April 2013, Vol 2, No 2
The Affordable Care Act and Oncology Personalized Medicine: Compatibility and the Governing Dynamics of HealthcareThe Last Word
Our last column examined the tripartite nature of healthcare: a clinical/business/policy entity with each of the 3 sectors influencing the net condition of healthcare. While the healthcare entity should act in balance, in reality each sector periodically springs forward with powerful initiatives and â€śtakes chargeâ€ť of healthcare until another sector responds with its initiative to redress the balance.
Significantly, insurance does not translate directly into care. The second principle on which healthcare rests is value: the balance of cost, quality, and access â€“ which again instinctively gravitates toward a balance of forces, since healthcare cannot exist as a simple matter of pure medical quality, pure cost-effectiveness, or perfect access, but a Lagrangian balance of the three.
The third 3-part principle of healthcare is wellness: a cycle of prevention, intervention, and innovation working together. No surprise hereâ€¦making it work requires a balance of these forces to keep healthcare viable, humane, and progressive.
Personalized medicine (PM) is clearly a Clinical initiative, relying heavily on innovation and individualized care, biomarkers, and biologics essential to its implementation. It has begun to â€śdriveâ€ť healthcare away from the old, imprecise blockbuster drug model. But because healthcare is not a unilateral entity, another sector â€“ Policy â€“ is making itself felt in the form of the Affordable Care Act (ACA). The practicing oncologist must now navigate new waters where Policy collides with Clinical. The operative question is, how compatible are PM and the ACA? The answers will be slow in coming, but it may help to examine this question through the lenses of value, sectors, and wellness.
The ACA is pure Policy designed to expand insurance coverage. But this is all so vagueâ€¦coverage of what? For whom? Paid for by whom? Who are the winners and losers? Can PM continue to progress, or will the ACA stifle this?
Nothing makes healthcare as invigorating as the collision of these core dynamics. The ACA did not glide into the healthcare system â€“ it dropped into it with a thump to broaden the access to insurance to 25 million more people. It does so by cost-shifting from one class of Americans to another. It is neither ideologically pure nor financially sound, but it will certainly impact.
Rather than rattle off projections as to how it will impact PM, it may be more instructive to pose questions based on the interaction of the aforementioned forces emanating from the dynamics of healthcare sectors, value, and wellness. Does the ACA help the uninsured while hurting others, reducing access to PM biologicals, imaging, and laboratory diagnostics by â€śdumbing downâ€ť healthcare into a tepid, egalitarian bowl of porridge? How much money can the Federal Reserve dare print to fund what critics call an inherently unaffordable initiative? Will the level of care be commensurate with true PM? Will the aging American population be receiving grade A care, or will healthcare quality suffer under the financial pressures involved in increasing the insured?
The ACA imposes obligations on other people to add 25 million insured lives, with a paradoxical effect. About 8 million people will lose private health insurance, and 3 to 4 million will drop their coverage. Some will go over to the government insurance, which does not have enough money to pay for all the newly insured patients. Will hospitals start restricting levels of care to patients? Will there be differences in care for government versus privately insured patients? How many of the newly added patients will need cancer care? Will there be an improvement in preventive screening to catch cancer early? Insurers wonâ€™t be able to charge newly insured people with cancer more than healthy people â€“ so how will the insurers remain solvent under these conditions, and will they devise elaborate eligibility measures for patients to receive PM care for cancer?
One highly significant characteristic of the ACA is how it differs fundamentally from PM: it is not about individuals. It is about populations and obligations to pay for other peopleâ€™s â€śrightsâ€ť as defined by law (which brings up the feisty question, is healthcare a right?). PM is based on crafting a solution based on an individualâ€™s needs, whereas the ACA does not regard patients in that way. If there isnâ€™t enough money, can we expect standardization of care, thereby causing long-term access denial to certain PM treatments because of the cost-shifting the ACA entails? The ACA looks at patients in large chunks/buckets. Rather than fostering innovation, will it tend to place a financial â€śgovernorâ€ť on it? The ACA is a social class entitlement initiative. So how will it affect the uptake of PM and the continuation of the immense research into biomarkers and new biologics?
The fact that someone has health insurance does not mean that he can afford a biologic. Cost-sharing and annual or lifetime limits only fail to apply to Medicaid patients â€“ giving these patients an advantage in getting access to expensive care, based on cost-shifting from the newly insured patient to the existing insurance market. Who will pay for that? Private companies. Will these companies be able to fund this level of coverage required for PM-styled care?
Is there sufficient evidence to convince payers to cover PM innovations? Given the fact that government lacks the money to fund the ACA, will PM run into a collectivist view of healthcare, stemming from the philosophy behind the ACA (ie, it is â€śunfairâ€ť for some people to get access to PM while others get conventional chemotherapy)? As biologics keep mainstream cancer patients alive for a long time, can we pay for it? What lambda will our society designate for the improvements that PM brings to cancer care? Will treatment be based on oneâ€™s â€śvalue to societyâ€ť? Will the ACA create a 2-tiered or 3-tiered system of care? Will the ACA result in more people having access to PM oncology care, or fewer? More access to quality biologics care, or less? A more equitable access to oncology careâ€¦that excludes PM?
Because it is necessary to increase the cost of insurance to everyone else to fund it for the indigent, will everyone get less of the whole? Can we afford to keep oncologists and oncology nurses reimbursed sufficiently to maintain a sufficient workforce? Has solid epidemiological study been done to dovetail this workforce to our aging population and the number of cancer patients who will require treatment? How much will premiums change? How will insurersâ€™ demands for guarantees of effectiveness and safety rise to qualify for coverage of PM screening, diagnostics, and treatment? If you think your fight is with the payer, keep in mind that insurers, under the ACA, are becoming regulated utilities â€“ and so are limited by the government.
The questions raised by the ACA are legionâ€¦and not going to go away on their own. They will require all to come to grips with what real forces govern healthcare and end the pretense that any healthcare sector can dictate the course of healthcare, or legislate in opposition to the true governing dynamics. So be prepared, fair oncologist, for encounters with your insurer and your government regarding attempts to place limits on PM. As Bette Davis uttered in All About Eve, â€śFasten your seatbelts, itâ€™s going to be a bumpy night.â€ť As to answers to the above questions, I assure you in full confidenceâ€¦Iâ€™m sure I donâ€™t know!
Robert E. Henry
Physician-Reported Clinical Utility of the 92-Gene Molecular Classifier in Tumors With Uncertain Diagnosis Following Standard Clinicopathologic Evaluation
Advances in understanding the genetic basis of many cancers and the development of molecularly targeted therapies are increasing the need for diagnostic resolution. Patient outcomes have improved with the use of predictive biomarker testing, targeted therapies, and site-specific chemotherapy regimens.1,2 However, tumor classification remains unknown or uncertain in a quarter [ Read More ]
About 3% to 5% of the general population is believed to have a mutation in the gene that encodes a major 5-fluorouracil (5-FU) metabolizing enzyme. This mutation can extend the half-life of 5-FU, leading to increased plasma concentrations and potential toxicities, said Colleen Rock, PharmD, PhD, at the Hematology/Oncology Pharmacy [ Read More ]