health

care providers share savings for providing high-quality care at

lower cost.

Know the LingoThe PML is a personal medica-

tion list that includes all medica-tions a patient is currently taking;

it is analogous to the patient medication record (PMR) in the

core elements of MTM.

The MAP is a patient medication action plan that lists actions that

the patient should take.


Standardized Pharmacy Notice for Medicare Part D Coverage Decisions

Under Medicare Part D, all PDPs must have a process for beneficiaries to appeal coverage decisions. requests for exceptions to coverage decisions include formulary exceptions (for Part D drugs that are not included on a PDP’s formulary) and tiering exceptions (for obtaining a non-preferred drug at the cost-sharing terms for drugs in the preferred tier). requests for exception are granted when a PDP determines that a requested drug is medically necessary for an enrollee. Therefore, the patient’s prescriber must submit a statement sup-porting the request to the PDP.18

Currently, pharmacies are required to post a notice in the pharmacy about these options. To streamline the process for informing patients of a coverage decision, pharmacy staff will be required (based on provisions in ACA) to give a printed notice to Medicare patients about their coverage determination options at the point of sale, beginning in 2012. Furthermore, CMS is requiring all PDPs to have a system that transmits codes so that network pharmacies can populate and/or provide a printed notice. This notice will explain to patients how they can appeal the coverage determination.19 CMS has provided a standard notice, which is available at https://www.flrx.com/download/files/medicare_part_d_beneficiary_rights.pdf.

Short-Cycle Dispensing in Long-Term Care Facilities

ACA attempts to address the waste of outpatient drugs in long-term care facilities (LTCFs) under Medicare Part D. PDPs are directed to use specific, uniform dispensing techniques (e.g., weekly, daily, or automated dose dispensing) commonly called “short-cycle dispensing” to reduce waste associated with 30-day fills in LTCFs. The law gave CMS regula-tory authority to provide specifications of the process.

APhA and other pharmacy stake-holders submitted comments to CMS describing concerns about logistics, staffing, and costs to pharmacy to

implement short-cycle dispensing. The proposed rule, issued November 2010, called for dispensing fills of 7 days or less. In the final rule released April 2011, CMS changed the required dispensing increment to 14 days or less and pushed back the effective date from January 1, 2012, to January 1, 2013. The rule also states that a patient’s total copayments under a shorter dispensing cycle may not exceed the amount that would have been charged had the usual, longer cycle been used.

Medications that have Food and Drug Administration (FDA) approved labeling that requires them to be dispensed in the original packaging are exempt from the 14-day requirement. Also exempt are medications, such as oral contraceptives, whose packaging helps patients comply with their pre-scribed regimen. CMS did not exclude controlled substances from the 14-day requirement.

Lastly, the final rule eliminated a provision in the proposed rule that would have required Part D plan sponsors to ensure that their required MTM services are coordinated with the LTCF’s monthly pharmacists’ review of medication use.19

Fraud, Waste, and abuseThe Health Insurance Portability and

Accountability Act of 1996 (HIPAA; Public Law 104-191) first established a national Health Care Fraud and Abuse Control Program. Since the enactment of this law, there has been an increased focus on preventing fraud, waste, and abuse in Medicare and Medicaid programs, and these efforts were intensi-fied under ACA. In 2010, the federal government won or negotiated approxi-mately $2.5 billion in health care fraud judgments and settlements. It opened 1,116 new criminal health care fraud investigations involving 2,095 potential defendants.20 ACA increased funding for auditing activities and created greater access to pharmacy records for auditors.

ACA creates new standards under the False Claims Act, which prohibits knowingly presenting a false claim for

payment to the government, making or using a false record or statement to have a claim paid by the government, conspiring to have a false claim paid by the government, or using false records to avoid paying the government. “Knowing-ly” includes not only actual knowledge but also deliberate ignorance or reckless disregard of the truth; specific intent to defraud is not required. Examples of false claims include partially filling a pre-scription but billing for the full prescrip-tion, dispensing a generic medication but billing for a branded medication or, in some situations, submitting a claim with an incorrect provider number.

Pharmacists should carefully review processes and procedures to ensure compliance with all billing requirements. Many improper claims stem from actions that can be considered billing mistakes rather than fraud. Common sources of such mistakes include: (1) services that do not meet Medicare’s medical neces-sity criteria, (2) services that were incor-rectly coded, (3) proper documentation not submit ted upon request, (4) claims based on outdated fee schedules, and (5) duplicate claims.21 Pharmacies often have suboptimal audit results because they simply cannot find the hard copy of the prescription.

Additionally, pharmacists should ensure compliance with new fraud, waste, and abuse provisions, including an updated compliance program, employee handbook, and training requirements. Pharmacists should know audit procedures and how to prepare for them. Each PDP for Medicare Part D must have a program for controlling fraud. Pharmacists who contract with Part D plans should expect to see various requirements and audits relating to the review of pharmacy records and compliance activities.22

ACA strengthens penalties associ-ated with fraud, waste, and abuse, including increased prison terms and larger fines. It also simplifies the process for the government to halt Medicare and Medicaid payments during fraud investigations and makes it easier for whistleblowers to bring lawsuits. Finally,


it is important to note that several states have false claims laws with additional requirements. Information about various state laws can be found at http://www.taf.org.

oTHEr rEGULATorY ACTIVITIES

A substantial amount of regulatory activity occurred in 2011 that did not re-late directly to ACA, particularly by FDA and the Drug Enforcement Administration (DEA). There also was ongoing activity to implement HIT. APhA continues to work with these agencies to minimize the regulatory impact on pharmacists.

Fda activitiesAmong the regulatory activities of

FDA in 2011 were several important issues for pharmacy including patient medication information (PMI), reautho-rization of the Prescription Drug User Fee Act (PDUFA), standardization of risk evaluation and mitigation strategies (rEMS), and heightened efforts for the security of the supply chain such as counterfeit drugs and drug shortages.

Patient Medication InformationFDA has been involved in several

initiatives in recent years to streamline the medication information provided to patients at the point of dispensing. The agency is working to create a new PMI document that is a more user-friendly resource to help patients receive informa-tion needed to use a medication safely. PMI would integrate existing Medication Guides, consumer medication informa-tion, and patient package inserts into a single document. FDA has solicited feedback in public meetings to develop the concept of PMI and eventually may implement a regulation change.

Prescription Drug User Fee Act Reauthorization and Risk Evaluation and Mitigation Strategies

PDUFA allows FDA to collect fees from drug manufacturers to fund the drug application review process. Since the passage of PDUFA in 1992, user fees

have played an important and growing role in expediting the drug review pro-cess. PDUFA fees provide nearly half of FDA’s funding with the other half coming from Congressional appropriations. The law must be reauthorized every 5 years with the next reauthorization scheduled by September 2012 (PDUFA V). As required by law, in 2010 and 2011 FDA held public meetings and conducted dis-cussions with both the regulated industry and stakeholder groups in developing recommendations for the next PDUFA program. Congress will begin the PDUFA reauthorization process in 2012 based

on FDA’s recommendations. Proposed PDUFA V recommenda-

tions address many aspects of the drug development, review, and approval process. Issues of the greatest interest to pharmacy focus on enhancing and modernizing FDA’s drug safety system. Potential actions to achieve this goal include standardizing rEMS, using the postmarket surveillance and the Sentinel Initiative to evaluate drug safety issues, and ensuring resources are in place to manage pharmacogenomic information.

As outlined by FDA and manufac-turers in a draft agreement released

Public-Private Partnerships: The million Hearts Campaign

In September 2011, CMS launched Million Hearts, a public-private partnership between the federal government and private partners. The private partners include, among others, APhA, the American Heart Association, and the YMCA. The campaign aims to prevent 1 million heart attacks and strokes over 5 years.

Some of the Million Hearts campaign’s wide-ranging activities include23:• Educational programs to increase awareness about heart

disease prevention and empower patients to take control of their heart health.

• Use of HIT and quality improvement initiatives to standardize and improve the delivery of care for high blood pressure and high cholesterol.

• Community efforts to promote smoke-free air policies and reduce sodium in the food supply.

The campaign encourages the use of its ABCs mnemonic:• Aspirin for people at high risk.• Blood pressure control.• Cholesterol control.• Stopping smoking.

APhA and other pharmacy organizations and corporations have partnered with HHS to work toward the Million Hearts goal. Numerous federal agencies are involved in the campaign to provide staff and funding. As part of this program, the Centers for Disease Control and Prevention announced a $2 million Pharmacy Outreach Project that will enroll pharmacists to provide advice and support to patients with high blood pressure. CMS will award $485 million over 5 years to 10 states to encourage Medicaid ben-eficiaries to participate in chronic disease prevention programs.24,25


in September 2011, FDA intends to initiate a public process in PDUFA V to explore strategies and initiate projects to standardize rEMS programs with the goal of reducing burden on practitioners, patients, and others in the health care setting. In addition, FDA will conduct public workshops and develop guidance on methods to assess the effectiveness of rEMS, the impact on patient access, and burden on the health care system.26

APhA has engaged in myriad activities that advocate for improving rEMS programs by decreasing burdens and maximizing effectiveness. APhA has been actively involved in many rEMS discussions with FDA and other stakeholders throughout the past few years and supports FDA’s efforts to assure patient safety and the appropri-ate and safe use of medications. FDA has acknowledged the important role of pharmacists and pharmacies in implementing rEMS programs and the administrative and workflow challenges that must be addressed for both prescrib-ers and pharmacists. APhA continues to work with FDA and manufactures to help rEMS programs achieve their intended outcomes without being overly burden-some on the health care system. The APhA 2011 rEMS white paper provides a thorough review of APhA recommen-dations.27

FDA’s Sentinel Initiative is designed to implement a national electronic system for monitoring medication safety. FDA collaborates with federal, academic, and private entities to access and ana-lyze postmarket drug safety surveillance data. Under PDUFA V, FDA intends to

assess the feasibility of using Sentinel to evaluate drug safety issues that may require regulatory action. This may shorten the timeframe for identifying and understanding new or emerging drug safety issues.26

FDA also aims to use PDUFA to continue to direct resources for staff and outreach activities in the growing field of pharmacogenomics and personal-ized medicine. Much education is needed to help increase awareness and to educate practitioners on how this field can improve patient safety and outcomes. APhA has encouraged these efforts and convened a stakeholder meeting in March 2009 with FDA and HHS to identify steps for integrating pharmacogenomics into prescribing, dispensing, and patient care practices.28 Additionally, APhA released a white paper in october 2011 that explores the integration of pharmacogenomics in pharmacist-provided MTM services.28

Counterfeit Drugs and SecurityThreats to the security of the prescrip-

tion drug supply chain pose significant safety risks for patients. FDA first formed the Counterfeit Drug Task Force in 2003. Since then, the agency has created a multilayered approach to counterfeiting, diversion, and resale of stolen products. The Food and Drug Administration Amendments Act of 2007 requires FDA to develop standards for effective tech-nology to secure the drug supply chain. In March 2010, FDA issued a final guid-ance for prescription drug serialization (i.e., unique identifiers on each product). In February 2011, FDA held a workshop to explore the development of a track and trace system.29 The track and track system would identify every entity that has handled a medication throughout the supply chain from the point of manufac-ture to the point of dispensing.

APhA supports FDA’s efforts to ensure the availability of safe and ef-fective drugs through a track and trace system and encourages FDA to focus on interoperability of track and trace systems with pharmacy systems, processes for authentication, and system requirements/

processes for data management.30

Drug ShortagesThe frequency and severity of drug

shortages has increased in recent years and is adversely affecting patient care. To address the growing problem of drug shortages, President obama signed an executive order october 31, 2011, directing FDA to broaden reporting of potential shortages; take steps to speed up regulatory reviews that can help prevent, mitigate, or respond to shortages; and work with the U.S. Department of Justice to examine whether potential shortages have led to illegal price gouging or stockpiling.

Early notification of potential drug shortages can help FDA work with drug manufacturers, hospitals, physicians, and patients to prevent or mitigate shortages. Currently, federal law requires drug manufacturers to notify FDA when discon-tinuing critical drugs that are produced by only one manufacturer. The President’s order directs FDA to broaden reporting of potential shortages of certain prescrip-tion drugs.31 Congress also has begun to address the drug shortage issue with Congressional hearings and introduction of legislation (H.r. 2245/S. 296).

dea activitiesPrescription drug abuse is a growing

public health problem in the United States. DEA’s activities in 2011 that impact pharmacists include creating mechanisms for the disposal of unused controlled substances and implement-ing electronic prescribing of controlled substances.

Disposal of Controlled SubstancesStudies show that a majority of

abused prescription drugs are diverted from legitimate prescriptions filled for family and friends, including removal from the home medicine cabinet.

The Secure and responsible Drug Disposal Act of 2010 (Public Law 111-273) became law in october 2010 to address the need to have a safe process for disposing of unused controlled sub-stances. This law amends the Controlled

Know the LingoPMI, or patient medication

information, is a single document that would integrate Medication Guides, consumer medication

information, and patient package inserts.


Substances Act to allow the Attorney General to develop drug disposal pro-grams, and allows LTCFs to dispose of drugs on behalf of their residents. regu-lations for implementing this law are expected in 2012. In the meantime, DEA will continue to sponsor the semi-annual national prescription drug take-back days that were begun in 2010. 32

eRx and Controlled Substances on March 31, 2010, DEA issued an

interim final rule for the e-prescribing of controlled substances. Beginning June 1, 2010, appropriately credentialed prescribers were able to e-prescribe Schedule II through V controlled sub-stances. APhA and three other pharmacy organizations submitted comments to DEA recommending that the agency consider providing additional clarifica-tion and guidance on various aspects of the e-prescribing process for controlled substances.33 The final rule on the e-prescribing of controlled substances is expected to be released in 2012. once the final rule is issued, system vendors will work to finalize the infrastructure to allow these prescriptions.

other executive branch Prescription drug abuse initiatives

National Drug Control StrategyIn July 2011, the White House

office of National Drug Control Policy (oNDCP) released its 2011 National Drug Control Strategy emphasizing three policy priorities: reducing prescription drug abuse, decreasing drugged driv-ing, and preventing drug use before it begins. The report is divided into seven areas, including two focused on health care—“seeking early intervention oppor-tunities in health care” and “integrating treatment for substance use disorders into mainstream health care and expand-ing support for recovery.” The oNDCP strategy calls attention to the importance of public health, not just law enforce-ment, in addressing prescription drug abuse.34 oNDCP’s work on prescription drug abuse relating to pharmacy focuses

on education, disposal (i.e., take-back days), monitoring, and enforcement. APhA continues to work with oNDCP on these important issues.

Health Information Technology Initiatives

The American recovery and reinvest-ment Act of 2009 (Public Law 111-5; also known as “the stimulus”), included the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH directs HHS to establish programs to improve health care quality, safety, and efficiency through the promo-tion of HIT, including EHr.

Under HITECH, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHr technology and use it to achieve specified objectives. (Pharmacists and pharmacies are not eligible.) Providers must demonstrate “meaningful use” of the technology in order to qualify for the incentive payments. As a result of these new laws, pharmacists can expect to see a growing number of electronic prescriptions in coming years.

The meaningful use criteria are divided into three stages, with the first stage beginning in 2011. The Stage 1 meaningful use criteria focus on electroni-cally capturing health information, using that information to track key clinical conditions, communicating that informa-tion for care coordination purposes, and initiating the reporting of clinical quality measures and public health informa-tion.35

Stage 2 will expand upon Stage 1 in the areas of disease management, clinical decision support, medication management support for patient access to their health information, transitions in care, quality measurement and research, and bi-directional communication with public health agencies. Stage 3 would focus on achieving improvements in qual-ity, safety, and efficiency focusing on decision support for national high priority conditions, patient access to self man-agement tools, access to comprehensive

patient data, and improving population health outcomes.35

To advocate for pharmacy’s needs in the development of the nation’s HIT infra-structure, APhA and eight other national pharmacy organizations formed the Pharmacy e-Health Information Technol-ogy Collaborative in 2010. Its purpose is to create a comprehensive and unified approach to ensuring integration of phar-macy’s requirements and contributions into the EHr. In the past year, the collab-orative has made important progress on advancing EHrs for pharmacy practice, addressing coding needs for pharmacist-provided patient care services, and increasing the profession’s involvement in HIT discussions on a national level.

SUPrEME CoUrT DECISIoNSThere were two Supreme Court

Decisions in 2011 that directly apply to pharmacists—Pliva v. Mensing and Sorrell v. IMS Health. Additionally, a Supreme Court decision is pending in a third case—Douglas v. Independent Living Center of Southern California— which will have an important influence on pharmacy reimbursement and will likely be decided in 2012.

Pliva v. Mensing Pliva v. Mensing concerned whether

federal law preempts state-law negli-gence actions.36 Specifically, it consid-

Know the LingoMeaningful use criteria are requirements for the use of

electronic health records that qualified health care providers must comply with in order to

earn incentive payments through “the stimulus” law of 2009.


ered whether generic drug manufacturers should provide different or additional warnings from those provided on brand-name drug labeling. The case involved two women who were prescribed the brand-name product reglan in 2001 and 2002 by their physicians but generic forms of metoclopramide were dispensed by their pharmacists, and the women developed tardive dyskinesia after several years of therapy. They sued the generic manufacturers involved for failing to include adequate warnings of this adverse effect in product labeling. The generic manufacturers responded that FDA required their labeling to be identical to that of the brand-name reglan product, which at the time did not prominently list tardive dyskinesia as a possible adverse effect of long-term use.

In 2009, the Court held in Wyeth v. Levine that federal law does not always preempt lawsuits based on a brand manufacturer’s failure to include different or additional warnings not required by FDA.37 The Court distinguished Pliva from Wyeth, ruling that FDA’s require-ment that generic labeling be identical to brand-name labeling left no latitude

for generic manufacturers to include additional warnings, and therefore the conflicting state law that required a more robust duty to warn of adverse effects was preempted.

APhA supports patient access to lower priced generic drugs. However, it is important to note that this ruling could have an array of unintended conse-quences. For example, many generic drugs no longer have a brand-name product, and thus would limit legal recourse for patients in those situations.38

Sorrell v. IMS HealthThis case considered the right of

pharmacists to sell de-identified prescrip-tion drug information to data mining companies that aggregate and sell the data to pharmaceutical manufacturers, which in turn use the data when detailing prescribers.39 The plaintiffs argued that this selling of data was protected speech under the First Amendment.

The ruling opinion upheld the right to sell the data and noted that Vermont’s law particularly targeted industry detail-ing, but did not prevent others, such as researchers, from using the data.

Because the law discriminated on the basis of the speaker, it was considered a First Amendment violation. Addition-ally, Vermont argued that detailing by manufacturers should be curbed because of its influence on prescribing decisions. The Court disagreed with this argument, noting that “[F]ear that speech might persuade provides no lawful basis for quieting it.”

Douglas v. Independent Living Center of Southern California

The first oral argument of the Supreme Court’s 2011 term concerned a challenge by health care providers (including pharmacies) and patients to California’s repeated cuts to Medicaid reimbursements. The case addresses whether individuals can sue states that enact laws in conflict with federal requirements.40 It does not address the issue of whether the state law in question violates federal law; rather, this case considers whether the individuals involved have the right to sue to enforce the federal law. A decision is expected in the spring of 2012.

resourCesamerican Pharmacists association government affairshttp://www.pharmacist.com/ga

center for medicare and medicaid innovation innovation centerhttp://innovations.cms.gov

centers for medicare and medicaid servicesPharmacist centerhttp://www.cms.gov/center/pharmacist.asp

drug enforcement administration electronic Prescriptions for controlled substanceshttp://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html

Food and drug administration drug shortageshttp://www.fda.gov/drugs/drugsafety/drugshortages/default.htm

Prescription drug user Fee act http://www.fda.gov/forindustry/userfees/prescription druguserfee/default.htm

Postmarketing drug safety information for Patients and Providers (including rems) http://www.fda.gov/drugs/drugsafety/Postmarketdrug safetyinformationforPatientsandProviders/default.htm

The White house office of national drug control Policy Prescription drug abusehttp://www.whitehouse.gov/ondcp/prescription-drug-abuse


CoNCLUSIoNThis monograph presents an over-

view of several legislative, regulatory, and judicial actions in 2011 that affect pharmacy practice. ACA played an important role in shaping developments as new regulations are promulgated and provisions of the law are put into action. However, ongoing legislative activity may have an even greater effect on pharmacists, particularly as the federal government explores options to curtail spending and reduce the national debt. Throughout these discussions, it is critical for pharmacists to become involved in efforts to educate policy makers about

the value pharmacists provide to patient outcomes, health care teams, and the overall health care system. Pharmacists can point to a robust body of evidence demonstrating that payment to pharma-cists for MTM and other clinical services reduces overall health care costs.

In addition to keeping pharmacists informed about the national budget de-bate’s impact on health care, APhA helps pharmacists remain abreast of a variety of ongoing national developments that affect pharmacy. APhA offers a compre-hensive review of legislative and regula-tory issues, and provides numerous tools and resources for pharmacists who wish to advocate on behalf of their profession.

Visit www.pharmacist.com/GA for more information and ideas for taking action.


rEFErENCES1. Yap D. The pharmacist and the budget. Pharmacy

Today. october 2011;26–7.2. Smith M, Giuliano Mr, Starkowski MP. In Connecticut:

improving patient medication management in primary care. Health Aff. 2011;30:646–54.

3. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48:203–11.

4. Chrischilles EA, Carter BL, Lund BC, et al. Evaluation of the Iowa Medicaid pharmaceutical case management program. J Am Pharm Assoc. 2004;44:337–49.

5. American Pharmacists Association. re: Docket No. oCIIo–9998–IFC, rIN 0950-AA06; Health Insurance Issuers Implementing Medical Loss ratio (MLr) requirements Under the Patient Protection and Affordable Care Act [letter]. January 31, 2011. Avail-able at: http://www.pharmacist.com/AM/Template.cfm?Section=Home2&TEMPLATE=/CM/ContentDis play.cfm&CoNTENTID=25219. Accessed November 26, 2011.

6. National Association of Insurance Commissioners. regulation for Uniform Definitions and Standardized Methodologies for Calculation of the Medical Loss ratio for Plan Years 2011, 2012 and 2013 per Section 2718(b) of the Public Health Service Act. october 2010. Available at: http://www.naic.org/documents/committees_ex_mlr_reg_asadopted.pdf. Accessed November 26, 2011.

7. Department of Health and Human Services. Health Insurance Issuers Implementing Medical Loss ratio (MLr) requirements Under the Patient Protection and Af-fordable Care Act. Fed Regist. 2010;75:74864–934.

8. Yap D. No major changes: final medical loss ratio rule announced. December 6, 2011. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/CM/ContentDisplay.cfm&ContentID=27384. Accessed December 6, 2011.

9. Institute of Medicine. Essential Health Benefits: Balanc-ing Coverage and Cost. october 6, 2011. Available at: http://www.iom.edu/reports/2011/Essential-Health-Benefits-Balancing-Coverage-and-Cost.aspx. Accessed october 27, 2011.

10. American Pharmacists Association. Center for Medicare and Medicaid Innovation (CMMI) Grant Information. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=MTM&TEMPLATE=/Membersonly.cfm&CoNTENTID=26794&NAVMENUID=1582&DIrECTLISTCoMBoIND=D. Accessed october 26, 2011.

11. Centers for Medicare and Medicaid Services. Medicare Program; Solicitation for Proposals for the Medicare Community-Based Care Transitions Program. Fed Regist. 2011;76:21372–3.

12. Centers for Medicare and Medicaid Services. Medicare Program; Medicare Shared Savings Program: Accountable Care organizations. Fed Regist. 2011;76:19528–654.

13. Berwick DM. Making good on ACos’ promise—the final rule for the Medicare Shared Savings Program. N Engl J Med. october 20, 2011 [epub ahead of print].

14. Centers for Medicare and Medicaid Services. Medi-care Program; Medicare Shared Savings Program: Accountable Care organizations. Available at: http://healthblawg.typepad.com/files/2011-27461_pi-final-aco-regs.pdf. Accessed November 1, 2011.

15. American Pharmacists Association; National Associa-tion of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Ele-ments of an MTM Service Model. Version 2.0. March 2008. Available at: http://www.pharmacist.com/MTM. Accessed September 20, 2011.

16. Centers for Medicare and Medicaid Services. Standardized format for the comprehensive medication review action plan and summary—request for com-ment. March 11, 2011. Available at: http://www.cms.gov/PrescriptionDrugCovContra/Downloads/MemoMTMPDraftStandardFormat_03.11.11v2.pdf. Accessed November 1, 2011.

17. American Pharmacists Association. re: Standardized Format for the Comprehensive Medication review Action Plan and Summary [letter]. March 25, 2011. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=Government_Affairs&CoNTENTID=25797&TEMPLATE=/CM/ContentDisplay.cfm. Accessed November 1, 2011.

18. Centers for Medicare and Medicaid Services. Exceptions. Available at: https://www.cms.gov/ medprescriptdrugapplgriev/04_Exceptions.asp. Accessed November 1, 2011.

19. Centers for Medicare and Medicaid Services. Medi-care Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and other Changes. Fed Regist. 2011;76:21432–577.

20. Department of Health and Human Services; Depart-ment of Justice. Health Care Fraud and Abuse Control Program. Annual report for Fiscal Year 2010. January 2011. Available at: http://oig.hhs.gov/publications/docs/hcfac/hcfacreport2010.pdf. Accessed Novem-ber 1, 2011.

21. Centers for Medicare and Medicaid Services. The Medicare recov ery Audit Contractor (rAC) Program: An Evaluation of the 3-Year Demonstration. Available at: http://www.cms.gov/recovery-Audit-Program/Downloads/rACEvaluationreport.pdf. Accessed November 26, 2011.

22. Centers for Medicare and Medicaid Services. Prescrip-tion Drug Benefit Manual. Chapter 9—Part D Program to Control Fraud, Waste, and Abuse. April 25, 2006. Available at: https://www.cms.gov/PrescriptionDrug CovContra/Downloads/PDBManual_Chapter9_FWA.pdf. Accessed November 1, 2011.

23. Million Hearts. About the Campaign. Frequently Asked Questions. Available at: http://millionhearts.hhs.gov/about-mh-faq.shtml. Accessed November 2, 2011.

24. Posey LM. APhA joins Million Hearts campaign. Pharmacy Today. october 2011;68.

25. U.S. Department of Health and Human Services. New public-private sector initiative aims to prevent 1 million heart attacks and strokes in five years [press release]. September 13, 2011. Available at: http://million hearts.hhs.gov/docs/Million_Hearts_Press_release.pdf. Accessed october 27, 2011.

26. Food and Drug Administration. Prescription Drug User Fee Act; Public Meeting. Fed Regist. 2011;76:56201–5.

27. American Pharmacists Association. APhA 2011 rEMS white paper: summary of the rEMS stakeholder meet-ing on improving program design and implementation. J Am Pharm Assoc. 2011;51:340–58. Available at: http://www.pharmacist.com/rems2011. Accessed December 5, 2011.

28. American Pharmacists Association. Integrating pharmacogenomics into pharmacy practice via medication therapy management. J Am Pharm Assoc. 2011;51:e64–e74.

29. Food and Drug Administration. Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop. Fed Regist. 2011;76:1182–3.

30. American Pharmacists Association. re: Docket No. FDA–2010–N–06333. Determination of System Attributes for the Tracking and Tracing of Prescrip-tion Drugs [letter]. June 22, 2011. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=Government_Affairs&TEMPLATE=/CM/ContentDisplay.cfm&CoNTENTID=26245. Accessed october 27, 2011.

31. White House office of the Press Secretary. Fact Sheet: obama Administration Takes Action to reduce Prescription Drug Shortages in the U.S. october 31, 2011. Available at: http://www.whitehouse.gov/the-press-office/2011/10/31/fact-sheet-obama-administration-takes-action-reduce-prescription-drug-sh. Accessed November 1, 2011

32. Drug Enforcement Administration. National take back initiative. Available at: http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html. Accessed November 1, 2011.

33. American Pharmacists Association. re: Docket No. DEA-218I, Electronic Prescriptions for Controlled Substances, Interim Final rule With request for Comment [letter]. June 1, 2010. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=Issues&TEMPLATE=/CM/Content Display.cfm&CoNTENTID=23536. Accessed october 27, 2011.

34. Yap D. White House oNDCP strategy targets prescription drug abuse. September 6, 2011. Avail-able at: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&template=/CM/ContentDisplay.cfm&ContentID=26848. Accessed october 27, 2011.

35. Centers for Medicare and Medicaid Services. CMS finalizes definition of meaningful use of certified electronic health records (EHr) technology. July 16, 2010. Available at: http://www.cms.gov/apps/media/press/factsheet.asp?Counter=3794&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchopt=0&srchData=&keywordType=All&chkNewsType=6&intPage=&showAll=&pYear=&year=&desc=&cboorder=date. Accessed November 2, 2011.

36. Pliva v. Mensing. Decided June 23, 2011. Available at: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf. Accessed December 5, 2012.

37. Wyeth v. Levine. Decided March 4, 2009. Available at: http://www.supremecourt.gov/opinions/08pdf/06-1249.pdf. Accessed December 5, 2012.

38. Posey LM. High Court limits generic companies’ duty to warn. June 24, 2011. Available at: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&template=/CM/ContentDisplay.cfm&ContentID=26253. Accessed october 27, 2011.

39. Sorrell v. IMS Health. Decided June 23, 2011. Available at: http://www.supremecourt.gov/opinions/10pdf/10-779.pdf. Accessed December 5, 2011.

40. Douglas v. Independent Living Center of Southern California. Argued october 3, 2011. Available at: http://www.supremecourt.gov/oral_arguments/argu-ment_transcripts/09-958.pdf. Accessed December 5, 2011.

APhA Pharmacy Law Matters 2011CPE ExAM

1. under the budget control act of 2011, the “super committee” was charged with which of the following activities?a. Identifying a package of $1.2

trillion to $1.5 trillion in federal bud-get cuts over the next 10 years.

b. overseeing the implementation of the Affordable Care Act (ACA).

c. Identifying the essential benefits package for health insurers who participate in state exchanges beginning in 2014.

d. Managing the Center for Medi-care and Medicaid Innovation (CMMI).

2. The pending medication Therapy management (mTm) benefits act of 2011 would require which of the following activities? a. Expansion of MTM program

requirements under Medicare Part D to state Medicare programs.

b. require a minimum number of follow-up MTM visits annually for all patients who have a compre-hensive MTM review.

c. Establish credential requirements for pharmacists who provide MTM services.

d. require Medicare Part D prescrip-tion drug plans to compensate MTM providers based on resources and time for providing the service.

3. What is the purpose of the medical loss ratio requirement in aca?a. Ensuring that individuals do not

have to spend more than a certain percentage of their income on health insurance premiums.

b. Ensuring that insurance policy hold-ers receive value for the premiums that they pay.

c. Protecting insurance companies against risk of overutilization of services.

d. Minimizing the amount of


Instructions: The assessment questions printed below allow you to preview the online CPE exam. Please review all of your answers to be sure you have marked the proper letter on the online cPe exam. There is only one correct answer to each question.

money lost through waste, fraud, and abuse.

4. The institute of medicine report on essential benefits encourages the department of health and human services to develop a benefit pack-age that achieves which of the follow-ing goals?a. Maximizing patient access to

medically necessary services by in-cluding a broad range of services.

b. Maximizing patient access to coverage by limiting the range of services to keep costs low.

c. Balancing the need to provide coverage for essential services with the need to ensure that insurance options are affordable.

d. Balancing the need to provide affordable insurance options with the need to create plans that allocate sufficient reimbursement to providers.

5. The purpose of cmmi is to:a. Expand access to patient care

services.b. Perform cost-effectiveness research.c. Encourage states to adopt public

health initiatives for underserved populations.

d. Study new health care delivery and payment models and rapidly scale up successful models.

6. changes made in the final regula-tions for accountable care organiza-tions that varied from the proposed regulations include which of the following items?a. Adding a requirement for the use of

electronic health records (EHr).b. Eliminating medication recon-

ciliation as a quality performance measure.

c. Creating an advance payment model, in which the Centers for Medicare and Medicaid Services will advance a portion of future shared savings to increase partici-pation.

d. Increasing the number of quality performance measures.

7. aca implemented which of the fol-lowing changes to laws designed to address waste, fraud, and abuse?a. Expanding auditing activities for

federal programs. b. Creation of the national Health

Care Fraud and Abuse Control Program.

c. redefining the term “knowingly” in the False Claims Act to require prosecutors to prove a specific intent to defraud.

d. Making it more difficult for whistle-blowers to bring lawsuits alleging fraud.

8. under aca, when must Part d prescription drug plans begin using a standardized format for the patient medication list?a. January 1, 2012.b. January 1, 2013.c. January 1, 2014.d. January 1, 2015.

9. changes from the proposed regula-tion to the final regulation for short-cycle dispensing in long-term care facilities include:a. Lengthening the required maximum

dispensing increment from 7 days to 14 days.

b. Moving the effective date of the regulation 1 year earlier to January 1, 2012.

c. Exempting controlled substances from the 14-day requirement.

d. Adding a provision requiring coordination of MTM services with the facility’s monthly pharmacists’ review of medication use.

10. The million hearts campaign is an example of what type of program?a. A CMMI grant program.b. An Agency for Healthcare

research and Quality research program.

c. A public-private partnership.d. A component of the Food and

Drug Administration’s (FDA) Safe Use Initiative.

11. Which of the following correctly describes patient medication informa-tion (Pmi) initiatives at Fda?a. PMI includes safety information

provided by patients in postmarket-ing surveillance initiatives.

b. PMI would be a single document that integrates information from Medication Guides, consumer medication information, and patient package inserts.

c. PMI will be a new section of ap-proved prescribing information that describes information the prescriber should tell the patient.

d. PMI will be a new section of the FDA website that is intended to assist patients in being better informed consumers of health care information.

CPE INSTrUCTIoNSCompleting a posttest at www.pharmacist.com/education is as easy as 1. Go to online CPe Quick list and click on the title of this activity.2. log in. APhA members enter your user name and password. 3. Go to www.pharmacist.com/ CPemonitor to provide APhA with your required NABP e-Profile ID4. Successfully complete the CPE exam and evaluation form to gain immediate access to your Statement of Credit.

Live step-by-step assistance is available Monday through Friday, 8:30 am to 5:00 pm ET from APhA Member Services at 800-237-APhA (2742) or e-mail [email protected].

CPE MoNITorNew! As a provider of continuing pharmacy education (CPE), APhA is required to use the new CPE

Monitor system from the Accreditation Council for Pharmacy Education (ACPE) and the National Association of Boards of Pharmacy (NABP).

And, as a Pharmacist or Technician, you are required to have an NABP e-Profile ID to obtain credit for CPE activities.

Go to www.pharmacist.com/CPemonitor for information on setting up your e-Profile ID and submitting it to APhA. After you send your new e-Profile ID to APhA, completing CPE activities is still easy.


12. Fda is aiming to integrate which of the following topics into the 2012 reauthorization of the Prescription drug user Fee act?a. Standardization of requirements

for risk evaluation and mitigation strategies.

b. PMI initiatives.c. The Safe Use Initiative.d. Track and trace requirements.

13. To address the issue of drug short-ages, an executive order signed october 31, 2011, directs Fda to:a. Broaden reporting of potential

shortages.b. require that manufacturers continue

to produce drugs that are identified as meeting a critical unique health care need.

c. Waive certain regulatory require-ments governing good manufactur-ing practices for drugs experienc-ing a shortage.

d. Levy fines for manufacturers that are responsible for prolonged shortages.

14. in stage 1 of the “meaningful use” criteria, what action must qualified health care providers implement in 2011 to earn incentive payments for ehr? a. Issue at least 50% of all prescrip-

tions electronically. b. Demonstrate quality improvement

through the use of EHr.c. Provide patient access to self-

management tools. d. Capture health information

electronically and track key clinical conditions.

15. a potential unintended consequence of the supreme court decision in Pliva v. Mensing is:a. Increased cost of generic

medications.b. reduced access to generic

medications.c. reduced protections for patients

who use generic medications.d. Increased discrepancy between

prescription labeling for branded and generic products.

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