Cornell Journal of Law and Public Policy最新文献

Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery. Yet, notwithstanding the frequency of surgical procedures and their often critical importance to patient health, no state or federal agency either approves the use of new surgical procedures or directly regulates existing procedures. The absence of surgical procedure regulation differs from the regulation of new pharmaceutical products, which can be introduced into interstate commerce only after the Food and Drug Administration (FDA) has reviewed "adequate and well-controlled [clinical] investigations" and concluded the data from those studies sufficiently establish the drug's safety and efficacy. Surgical procedures, by contrast, are more often conveyed from professor to student, the result being that surgical approaches may vary considerably from one geographic region to another. Whether different techniques produce different outcomes is not always clear, in part because the absence of regulation means that evidence often has not been systematically generated or may be in a form not suitable for comparison. Commentators have noted the differing treatment that persists between surgery and pharmaceuticals and have offered a number of justifications. For example, they have suggested that the surgical profession should self-regulate, that excessive regulation could deter surgeries of unproven benefit even when the surgery may be in the best interest of the patient, and that surgical trials could disrupt the doctor-patient relationship, such as by emphasizing uncertainty in a context where patient trust is important. In the context of innovative (as opposed to established) surgical procedures, controlled trials might be disfavored due to concern that desperate patients might unwisely submit themselves to risky experimental treatments undertaken by overzealous researchers. When commentators advocate for increased surgical regulation, they generally limit their calls for reform to innovative surgical procedures. The absence of direct regulation, however, has implications for the quality of evidence available to support an optimal choice from among all of the alternatives in the surgeon's armamentarium, whether innovative or standard, and whether surgical or non-surgical. This Article first examines the current framework of indirect regulation surrounding surgical procedures and then offers potential explanations as to why surgical procedures themselves are not already subject to direct federal regulation. Finally, it considers possible contributions of increased surgical regulation, including the identification of evidence gaps, the generation or collection of evidence to fill those gaps, and the impact on surgeon decision-making and patient consent.

President Donald J. Trump has said he will repeal the Affordable Care Act (ACA) and replace it with health savings accounts (HSAs). Conservatives have long preferred individual accounts to meet social welfare needs instead of more traditional entitlement programs. The types of "medical care" that can be reimbursed through an HSA are listed in section 213(d) of the Internal Revenue Code (Code) and include expenses "for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body." In spite of the broad language, regulations and court interpretations have narrowed this definition substantially. It does not include the many social factors that determine health outcomes. Though the United States spends over seventeen percent of gross domestic product (GDP) on "healthcare", the country's focus on the traditional medicalized model of health results in overall population health that is far beneath the results of other countries that spend significantly less. Precision medicine is one exceptional way in which American healthcare has focused more on individuals instead of providing broad, one-size-fits-all medical care. The precision medicine movement calls for using the genetic code of individuals to both predict future illness and to target treatments for current illnesses. Yet the definition of "medical care" under the Code remains the same for all. My proposal for precision healthcare accounts involves two steps-- the first of which requires permitting physicians to write prescriptions for a broader range of goods and services. The social determinants of health are as important to health outcomes as are surgical procedures and drugs--or perhaps more so according to many population health studies. The second step requires agencies and courts to interpret what constitutes "medical care" under the Code differently depending on the taxpayer's income level. Childhood sports programs and payments for fruits and vegetables may be covered for those in the lower income brackets who could not otherwise afford these items and would not choose to spend scarce resources on them if they could. This all assumes that the government takes funds previously used to subsidize the purchase of health insurance under the ACA (or allocates new funds) and puts the funds in individual accounts so the poor or near poor have money to pay for these expenses. Section I of this Article will explore the current definition of medical care, which excludes the social determinants of health from "healthcare" spending. I then address how precision medicine has changed the types of services and treatments that it makes sense to reimburse for each individual. If efficacy can vary from person to person based on genetic code, then it also can vary depending on environment. There is an opportunity to not only vary the types of "medical care" that can be reimbursed or deducted within the traditional ran

The Social Security system has come under attack for having illegitimately transferred wealth from younger generations to the Baby Boomgeneration. This attack is unfounded, because it fails to understand how the system was altered in order to force the Baby Boomers to financetheir own benefits in retirement. Any challenges that Social Security now faces are not caused by the pay-as-you-go structure of the system but byBaby Boomers' other policy errors, especially the emergence of extreme economic inequality since 1980. Attempting to fix the wrong problem allbut guarantees a solution that will make matters worse. Generational justice and distributive justice go hand in hand.