As a representative of an industry committed to discovering new cures and ensuring patient access to those cures, the Biotechnology Industry Organization (BIO) is carefully monitoring proposed payment system reform (PSR) policies and the impact that these policies could have on patient access to life-saving therapies, diagnostics and vaccines. From specific proposals to bundle payment for particular disease states to more wide-ranging reforms such as Accountable Care Organizations (ACOs) and Patient Centered Medical Homes, PSR policies could potentially affect patient access to breakthrough therapies—as well as the incentives necessary to develop those therapies.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are at the forefront of discovering, developing and bringing to market the next generation of life-saving medicines. BIO has developed the following principles to aid our organization and members in monitoring and working to refine various PSR policies. BIO’s primary goals are to ensure that patients have access to appropriate therapies and to protect the incentives needed to develop breakthrough medicines to treat the patients of tomorrow.
1. QUALITY: Protect high quality care. The use of payment bundling and other mechanisms can shift the focus to the cost of care instead of the quality of care. Therefore, alternative delivery models should be value-based and accompanied by appropriate externally developed quality measures—particularly measures that focus on the outcomes of interventions subjected to these reforms.
2. PATIENT IMPACT: Integrate a “patient impact” assessment into proposed payment system reforms. Decisions to change payment policies can have intended and unintended impact on patient health. Any policy changes should consider the potential ramifications for patients—whether direct or indirect.
3. ACCESS: Protect patient access to appropriate therapies, drug delivery devices, diagnostics and vaccines. Most treatments cannot be administered using a “one size fits all” approach; this is especially true for rare or complex diseases. Treatments chosen for a particular patient must be tailored to the individual patient’s needs and characteristics. Payment reform policies must maintain flexibility for patients and their physicians to choose the therapy most appropriate for achieving the optimal quality outcome. No treatment should be universally excluded from coverage, particularly for FDA-approved indications and other clinically accepted uses supported in peer-reviewed medical literature or compendia.
Moreover, appropriate payment adjustments must be available to hold patients and their physicians harmless in situations where choice of appropriate therapy results in an increased cost burden.
4. ADHERENCE: Support patient adherence to therapies. Patient adherence to physician directed medication regimens can have a significant positive impact on health outcomes and create overall cost savings. Payment system reforms should recognize the potential for medications to reduce costs and improve health outcomes over the long term, and new models should incorporate opportunities to gather data on this correlation. Reforms should also adequately reimburse for approaches that support patient adherence to therapies. Barriers to accessing treatments such as requiring prior authorization for particular prescription medicines, could impact patient adherence to those treatment regimens. Payment reform policies should not interfere with patients staying on treatment regimens that work for them.
5. INNOVATION: Maintain incentives to develop breakthrough therapies to address patients’ unmet needs and to discover the cures of tomorrow. Policymakers must ensure that any reforms ultimately enacted maintain adequate incentives for investment in continuing innovation in health care. Fostering innovation is the best way to sustain the growth in value of the health care delivery system. Innovations such as new medical therapies can reduce the burden of, or even cure, costly diseases, as well as keep total societal costs down. Proposals that limit access to novel medical therapies and technologies can lead to potential delays in obtaining care, or sub-optimal care, resulting in higher health costs and poor health outcomes. The research and development of new cures and breakthrough therapies continues to be a high priority in our nation’s health care system.
6. EVIDENCE: Ensure that sound evidence is used for payment policy changes. Any potential changes to payment policies that will impact patient care must be based on a comprehensive analysis of appropriate, scientifically rigorous evidence to ensure that patient access to quality care is maintained.
7. TRANSPARENCY: Ensure sufficient stakeholder input through a transparent and inclusive process. Payment system reforms must be adopted using transparent, predictable procedures that provide for adequate stakeholder input, and appeals processes. Patients, physicians, manufacturers and other stakeholders must have a mechanism to conduct a comprehensive review and provide feedback through a formal comment-making process prior to implementation of reforms. Cost and outcomes data generated through the implementation of reforms should be shared with stakeholders. When pilot programs and demonstration projects are attempted, patient participation should be fully transparent and voluntary.
8. ADEQUATE REIMBURSEMENT: Proceed cautiously before implementing payment bundles or reforms that eliminate separate reimbursement for drugs and biologicals. Discontinuing separate reimbursement, particularly for costly therapies, should not be undertaken without comprehensive evidence that such changes will improve outcomes while lowering overall costs. Any such policy must be undertaken with significant procedural protections to ensure that appropriate patient access is the primary goal. In particular, it is critical that consideration be given to adjusting bundled payments for differences in patients’ risk profiles (to avoid adverse patient selection). The burden should be on the sponsors of such policies to ensure that access to quality patient care and outcomes remain the cornerstone of any payment system reform