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APhA Policy Manual

FEDERAL PROGRAMS AND POLICIES

Browse policies organized by category. Select a category to view the related policy statements.

1 categories • 19 policies
Ensuring Access to Pharmacists' Services

  1. Pharmacists are health care providers who must be recognized and compensated by payers for their professional services under medical benefit payment structures.
  2. APhA supports integration pharmacists' provision of health care services into existing standardized processes under the medical benefit.
  3. APhA affirms that pharmacists’ must be compensated for their services consistent with the processes of, and in parity with, other health care providers.
  4. APhA advocates for the development and implementation of a standardized credentialing process for compensation of pharmacist services.
  5. APhA advocates for pharmacists’ access and contribution to clinical and claims data to support treatment, payment, and health care operations.
  6. APhA supports the integration of pharmacists’ service level and outcome data with other health care provider and claims data.
  7. APhA advocates for the in-network inclusion of pharmacists under medical benefits to increase access to health care services.
  8. APhA opposes policies or practices that prevent or undermine billing for pharmacist-provided services under the medical benefit by any health plan, payer, pharmacy benefit manager (PBM), or other entity.

Critical Access Pharmacy Model

  1. APhA encourages the creation by Congress of a Critical Access Pharmacy designation for the Medicare program to ensure financial viability and high-quality care to beneficiaries in low access areas.
  2. APhA supports the implementation of a Critical Access Pharmacy designation by the Centers of Medicare and Medicaid Services (CMS) that incorporates both financial incentives and quality measures that improve business sustainability while maintaining quality of care.
  3. APhA supports the expansion of state and federal scholarships and student loan repayment programs to include pharmacists and technicians employed by Critical Access Pharmacies.

Biologic, Biosimilar, and Interchangeable Biologic Drug Products

  1. APhA urges the development of laws, regulations, and policies that facilitate patient access to and affordability of biologic products.
  2. APhA urges the Food and Drug Administration (FDA) to expedite the development of standards and pathways that will evaluate the interchangeability of biologic products.
  3. APhA recognizes the Food and Drug Administration’s (FDA) Purple Book as an authoritative reference about biologic product interchangeability within the United States.
  4. APhA opposes interchangeable biologic product substitution processes that require authorization, recordkeeping, or reporting beyond generic product substitution processes.
  5. APhA encourages scientific justification for extrapolation of indications for biologic products to ensure patient safety and optimal therapeutic outcomes.

Drug Supply Shortages and Patient Care

  1. APhA supports the immediate reporting by manufacturers to the U.S. Food and Drug Administration (FDA) of disruptions that may impact the market supply of medically necessary drug products to prevent, mitigate, or resolve drug shortage issues and supports the authority for FDA to impose penalties for failing to report.
  2. APhA supports revising current laws, regulations, and policies that restrict the FDA’s ability to provide timely communication to pharmacists, other health care providers, health systems, and professional associations regarding potential or real drug shortages.
  3. APhA encourages the FDA, the Drug Enforcement Administration (DEA), and other stakeholders to collaborate in order to minimize barriers (e.g., aggregate production quotas, annual assessment of needs, unapproved drug initiatives) that contribute to or exacerbate drug shortages.
  4. APhA should actively support legislation to hasten the development of an efficient regulatory process to approve therapeutically equivalent generic versions of biologic drug products.
  5. APhA encourages pharmacists and other health care providers to assist in maintaining continuity of care during drug shortage situations by (a) creating a practice site drug shortage plan as well as policies and procedures; (b) using reputable drug shortage management and information resources in decision making; (c) communicating with patients and coordinating with other health care providers; (d) avoiding excessive ordering and stockpiling of drugs; (e) acquiring drugs from reputable distributors; and (f) heightening their awareness of the potential for counterfeit or adulterated drugs entering the drug distribution system.
  6. APhA encourages accrediting and regulatory agencies and the pharmaceutical science and manufacturing communities to evaluate policies/procedures related to the establishment and use of drug expiration dates and any impact those policies/procedures may have on drug shortages.
  7. APhA encourages the active investigation and appropriate prosecution of entities that engage in price gouging and profiteering of medically necessary drug products in response to drug shortages.

Integrated Nationwide Prescribing Drug Monitoring Program

  1. APhA advocates for nationwide integration and uniformity of prescription drug monitoring programs (PDMP) that incorporate federal, state, and territory databases for the purpose of providing health care professionals with accurate and real-time information to assist in clinical decision making when providing patient care services related to controlled substances.
  2. APhA supports pharmacist involvement in the development of uniform standards for an integrated nationwide prescription drug monitoring program (PDMP) that includes the definition of authorized registered users, documentation, reporting requirements, system response time, security of information, minimum reporting data sets, and standard transaction format.
  3. APhA supports mandatory prescription drug monitoring program (PDMP) enrollment by all health care providers, mandatory reporting by all those who dispense controlled substances, and appropriate system query by registrants during the patient care process related to controlled substances.
  4. APhA advocates for the development of seamless workflow integration systems that would enable consistent use of a nationwide prescription drug monitoring program (PDMP) by registrants to facilitate prospective drug review as part of the patient care process related to controlled substances.
  5. APhA advocates for continuous, sustainable federal funding sources for practitioners and system operators to utilize and maintain a standardized integrated and real-time nationwide prescription drug monitoring program (PDMP).
  6. APhA supports the use of interprofessional advisory boards that include pharmacists to coordinate collaborative efforts for (a) compiling, analyzing, and using prescription drug monitoring program (PDMP) data trends to identify misuse of controlled substances and/or fraud; (b) providing focused provider education and patient referral to treatment programs; and (c) supporting research activities on the impact of PDMPs.
  7. APhA supports education and training for registrants about a nationwide prescription drug monitoring program (PDMP) to ensure proper data integrity, use, and confidentiality.

Internal Revenue Service Drug Deduction

APhA supports amendment of personal income tax laws, regulations, and policies to permit all personal expenditures for medicines and drugs to be totally deductible and exempt from any exclusionary limits.

Non-execution-Related Use of Pharmaceuticals in Correctional Facilities

  1. APhA opposes drug manufacturers' refusal to supply certain drugs to correctional health services units necessary to provide medical treatment of those who are incarcerated.
  2. APhA advocates for those who are incarcerated to have an opportunity, equal to that of nonmates, to access medications that correctional healthcare providers deem medically necessary for appropriate and humane health care treatment.
  3. APhA advocates for correctional healthcare providers to have opportunity, equal to that of non-correctional healthcare providers, to access, prescribe, and procure pharmaceuticals deemed necessary for medical treatment of those incarcerated.

Protecting Pharmaceuticals as a Strategic Asset

  1. APhA asserts that the quality and safety of pharmaceutical and other medical products and the global pharmaceutical and medical product supply chain are essential to the United States national security and public health.
  2. APhA advocates for pharmacist engagement in the development and implementation of national and global strategies to ensure the availability, quality, and safety of pharmaceutical and other medical products.
  3. APhA calls for the development, implementation, and oversight of enhanced and transparent processes, standards, and information that ensure quality and safety of all pharmaceutical ingredients and manufacturing processes.
  4. APhA calls on the federal government to penalize entities who create barriers that threaten the availability, quality, and safety of United States pharmaceutical and other medical product supplies.
  5. APhA calls for the development of redundancy and risk mitigation strategies in the manufacturing process to ensure reliable and consistent availability of safe and high-quality pharmaceutical and other medical products.
  6. APhA advocates for legal regulatory, policy, and market incentives that bolster the availability, quality, and safety of pharmaceutical and other medical products.
  7. APhA calls for greater transparency, accuracy, and timeliness of information and notification to health care professionals regarding drug shortages, product quality and manufacturing issues, supply disruption, and recalls.
  8. APhA encourages pharmacy providers, health systems, and payers to develop coordinated response plans, including the use of therapeutic alternatives, to mitigate the impact of drug shortages and supply disruptions.
  9. APhA supports federal legislation and regulations that engages pharmacists, other health professionals, and manufacturers in developing a United States-specific essential medicines list and provides funding mechanisms to ensure consistent availability of these products.
  10. APhA recommends the use of pharmacists in the delivery of public messages, through media and other communication channels, regarding pharmaceutical supply and quality issues.

Reduction of Federal Laws and Regulations (Paperwork Burden)

APhA supports the reduction and simplification of laws, regulations, and policies for record-keeping requirements that affect pharmacy practice and are not beneficial in protecting the public welfare.

Revisions to the Medication Classification System

  1. APhA supports the Food and Drug Administration's (FDA) efforts to revise the drug and medical device classification paradigms for prescription and nonprescription medications and medical devices to allow greater access to certain medications and medical devices under conditions of safe use while maintaining patients' relationships with their pharmacists and other health care providers.
  2. APhA supports the implementation or modification of state laws, regulations, and policies to facilitate pharmacists’ implementation and provision of services related to a revised drug and medical device classification system.
  3. APhA supports a patient care delivery model built on coordination and communication between pharmacists and other health care team members in the evaluation and management of care delivery.
  4. APhA affirms that pharmacists are qualified to provide clinical interventions on medications and medical devices under FDA’s approved conditions of safe use.
  5. APhA urges manufacturers, FDA, and other stakeholders to include pharmacists’ input in the development and adoption of technology and standardized processes for services related to medications and medical devices under FDA’s defined conditions of safe use.
  6. APhA supports the utilization of best practices, treatment algorithms, and clinical judgment of pharmacists and other health care providers to guide the evaluation and management of care delivery related to medications and medical devices under FDA’s approved conditions of safe use.
  7. APhA encourages the inclusion of medications, medical devices, and their associated services provided under FDA’s defined conditions of safe use within health benefit coverage.
  8. APhA supports compensation of pharmacists and other health care professionals for the provision of services related to FDA’s defined conditions of safe use programs.

Uncompensated Care Mandates in Pharmacy

APhA calls for commensurate compensation for the provision of compulsory or mandated pharmacy services that include all products, supplies, labor, expertise, and administrative fees based on transparent economic analyses of existing and future services.

Access and Reimbursement for Diabetes Education, Support, and Prevention Services

  1. APhA supports the expansion of patient access to diabetes education, support, and prevention, including but not limited to the National Diabetes Prevention Program or DSMES.
  2. APhA calls upon public and private payers to expand reimbursement for pharmacist-based services as providers of diabetes education, support, and prevention regardless of practice setting.
  3. APhA advocates for campaigns focused on increased community wellness awareness and health benefits for diabetes education, support, and prevention.

Consolidation Within Health Care

  1. APhA advocates that health care mergers and acquisitions must preserve the pharmacist–patient relationship.
  2. APhA supports optimizing the role of pharmacists in the provision of team-based care following health care mergers and acquisitions in order to: (a) enhance patient experience and safety; (b) improve population health; (c) reduce health care costs; and (d) improve the work life of health care providers.
  3. APhA asserts that the scope of review by federal agencies must have a focus on the impact of health care mergers and acquisitions on patient access and the provision of care to ensure optimal patient outcomes. Therefore, APhA calls for (a) reform of the pre–health care mergers and acquisitions process; (b) implementation of an ongoing post–health care mergers and acquisitions evaluation process to preserve patient choice and access to established patient–pharmacist relationships, and (c) continuous transparent dialogue among stakeholders throughout the process.
  4. APhA calls for the Federal Trade Commission (FTC) to develop a task force to monitor health care mergers and acquisitions activity.

Qualification Standards for Pharmacists

APhA adamantly opposes the basic education requirement within the Office of Personnel Management’s Classification and Qualifications –

Pharmacists as Providers Under the Social Security Act

APhA supports changes to the Social Security Act to allow pharmacists to be recognized and paid as providers of patient care services.

Pharmacists Providing Primary Care Services

APhA advocates for the recognition and utilization of pharmacists as providers to address gaps in primary care.

Controlled Substances Regulation and Patient Care

  1. APhA encourages the Drug Enforcement Administration (DEA) and other regulatory agencies to recognize pharmacists as partners that are committed to ensuring that patients in legitimate need of controlled substances are able to receive the medications.
  2. APhA supports efforts to modernize and harmonize state and federal controlled substance laws.
  3. APhA urges DEA and other regulatory agencies to balance patient care and regulatory issues when developing, interpreting, and enforcing laws and regulations.
  4. APhA encourages DEA and other regulatory agencies to recognize the changes occurring in health care delivery and to establish a transparent and inclusive process for the timely updating of laws and regulations.
  5. APhA encourages the U.S. Department of Justice to collaborate with professional organizations to identify and reduce (a) the burdens on health care providers, (b) the cost of health care delivery, and (c) the barriers to patient care in the establishment and enforcement of controlled substance laws.

Discontinuation of the Sale of Tobacco Products in Pharmacies and Facilities That Include Pharmacies

  1. APhA urges pharmacies and facilities that include pharmacies to discontinue the sale of tobacco products.
  2. APhA urges the federal government and state governments to limit participation in government-funded prescription programs to pharmacies that do not sell tobacco products.
  3. APhA urges state boards of pharmacy to discontinue issuing and renewing licenses to pharmacies that sell tobacco products and to pharmacies that are in facilities that sell tobacco products.
  4. APhA urges colleges of pharmacy to only use pharmacies that do not sell tobacco products as experience sites for their students.
  5. APhA urges the Accreditation Council for Pharmacy Education (ACPE) to adopt the position that college-administered pharmacy experience programs should only use pharmacies that do not sell tobacco products.
  6. APhA urges pharmacists and student pharmacists who are seeking employment opportunities to first consider positions in pharmacies that do not sell tobacco products.

Small Business Set-Asides

APhA encourages all federal agencies (such as the Office of Personnel Management) to eliminate inconsistencies in federal contracts that in any way affect community pharmacies operating as small businesses.

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