Thursday, September 26, 2013

Learning from primary care in Canada and Europe

What can family medicine in the U.S. learn from the organization of primary care in other Western countries? In this month's Georgetown University Health Policy Seminar, we explored two recent studies that shed light on successes and challenges of primary care reforms in Ontario, Canada and the European Union.


Starting in 2000, policymakers in Ontario implemented a primary care reform strategy based on five national objectives, which are strikingly similar to many proposed U.S. reforms: "1) increasing access to primary care organizations that would provide a defined set of services to a defined population; 2) increasing emphasis on health promotion, disease and injury prevention, and chronic disease management; 3) expanding all-day, every-day access to essential services; 4) establishing interdisciplinary primary care teams; and 5) facilitating coordination and integration with other health services." As a result, an almost entirely fee-for-service primary care system was gradually replaced with a mixture of salary-based, capitation-based, and blended fee-for-service payment models by 2012. Far from being demoralized by the rapid changes, Ontario primary care physicians actually reported increasing satisfaction during this transition period.


Another study in the same issue of Health Affairs analyzed associations between the strength of primary care systems in 31 European countries, national health expenditures, and measures of population health. The study found that countries with more robust primary care had lower hospitalization rates and less socioeconomic inequality in self-rated health, in addition to better chronic disease outcomes. However, these advantages came at the cost of higher baseline health care spending, though spending growth appeared to be slower in countries with a comprehensive primary care bedrock.

What lessons should U.S. policymakers take home from this research?

- Kenny Lin, MD, MPH
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

Monday, September 16, 2013

The sense and nonsense of CT screening for lung cancer

Supporters of evidence-based preventive medicine cheered when the Affordable Care Act required Medicare and private health insurers to provide first-dollar coverage for all preventive services assigned an "A" or "B" recommendation grade by the U.S. Preventive Services Task Force. However, editorials published in JAMA and BMJ earlier this year expressed concerns that explicitly linking Task Force determinations with coverage decisions would politicize the guideline development process. Also, since the USPSTF is permitted to consider only clinical effectiveness, not cost effectiveness, it could potentially put taxpayers on the hook for cost-prohibitive screenings.

In this context, our August 2013 Georgetown University Health Policy Seminar debated the USPSTF's recent draft recommendation statement that endorsed annual low-dose CT screening for lung cancer in longtime smokers. This Grade "B" recommendation applies to "healthy persons with a 30 pack-year or more history of smoking who are ages 55 to 79 years and have smoked within the past 15 years," a population that includes up to 8 million persons in the U.S. Using data from the National Lung Screening Trial and five modeling studies, the Task Force estimated that implementation of their recommendation could prevent up to 20,000 lung cancer deaths each year. They downplayed the potential harms of false positive screens (which affected 1 in 4 participants in the NLST), overdiagnosis, and radiation-induced cancers.

Images from the Lung Cancer Foundation's Demand A CT Scan campaign.

Lung cancer screening advocacy groups, which had been pressing for years for patients at high risk of lung cancer to "demand a CT scan," were quick to praise the USPSTF's decision. Notably, the American Cancer Society's guideline for lung cancer screening, also released this year, advocates a more conservative approach: initiating a shared decision-making discussion about benefits and harms of lung cancer screening in high-risk persons in otherwise good health, rather than simply recommending screening. The USPSTF's approach is certain to be far more costly, and may discourage clinicians from explaining the many downsides of this screening test to their patients.

- Kenny Lin, MD, MPH
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

Monday, June 24, 2013

Caring for the underserved: The National Health Service Corps

Forty years ago, Eric Redman's classic book The Dance of Legislation provided a compelling "insider's account" of how the U.S. Senate worked by following the winding path of Public Law 91-623 (The Emergency Health Personnel Act of 1970), which created the National Health Service Corps (NHSC). Envisioned by Seattle pediatrician Abraham Bergman, MD as a way to recruit idealistic young physicians to "doctor deficient" communities throughout the U.S., the NHSC and its authorizing legislation successfully navigated a perilous policymaking process, an unsupportive Administration, and the threat of a pocket veto to become law in the final days of the 91st Congress. Later legislation added scholarship and loan repayment programs to the NHSC, and recent funding increases provided by the American Recovery and Reinvestment Act and the Affordable Care Act have tripled the size of the corps from 3600 to nearly 10,000.


In this month's Georgetown University Health Policy Seminar, we critically evaluated the accomplishments and limitations of the NHSC in improving access to care for the medically underserved. A literature review by Dr. Robert Politzer and colleagues in 2000 found mixed results: although the NHSC relieved health professional shortages in many communities over the years, physicians often did not stay in these communities beyond their 2-year service commitments, and the neediest areas were actually less likely to be successful in recruiting clinicians. The absence of a service analogous to the National Resident Matching Program meant that the NHSC placement process favored well-organized communities with more resources, rather than matching greater numbers of clinicians to areas with greater needs. At around the same time, a commentary by Dr. Fitzhugh Mullan advocated for a more expansive role for the NHSC in the 21st century, including options to practice community-oriented primary care, in urban hospitals, in public health, and in prison and international health settings.


Currently, the collective impacts of the individual and employer mandates and guaranteed insurance issue provisions of the Affordable Care Act on underserved communities remain uncertain. Will the implementation of the ACA make the NHSC less necessary, or will projected gaps in coverage among immigrants and Medicaid-ineligible adults continue to leave many areas with health professional shortages? Physicians of all ethnic and cultural backgrounds tend to migrate to affluent areas, and retirements of small-town family doctors may end up relegating some communities to welcoming a new crop of primary care clinicians every few years. Are there alternative health policies that could attract primary care and subspecialist physicians to areas where they are most needed?

- Kenny Lin, MD, MPH
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

Monday, May 20, 2013

Biased research, aggressive sales, harmful drugs

Approval from the U.S. Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. In this month's Georgetown University Health Policy seminar, we discussed two examples, anemia drugs and the diabetes drug rosiglitazone (Avandia), which were prominently featured in recent articles by Peter Whoriskey in The Washington Post.

Image courtesy of scienceblogs.com

The original impetus for the development of the anemia drugs Epogen, Procrit, and Aranesp, which mimic the  actions of the hormone erythropoietin, was to spare dialysis patients with severe anemia the inconvenience and risks associated with periodic blood transfusions. However, noted Whoriskey, pharmaceutical companies moved aggressively to market these drugs to a far larger patient population who were much less likely to benefit from them:

The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.

Doctors were motivated to give more doses of these drugs due to generous financial incentives (estimated at between $100,000 and $300,000 annually for a typical oncologist) and the seductive thinking that if some drug was good, more was better. Even the publication of a 1998 study in the New England Journal of Medicine showing no survival advantage to boosting hematocrit levels to normal ranges in cardiac patients did little to discourage overprescribing. Not until 14 years later did an independent researcher obtain access to the complete study report from the FDA and conclude that the NEJM authors had used statistical slight-of-hand to obscure an increased risk of heart attacks and death in the normal-hematocrit group. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses.

Similarly, the evidence that rosiglitazone (Avandia) increased the risk of heart attacks was slow to come to light, due in part to the drugmaker's research emphasis on the surrogate outcome of glycemic control. Although a 2007 meta-analysis first sounded the alarm about rosiglitazone's cardiovascular risks, the manufacturer successfully stalled regulatory action in the U.S. for three more years, during which thousands of new patients were prescribed the drug.

Could the FDA and other U.S. government agencies do more to protect patients from the effects of biased research and aggressive sales tactics for newly marketed drugs? What concrete steps could health policymakers take to encourage research to identify unexpected harms earlier in the drug approval process?

- Kenny Lin, MD
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

Tuesday, May 7, 2013

Medicaid expansion is in the eye of the beholder

To supporters of the Affordable Care Act, legislative expansion of the Medicaid program is a welcome financial and health care bonanza for states and uninsured patients. To the ACA's detractors, Medicaid expansion is a hostile government takeover that must be opposed in principle, regardless of potential benefits of an infusion of federal dollars. The stage for these state-level clashes was set by a surprising Supreme Court decision last summer that upheld most major provisions of the Affordable Care Act, but declared unconstitutional the mandatory Medicaid eligibility expansion that the law's authors had expected would extend coverage to millions of currently uninsured Americans. Instead, the Court gave individual states the option to accept or decline the expansion, which, though far more generous with federal matching funds than the existing program, would still require states to spend more within already strapped budgets.

Medicaid Expansion map courtesy of Avalere Health via The Washington Post Wonkblog 5/5/13

In last month's Georgetown University Health Policy seminar, we discussed the complex role of the Medicaid state-federal partnership (which currently provides health insurance to 1 in every 5 Americans) in improving access to care and health outcomes. In fiscal year 2011, Medicaid spending totaled $414 billion, with two-thirds going to services for disabled elderly persons. Long-term care services (nursing homes, mental health, home health care) accounted for 3 in every 10 dollars that the program spent.

Currently, to qualify for Medicaid coverage, individuals must be not only poor, but belong to one of several "core eligibility groups" defined by federal law: children, pregnant women, people with disabilities, seniors, and adults with dependent children. Income thresholds vary widely across states, especially for working parents, who might find themselves eligible for coverage in more generous states but not in others. Few states provide significant coverage for non-disabled adults without dependent children, whose services were generally excluded from federal matching funds prior to the ACA.

In 2014, states that accept the ACA's Medicaid expansion will be required to extend eligibility to all adults (parents or not) earning less than or equal to 138 percent of the federal poverty level, which works out to annual incomes of $15,856 for an individual and $26,951 for a family of three. According to the Kaiser Family Foundation, more than half of today's 48 million uninsured have incomes below the new Medicaid threshold. In states that decline Medicaid expansion, there appear to be few feasible alternatives to leaving these persons without affordable coverage, except for those earning more than 100 percent of the federal poverty level who may be able to purchase subsidized private plans in state or federal health insurance exchanges. For example, in Florida, whose legislature rejected the Medicaid expansion last week against the wishes of Republican governor Rick Scott, only one quarter of the 1.3 million low-income residents who would have been covered by the expansion will be eligible for tax subsidies toward private coverage in the federal insurance exchange.

- Kenny Lin, MD
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

Thursday, March 14, 2013

Politics and practice guidelines: a volatile mix

Health services research in the United States has historically been the "poor cousin" of biomedical research in federal funding and support. The annual budget for the National Institutes of Health, for example, is typically around 100 times that of the Agency for Healthcare Research and Quality (AHRQ). In this month's Georgetown University Health Policy seminar, we discussed the financial and political challenges that AHRQ and its predecessor, the Agency for Health Care Policy and Research (AHCPR) have faced while trying to improve outcomes and effectiveness of medical care since the latter's founding during the first Bush Administration.


Citing John Wennberg's pioneering geographic analyses of medical practice variations and potentially inappropriate use of health services across the U.S., AHCPR's supporters wanted the new agency to produce practice guidelines to promote evidence-based care. However, when one of those guidelines suggested that spinal fusion surgery was unnecessary for most patients with acute low back pain, AHCPR found its budget under attack. It didn't help that the agency was also identified with the failed Clinton health reform plan and had few defenders left in a Republican Congress after the 1994 elections. Although the agency survived, this experience eventually drove it out of the guideline-producing business for good. When AHRQ was reauthorized in 1999, the word "policy" was removed from its name.

From 2010 AHRQ Annual Conference presentation by Dr. Francis Chesley, Jr.

It's understandable that this episode made future AHRQ leaders reluctant to wade into explosive scientific controversies, especially regarding sacred cows of medicine such as mammography and prostate cancer screening. When the AHRQ-supported U.S. Preventive Services Task Force chose to do so, the political fallout again put the agency in an uncomfortable position. Distancing itself from the USPSTF's recommendation against routine mammography in women younger than 50 and repeatedly delaying the release of another that advised clinicians to stop prostate-specific antigen testing altogether, AHRQ still found itself under heavy fire from health reform opponents on Capitol Hill. In July 2012, it was deja-vu all over again as AHRQ's budget was singled out for elimination by an appropriations subcommittee in the House of Representatives. Supporters of health services research in the U.S. lined up to defend the agency. The bill was not taken up by the Senate, and of this writing, AHRQ appears to have survived another "near death experience."

- Kenny Lin, MD
  Director, Robert L. Phillips, Jr. Health Policy Fellowship
  Department of Family Medicine
  Georgetown University School of Medicine

*Note: I was employed as a medical officer at AHRQ from October 2006 through December 2010.

Tuesday, February 12, 2013

The Massachusetts Avenue of health reform

In contrast to the personality-driven path that Lyndon Johnson took to navigate legislative obstacles to Medicare and Medicaid, former management consultant Mitt Romney charted a decidedly different course to expanding health insurance when he became governor of Massachusetts in 2003. This month's Georgetown University Health Policy Seminar explored the politics of "Romneycare," a state-level health reform which in many ways made possible the future Affordable Care Act. Both readings for this session, a New Yorker article and a Health Affairs paper, portrayed Romney as a “data wonk” who viewed the issue of the uninsured as a problem-solving challenge rather than a grand moral imperative. Yet much like LBJ's inspirational leadership, Romney's data-crunching approach produced tangible results.

Governor Mitt Romney signs the Massachusetts health reform bill as Ted Kennedy looks on.

In an Op-Ed about his nascent reform plan that appeared in the Boston Globe in November 2004, Governor Romney proposed applying "carrots and sticks" to persons who could afford private health insurance but had chosen not to purchase it. At that point, he had not yet committed to the individual health insurance mandate that made his reforms possible but later became a political liability during his Presidential campaigns. According to New Yorker columnist Ryan Lizza:

Romney and his aides had a lengthy debate about the merits of the mandate, which evolved into a broader philosophical discussion. Personal responsibility was important, some aides argued, but what about the libertarian view that the government had no business requiring people to buy something? It was one thing to ask drivers to buy car insurance. Owning a car is a choice. But the health-insurance mandate demanded the purchase of a product just for being alive.

Once he made the decision to incorporate the individual mandate into his reform plan, Governor Romney found an unlikely ally in Senator Ted Kennedy, whom he had tried unsuccessfully to unseat in 1994. Together, Romney and Kennedy approached the George W. Bush Administration and reached an agreement to redirect a multi-million dollar fund for Massachusetts hospitals to provide subsidized health insurance for lower income workers. Romney also alternately courted and cajoled the Democratic leaders of the Massachusetts legislature, whose support was essential to passing his plan.

Health reform in Massachusetts has been judged a mixed success. On one hand, the percentage of state residents who were uninsured fell from 6.4% in 2006 to 1.9% in 2010, as the national average rose from 15.2% to 16.3%. However, Romney's hope that insurance expansion would help control costs has not been fulfilled, as the percentage of the state budget spent on health services has risen from 29 to 43 percent.

Compared to the policy environment that confronted President Barack Obama in passing the Affordable Care Act, seminar participants identified some key advantages for Romney: Massachusetts's already low uninsurance rate provided a "fertile environment" for reform, and he could focus his attention on health care without having to simultaneously manage financial crises and war. Although Romney "had little choice as governor about grappling with health care," wrote Martha Bebinger in Health Affairs, "for the most part he embraced the issue. Aides say Romney was enticed by the challenge of solving a complex problem, one that had eluded politicians for decades." How critical do you think Romney's public embrace of health reform was to the law's eventual passage? Was it as important, for example, as LBJ's advocacy for Medicare?

-  Kenny Lin, MD
   Director, Robert L. Phillips, Jr. Health Policy Fellowship
   Department of Family Medicine
   Georgetown University School of Medicine

Thursday, January 3, 2013

Legislative passage of Medicare

"Don't let dead cats stand on your porch." This famous quotation, attributed to President Lyndon Johnson during his strenuous and ultimately successful efforts to pass the 1965 bills that established the Medicare and Medicaid programs, embodied his approach to arguably the most important U.S. health care legislation until the 2010 Affordable Care Act. Translated, it meant that the best strategy for passing health care (and other potentially controversial) legislation was to act quickly and move bills along in the Congressional process before political opponents or outside advocacy groups had time to organize themselves.


The legislative passage of Medicare was the subject of the first of a series of monthly one-hour health policy seminars for Family Medicine fellows and residents at Georgetown University School of Medicine. The goal of this monthly series is for participants to gain a better understanding of the policy process at the federal, state, and local levels by reading and discussing real-life examples in a small group. These seminars will be led by me and the current Robert L. Phillips, Jr. Health Policy Fellow as well as selected guest faculty. Participants complete one or two short readings prior to the seminar (this inaugural session's assignment was "The Secret History of Medicare" from David Blumenthal and James Morone's The Heart of Power, pictured above).

Remarkably, Medicare was fully implemented only 11 months after the bill's signing, overcoming obstacles such as hospital segregation in the South, resistance from physician organizations such as the American Medical Association, and the logistical issues involved in issuing insurance cards to 18 million eligible seniors. As Medicare approaches its 50th anniversary, it faces huge budgetary challenges driven by increasing costs of health care and the demographics of the enormous "Baby Boom" generation, the first member of whom became eligible for Medicare benefits in 2011. This short video produced by the Kaiser Family Foundation summarizes changes that occurred in the program in the intervening years.


Liberal legislators saw Medicare as the first step toward enacting federally-administered universal health insurance for all Americans, while others saw it as a program, like health programs for active-duty military, veterans, and Native Americans, whose benefits were appropriately limited to specific groups and therefore must be defended against encroachment by future wide-ranging health reforms. Princeton professor Paul Starr has called this resistance to change by protected groups the "policy trap" that contributed to the defeat of the Clinton health reform proposal in 1994 and the near-defeat of the Affordable Care Act 16 years later.

Other points raised during today's seminar included the book's observation that "an honest economic forecast would have very likely sunk Medicare." Like every federally financed health insurance initiative to come, Medicare ended up costing substantially more than initially projected. (In fact, the reason that most provisions of the ACA, passed in 2010, don't take effect until 2014 was to allow the Congressional Budget Office - which didn't exist in 1965 - to artificially score it as deficit-reducing over a 10-year time period.) Ethical or not, Lyndon Johnson's decision to "lowball" the estimated costs of Medicare was essential to getting it through Congress.

Was President Johnson - the last President to previously hold the position of Senate Majority Leader - a political anomaly, or can lessons from his deft management of the Congressional process be applied to national health care policy today? What do you think about Blumenthal and Marone's lessons for future Presidents, listed below?

1. Presidents must be deeply committed to health reforms.
2. Speed is essential. Waiting makes reforms a lot harder to win.
3. Presidents should concentrate on creating political momentum.
4. Presidents must actively manage the Congressional process.
5. Know when to compromise and know when to push.
6. Pass the credit.
7. Muzzle your economists. First expansion, then cost control.

-  Kenny Lin, MD
   Director, Robert L. Phillips, Jr. Health Policy Fellowship
   Department of Family Medicine
   Georgetown University School of Medicine