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 111^th Congress:

• NPAF Patient-Centered Health Care Reform Solutions
• Preexisting Conditions
• High-Risk Pools(s)
• Annual and Other Limits on Coverage/Benefits
• National Comprehensive Health Benefits
• Medical Bankruptcy Reform
• Comparative Effectiveness Research
• Health Information Technology
• Medicare Physician Reimbursement Impact on Access
• Follow-on Biologics
• Value-Based Purchasing
• Prescription Drug Reimportation
• Medical Imaging
• Appropriations
• Prescription Drug Price Negotiation

Archived Statement of Principles 

109th Congress - Summary

Statement of Principles Preexisting Conditions

According to the Centers for Disease Control & Prevention, approximately 133 million Americans, or 45% of the population, have at least one chronic disease, placing them at potential risk of a preexisting condition exclusion. In addition, 20% of school-aged children have at least one chronic condition.  Our current laws allow significant gaps in coverage. These gaps are particularly devastating for Americans struggling to treat or manage a preexisting condition, which can include anything from seasonal allergies to cancer to heart disease.  Since 2006, Patient Advocate Foundation has aggressively tracked and documented the barriers that currently exist in our health insurance system for those with preexisting conditions. From 2007 to 2008, PAF saw a 146% increase in the number of cases related to preexisting condition denials and waiting periods.

NPAF strongly supports the principle that affordable health insurance absent waiting periods based on preexisting conditions is required as a cornerstone of healthcare reform. The imposition of preexisting requirements is the gate blocking access for those who today have at least one chronic illness that subjects them to preexisting condition limitations and locks them into existing plans and employment. Without the complete elimination of preexisting conditions, patients will continue to be denied insurance coverage or be forced to wait for necessary care.

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Statement of Principles High-Risk Pool(s)

Thirty-four states currently operate high-risk pools to provide health insurance to people who are unable to acquire health insurance on their own, usually due to preexisting health conditions.  Nationally, approximately 200,000 individuals receive health coverage through a state high-risk pool.  High-risk pools were created for the purpose of aiding individuals who are locked out of health insurance due to preexisting conditions.  

Health insurance reform is expected to establish a temporary national or state-based high-risk pool(s) to provide health coverage to individuals with preexisting conditions; $5 billion in funding will be provided.  The high-risk pool(s) will be established immediately after enactment and will be operational until the health insurance exchange is up and running.  NPAF believes that the creation of a temporary high-risk pool(s) will provide a coverage option for individuals who are currently "uninsurable" so that they may have affordable access to insurance prior to the exchange opening in 2013/2014.  NPAF will monitor the implementation of this provision poised to advocate for an accelerated roll-out if implementation is unnecessarily delayed and for supplemental funding if that should become necessary to assure that all those eligible achieve health care coverage. CMS has projected that the $5 billion currently provided in the House and Senate health insurance reform legislation for the high risk pool will be exhausted by 2011 or 2012.

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Statement of Principles on Annual and Other Limits on Coverage/Benefits

Annual and lifetime limits on insurance coverage, both dollar limits and limits on specific benefits/services, are routinely imposed by insurance companies.  The experience of the patients served by Patient Advocate Foundation indicates that exceeding benefit maximums, either monthly, annual or lifetime is a major driver of medical debt crisis and access to health care issues.

Health insurance reform is expected to eliminate lifetime and annual limits; however, the final provision may have loopholes that could effectively deny care to patients.  Under the legislation, lifetime limits are eliminated in 2010 but in the House bill, annual limits are not prohibited until the exchange is up and running in 2013 and in the Senate bill, "unreasonable" annual limits are eliminated in 2010, but it is left up to the discretion of the Secretary to determine the meaning of "unreasonable."  In addition, both bills initially prohibit lifetime limits on dollar amounts only. Other limits, such as a limit on radiation visits, surgeries or disease/condition specific benefit limits such as cancer treatments would be permissible and would remain so under the Senate bill. Beginning in 2013, the House bill does not allow annual and lifetime limits on the coverage of any covered item or service. 

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Statement of Principles on National Comprehensive Health Benefits

In our current health care system, there is no established national comprehensive benefits structure that health insurance plans must fulfill in order to assure that adequate health insurance is available to all.  The result is that over 25 million Americans are defined as underinsured because they have inadequate benefits under their health plan.  NPAF believes health reform legislation should include a national comprehensive health benefits package accessible to all Americans, including the 46 million uninsured.  The uninsured in America receive unreimbursed health services, though often inadequate, that are a hidden tax on those who pay premiums for their insurance.  Expanded coverage can lower premium costs by reducing unreimbursed care. 

NPAF supports national comprehensive health benefits that include the following services: hospitalization; outpatient hospital and outpatient clinic services including emergency department services; ambulatory patient services; laboratory services; professional services of physicians and other health professionals; services, equipment and supplies incident to the services of a physician's or a health professional's delivery of care in institutional settings, physician offices, patients' homes or place of residence or other settings; prescription drugs; rehabilitative and habilitative services; mental health and substance use disorder services; preventive services including chronic disease management; maternity care; well-baby and well-child care and oral health, vision, and hearing services, equipment, and supplies for children under 21 years of age; and durable medical equipment, prosthetics, orthotics and related supplies.                                           

Health reform legislation should also include policies to maximize health care access such as an affordable cap on out-of-pocket (OOP) expenses, subsidies to make the purchase of insurance affordable, requirements that health plans meet medical loss ratios, and a review process for unreasonable premium increases.  NPAF will closely follow the implementation of any enacted health reform legislation to assure the adequacy and affordability of the benefits. 

NPAF will evaluate approaches to maximize access to adequate health insurance coverage including but not limited to the use of national and state health insurance exchanges through which individuals and small business can purchase coverage and essential benefits may be assured.  NPAF will monitor legislation and regulations relating to the establishment of essential benefits package standards as well as all approaches including health insurance exchange(s) which seek to expand access to health coverage because current proposals lack operational details which will have a very significant impact on patients.  

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Statement of Principles on Medical Bankruptcy Reform

As noted in Patient Advocate Foundation's Patient Data Analysis Report, the number of patients contacting PAF for assistance with managing medical debt reinforces the trend of increasing medical debt across all patient populations, regardless of age, insurance status, and ethnicity.  For patients, the problem is not just increasing premiums, co-pays, and deductibles, but also caps on benefits and the use of inadequately regulated health care credit cards that result in quick accumulation of medical debt.  While it is hoped that health insurance reform, once fully implemented, will significantly reduce medical debt crisis and medical bankruptcy issues for patients, NPAF will continue to explore the need for medical debt/bankruptcy legislation.

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Statement of Principles on 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 patients to take responsibility for their health and become actively involved in informed decision-making with their personal physicians, 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. could 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.

Patient Needs and Personalized Care.  It is of the utmost importance that this research be performed for the purpose of improving 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. 

Organization and Funding.  Any established entity intended to perform such research would need to be structured 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 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 entity 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 existing federal agencies and that of a proposed independent entity.

Stakeholder Participation.  It is essential that the composition of the steering organization of the research entity consists of all relevant stakeholders, including patient and consumer groups, representatives from the public and private sectors, such as government, physicians and other health care providers, medical specialists, 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 the same.

Scope, Selection and Prioritization 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.

Given the vast array of possible research topics, the earliest studies should be selected and prioritized by stakeholders including patients, providers, and researchers.  Initial activities should be focused on conditions with significant impact on overall national health.  For example, priorities might include the multitude of treatments for commonly occurring conditions such as obesity, 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.

Special patient populations, including minorities, should be integrated into comparative effectiveness research.  NPAF is concerned that under our current system, the majority of clinical trials lack a balanced representation of minority populations who could be unduly burdened as a result of decisions made through comparative effectiveness research that did not include data relative to clinical research for these populations.  Comparative effectiveness guidelines should only apply to those populations that have been included in the research.

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 believe that it should only 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.  NPAF supports comparative effectiveness research inclusive of the collection of financial information i.e. cost effectiveness of a given treatment, in an effort to more fully inform patients of their out-of-pocket costs for treatment decisions being made between the treating physician and patient.  Additionally, cost effectiveness information may be used to reflect broad disparities in cost of services from one region of the country to another allowing improved opportunity for stakeholders to more appropriately define treatment and coverage decisions. Comparative effectiveness research should inform 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 payors, 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.

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Statement of Principles on Implementation of Health Information Technology

National Patient Advocate Foundation supports the rapid deployment of health information technology (IT) and wishes to ensure that patient concerns including privacy and security safeguards are considered in the 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 and use 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 through a balanced process that affords equal opportunities to smaller and community hospitals and providers;
• Provide and promote patient education to encourage the use of HIT; and
• Establish Federal and State roles to resolve HIT issues.

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 supported language included in the "Medicare Improvements for Patients and Providers Act of 2008" (MIPPA) which mandated e-prescribing under Medicare and encourages further adoption of e-prescribing for non-Medicare providers.   Again, NPAF would like to emphasize the importance of positive 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 patients as part of the Health IT Now! Coalition 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 on Medicare Physician Reimbursement Impact on Access

National Patient Advocate Foundation is concerned that reductions in Medicare physician payment may adversely affect patients.  Last year, nearly 23% of patients contacting Patient Advocate Foundation (PAF) were insured through Medicare.  Within the PAF Medicare population, 56% were aged while 44% were disabled individuals.  Because PAF serves such a large number of Medicare beneficiaries, cuts to physician reimbursement are especially troubling since decreased reimbursement to physicians provide them with less incentive to treat Medicare beneficiaries and will ultimately lead to decreased access to necessary care for patients.     The decision by some physicians not to accept any Medicare beneficiaries at all is particularly worrisome for patients living in rural settings and some urban areas that may already have limited access to healthcare providers.

Further, the PAF Medicare patient population tends to live on a fixed income - nearly 72 percent of PAF Medicare patients have incomes of less than $23,000.  They face challenges with meeting both the coverage gap associated with Medicare Part D, as well as the 20% out-of-pocket expenses incurred with the delivery of any healthcare service reimbursed under basic Medicare coverage. 

Over the past several years, Congressional action has blocked scheduled physician reimbursement cuts from going into effect.  Temporary fixes are not an effective or efficient way to address physician reimbursement; 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 January 2008 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 Congress work with all national healthcare stakeholders 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 in watching for 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. In 2005 NPAF commissioned a Geographic Access to Care study as part of its Global Access project .  This study was published by researchers at the University of North Carolina and summarized the distribution of cancer patients and cancer care providers across regions and population types, paying special attention to potential differences in access to care that might be relalted to rural location, race, ethnicity or low-income status.  The study found that:

Forty-five percent of all rural counties in the study states have no oncology service providers at all - neither a hsopital nor a hematology or medical oncologist....Nearly one-fourth of the urban counties also have no cancer care providers , but these are located at the fringes of the metropolitan areas with relatively few residents....Eighteen percent of rural counties have hsopitals that report providing oncology services, yet there are no oncology physicians located within the county  according to the CMS files.

The Medicare physician reimbursement in the current healthcare reform legislation passed by the House provides a permanent solution to the SGR cuts.  The Senate-passed health reform bill had no provision. The formula used to determine physician reimbursement under Medicare needs to be replaced with a mechanism to assure that physicians are adequately compensated for providing care to Medicare patients.  Otherwise, increasing numbers of Medicare beneficiaries will be unable to access care as more physicians decline to accept Medicare patients.  This problem will be most acute, as noted above, in rural areas and some urban counties.

We strongly urge the Senate to adopt the House SGR provisions, either as part of  health care reform legislation or as a stand-alone bill, in order to provide a permanent solution to this problem and security to Medicare patients.

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Statement of Principles on Follow-on Biologics

Where We Stand

National Patient Advocate Foundation actively supports legislation and regulations that protect patient safety and increase patient access to effective low-cost biotechnology therapeutics.  Patient safety should stand at the center of a regulatory approval pathway for follow-on biologics.

Background

Chemical drugs are typically made by mixing together well-defined chemicals in controllable "recipes" following the formulas and the predictable rules of organic chemistry.  The same final product can sometimes be obtained through a very different process, and the product can be analyzed in a laboratory to confirm that it is exactly what it is supposed to be.  It is a relatively straightforward exercise to show that a generic chemical product is the same as a branded product.  Evidence from clinical trials is not necessary, and cannot be submitted in an application for a generic product.

Biologics are more complex molecules than chemical drugs; they are not manufactured through chemical synthesis but instead are made by genetically engineering living cells to become miniature factories producing the desired molecules (proteins).  These living cells are inherently variable and susceptible to slight changes in their environment that can significantly alter the proteins they are engineered to produce.  Because no two living cell lines are identical, no two biologics manufacturing processes have identical starting materials or proceed in the same way.  A follow-on biologic manufacturer that uses different starting materials and a different process will produce a product that is different from the innovative product.  In addition, the complexity of biologics currently makes it impossible to show in the laboratory that a follow-on biological product will work the same as the innovator in patients.  The effects of the difference between a follow-on biologic and its respective innovator product can only be determined by subjecting the follow-on to substantial clinical testing in patients to prove that it is safe and effective.

Because of the complex science involved, the Food and Drug Administration (FDA) has indicated that the generic drug approval pathway is not appropriate for complex biologics.

With patents for a number of blockbuster biologics expiring in the next several years, Congress and the FDA have been under pressure to establish an expedited approval pathway for follow-on biologics, thus paving the way for the development of a U.S. follow-on biologics industry.  We anticipate that the healthcare reform legislation will include provisions relating to follow-on biologics, since both House and Senate versions of the bill contain them.

NPAF recommends Congress and regulatory agencies recognize and adopt the following principles as they explore the creation of a regulatory pathway for follow-on biologics:

• Patient Safety.  Patients should not have to accept greater risks or uncertainties in using a follow-on product than an innovator's product.  Thus Congress should:
  • Ensure that approval of follow-on biologics is based on rigorous standards of safety, purity and potency applied by the FDA for the approval of pioneer biotechnology products
  • Recognize that clinical trial evidence and data are fundamental for evaluating and demonstrating safety and effectiveness of a follow-on biologic, and must be required for all biosimilars

• Maintain the Physician-Patient Relationship.  Small molecule generic drugs can be designated as therapeutically equivalent and may be dispensed interchangeably with innovator products without physician knowledge.  The current state of science is not sufficient to establish interchangeability for complex follow-on biologics. Accordingly, Congress should insure that patients are not given follow-on biologics unless expressly prescribed by a physician.
  
  
• Preserve Incentives for Innovation.  In order to preserve incentives for the research, development and manufacturing of new innovative therapies, as well as new indications for biologic products, any statutory pathway must include:
  
  
  • Substantial non-patent data exclusivity.  Follow-on manufacturers should not be able to rely on FDA's prior approval of pioneer biologics to support approval of their own products.  Such data exclusivity is necessary because a follow-on biologic may be similar enough to a pioneer biologic for regulatory purposes, but different enough to avoid the innovators' patent.  Thus non-patent exclusivity is necessary to maintain effective market protection.  Further, the biologics industry maintains heavy dependence on access to significant amounts of high cost public-private investment capital, and high risks and costs involved in the development of new biologic medicines all warrant a substantial period of exclusivity.
    
    
• Continue to Prioritize FDA Review and Approval of New Therapies and Cures.  Any applications for approval of follow-on biologics will raise novel and complex questions of science and law, requiring substantial time and additional resources to ensure a thorough regulatory review for safety, purity and potency.  In order to avoid slowing down FDA's review and approval of new therapies and cures, Congress must ensure that workload associated with these new applications does not harm FDA's ability to efficiently review new drugs and biologics, and new treatments continue to have the highest review priority.

Biopharmaceutical innovation can provide major improvement with respect to the quality and length of human life but could also exacerbate cost pressures and access disparities in health care.  NPAF strongly urges Congress and the FDA to balance the objectives of innovation incentives and price competition as well as ensure patient safety and will monitor and comment upon the implementation of follow-on biologics legislation within that context.

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Statement of Principles on Value-Based Purchasing

Background.  "Value-based purchasing" is a term used to describe a health care provider reimbursement methodology that integrates provider performance and payment incentives into reimbursement and fee-schedule determinations.  Under value-based purchasing 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 value-based purchasing methodologies designed to offer incentives for the delivery of high-quality care, rather than penalizing those services that do not meet the prescribed standards.  However, NPAF does recognize that "never-events" are an exception in a value-based system.  Provider reimbursement should not be reduced under a value-based purchasing 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 value-based purchasing 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 value-based purchasing 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 may contribute to appropriate reimbursement standards and may 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 including: Medicare beneficiaries; 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 value-based purchasing 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, nausea, and mobility.  Patients define independent 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 value-based purchasing 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 use 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 measured across all payor types 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 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.  In 2008, nearly 12% of PAF patients reported pharmaceutical co-payment issues as their primary access issue.  Additionally, of patients reporting pharmaceutical issues, 41% reported inadequate or no pharmaceutical coverage.  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; monthly/annual/lifetime policy limitations and coverage caps; and assistance requests 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 the 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.  In total, 14% of PAF patients who reported encountering pharmaceutical related issues cited "no pharmacy coverage" as their primary pharmaceutical access issue in 2008.  In addition, almost 14% of patients reported they had exceeded their pharmacy benefit maximum, and 14% had inadequate prescription drug coverage.

As a patient advocacy organization, NPAF is concerned about the quality and safety of pharmaceutical products when they reach the consumer, regardless of where they are manufactured.  Health care reform may allow for the reimportation of prescription drugs for patients.  In addition, a handful of states have already 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 only brand name drugs are included in the state's reimportation program.

If reimportation is included in health care reform, National Patient Advocate Foundation will closely monitor its implementation paying close attention to patient safety issues.  Strict safeguards must be in place in order to guarantee the quality, safety, and authenticity of foreign 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.  Finally, 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

National Patient Advocate Foundation believes that medical imaging services, such as ultrasound, x-ray, CT scans, and MRIs, are essential tools to 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 is acutely aware of recent reports of over-utilization of imaging services by providers and supports efforts to remedy this finding.  A June 2008 study by the Government Accountability Office (GAO) found that the Medicare Part B program spent $14.11 billion on imaging services in 2006, up 48% compared to $6.89 billion in spending in 2000.  The report found a connection between in-office imaging and spending growth, with the proportion of Medicare spending on in-office imaging rising from 58% in 2000 to 64% in 2006.  Finally, the report found that in 2006 Medicare spending on imaging varied widely by state, from $62 per beneficiary in Vermont to $472 per beneficiary in Florida. NPAF 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 when appropriately prescribed and supported by guidelines.  Because of less-invasive care, fewer complications, earlier detection, shorter hospital stays, and better patient management, medical imaging can be an overall cost-saver for patients and for the healthcare system in general.   NPAF supports the use of imaging guidelines, specifically those developed by physician specialty societies, which encourage compliance with established guidelines in an effort to reduce unnecessary radiation exposure to patients and unnecessary costs to the nation's health care system.  In addition physicians should discuss specialty society guidelines with patients at the time of prescribing. NPAF supports federal funding of grants to medical specialty groups to develop medical imaging guidelines and appropriateness criteria. 

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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Statement of Principles on Fiscal Year 2011 Appropriations

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.

National Patient Advocate Foundation supports the appropriation recommendations developed by One Voice Against Cancer (OVAC), a collaboration of national non-profit organizations representing cancer patients.  As an OVAC member, NPAF urges Congress to appropriate the levels of funding recommended by OVAC for the National Institutes of Health, National Cancer Institute, Centers for Disease Control & Prevention, Food and Drug Administration, and Health Resources and Services Administration programs.  OVAC appropriations recommendations are expected to be finalized in January 2010.

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Statement of Principles on Prescription Drug Price Negotiation

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) established a prescription drug benefit for Medicare beneficiaries under Medicare Part D, beginning on January 1, 2006.  The MMA's "noninterference" clause prohibits CMS from interfering with drug price negotiation between manufacturers and Medicare drug plan sponsors and from instituting a formulary or price structure for prescription drugs.

The framework created by the MMA attempts to lower drug prices though competition.  Part D plans are expected to negotiate prices and/or rebates with manufacturers and compete for enrollees by passing on the savings through lower premiums and cost-sharing requirements.  Those unhappy with the savings achieved under Part D want to repeal the noninterference clause so CMS can actively attempt to negotiate lower drug prices with manufacturers.  It is possible that the repeal of the "noninterference" clause may be included in health care reform.

Principles

NPAF is concerned that repeal of the noninterference clause may hamper the development of new drug therapies and lead to widespread adoption of restrictive formularies that inappropriately limit access to newer or more expensive treatment options.  Additional savings to the federal government must not be achieved at the expense of patient access to medically appropriate therapies.

Drug Innovation -While there is disagreement over the relationship between pharmaceutical R&D and the introduction of new drugs, a recent study concluded government-mandated price negotiations would reduce the number of life-saving drugs developed each year by about a dozen and "yield a loss of 5 million life-years annually," an adverse effect valued at > $500 billion/year.

Access to Reasonably Priced Drugs-As of mid-2006, almost 40% of Medicare-eligible veterans with VA benefits were enrolled in Part D, a fact believed to reflect a desire by veterans to avoid the VA's restrictive formulary. If a federal formulary were to become a de facto national formulary used by the majority of Part D and commercial plans, it could severely restrict access to unlisted drugs and potentially lengthen the time required for innovative products to achieve covered status.  Patients would be forced to pay out-of-pocket for unlisted drugs.  If discounts are negotiated by the federal government, drug companies may respond by increasing the prices charged to other buyers thus shifting the Medicare burden to employers and commercially insured individuals.

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