110th Congressional Positions

National Patient Advocate Foundation actively supports public policy initiatives that improve access to healthcare. The Federal Government Affairs Program works collaboratively with other organizations to assure access to quality healthcare by: providing development and guidance on healthcare policy for the U.S. Congress, the White House and government agencies; conducting research through the Global Access Project (GAP) established in 2004; and conducting briefings for members of Congress and staff. NPAF has outlined its legislative position statements for the 110th Congress:

Archived Statement of Principles

109th Congress - Summary

Statement of Principles for Assisting Un and Underinsured Americans

National Patient Advocate Foundation remains extremely concerned with the growing number of Americans who lack any health insurance coverage, and also those who have insufficient health insurance coverage.  According to the U.S. Census Bureau, the number of uninsured Americans increased to 47 million in 2006 up from 44.8 million in 2005.  The number of uninsured children under age 18 also increased to 8.7 million (11.7%) up from 8 million (10.9%) in 2005.  National Patient Advocate Foundation is concerned with the downward trend in the number of employers that are offering healthcare coverage to their employees as well.  The Census Bureau found that 59.7 percent of employers offered coverage in 2006 compared to 60.2 percent in 2005.  The high cost of offering health benefits is forcing many employers to stop offering health coverage for employees and their dependents.

In addition to the uninsured, National Patient Advocate Foundation is concerned with the number of Americans that are underinsured.  It is difficult to classify how many Americans were underinsured in 2006 but rising healthcare costs are forcing employers to pare down benefits and increase employee cost sharing.  As a result, an increasing number of Americans are dealing with the reality that health related expenditures consumer a bigger chunk of their paychecks and their health plan provides them with fewer benefits.  Some health analysts classify the underinsured as those individuals covered by private insurance who spend 10 percent or more of family income on out-of-pocket health expenses.  In 2008 it is projected that 61.6 million Americans under the age of 65 (approximately 80 percent of whom are insured) will spend more than 10 percent of their pre-tax income on health care costs (Families USA, 2007).

National Patient Advocate Foundation has carefully reviewed proposals to provide assistance to uninsured Americans, and we commend the efforts of lawmakers in this regard. We find great merit in many of the recommendations designed to decrease the number of uninsured. National Patient Advocate Foundation supports the following legislative remedies:

NPAF supports a responsible healthcare system that is accessible to all Americans (see separate statement of principles)

  • Establish tax credits for employers providing health insurance coverage to their employees;

  • Establish tax credits for individuals to purchase health insurance coverage;

  • Permit small businesses to form coalitions to purchase health insurance coverage while maintaining state regulatory oversight;

  • Permit states to expand Medicaid eligibility criteria;

  • Establish a program whereby low-income patients who do not qualify for Medicaid may purchase coverage through this program;

  • Provide Medicaid coverage for uninsured Americans with a diagnosis of cancer;

  • Eliminate barriers to health insurance for individuals with pre-existing conditions; and

  • Provide government re-insurance for catastrophic care.

National Patient Advocate Foundation believes the combination of targeted tax incentives and targeted Medicaid expansion could serve as the catalyst for bipartisan legislation to provide assistance to patients throughout our country who are in need of health care coverage.

Pre-existing Condition Exclusions

National Patient Advocate Foundation is also concerned about barriers to health insurance that individuals with pre-existing conditions face in the group and individual health insurance markets.  NPAF supports legislation (H.R. 2833/S. 2236 & H.R. 2842) which helps ensure access to health insurance for individuals who have become uninsurable due to a pre-existing condition or a family history of chronic, debilitating, or life-threatening conditions. 

View Patient Advocate Foundation's report:

The Uninsured: Voices of Despair

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Statement of Principles for Responsible Health Care

National Patient Advocate Foundation is concerned about the current state of our health care system.  With the uninsured rolls continuing to expand, and the costs of healthcare continuing double digit annual increases, the status quo now threatens individuals and American businesses.  NPAF believes there must be a national solution aimed to expand access to health coverage while reigning in costs and spending.  NPAF believes that reform needs to occur in order to transform our health care system to an equitable, patient-centric system that promotes quality care through prevention and disease management while encouraging individual accountability.  Additionally, NPAF supports the promotion of coordinated care through the implementation of health information technology inclusive of e-prescribing, electronic health records (EHRs), and ultimately personal health records (PHRs).  NPAF believes that a responsible health care system should be based upon the following principles:

  • Universal - every American should have access to health coverage. NPAF supports a multi-faceted healthcare system that includes and supports roles for all stakeholders including: government, business, charitable organizations, and individuals.

  • Affordable - coverage should be available that is affordable for individuals, families, businesses and government. More Americans find themselves uninsured every year because they cannot afford coverage and/or their employers cannot afford to offer coverage. Small businesses need assistance so they can offer affordable coverage to their employees without facing financial ruin.

  • Quality - every American should have timely access to quality coverage including a minimum standard set of benefits; the healthcare system should incent quality and promote transparency to encourage patients to be better purchasers of health care. The use of quality measures, comparative effectiveness research, and evidence based medicine are tools that should be utilized to help improve the level of quality Americans receive in our health care system.

  • Fair and Equitable - no person should be discriminated against due to health status. Under our current system, individuals are denied coverage, experience waiting periods for treatment, face exorbitant premiums and may have their health insurance policy rescinded when they need coverage the most. A responsible health care system must be unbiased while providing necessary coverage to those who need it when they need it.

  • Portable - patients should be allowed to take their health coverage with them when they change jobs or move. NPAF is concerned that under our current system more and more Americans find themselves experiencing "job-lock", a phenomena that literally locks an individual in a particular job for fear of losing health coverage. Job-lock not only hurts patients, but it stymies innovation by reducing upward professional mobility across employer groups and it is not beneficial for the country's economy.

Help Small Businesses

Currently, small businesses and the self-employed face the most substantial challenges when it comes to gaining and maintaining health coverage.  High costs make purchasing an individual policy impossible for many and limit the number of small businesses that can afford to offer coverage to their employees.  NPAF supports reforms that allow small businesses the opportunity to provide their workers with health insurance coverage.   National Patient Advocate Foundation supports the following legislative remedies:

  • Establish tax credits for employers providing health insurance coverage to their employees;

  • Establish tax credits for individuals to purchase health insurance coverage; and

  • Permit small businesses to form coalitions to purchase health insurance coverage while maintaining state regulatory oversight and preserving consumer appeals.

Making health insurance coverage more accessible to self-employed individuals and individuals working for small businesses is integral to creating a responsible health care system for all Americans.

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Statement of Principles on Health Information Technology

National Patient Advocate Foundation supports the rapid deployment of health information technology (IT) and wishes to ensure that patient concerns are considered in development of health IT policy, standards and innovations.  Health IT remains a critical issue relative to both health care access and quality.  NPAF supports widespread adoption of health IT to help reduce the nearly 100,000 deaths that occur each year due to medical errors.  The U.S. Department of Health and Human Services has estimated that adoption of health IT could reduce health spending by as much as 30 percent annually.  In addition, health IT would improve the quality of care, reduce duplicity, and increase medical efficiency for patients.

As a member of the Health IT Now! Coalition, which unites patients, practitioners and employers, NPAF supports federal legislation to promote a connected health IT system.  NPAF supports the following Coalition principles:

  • Create a public-private process to establish HIT standards;

  • Offer Federal grants, subsidies, reimbursement to physicians and hospitals to adopt HIT;

  • Provide and promote patient education to encourage the use of HIT; and

  • Establish Federal and State roles to resolve HIT issues.

Additionally, National Patient Advocate Foundation supports the Administration's innovations through its participation in the American Health Information Community (AHIC), a committee established by the Secretary of the Department of Health and Human Services to advise him on health IT.  Nancy Davenport-Ennis, President & CEO, NPAF, serves as a member of the AHIC and co-chairs the AHIC Consumer Empowerment Working Group.  NPAF, through its participation in the American Health Information Community and other activities, urges consideration of patient needs and concerns, including privacy and security in the collection, transport and transference process of their medical information. This perspective is integral to the development of national health IT policy. 

E-prescribing

An issue related to HIT, e-prescribing, is cost-effective, provides immediate access to information, improves medication management and provides for safer care.  NPAF supports mandating e-prescribing under Medicare and encourages consideration of the recommendations made by the AHIC related to e-prescribing.  Flexibility in implementing and funding options for providers must be maintained if mandating e-prescribing and prior to implementation the following requirements must be met: participation by all pharmacies and PBMs; assurance of easily transmissible prescriptions; development of certification process including interoperability and safety standards; and establishment of incentives for providers to adopt e-prescribing technology.  Again, NPAF would like to emphasize the importance of incentives for providers, especially those serving underserved and high-risk populations, who may struggle to adopt this system. 

Collaboration with Patients in the Development of Health IT.  It is critical that the consumer/patient voice be considered and heard as health IT innovations are developed and that this perspective is integral to the development of national policy.  NPAF will continue to represent the patient/consumer concerns as part of the Health IT Now! Coalition and before the AHIC, to ensure that this perspective is integral to the development of national policy.  Additionally, NPAF will continue to urge patient appointments to committees directing these efforts in the government and private sector.

Interoperability. It is important to develop a national health IT framework that will be interoperable throughout the country so that hospitals, clinics, doctors, public agencies, and other entities are not each investing in creating redundant systems that are unable to communicate effectively with other systems.  These systems must be affordable, devoid of redundancy and must address gaps in the continuum of health care delivery.  Health savings would also result from accurate, portable patient records that would reduce the number of repeated tests and procedures.  Electronic medical records, personal health records, e-prescribing and other IT tools could also result in quality improvements based on a reduction of secondary adverse reactions and medical errors resulting from contraindicated drugs, treatments or therapies or unclear handwritten prescriptions or records.  These IT tools must be certified, work well, not be burdensome, and serve as a resource that adds to efficiency to incent utilization.

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Statement of Principles for Physician Payment

National Patient Advocate Foundation is concerned that reductions in physician payment may adversely affect patients.  In 2006, almost one-third of patients contacting Patient Advocate Foundation (PAF) were insured through Medicare.  Because PAF serves such a large number of Medicare beneficiaries, cuts to physician reimbursement are especially troubling since decreased reimbursement to physicians will ultimately lead to decreased access to necessary care for patients.  In addition, physicians will have less incentive to treat Medicare beneficiaries if future cuts to reimbursement are implemented.  This will lead to some physicians deciding not to accept any Medicare beneficiaries at all which is particularly troubling for patients living in rural settings that may already have limited access to healthcare providers.

Physicians recently averted a 10.1% cut in reimbursement scheduled to go into effect January 1, 2008.  In December 2007, Congressional action provided a temporary (six month) reimbursement increase of 0.5 percent to physicians; however, a long-term solution needs to be adopted to fix the flawed Sustainable Growth Rate (SGR) system.  A 2007 American Medical Association ("AMA") survey suggested that 60% of physicians would have been forced to limit the number of Medicare patients they treated had the 10.1% payment cut gone into effect.  Also, between now and 2015, eight in ten physicians said they expect to reduce or delay purchases of new and innovative medical equipment and/or more sophisticated information technology if cuts to reimbursement occur in the future.

Sustainable Growth Rate. Sections 1848(d) and (f) of the Social Security Act (the Act) require the Secretary to set the physician fee schedule update under the Sustainable Growth Rate (SGR) system. Based on this update system, as discussed above, CMS anticipates further negative updates in later years, absent further Congressional intervention and a revision of the SGR.

NPAF continues to be concerned that the SGR is problematic as it results in negative updates that can impact poorly on patient access. The SGR formula fails to consider other factors affecting the actual cost of providing physician services such as growth in the beneficiary population, program changes and utilization factors unrelated to economic trends.  NPAF suggests that CMS and Congress work together to restructure this reimbursement calculation system so that patients' needs, which do not diminish in slower economies, are met, and to ensure that fee schedule payments increase annually to reflect real increases in the cost of providing patient care.  NPAF also asks that CMS be vigilant to potential indicators of pending access problems such as reductions in chemotherapy claims volume and intervene appropriately to reverse those access issues.  NPAF will continue its association and collaboration with members of the provider community to monitor access issues and to intervene appropriately.  Nationally, the research through NPAF's Global Access Project (GAP) is tracking and reporting access issues.

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Statement of Principles on Pay for Performance

Background. "Pay for Performance" (often abbreviated as "P4P") and "value-based purchasing", are terms used to describe a health care provider reimbursement methodology that integrates provider performance and payment incentives into reimbursement and fee-scheduling determinations, such as in the Medicare program.  Under pay for performance policies, reimbursement rates are determined based on providers' performance as evaluated pursuant to quality-related standards, as laid out by plans, to meet pre-established targets for delivery of a wide range of health care services.  This payment model seeks to reward physicians, hospitals and other providers for meeting certain measures of quality and efficiency for medical care they provide.

Quality Improvements.  National Patient Advocate Foundation favors pay for performance methodologies designed to offer incentives for the delivery of high-quality care, rather than penalizing those services that do not meet the proscribed standards.  Provider reimbursement should not be reduced under a P4P system; physicians, for example, should not be dropped from a plan because they provide more costly services to patients in relation to other providers.  Payment reductions based on performance evaluation would make services even more inaccessible for patients, as disincentives may reduce the availability of eligible providers.  In contrast, we believe that incentives that encourage improved quality of care delivered would be a benefit to both patients and providers.  We therefore recommend that these reimbursement systems be compensatory in nature, not punitive.  

Patient Access.  As this payment methodology becomes more prevalent, NPAF will seek to ensure that the needs of patients are addressed.  NPAF believes that implementation of a pay for performance system of quality measures would support both improvements to beneficiaries' quality of care, as well as the implementation of appropriate reimbursement updates, but must be structured to provide incentives for high-quality care.  For instance, payments should not be directly linked to outcome improvements, as this may negatively impact a physician's willingness to treat high-risk patients or those with inevitable or irreversible outcomes.  As pay for performance models develop, it is imperative that patient access to quality care be facilitated and that standards of quality outcomes reflect the latitude of changes in disease status that contribute to debilitation even with quality care.   

Need for Adequate Reimbursement.  As an advocate for America's patient community, NPAF recognizes that adequate reimbursement for professional services is an essential component to ensuring patient access to care.  NPAF also recognizes the need for maintaining strict safeguards to protect the safety and well-being of health care consumers.  Implementing performance-based programs will contribute to appropriate reimbursement standards and will likely advance the safety and quality of care and its delivery.

Development of Performance Standards and Stakeholder Participation.   A number of parties within the health care sector support the use of incentive programs to improve the quality of health care, however some have expressed concerns with the development and legitimacy of quality indicators, increased administrative burdens, physician autonomy and the rights and privacy of patients.  Therefore, NPAF urges policymakers to include all stakeholders in a collaborative process to develop appropriate evaluation standards.  We also urge that standardized and consistent quality-related measures be developed and adopted by all stakeholders to ensure the programs' integrity and maintain the best interests of the patient population.  We also note the importance of developing distinct standards to evaluate performance relative to our most vulnerable patient populations; Medicare beneficiaries including the elderly, disabled and those suffering from chronic, debilitating and/or life-threatening illnesses.

Quality Indicators and Standards.  As noted above, standardized and consistent quality-related measures are critical if pay for performance programs are to meet the intended goal of improving the quality of care.  A system that evaluates performance as it relates to cost, volume or efficiency is all too often contrary to patient needs and access to quality care.  Policymakers must carefully consider how "quality of care" will be defined, measured and evaluated including a process to assure attention to the management of pain, emesis, and mobility.  Patients define individual living as a primary goal in disease management and the primary standard for defining quality.  It is important to recognize that the term "quality indicator" could be used to describe indicators that result in determinations that overly expensive care has been provided, as well as indicators that result in determinations that the provided care could be harmful to the patient's well-being.  These two concepts are quite different and must be addressed prior to implementation.

Data Collection and Reporting Costs.  NPAF is concerned that the collection of such data should not be overly time-consuming, resource-intensive, expensive, duplicative or otherwise burdensome so as to discourage provider participation.  We recognize also that the cost of compliance and participation is likely to include information system or software investments as well.  It is important that any legislative proposals include provisions for incenting or subsidizing physicians in obtaining the technology needed to participate in a P4P program.  We also encourage that data collection requirements be developed in consideration of the variable accessibility of different types of data and recognize, for example, that administrative or claims data may be easier to collect and report than encounter data.  NPAF supports the development and implementation of interoperable electronic health infrastructures that will facilitate collection, transmittal and evaluation of performance-related data without creating a financial or labor burden for providers, which, subsequently, would threaten patient access to care through diminished resources and professional staff.

Patient Choice.   Finally, NPAF recommends that the performance ratings for each provider be made available publicly in order to ensure transparency and assist patients in selecting a provider.  Patients make the greatest investment in any healthcare transaction and ultimately it is the patient who entrusts their life to physicians.  A system of informing the public of physician performance ratings will encourage utilization of those most qualified physicians and will hopefully lead to more qualified physicians.

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Statement of Principles for an Expanded Federal Role for Comparative Effectiveness Research

As an advocate for America's patient community, National Patient Advocate Foundation supports the development of research on the comparative clinical effectiveness of the multiple treatment options for those with chronic, debilitating and life-threatening conditions, in order to educate individuals on the options available, and to better equip them for the decisions they must make with their physicians regarding the best course of action in treatment.  NPAF acknowledges that, in the cases of certain conditions and illnesses, there is a limited amount of evidence available on which treatments work best for which patients.  These knowledge gaps have presented an opportunity for an expanded federal role in the study of the comparative clinical effectiveness of various medical interventions. 

Background.  In weighing the options for an expanded federal role in the study of comparative effectiveness, we must define "comparative effectiveness" ("CE") as applied in the health care sector.  Comparative effectiveness research is broadly defined as the comparison of the various impacts of different options that are available for the prevention, detection and/or treatment of a given medical condition, for a particular set of patients.  These studies might be comparisons of similar treatments, such as competing drugs indicated for the treatment of the same condition; or they may analyze different approaches to care, such as surgical intervention versus a less-invasive procedure, or pharmacotherapy.  The analysis should focus on measuring the relative medical benefits and risks of a given treatment, inclusive of enhanced quality outcomes for the patient, to determine which patient populations would have the most to gain from a particular medical intervention.  While some information regarding the effectiveness of a new drug, device or procedure is often publicly available, rigorous comparisons of the different treatments are far less common.

NPAF believes that all health care decisions should be informed by the best scientific and clinical evidence available.  In order for a patient to take responsibility for their health and become actively involved in informed decision-making with their personal physician, they must be armed with the best available evidence regarding the condition and its methods of treatment.  A national comparative clinical effectiveness research entity in the U.S. would have the potential to create a more centralized approach to the coordination of research and its findings, enhancing the safety and quality of care, while improving clinical practice and delivery, and possibly leading to the genesis of new areas of research and scientific discovery.

Organization and Funding.  Any established entity intended to perform such research would need to be structured in a way as to ensure the highest level of accountability and credibility, while maintaining functional autonomy and operating free from external political pressures.  The choice of organizational arrangement, as well as any arrangement of a funding mechanism, will have a great impact on the entity's direction, independence and accountability.  NPAF would support the establishment of a new body, obtaining its funds from both federal appropriations and pre-established contributions from sources within the private sector.  This establishment would coordinate research priorities, while allowing academic institutions and research centers throughout the country to perform reviews on a set of previously determined conditions and interventions.  This process would eliminate inherent conflicts that may exist between the mission of an existing federal agency and that of a proposed independent entity.

Scope of Research.  Comparative effectiveness research should encompass all aspects of medical treatment, from standard methods of prevention, screening and diagnostic testing, to drug therapies, procedures and surgical interventions, to the use of medical devices.  Focusing on the full spectrum of available approaches to care will encourage the ideal of a patient receiving the right care, at the right time, in the right setting enhancing quality outcomes.

Stakeholder Participation.  It is essential that the composition of the steering organization of the research entity consists of all relevant stakeholders, including representatives from the public and private sectors, including government, physicians and other health care providers, medical specialists, patient and consumer groups, insurers, and manufacturers of drugs and medical devices.  These stakeholders should be involved in every step of the process, from setting the research agenda, and developing study methodology, to the translation and dissemination of findings.  The stakeholders must have no conflict of interest and certify same.

Selection and Prioritization of Research Agenda.  Given the vast array of possible research topics, the earliest studies should be selected and prioritized based on what information would be most valuable to patients at this point in time.  Initial activities should be focused on conditions with the greatest impact on overall national health.  For example, priorities might include the multitude of treatments for commonly occurring conditions such as heart disease, diabetes, or cancer.  Research on these subjects is likely to have a wealth of information available for review.  However, in these fields there may also be a great amount of confusion surrounding the relative benefits and risks of new technologies in comparison with the older standards of care.

Chronic conditions are often associated with a disproportionate cost burden due to the extensive and prolonged course of treatment, while some conditions simply carry a higher price tag because of costly treatments required (e.g. radiation and chemotherapy).  These areas deserve special attention from researchers when setting priorities, but once the research agenda has been established, cost should not be used as a measurement in evaluating the comparative effectiveness of a product or procedure.  The prioritization of the research process is the only point at which NPAF believes cost should be taken into consideration.

Use of Research Findings.  NPAF acknowledges that an inherent long-term goal behind the study of comparative effectiveness is to reduce overall expenditures on health care in the United States; however, we feel that it will do so through the improved management of health care delivery (e.g., by reducing waste and misuse, defining appropriate interventions and encouraging physician best practices).  We do not support the research entity in question using CE research to determine cost-effectiveness of a given treatment, and we are opposed to the use of these findings in coverage and reimbursement decisions.  Findings should be used solely for informing patients and physicians as to what treatments offer the most benefits with the fewest relative risks, thus improving, not impeding, good clinical practice.

Transparency and Dissemination of Findings.  In order to best serve payers, clinicians and patient populations, research findings should be translated in a manner suitable for their respective audience.  Information should be summarized and described in detail as to inform medical professionals, but should also be made available in a clear manner to be easily managed by the average patient.  The process should be transparent from beginning to end.

Patient Needs and Personalized Care.  It is of the utmost importance that this research be performed in order to improve the quality, safety and delivery of care, not to limit access, deny treatment or reimbursement.  While CE studies will help to inform health care decision-making, NPAF strongly urges that the findings should not over-look subpopulations that may benefit from a particular treatment, or neglect the needs of patients for whom the findings are not necessarily supportive which may include patients with multiple co-morbid, complex conditions.  Physicians must have the latitude to define appropriate personalized medicine.  Health care decisions should continue to be tailored to fit an individual's needs, where CE research should inform, but not dictate, the patient's treatment options.

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Statement of Principles on Drug Safety and Efficacy Standards

Background.  The Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed into law in September 2007 with the aim to make prescription drugs safer.  The legislation allows the FDA to require drug companies to change labeling information if safety issues emerge, and provides necessary resources to the FDA in an effort to help promote innovation in biomedical research and better access to new therapies for physicians and patients.  Under the legislation, post-market surveillance is enhanced and will help to more accurately identify potential adverse effects of pharmaceutical products through the use of databases maintained by the Department of Veterans' Affairs, the Medicare program and other large insurers. 

The legislation also created the Reagan-Udall Foundation to establish a public-private partnership for the advancement of the FDA's Critical Path Initiative, and to help modernize product development, accelerate innovation and increase product safety.  Additionally, the bill establishes risk evaluation and mitigation strategies (REMS) and codifies the FDA's authority to require additional studies on the safety of a product once it has reached the market, and to determine whether it is appropriate to ensure the benefits of a drug outweigh its risks. 

Recent reports of adverse effects from approved prescription drugs have heightened awareness regarding the need for monitoring products' usage and to ensure that the highest standards of safety and efficacy are achieved.  National Patient Advocate Foundation welcomes the recent discussions about how we can make our drug approval process better, but we are mindful of the fact that patients with life-threatening and life-altering diseases like cancer are given hope because of the advantages of scientific discovery, and new product development.  We support reform that makes drugs safer for their intended populations, but caution against those actions whose unintended consequences might hinder the improvement of technologies for treatment, prevention, screening and detection - or that discourage their creation altogether.

As Congress continues to deal with this issue and considers options to strengthen our standards of prescription drug safety and efficacy, NPAF believes such reforms must be matched with efforts to enhance the FDA's level of efficiency, scientific expertise, and overall capacity to fulfill its numerous priorities and mandates.   

Where the Issue Stands.  Effective December 2007, the omnibus spending bill passed through Congress included language that would effectively block the FDA from transferring any funds to the Reagan-Udall Foundation, demonstrating a belief in alignment with a number of consumer groups that the Foundation might be too susceptible to industry influences. 

Any federal effort to improve national standards for drug safety and efficacy should be based on the following principles:

  • Promote innovation in biomedical research and facilitate increased access to new therapies for physicians and patients.

  • Expand the use of post-market surveillance to continuously observe the impacts of a given pharmaceutical product, recognizing the potential for unintended consequences, side effects or adverse effects, and ensuring that the relative benefits of a drug outweigh its risks.

  • In the case of any new safety concerns, recommendations should be made for the appropriate adjustment of safety/warning information reflected in required labeling changes with patient safety/warning labels written in easy to understand/patient friendly language. 

  • Any and all efforts to improve drug safety should be transparent and independent of outside political pressures.

Where We Stand.  National Patient Advocate Foundation fully supports the implementation of practices to encourage the modernization, and advancement of drug safety priorities, and the improvement of the drug approval process.  However, we remain concerned that the appointments and staffing of the Foundation must be done in such a way as to maintain the critical transparency and independence to assure that the public has full faith and confidence in its work.  NPAF intends to closely monitoring the development and direction of the foundation in the coming months.

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Statement of Principles on Fiscal Year 2009 Appropriations Priorities

National Patient Advocate Foundation supports federal programs that will advance biomedical research in cancer and other chronic medical conditions. We support programs that are designed to reduce or eliminate health disparities among minority and uninsured patient populations. NPAF also supports programs to assist with cancer screening, prevention, education, detection and treatment, as well as programs designed to study cancer epidemiology.

In the past, National Patient Advocate Foundation has supported the One Voice Against Cancer appropriations recommendations and has urged Congress to appropriate the identified levels of funding for the important National Institutes of Health, Centers for Disease Control & Prevention, and Health Resources and Services Administration programs.

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Statement of Principles on Prescription Drug Reimportation

The high cost of prescription drugs poses a major threat to the health and safety of many Americans.  National Patient Advocate Foundation and its companion direct patient services organization, Patient Advocate Foundation (PAF), receive requests on a daily basis from patients throughout the country who are having difficulty acquiring needed prescription drugs.  From 2004-2006, the primary pharmacy issue PAF patients reported was "Drug Co-Pay/Co-Insurance Too High" at 42%.  Additionally, 41.3% of PAF patients reported no pharmacy coverage as their primary pharmaceutical access issue in 2006.  PAF receives requests from patients across the country seeking assistance with a variety of pharmaceutical issues including: acquiring drugs that are not included in health plan formularies; coverage and reimbursement for off-label uses of covered prescription drugs; inability to meet co-payment and other cost-sharing obligations; policy limitations and coverage caps; and from patients with no coverage for needed prescription drugs.

The greatest number of requests for assistance we receive is from patients who are unable to pay for needed prescription drugs. PAF resolves these cases through mediation and arbitration with health plans and employers and through their patient assistance programs established with the support of pharmaceutical and biotechnology companies. Patients are also given information regarding state and federal programs or other financial resources for which they may qualify, as well as assistance with expedited applications for benefits. Case managers also facilitate access to mail order pharmacy benefits or identify local pharmacies that provide the prescribed medication at a reduced cost.

As a national patient advocate organization we are concerned about the quality and safety of pharmaceutical products when they reach the consumer, regardless of where they are manufactured.  

A handful of states have established programs that allow citizens to purchase prescription drugs at lower retail prices from approved, foreign pharmacies.  Each of these states has created an inspection process aimed to ensure that the foreign pharmacies are safe, reputable, and reliable.  Since Americans generally receive very low cost generic drugs, often times only brand name drugs are included in the state's reimportation program.

National Patient Advocate Foundation looks forward to a time when the federal government is able to put into place a system of strict safeguards to guarantee the quality, safety, and authenticity of pharmaceutical products.

NPAF recognizes there are legitimate concerns with regard to the safety of foreign manufactured and/or reimported prescription drugs including the possibility of corrupt or counterfeit drugs entering the market or inadequate manufacturer inspection processes.  NPAF believes there needs to be a federal process put in place that can assure the safety of foreign manufactured and reimported products.  The Secretary of the Department of Health and Human Services has not yet certified a federal program or process for the reimportation of drugs; NPAF believes that the Food and Drug Administration (FDA) should be provided the necessary resources in order to implement a safe, reliable prescription drug reimportation program.

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Statement of Principles on Medical Imaging

On January 8, 2006, the President signed into law the Deficit Reduction Act of 2005 (the "DRA").  The DRA, a cost-savings "reconciliation" bill required by the Congressional budget resolution, reduced Federal spending by $99 billion over 10 years.  More than 1/3 of the total Medicare savings in the bill, approximately $8.1 billion, was derived from dramatic cuts to payments for imaging services under Medicare.  These cuts were not contained in the House or Senate passed versions of the DRA; rather they were slipped in during conference without any public debate and appear to have had no champions in the Congress.  DRA imaging cuts went in effect January 1, 2007. 

National Patient Advocate Foundation believes that medical imaging services, such as ultrasound, x-ray, CT scans, and MRIs, are essential tools that help detect, stage and treat life-threatening and debilitating diseases like cancer, stroke and heart disease.  Medical imaging provides less-invasive evaluation and treatment protocols which often enhance the recovery process for patients.  NPAF is concerned that cuts to medical imaging services disproportionately impact access to care for patients living in rural and underserved urban communities.  The impact of these cuts on patients is immediate and harmful.  NPAF strongly opposes any new cuts to medical imaging and supports the following principles.

Medical imaging saves lives.  Medical imaging enables better, less-invasive care which often means easier recoveries and greater patient comfort.  Medical imaging often detects critical illnesses at their most curable stage when they are also least costly to treat.  The majority of cancer patients served through Patient Advocate Foundation require multiple forms of imaging.

Medical imaging is cost-effective.  Because of less-invasive care, fewer complications, earlier detection, shorter hospital stays, and better patient management, medical imaging is an overall cost-saver for patients and for the healthcare system in general.  Because medical imaging helps keep workers healthy and on the job by helping them avoid surgery, long recuperation, and disability, medical imaging is good for the economy and the individual being served.

Medical imaging is the future.  Medical imaging technology provides physicians with a remarkable vision of the body's structure and functioning without surgery and is one of the essential tools of modern medicine.  Medical imaging is a core component of the digital revolution enabling productivity gains through electronic health records, rapid access to images, and greater information and flexibility resulting in better outcomes for patients. 

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