In March, the Center for Medicare & Medicaid Innovation (CMMI), a part of the Centers for Medicare and Medicaid Services (CMS) issued a proposal of a mandatory experiment designed to evaluate mechanisms to reduce expenditures on prescription drugs reimbursed through Medicare Part B. This proposal would dramatically affect all those within the Medicare ecosystem, and has generated significant controversy since its unveiling. Indeed, the proposal has unleashed a maelstrom of commentary and criticism from nearly every stakeholder, including physicians, patients, and policy makers.
Those opposed to the proposal contend it was developed without sufficient stakeholder input, with too many changes affecting too many executed too quickly, and should be either significantly altered or not implemented. In early May, 242 members of Congress wrote to the Obama administration requesting the proposal be withdrawn, noting it would “unnecessarily disrupt care” for seniors covered under Medicare, and severely limit patient access to necessary medications.
The Community Oncology Alliance sent a letter to CMS stating it is “vehemently opposed” to the proposal, and will consider legal action based upon CMS overstepping its authority to make changes that would have a negative impact on patients.
In the May 17 House Energy & Commerce Committee hearing to review patient and physician feedback on the proposal, Committee Chairman Fred Upton (R-Mich.) cautioned that the proposal “represents a dangerous precedent where future administrations could change the statutory reimbursement for any provider or service, anywhere or everywhere in the country, under the guise of a demonstration, without any input from patients, providers, or Congress.”
Health subcommittee Chairman Joseph Pitts (R-Pa.) continued, stating that the proposal was developed “by unelected bureaucrats behind closed doors.”
Those in favor of the experiment contend that it is a step toward curbing prescription drug spending, and that it would increase access to patients. AARP, Aetna, and 23 other signatories submitted a letter in support of the proposal, stating it “has the potential to improve care quality and value for Medicare beneficiaries and support Medicare providers in delivering the right care at the right time.”
Democrats on the Senate Finance Committee issued a letter in support of the proposal with modifications such as limiting the scope to “no larger than necessary to allow a meaningful assessment.” Heather Block, a patient advocate who has repeatedly been treated for stage 4 breast cancer, testified in the May 17 hearing that the experiment was at least one step toward making life-changing medicines accessible to patients, and that it would reduce physician incentives to prescribe higher-cost medications, the savings from which will be passed on to patients.
With consideration of both points of view, as a former practicing physician and scientist, and having been involved in the healthcare industry for over 20 years including leading teams developing a number of products which have addressed unmet medical needs, the implications of this mandatory “experiment” is deeply concerning, which could have significant implications on patient care. Putting aside the issue that such actions appear to be a Federal agency legislating, a duty which is reserved for Congress, this experiment could limit patient access to treatments for the most complex diseases.
CMMI has created experiments within the marketplace previously; however, the difference with this latest proposal is the mandatory component and broad involvement of patients and providers. Many stakeholders in opposition of the experiment have criticized this aspect of the proposal. Debra Patt, MD, MPH, MBA, vice president of Texas Oncology in Austin, medical director of The U.S. Oncology Network, and Chair of the American Society of Clinical Oncology (ASCO) Practice Committee, testified at the noted May 17 hearing.
Dr. Patt expressed significant concern, noting such experiments, affecting providers and patients, should not be mandatory before a firm understanding of the implications of such changes. Moreover, she noted there appear to be no mechanisms built into the Part B experiment to monitor for adverse events, or to measure the quality of patient care, or outcomes for beneficiaries. As providers of health care are well aware, such assessments are critical requirements of any clinical study, such as this Part B proposal.
Patients may be forced into suboptimal therapies, not receiving the most current appropriate treatment for a particular disease, thus limiting access on the basis of expenditure—and not measured by this uncontrolled experiment. As physicians and physician-scientists, we have seen novel treatments dramatically improve patient health, studied in well-designed and adequate clinical evaluations; this broad mandatory proposal has none of the components by which to measure patient outcomes, but rather, focuses only on costs. As an experiment, then, it lacks the necessary components to assess clearly at least tantamount if not paramount endpoints, viz. how well patients fare.
For providers, the experiment could result in drastically lower reimbursement to a point where such reimbursement could be at a rate well below that paid for a particular medication. Providers would, therefore, be forced to decide whether to prescribe the best treatment for their patient—for which they are at risk to subsidize some of the cost—or provide a potentially less appropriate, less effective treatment that would allow for reimbursement, at the expense of compromised patient care. No provider should have to make this choice.
For patients, this directly impacts access for the most appropriate therapy as a sacrifice to curb prescription drug spending. It ignores the partnership relationship between those providing care and those receiving it—e.g. physician and patient—and creates a perverse wedge based on reimbursement. While it is clear efforts need to be made in order to create solutions effecting more affordable healthcare, it should not be done in poorly designed experiments which ignore the needs of patients, nor create an adversarial relationship between providers and those who require care.
Innovation is key to be able to address the challenges to provide access to affordable health care. However, such innovation cannot be done outside the context of considerations of stakeholders such as providers and patients. It might be wise, prior to implementing such far-reaching and broad changes, to follow the aphorism of ancient physicians, of which all medical school graduates are familiar, i.e. primum non nocere—first, do no harm.
Dr. Bert Liang is the founding and current CEO of Pfenex Inc., a biologics company focused on providing access to biosimilars. Dr. Liang is the Chair of the Biosimilars Council, a division of the Generic Pharmaceuticals Association and is the immediate past Chair of the Biodefense Policy Advisory Committee of BIO. Engage with him on Twitter @Bert_Liang.