There are 2 types of medical practice: retail and wholesale. Retail medicine occurs at the individual patient level in clinics, operating rooms, and hospital wards where physicians and patients work together to prevent and cure disease. Wholesale medicine, in contrast, occurs at the population and healthcare system levels, where policy makers set the rules that govern the retail practice of medicine. Physician engagement in the political process is an important mechanism for altering the trajectory of healthcare policy. This article discusses the wholesale side of medicine, exploring the why and how of physician involvement in healthcare policy.

Before we explore the how and why of physician involvement in healthcare policy, we will first define what is meant by this concept. In general, we know that a policy is a rule, or set of rules, designed to achieve a particular end by incentivizing desirable behavior. A policy aims to steer individual and collective decision making toward a predetermined goal. Based on this definition, we can conceptualize healthcare policy in terms of its goals and the means for achieving those goals.

The goals of healthcare policy are manifold. Up until the past decade, healthcare policy goals were commonly framed in terms of access, cost, and quality. Policy makers and thought leaders sought to expand access to care, minimize costs, and maximize quality. The conventional wisdom, however, was that the price for minimizing cost would always be paid either by diminished access to care or lower-quality care.

The past decade has seen an evolution in the framing of these healthcare policy goals. Borrowing from longstanding principles in management science, “value” has become the focus of healthcare policy. Defined by a direct relationship with quality and an inverse relationship with cost (value ≈ quality/ cost), this new value era in healthcare has combined the aforementioned policy goals of minimizing cost and maximizing quality into a single policy target. Framed in this way, the goal of healthcare policy is to maximize the value of healthcare such that it is worth expanding access to healthcare.

But if the goal of healthcare policy is to maximize value, the next question is, “Value for whom?” The constituents of healthcare policy makers include patients, providers, payers, and purchasers, and these highly integrated and related groups can have highly disparate perceptions of value. For example, for patients—the majority of whom are responsible for only a fraction of the total cost of their healthcare consumption&mdash;the value proposition is largely centered on maximizing quality. In contrast, payers (eg, private insurance companies) and purchasers (eg, employers that purchase healthcare services or health insurance on behalf of their employees) are more cost-sensitive.

Some providers, particularly physicians, have professional obligations to healthcare quality and patient welfare that must be balanced against the financial realities of managing a practice; however, other providers, such as hospitals, are not bound by professional obligations, but must deliver care in a manner that preserves operating margins. And while it may be appealing, often appropriate, and always politically expedient to elevate patient notions of value above all others, the answer to the question, “Value for whom?” must be an inclusive one. With this understanding of value, its multiple dimensions, and its place in the goals of healthcare policy, we now have an outstanding opportunity to explore how the next generation of physicians can engage and influence the value conversation in healthcare policy.

The means by which policy achieves its ends are rules that can influence the behavior of both individuals and the systems of which they are a part. For a rule to effectively influence behavior, it must be enforceable, and to be enforceable, it must be backed by the force of the law. This can occur in the setting of legally enforceable contracts between private parties, judicial rulings, legislative statutes, or administrative regulations. Legislation and regulation can occur at both the federal and state levels.

The opportunity for physicians to influence healthcare policy—both in its goals and the rules to achieve those goals&mdash;is greatest at the federal and state levels, where legislatures enact healthcare legislation and administrative agencies (ie, regulators) execute the legislation through a process called rulemaking. This is, in large part, due to federal and state government programs that provide health insurance coverage under Medicare, Medicaid, and the State Children’s Health Insurance Program. In administering these programs, federal and state policy makers not only influence the policies that govern the delivery of care for more than 40% of the US population (more than 130 million beneficiaries are enrolled in these programs),

 but they also influence the behavior of private healthcare entities, such as insurance companies, hospital systems, and physician group practices.

To illustrate the lifecycle of the legislative and regulatory process that culminates in healthcare policy, consider the following example: In 2010, President Obama signed the Affordable Care Act (ACA), which had been passed by Congress. The ACA, a broad and sweeping piece of legislation, directed the executive branch to promulgate a variety of regulations. One of the directives from the legislation was to create an “innovation center” within Medicare that would be responsible for developing and testing new policies for paying physicians, hospitals, and other care providers.

Based on this legislative mandate, and with a $10-billion appropriation over 10 years, the Center for Medicare and Medicaid Innovation (CMMI) was established in 2011. To date, CMMI has implemented dozens of payment models. One of the most recently proposed payment models includes the Medicare Part B Drugs Payment Model, published in the Federal Register in March 2016, which directly impacts how medical oncologists and other physicians are paid for delivering medications, including chemotherapy, in their offices or hospital outpatient settings.

Physicians need to engage in healthcare policy because it has altered, and will continue to fundamentally alter, the practice of medicine. Seminal moments in the history of healthcare policy, including the creation of Medicare and Medicaid in 1965,

 the Medicare transition to a hospital inpatient prospective payment system in 1983,

 the development of the New York state clinical registry for cardiac surgery in 1989,

 and many others, continue to have a significant impact today. Without real-world input from the physician community, we risk letting policy development occur in a vacuum, almost certainly resulting in disruptive and detrimental downstream consequences in healthcare delivery.

To illustrate the impact of involvement in the healthcare policy process, consider the Comprehensive Care for Joint Replacement (CJR) model.

 This bundled payment model was proposed by CMMI, in July 2015 and finalized in November of the same year. The payment model is a mandatory 5-year program that bundles the hospital, physician, and post—acute care provider costs over a 90-day period for total hip and knee replacements. Hospitals in the model that perform a hip or knee replacement will be financially responsible for all related Medicare spending in the 90 days following discharge. If 90-day episode spending exceeds prospective target prices, then these hospitals may owe Medicare a repayment amount. However, if this spending is less than the prospectively set target prices, these hospitals may receive a portion of that savings.

The proposed CJR rule did not incorporate any clinical risk stratification in the bundled payment policies. As a result, hospitals performing hip and knee arthroplasty would receive the same prospective target for patients regardless of the clinical indication for the operation. The response of the orthopedic surgery community to this proposal during the comment period was robust. Hundreds of comments were received by CMMI, particularly regarding the lack of any clinical risk-stratification. In response to this physician engagement during the regulatory notice and comment period, the final CJR rule was published with a risk-stratified payment methodology based on the presence of hip fracture. CMMI listened to the response from the physician community, confirmed that the need for adjusting target prices based on the presence of absence of hip fracture was supported by claims data, and then changed the final policy in response.

Although it is impossible to know what the final policy would have been without an organized response from orthopedic surgeons, it is highly unlikely that CMMI would have modified the proposed rule without input from providers.

The CJR rulemaking experience proves that physician involvement in the healthcare policy process matters and that such engagement can result in better policy making.

Given this understanding of what healthcare policy means and why it matters, I close with a series of recommendations on how physicians can get involved in shaping future policies. The basic principle is to make your voice heard. So, the question is, how do we do this? There are 3 general approaches that all physicians can take to influence the trajectory of healthcare policy.

First, get involved in the advocacy efforts of your professional society. Professional societies are uniquely positioned to advocate effectively on behalf of physicians and their patients. These organizations are typically well funded and staffed with skilled personnel who are dedicated to monitoring and responding to healthcare policy developments.

This staff expertise translates into more effective and efficient advocacy strategies than can be achieved by individual physicians alone augmenting the policy impact of these efforts. In the CJR discussion above, for example, the organized response of orthopedic specialty societies allowed for a more rapid and appropriately messaged response than could be achieved by individual surgeons. The advocacy arms of these organizations are typically located in proximity to the federal legislative offices and executive agencies such that they can respond to urgent policy concerns in a timely and face-to-face fashion.

Having argued for increased involvement in professional society advocacy efforts, it is important to address a common physician concern: that the policy priorities of physicians and the organizations that represent them are not in alignment. Some physicians believe that the policy platforms promoted by their professional societies do not address the policy burdens borne by physicians in daily practice in the clinic and the operating room. Although it is reasonable to object to the policy priorities being advanced by professional societies, the appropriate response should be further engagement—not less. The policy platforms of specialty societies are built by individuals, not by organizations. As a result, these platforms can be restructured, a process that can only result from member engagement, not disengagement.

Cultivating relationships with elected officials and their staff is another important avenue for physician engagement in healthcare policy. Members of Congress have significant authority over healthcare policy through both the passage of legislation and oversight of the administrative agencies that execute legislation. These legislators, however, must be responsive to the full spectrum of public policy and are, therefore, rarely experts in the issues faced by physicians. This presents an opportunity for physicians, a highly respected voting block of constituents, to step in as subject matter experts who can support the healthcare policy efforts of their elected officials. Additionally, connecting with a legislator’s staff can facilitate ongoing communication with those members of the legislative team specifically tasked with healthcare policy issues.

Finally, physician engagement in the political process is an important mechanism for altering the trajectory of healthcare policy. Politics is a messy game, and physicians are justifiably reticent to engage in this space. The merit-based system of medicine that starts with competitive admission to medical school continues with matching in residency and fellowship and culminates in a successful practice at odds with the retail politicking and glad-handing that define the political process. Wanting to remain unsullied, many physicians simply refuse to participate. Although there is merit in this position, there is a practical reality that we, as physicians, must confront. The consequences of elections and the political milieus that follow are going to play an increasingly larger role in how we deliver care to our patients. If we choose to ignore this reality, the process will move forward without considering us or our interests. However, if we choose to participate in the political process, we can shape the political landscape and clear a viable path for effectuating our healthcare policy goals.

Physicians need to engage in healthcare policy, and there are several ways to become involved. Whether through engaging with professional societies, cultivating relationships with legislators, or becoming active in the political process, physicians can influence the rules that govern how we practice. We know that wholesale medicine matters, now we just have to own it.

Total number of Medicare beneficiaries: timeframe: 2015. The Henry J. Kaiser Family Foundation website. http://kff.org/medicare/state-indicator/ total-medicare-beneficiaries/. Accessed August 15, 2016.

Medicaid enrollment by age: timeframe: FY2011. The Henry J. Kaiser Family Foundation website. http://kff.org/medicaid/state-indicator/ medicaid-enrollment-by-age/. Accessed August 15, 2016.

Total number of children ever enrolled in CHIP annually: timeframe: FY2014. The Henry J. Kaiser Family Foundation website. http://kff.org/ other/state-indicator/annual-chip-enrollment/. Accessed August 15, 2016.

Berenson RA, Cafarella N. The Center for Medicare and Medicaid Innovation: activity on many fronts. Robert Wood Johnson Foundation website. www.rwjf.org/en/library/research/2012/02/the-center-formedicare- and-medicaid-innovation.html. Published February 12, 2016. Accessed August 15, 2016.

Medicare Part B drugs payment Model. CMS.gov website. https://innovation. cms.gov/initiatives/part-b-drugs. Accessed August 15, 2016.

Starr P. The health-care legacy of the great society. In: Glickman NJ. Reshaping the Federal Government: The Policy and Management Legacies of the Johnson Years. Princeton, NJ: Princeton Unviersity. Princeton University website. www.princeton.edu/~starr/articles/articles14/Starr_LBJ_HC_ Legacy_1-2014.pdf. Accessed August 15, 2016.

A framework for evaluation: predicted effects of Medicare’s prospective payment system. Princeton University website. www.princeton.edu/~ota/ disk2/1985/8516/851604.PDF. Accessed August 15, 2016.

Hannan EL, Cozzens K, King SB 3rd, Walford G, Shah NR. The New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes. J Am Coll Cardiol. 2012;59(25):2309-2316. doi: 10.1016/j.jacc.2011.12.051.

Mechanic RE. Mandatory Medicare bundled payment--is it ready for prime time? N Engl J Med. 2015;373(14):1291-1293. doi: 10.1056/ NEJMp1509155.

Comprehensive Care for Joint Replacement model. CMS website. https://innovation.cms.gov/initiatives/CJR. Accessed August 15, 2016.

Medicare program: Comprehensive Care for Joint Replacement Payment model for acute care hospitals furnishing lower extremity joint replacement services: a rule by the Centers for Medicare & Medicaid Services on 11/24/2015. Federal Register website. www.federalregister. gov/articles/2015/11/24/2015-29438/medicare-program-comprehensive- care-for-joint-replacement-payment-model-for-acute-carehospitals. Published November 24, 2015. Accessed August 15, 2016.

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This article discusses the wholesale side of medicine, exploring the why and how of physician involvement in healthcare policy.

C.J. Stimson, MD, JD

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Wholesale Medicine: The Why and How of Physician Engagement in Healthcare Policy