Maine AllCare is about much more than who pays the bills
by Philip Caper, M.D. - Maine AllCare News - March 15, 2021
We have lost one of the most prominent champions of our cause, Dr. Bernard Lown, but we will continue working to fulfill his vision of quality, affordable healthcare for all and restoring the art of healing to medical practice.
On February 16, renowned cardiologist Bernard Lown died at age 99 at his home in Brookline, Massachusetts. I didn’t know Dr. Lown well, but have admired his work for many years, and had the honor of meeting him numerous times. He lived a remarkable life.
Bernie Lown, as he was known by many of us, had several ties to Maine. A bridge in Lewiston was re-named “The Bernard Lown Peace Bridge” in his honor in 2008. He attended Lewiston High School, graduating in 1938, and the University of Maine, graduating in 1942.
Many distinguished physicians are excellent clinicians, extraordinary researchers and innovators, or social activists attempting to make the world a better place. But few excel in all three aspects of our profession. Bernie Lown was one of them.
Dr. Lown was beloved by his many patients. He focused primarily on the prevention of sudden cardiac death, a longtime scourge that claimed many lives and for many years was considered to be an unavoidable result of chronic heart disease.
He worked hard to change the methods that were then generally accepted for treating heart attacks–restricting activity and prescribing long periods of bed rest. He and a few other prominent cardiologists believed that an early return to gradually increasing levels of activity after a heart attack would benefit the patients more, and proved it through his own style of practice and published studies. He later established a cardiac clinic in Brookline that focused on low-tech approaches to treating cardiac disease.
Dr. Lown was also an inventor of new medical technology. He helped to perfect the direct-current cardiac defibrillator, which shocks the heart during a short but critical interval during the cardiac cycle. This invention has saved literally millions of lives by re-starting the cardiac cycle after a cardiac arrest. He also introduced the use of Lidocaine and other drugs as effective treatments for cardiac arrhythmias. Most continue to be used today.
But despite his success in developing new medical technologies, Dr. Lown was also a critic of over-reliance on high-tech devices and drugs when more conservative and less invasive treatments could be as good or better. Why perform highly invasive (and more lucrative) cardiac surgery when much less traumatic treatments, such as medication, drugs, weight loss, exercise, and diet could produce better and much less costly results.
His enthusiasm for low-cost, non-intrusive treatment of heart disease didn’t win many friends in the medical-industrial complex, but produced many fans among young physicians and their patients, and has gradually become the standard of treatment for cardiac disease.
He also understood the critical importance of changing some of the mores and practices of our society as a way to administer the best medicine. I remember him telling a story about what inspired his social activism. While in medical school at Johns Hopkins, he had a moonlighting job working in the blood bank. At the time (1940s), it was customary to segregate the blood donated by Black patients from the blood donated by white patients. He resisted that practice as there was no scientific basis for it. He was almost thrown out of medical school for his insubordination. But eventually, the practice of blood segregation was abandoned.
In the early 1960s, he co-founded Physicians for Social Responsibility (PSR) to warn American physicians and the public about the catastrophic dangers of nuclear warfare. In 1980, with Soviet cardiologist Dr. Evgeny Chazov, he founded International Physicians for the Prevention of Nuclear War (IPPNW) to expand awareness of the dangers of nuclear war to humanity. Drs. Lown and Chazov won the Nobel Peace Prize in 1985.
Dr. Lown was also a fierce critic of the corporatization of American medicine. In his book “The Lost Art of Healing: Practicing Compassion in Medicine,” he lamented the corrosive effects of the commercialization, corporatization, and commodification of medical practice in the United States, and its destructive effects on the doctor-patient relationship that is so critical to curing disease and to the promotion of healing.
In 2012, he founded the Lown Institute to promote improvement in the quality of healthcare in America by calling out over-treatment, under-treatment, and mistreatment. In 2017 Maine AllCare, together with the Lown Institute and the medical associations of Maine, New Hampshire, and Vermont held a conference on “Professionalism in an Age of Corporatism.”
Of course, Dr. Lown was a strong supporter of a Medicare for All system of universal healthcare for the U.S. as the best way of counteracting the drift toward corporate medical care in America, and of assuring that all Americans have affordable medical care. He will be sorely missed.
Maine AllCare will continue Dr. Lown’s crusade for a more merciful,
just, and loving healthcare system by working to make healthcare a right
in Maine, and throughout our nation, thereby helping to fulfill Dr.
Lown’s vision.
Bernard Lown: a principled life
by Jeanne Lenzer - British Medical Journal - March 2, 2021
The remarkable achievements of Bernard Lown, a renowned cardiologist and activist, have been catalogued in numerous obituaries since he died. For a list of his awards and accomplishments, the New York Times obituary is instructive.
But what is missing from virtually all obituaries are the principles that drove him and how his stands would cost him dearly.
Inventor
Lown, most often noted for co-inventing the modern cardiac defibrillator, kept a letter of gratitude from a Cleveland Clinic surgeon who thanked him for his invention. Without the defibrillator, surgeons didn’t have a reliable way to restart a patient’s heart after surgery—with it, the floodgates for heart surgeries were opened.
Lown would come to rue this widespread use of his own invention. Convinced that love of technology and profits were driving unnecessary heart surgeries, he studied 171 patients who were told they needed surgery and came to him for a second opinion. He reported his results in 1992 in the Journal of the American Medical Association, concluding that fully half of the patients did not need surgery and could be managed medically.1 His findings were ignored.
It would take 15 years before William Boden and his colleagues published the Courage trial, which backed up Lown’s findings: stenting patients with stable angina provided no benefit over medical management.2
McCarthy era
In December 1952, Lown was a postdoctoral fellow at Harvard and his star was rising. Samuel A Levine, Lown’s mentor and one of the most revered cardiologists in history, was working to have Lown promoted to full professor at Harvard—until Lown refused to sign the “McCarran questionnaire,” confirming that he didn’t belong to any of the roughly 400 organisations deemed to be “un-American.” The list included civil rights organisations and unions as well as progressive or communist organisations. This was during McCarthyism, when many progressives lost their careers and some went to prison. Lown told The BMJ in 2015 that “exciting days” at Harvard were transformed into a “slow descent into hell.”
Lown was undeterred. He said McCarthyism was undermining democracy and that cooperating with its inquisitors was to become an accomplice to its demise. As a result, he was drafted into the army not as a medical officer but as a private, where he spent a good deal of time “cleaning latrines and picking up cigarette butts.”
When he was finally released from the army and returned to Harvard, he faced the full force of McCarthyism; the medical school rescinded its offer of a full endowed professorship and refused to grant Lown a position. Fortunately, the Harvard School of Public Health was willing to hire him, a post he took gratefully.
Lown went on to win many awards and accolades for his work. He founded or co-founded numerous organisations, including the International Physicians for the Prevention of Nuclear War, which was awarded the 1985 Nobel Peace Prize.
He frequently stood up against racism, including a time when he invited a black couple to live with him after they had trouble renting an apartment. Death threats followed.
Avoiding avoidable care
In 2012 Lown, then in his 90s, gave the keynote speech at the Avoiding Avoidable Care conference in Cambridge, Massachusetts.3 He opened by saying, “I’ve been waiting 60 years for this conference.” He said profit driven medicine led to the “Siamese twins” of undertreatment and overtreatment; undertreatment for people without money or insurance, and overtreatment of those with money. His speech inspired the formation of the Right Care Alliance, a grassroots movement advocating healthcare transformation.
Vikas Saini, president of the Lown Institute in Boston, says stubbornness was central to Lown’s personality. “It was easy to see him as an old man who can’t change his ways. But that stubbornness,” said Saini, “allowed Lown to continue his care of patients using minimal interventions and technologies. Every year there would be a new wave of fellows and residents who came to train with this great cardiologist, expecting to learn the latest technologies, and he would invariably fight that tide and disappoint them with his minimalist approach. That he could maintain an oasis of humanistic care in the midst of what was going on in US healthcare is a huge, underappreciated achievement.”
During his career, Lown published more than 400 medical journal articles, including seminal work on the role of potassium and digitalis in cardiac dysrhythmias and in identifying a rare heart rhythm that became known as Lown-Ganong-Levine syndrome.
Born in 1921 in Lithuania, Lown fled to the US in 1935 with his family. He received his medical degree from Johns Hopkins University in 1945. He died at 99 of congestive heart failure and pneumonia. His wife, Louise, died in 2019, and he leaves three children—Anne, Fredric, and Naomi Lown.
Bernard Lown (b 1921; q Johns Hopkins University, Baltimore, USA, 1945), died from congestive heart failure and pneumonia on 16 February 2021
https://www.bmj.com/content/372/bmj.n583.full
Human Connection
We must prioritize clinician-patient relationships to create the best environment for healing.
At its heart, health care is about people taking care of one another. It’s an intimate practice rooted in some of our best qualities as humans. People who choose healing professions understand this and commit themselves to years of training, so they are prepared to help relieve the suffering of others.
But in a system that demands high productivity and imposes excessive administrative burdens, clinicians find it increasingly difficult to provide the care their patients need. The industrialization of health care has corrupted the healing relationship. Health care has become more transactional, less personal. Too often, our system not only fails to heal, but creates new suffering.
We must restore the art of healing to its rightful place at the center of our health system. That means providing adequate time for clinicians to listen and talk to patients, reducing administrative burdens, and liberating clinicians from business concerns that draw their focus away from the distressed and vulnerable human being who is their patient. This is the type of environment that results in both the highest level of professional satisfaction for clinicians and the most effective healing for patients.
Current Issues
Mending the clinician-patient relationship
Is 15 minutes long enough to have a productive clinic visit? Whether or not it is enough time, 15 minutes or less has become the new normal, as primary care clinicians are under increasing pressure to see more patients in a shorter amount of time. This time crunch makes it difficult for clinicians and patients to develop meaningful relationships in which healing can occur, restricts conversations to the patient’s most pressing “complaint,” and contributes to clinician burnout. Primary care clinicians especially need sufficient time with patients to fully understand their health concerns, diagnose correctly, and foster a human connection.
Moral Injury
Why are doctors “dropping out” of medicine by the thousands? Why are clinicians feeling disconnected, depressed, and burnt out? It’s more than just the increasing administrative burden on clinicians—it’s the industrialization of health care. Clinicians are caught between their moral values pushing them to do what is best for their patients, and external forces pushing them to maximize profit, for their own practice, their clinic, or their hospital. This struggle leads to what Dr. Simon Talbot and Dr. Wendy Dean call “moral injury”, the anguish and loss that health care workers feel when they confront a system that cares only about profit.
Moral injury is epidemic among health care providers, leading to widespread job dissatisfaction and depression. Moral injury also hurts patients, because clinicians who are burnt out are more likely to make medical errors. Saving our clinicians and patients will require nothing less than transforming our health care system and elevating patient care and clinician well-being over profits.
Electronic Medical Records
Electronic medical records (EMRs) were hailed as the revolution in health care that would reduce medical errors and administrative burden, and make clinical data more accessible. Instead, EMRs were co-opted by private vendors and hospital billing sectors, turning them into vehicles for billing rather than seamlessly providing clinical information. EMRs overwhelm clinicians with administrative work, distract them during patient visits, replicate mistakes that cause medical errors, encourage overmedication, and restrict mobility for nurses. Studies show that clinicians spend more time working in the EMR than they do face-to-face with patients. Some institutions have created a work-around, providing medical scribes who enter data into the EMR for the clinicians. We can do better. Good medicine requires EMRs that provide the user-friendly simplicity of pen and paper with the potential for data collection and instant access to information.
Projects
Death by 1,000 Clicks
After Dr. Vikas Saini‘s op-ed, “Death by 1000 clicks” went viral, the Lown Institute led a discussion around systemic issues with electronic medical records systems at the WBUR studios. A later panel discussion featured Dr. Bruce Price at Massachusetts General Hospital.
The Lost Art of Healing: Practicing Compassion in Medicine
In his book published in 1996, Dr. Bernard Lown draws on four decades of practice as a cardiologist and a vast knowledge of literature and medical history to probe the heart and soul of the doctor-patient relationship. As Dr. Lown explains, the art of healing does not mean abandoning the spectacular advances of modern science, but rather incorporating them into a sensitive, humane, enlightened approach to medical care.
https://lowninstitute.org/lown-issues/human-connection/
The principles that drove Bernard Lown
Dr. Bernard Lown achieved so many things in his medical career, each one of which is incredibly impressive on its own. But an underappreciated facet of Dr. Lown’s legacy was his courage in sticking to his principles, even when doing so got him in trouble.
In a profile in The BMJ, journalist Jeanne Lenzer highlights some of the important times Dr. Lown took a stand and what this stubbornness cost him. Lenzer describes Dr. Lown’s fight to stop unnecessary heart surgeries (ironically, these surgeries were made possible by his own invention of the defibrillator) and his refusal to bow to the pressure of McCarthy-ism. In medical school, Dr. Lown also rebelled against the segregation of blood donations, which got him briefly expelled.
Dr. Vikas Saini, president of the Lown Institute, spoke on Dr. Lown’s steadfast nature:
“It was easy to see him as an old man who can’t change his ways,” said Saini in the BMJ. “But that stubbornness allowed Lown to continue his care of patients using minimal interventions and technologies. Every year there would be a new wave of fellows and residents who came to train with this great cardiologist, expecting to learn the latest technologies, and he would invariably fight that tide and disappoint them with his minimalist approach. That he could maintain an oasis of humanistic care in the midst of what was going on in US healthcare is a huge, underappreciated achievement.”
https://lowninstitute.org/the-principles-that-drove-bernard-lown/
The Drugs at the Heart of Our Pricing Crisis
Biologic drugs rack up billions in annual U.S. sales. Here’s a solution to lower the costs.
By Peter B. Bach and Mark R. Trusheim - NYT -
For around two decades, Roche’s breast cancer drug Herceptin has prolonged the lives of people with breast cancer, and AbbVie’s immunosuppressive drug Humira has eased the symptoms of rheumatoid arthritis patients.
Such are the remarkable benefits of biologic drugs — large molecules that are manufactured using living cells. These kinds of drugs are typically received either in doctors’ offices as an infusion, or self-administered by injection.
But for all their benefits, Herceptin, Humira and dozens of other older biologic drugs lie at the heart of the United States’ drug pricing crisis, racking up billions in annual U.S. sales from their persistently high prices.
It’s true that Congress grants monopolies to new drugs so that their makers can charge high prices. That is how drug companies reap financial rewards for their inventions. But that brief period of market exclusivity is supposed to be followed by competition that will ensure that those same drugs are affordable into the future.
This strategy worked well when drugs were mostly simple chemical pills or tablets. It was fast, easy and cheap for generic competitors to copy the brand product and then undercut it on price. As one example, a day’s dose of atorvastatin, a cholesterol lowering statin, fell from $5 to less than $1 once there were generics in the market.
But prices are not falling for biologic drugs as fast as they should, nor as much as they could. Billions in excess drug costs are shouldered by employers, taxpayers and patients as a result.
The United States needs a law that would yield comparable savings on older biologic drugs, and this law should require that biologic drug manufacturers lower their prices to affordable yet still profitable levels when their market exclusivity expires.
This new law would address the fact that Congress’s first attempt to reduce the prices of older biologic drugs is failing. The Biologics Price Competition and Innovation Act of 2009 envisioned a competitive market that replicated the success generic drugs have had in lowering the prices of older pills and tablets.
But the approach has been plagued by two fundamental challenges. The first is that biologics cannot be easily replicated. So Congress hoped a new category of knockoffs, called biosimilars, would play the role that generic drugs do in driving down the prices of pills and tablets.
But unlike the fast, easy and cheap manufacture of generic drugs, making biosimilar copies of biologics often costs hundreds of millions of dollars. Then they need to be extensively tested in long and expensive clinical trials. By our count, 85 percent of biologic drugs that should be squaring off against biosimilar competitors face none.
Even when a biologic drug encounters biosimilar competitors, prices don’t decline much at all. Herceptin today faces five knockoffs; even so the average price for trastuzumab (the generic name for Herceptin) remains 26 percent higher than the 2007 price for branded Herceptin in today’s dollars. Back then it had no competitors.
The second challenge is that branded biologic drug companies have built impassable patent blockades. No biosimilar will take on Humira’s $16 billion in 2020 U.S. sales until at least 2023 because 257 patent filings stand in the way. Another biologic, Enbrel, on the market since 1998, will not have its $5 billion in sales challenged until the end of 2028.
Requiring lower prices of older biologic drugs will not upend the rewards Congress intends the drug companies to receive. Biologic drug companies successfully lobbied for a guaranteed minimum of 12 years free from competition. For perspective, pills and tablets only receive five to seven years of protection from competition when they come to market.
Here is how the new law, which we are calling Production Plus Profit Pricing, or “P-quad,” would work. After 12 years, and regardless of patents, the maker of the original biologic would set a price that guarantees a 10 percent profit over and above the cost of making and distributing its product. That’s still more profit than most U.S. industries generate.
Independent consultants at Milliman estimated that over the next five years P-quad could yield an additional $265 billion in savings when compared to the current model of biosimilar competition: $95 billion to the federal budget which funds Medicare and much of Medicaid and $170 billion primarily to employers, employees, states and patients. In the employer-based health insurance market annual premiums could fall by $160 per person on average.
There is already bipartisan political agreement that the prices of older drugs should fall to make room for new products that will themselves be high priced. As one example, Senators Jeanne Shaheen, Democrat of New Hampshire; Bill Cassidy, Republican of Louisiana; and Tammy Baldwin, Democrat of Wisconsin recently introduced a bill that would end monopolies early for rare-disease drugs that earn revenues in excess of what was anticipated. The pharmaceutical industry and its investors also describe the expectation that prices should fall eventually as a “social contract” to which they should abide.
Prices of new drugs will continue to make headlines, as well they should. But we must fix the problem that older biologic drugs have perpetually high prices, and do so by passing a law that ensures that at the appropriate time their prices fall fast, and they fall far.
https://www.nytimes.com/2021/03/15/opinion/how-to-control-drug-prices.html?
Opinion: Congress just brought the country closer to universal health-care coverage
Editorial Board - Washington Post - March 14, 2021
TUCKED INTO the covid-19 relief bill that President Biden signed Thursday was perhaps the most significant health-care reform policy to pass Congress since the 2010 Affordable Care Act (ACA). It is a major down payment on Mr. Biden’s promise to build on that law, also known as Obamacare, and move the nation closer to universal coverage without excessive cost or disruption.
The ACA was supposed to cover people with very low incomes through the Medicaid program, and to cover everyone else who lacked employer-based insurance through private marketplaces, which would be regulated to guarantee a basic level of coverage and to protect people with preexisting conditions. People with moderately low incomes would get federal subsidies to help them buy private plans on these marketplaces.
But problems emerged. Many Republican-led states refused to expand their Medicaid programs, leaving millions of desperate people with no good option. Many other people earned too much to qualify for subsidies but still couldn’t afford the premiums. Some of them bought inadequate plans outside the marketplaces; others went without insurance altogether. The Trump administration made things worse by encouraging people to buy into those shoddy plans.
Those who opted out tended to be healthier, so insurance companies were saddled with high costs covering those who were left, forcing the insurers to raise premiums. This resulted in horror stories about premiums well above $1,000 a month, plus deductibles and other out-of-pocket costs. Because of these shortcomings, the ACA failed to meet its goal of ending “job lock,” in which employees feel they cannot go out on their own because they need employer-sponsored health-care coverage.
The relief bill addresses these problems. It offers more money to states that expand their Medicaid programs, increasing the incentive for them to cover their residents. It was already irrational for these states to refuse; now it is indefensible. The bill also enhances the subsidies available to people buying private insurance in the marketplaces, ensuring that no one, regardless of their take-home pay, must dish out more than 8.5 percent of their income on marketplace insurance premiums. The Congressional Budget Office reckons that a 64-year-old making $58,000 a year would see her monthly premium drop from $1,075 to $412.50 — still substantial but far more reasonable in proportion to her income. With more people buying marketplace plans, the whole system will be more stable, restraining premiums for upper-income people paying full freight, too.
Underlying this shift is the notion that the government should ensure that all Americans can buy quality coverage they can afford, an aspiration the Affordable Care Act did not quite reach.
Mr. Biden’s work is not finished. Some states still might refuse to expand their Medicaid programs. The marketplace subsidy reforms run for only two years; if they succeed, Congress should make them permanent and raise revenue to pay for them. Moreover, the covid relief package’s reforms do not address the astronomical amounts the United States spends on health care each year, a problem of generational importance.
Wyoming Edges Closer to Medicaid Expansion
Buried in President Joe Biden’s COVID-19 relief bill is a provision intended to entice 12 holdout states to extend health coverage to more low-income adults by expanding Medicaid under the Affordable Care Act.
Although Congress has not yet passed the legislation, Biden’s strategy appears to be working. A key Wyoming Senate committee this week approved a measure that would extend Medicaid benefits to all poor adults—not just older adults, those with disabilities and pregnant women. The bill now moves to the Wyoming Senate floor.
If it passes, the law would add about 24,000 Wyoming residents to the Medicaid rolls, according to estimates released by the state’s Department of Health last month.
The Wyoming bill passed the all-Republican Senate Labor, Health and Social Services Committee by a vote of 3-2, according to the Casper Star Tribune.
The Wyoming bill’s sponsor, Democratic state Sen. Chris Rothfuss, touted Biden’s plan as an added incentive for the state to expand Medicaid eligibility, which he said would bring an additional $120 million federal Medicaid dollars into Wyoming over a two-year period. The U.S. Senate passed the Biden bill Saturday. It is now with the House.
For current holdout states that choose to expand, the Biden bill would increase the federal Medicaid match by five percentage points for two years. Medicaid is jointly financed by the federal and state governments, with the match rate varying based on a state’s per capita income.
The federal Medicaid match in Wyoming is 56.2% during the pandemic. If the state expands Medicaid, its match rate would climb to 61.2%. (Early in the COVID-19 pandemic, Congress temporarily increased every state’s match rate by 6.2 percentage points for the duration of the crisis.)
The match rate in the Biden plan would apply to the existing Medicaid population rather than new beneficiaries who would gain coverage under expansion. The federal match for expansion Medicaid populations in all states is 90%.
Wyoming is the first non-expansion state to show interest in the Medicaid provisions in Biden’s plan. But expansion advocates in many of the other holdout states have begun citing the higher match rate in their arsenal of arguments.
House Democrats bring back Medicare-for-all, seeking to push Biden left
More than 100 representatives join the effort, but face steep odds in a closely divided Congress and with a skeptic in the White House
by Dan Diamond - Washington Post - March 17, 2021
House Democrats on Wednesday will renew their effort to enact Medicare-for-all, arguing the year-long pandemic was a “wake-up call” to replace the nation’s fragmented health insurance system — and betting they can pressure President Biden to embrace a government-run program that he famously rejected.
“Everybody is seeing the chaos and the destruction that the pandemic has caused,” said Rep. Pramila Jayapal (D-Wash.), the chair of the Congressional Progressive Caucus and one of the bill’s lead authors. “And it’s really making people look and [ask], could we have had something different had we had a Medicare-for-all system in place?”
Advocates acknowledge that a Medicare-for-all bill has never cleared a single committee, let alone Congress. But Jayapal, co-lead author Rep. Debbie Dingell (D-Mich.) and their 109 co-sponsors, who represent more than half of the Democratic caucus, argue the case for it has never been stronger. They cite data that the coronavirus disproportionately affected low-income Americans who lacked sufficient health coverage and had preventable preexisting conditions, and that millions of Americans lost their job-based health insurance as businesses shuttered.
What is different this time round is that their most formidable opponent is a president from their own party who won last year’s Democratic presidential primary after breaking from his rivals’ embrace of a single-payer health system.
“Throughout his campaign, the President did not support Medicare-for-all,” said a White House official, who spoke on the condition of anonymity to discuss a bill that had yet to be formally introduced. “He campaigned on his own plan and that is the plan the American people voted for. He is continuing to pursue his own plan, not Medicare-for-all.”
But the effort by the party’s progressive flank poses a predicament for a president who needs to hold his governing coalition together and who’s pledged to focus on “unity.” Allies fear the single-payer health-care bill will distract from Biden’s other priorities, with many Democrats and independents saying they’d prefer to keep their private health plans and Republicans heavily opposed to the idea.
“The polling for two years was very consistent,” added ALG Research’s John Anzalone, a pollster who advised Biden’s campaign. “The best way to approach this is to improve and build on the Affordable Care Act and pursue other health care steps … people are in love with their private health insurance.”
Biden will find himself on the same side as health-care industry lobbyists willing to spend tens of millions of dollars to protect their business interests; congressional Republicans eager to paint the legislation as an effort that will weaken existing Medicare benefits for seniors; and skeptical Democrats worried about risking the party’s narrow political edge in Congress.
Larry Levitt, the executive vice president for health policy at the Kaiser Family Foundation, which is unaffiliated with the health insurance company Kaiser Permanente, said that Dingell and Jayapal’s bill “has no clear path” to becoming law given Biden’s opposition. But he argued that its reintroduction “could still have important political implications” by pushing the president to stick to his other health-care commitments.
“President Biden campaigned on a Medicare-like public option and lowering the age of Medicare eligibility, but has not yet sent those proposals to Congress,” Levitt said. “The stronger the push for action on health care from the progressive wing of the party, the more pressure there will be on President Biden to carry out his health agenda.”
KFF in October 2020 found that 53 percent of adults supported the idea of a national health plan, although the organization halted polling on Medicare-for-all after Biden won the presidency. “There has consistently been majority support among the public for Medicare-for-all, but that’s before the inevitable lobbying onslaught from the health-care industry,” Levitt said. “Bumper sticker reform is always more popular than actual legislation.”
Buoyed by such polling, Medicare-for-all champions say they’re not dissuaded by Biden’s expected resistance. “I think he gets nervous about going too far. But I’m too nervous about us not going far enough,” said Dingell. “And if we create the momentum in the Congress, he can’t ignore it.”
Thirteen Democratic committee leaders, including the chairs of the House budget, oversight and financial services panels, are joining the effort led by Dingell and Jayapal, who will hold a virtual kickoff event on Wednesday with colleagues, unions and progressive groups. The legislation also boasts backers like Rep. Alexandria Ocasio-Cortez (D-N.Y.) and Sen. Bernie Sanders (I-Vt.).
“Senator Sanders agrees with his colleagues in the House of Representatives that now more than ever, that we must guarantee health care as a human right,” said Mike Casca, a spokesperson for Sanders. “He will soon introduce Medicare-for-all legislation in the Senate.”
But many influential Democrats, including House Speaker Nancy Pelosi (D-Calif.), continue to distance themselves from the bill. House Energy & Commerce Chair Frank Pallone Jr. (D-N.J.) — whose committee hearing room is named in honor of former congressman John Dingell, Debbie Dingell’s deceased husband and a longtime Medicare-for-all sponsor — initially balked at scheduling a hearing on a single-payer bill in the last session of Congress.
Pallone’s committee is “where I’m very focused,” said Dingell, given that the wide-ranging panel helps oversee health-care legislation. “I’ve talked to Frank, I’ve talked to Anna [Eshoo, the California congresswoman who oversees the panel’s health subcommittee]. We’re going to have hearings.”
Pallone said he was committed to a hearing on Medicare-for-all, telling The Washington Post “the goal of universal coverage is going to be at the center of everything we’re going to do on health care.”
Biden and other centrist Democrats, meanwhile, have focused on touting health reforms contained in their $1.9 trillion American Rescue Plan, which passed last week and overhauls the Affordable Care Act’s insurance provisions.
“When I travel around my district talking about what it means for a family that was paying 20 percent or 25 percent of their income on premiums, to now having this legislation offering people great care at 8.5 percent of their income, it’s significant,” said Rep. Lauren Underwood (D-Ill.), referencing a bill she introduced that was included in last week’s stimulus package.
“I think the Medicare-for-all conversation was certainly important in the context of the Democratic presidential primary,” added Underwood, who flipped a district long-held by Republicans in 2018 and narrowly defended her seat last year. “At least in my community, people were very oriented around a solution that could pass and a solution that would make a difference in their lives.”
The bill’s champions insist that they’re taking both the short- and long-term approach.
“This has been a Dingell priority for a long time,” said Dingell, referring to the decades of work by her husband and deceased father-in-law, a former House Democrat who was also a Medicare-for-all champion. “The day John died, I made a promise to him that I would get it over the finish line somehow, some way, and I have every intention of doing it.”
Ethical and Professionalism Implications of Physician Employment and Health Care Business Practices: A Policy Paper From the American College of Physicians
Medicine, a moral community (1) and learned profession, is characterized by a specialized body of knowledge its members must share and teach, a code of ethics and duty of service elevating patient care above self-interest, and a duty and privilege of self-regulation (2). Its commitment entails individual and collective obligations to uphold ethical duties that may conflict with other goals and practices, including those of employers of physicians, physician-employers, health systems, or institutions.
Today, changing practice dynamics place greater focus on the business aspects of medicine. Although employment or consolidation within larger organizations may not be problematic per se, physicians, regardless of practice setting, should challenge business concerns that are placed above the best interests of patients.
The Changing Practice Environment
Most states prohibit the “corporate practice of medicine,” although exceptions exist for certain organizational structures and for physician employees or independent contractors (3). Based in state medical practice acts, this doctrine also reflects concerns about the commercialization of medical practice (4), interference with physician clinical judgment and professional self-regulation, and the differing obligations of corporations to shareholders versus physicians to patients. However, questions have been raised about organized medicine's motives in this area and attempts to restrain competition (5, 6). Definitions and enforcement vary by state, but the underlying principle is that individuals or entities without medical licenses should not direct or practice medicine. For example, Indiana's statute allows employment or contractual relationships “if the entity does not direct or control independent medical acts, decisions, or judgments of the licensed physician” (7).
For physicians in changing practice environments, the legal doctrine and practice reality may not align. In 2018, employed physicians outnumbered those owning their own practices (8). Changing market dynamics (including mergers and acquisitions), concerns about the undervaluing of primary care (9), value-based payment models, and regulatory issues (on reporting, compliance, and electronic health record [EHR] requirements) have accelerated. The coronavirus disease 2019 (COVID-19) pandemic is disrupting health care delivery and revenue necessary to sustain medical practices.
Ethics, Professionalism, and the Business of Medicine
Health care delivery arrangements come with advantages, disadvantages, and salient issues for ethics and professionalism. Regardless of employment status, fee-for-service incentives may result in more (and potentially unnecessary) tests and treatments; other incentive arrangements might encourage undertreatment (2). Retainer fees or direct primary care practice can raise access, equity, and cost issues (10). Larger organizations may facilitate efficient, innovative, high-quality, and well-coordinated care (11) or access to specialty care, and the accountability created by organizational structures can support physicians' other ethics and professionalism obligations (including medical education and peer review). However, physicians employed in large organizations may experience challenges to the exercise of clinical judgment, professional integrity, or the ability to put patients first (as when outpatient scheduling frequency unreasonably reduces visit time).
Employment of physicians likewise has advantages, such as financial stability, practice management assistance, and opportunities for collaboration and continuing education, but there is also the potential for dual loyalty when physicians try to be accountable to both their patients and their employers (12). Dual loyalty is not new; for example, mandatory reporting of communicable diseases may place societal interests in preventing disease at odds with patient privacy interests. However, the ethics of everyday business models and practices in medicine has been less explored (13).
Trust is the foundation of the patient–physician relationship (2). Trust, honesty, fairness, and respect among health care stakeholders support the delivery of high-value, patient-centered care. Trust depends on expertise, competence, honesty, transparency, and intentions or goodwill (14). Institutions, systems, payers, purchasers, clinicians, and patients should recognize and support “the intimacy and importance of patient–clinician relationships” and the ethical duties of physicians, including the primary obligation to act in the patient's best interests (beneficence) (15).
Business ethics does not necessarily conflict with the ethos of medicine (16, 17). Today, physician leadership of health care organizations may be vital for delivering high-quality care and building trust (18), including in health care institutions. Truly trustworthy institutions may be more successful (in patient care and financially) in the long term (19, 20).
Blanket statements about business practices and contractual provisions are unhelpful; most have both potential positives and potential negatives. Nevertheless, it is important to raise awareness of business practices relevant to ethics and professionalism in medical practice and promote the physician's ability to advocate for arrangements that align with medicine's core values. In this paper, the American College of Physicians (ACP) highlights 6 contemporary issues and offers ethical guidance for physicians. Although the observed trends toward physician employment and organizational consolidation merit reflection, certain issues may also resonate with independent practices and in other practice settings.
Methods
This paper was developed on behalf of the ACP Ethics, Professionalism and Human Rights Committee (EPHRC). Committee members abide by the ACP's conflict-of-interest policy and procedures (www.acponline.org/about-acp/who-we-are/acp-conflict-of-interest-policy-and-procedures), and appointment to and procedures of the EPHRC are governed by the ACP's bylaws (www.acponline.org/about-acp/who-we-are/acp-bylaws). After an environmental assessment to determine the scope of issues and literature reviews, the EPHRC evaluated and discussed several drafts of the paper; the paper was reviewed by members of the ACP Board of Governors, Board of Regents, Council of Early Career Physicians, Council of Resident/Fellow Members, Council of Student Members, and other committees and experts; and the paper was revised to incorporate comments from these groups and individuals. The ACP Board of Regents reviewed and approved the paper on 15 September 2020.
Business Practices, Employment, and Ethics: Recommendations
Incentives in the Shift to Value-Based Care
Health care financing is shifting from volume-based fee-for-service to value-based health care to try to achieve better patient outcomes and lower costs while reducing inequities in care. Primary care necessarily plays a central role in achieving these goals (9). This requires investment in primary care and the clinical relationships that patients value.
When aligned with medical ethics and professionalism to promote the best interests of all patients and to support evidence-based care, value-based care incentives can support high-quality care delivery (21). However, previously voiced concerns about pay-for-performance seem applicable now (22, 23) and may be validated by mounting evidence (24). These concerns include inappropriately influencing patient or physician choice, failing to account for complex medical illnesses (particularly for older adults), failure to demonstrate appropriate respect for autonomy, and creation of barriers to access for disadvantaged patient groups. A fundamental concern is whether the use of extrinsic incentives—financial or nonfinancial—actually undermines the intrinsic motivation of physicians (a phenomenon known as “motivational crowding”). Paying physicians incentives could reduce intrinsic reasons or motivations of professionalism, clinical integrity, and the sense of medicine as a calling (25–27).
Referral-based incentives can encourage efficient, coordinated care but may also restrict patients' choice of physician and affect how care is delivered. Ethics requires that incentives for referrals be transparent to patients and physicians; be based on appropriate, patient-centered metrics, such as continuity, convenience, time, and costs (particularly to the patient); and not inappropriately influence decision making (28). Incentives must not disadvantage classes or categories of patients, including underinsured and uninsured patients (2).
The potential for conflicting incentives must be recognized. When performance incentives are based on volume (for example, number of patients seen or procedures performed), it can be challenging for physicians, who are increasingly taught to focus on value, to “do the right thing.” It is inconsistent to judge physicians solely on relative value unit (RVU) performance when, increasingly, the societal goal is instead to deliver high-value care.
An obligation exists to monitor for adverse effects and unintended consequences of external motivators. Professionalism can be co-opted. Physicians' commitments to excellent patient care and their efforts to engage in such activities as charting, responding to patient portal messages, or authorizing electronic refills at all hours of the day can inadvertently hide system inefficiencies, harm clinician well-being, and lead to clinician deprofessionalization. Regardless of system incentives for fee-for-service or capitation arrangements, “physicians must not allow such considerations to affect their clinical judgment or patient counseling on treatment options, including referrals” (2). ACP ethics position papers further discuss these issues (15, 22).
ACP Recommendation 1: Ethics and professionalism must be emphasized and explicitly addressed in the implementation of business practices and employment relationships, including in the face of external motivators for clinicians, such as financial incentives.
Contract Clauses Affecting Care
In-Network Referrals
Contracts may require physician referral within the institution or system, resulting in narrow or closed referral networks. A recent Supreme Court ruling, when applied to health care, could allow large health insurers or systems to create contract-based barriers to referring out of network (29). In principle, such provisions may aid patient care responsibilities (for example, by avoiding unnecessary duplicative testing done because records cannot be accessed “out of network”) and consultation (for example, by improving care coordination). In practice, whether because of strict payer restrictions or financial constraints, such as higher out-of-pocket costs, they may also unduly limit physician recommendations (as the unfortunate term to describe them, “leakage control,” may imply), patients' choice of physician, or equitable access to the most skilled physician for a particular condition (28).
“Outside” Activities
Contract provisions prohibiting the practice of medicine outside one's employment may limit physicians' nonclinical “outside” activities. These provisions could restrict or appear to prevent physicians from fulfilling their societal commitment to teach, to engage in unbiased research, and “to advocate for … the public” (2).
Restrictive Covenants
Restrictive covenants, or “noncompete clauses,” are governed by state law. They attempt to balance the interests of employers (who may have invested resources in helping a physician develop a patient panel and requisite skills) and the public (through regulation and stabilization of a competitive marketplace by, for example, preventing “bidding wars” over physicians) with the interests of the physician who leaves the practice later. They may restrict physicians from practicing for a specific period within a particular geographic area after departure. Although higher compensation or other benefits may accompany restrictive covenants (30), restrictions may disrupt patient–physician relationships or access to care or interfere with the responsibility to notify patients or forward medical records if a physician leaves a practice (2).
The maintenance of strong patient–physician relationships is paramount. Employment contracts should not restrict physicians' actions to promote patients' best interests. ACP supports the American Medical Association recommendation that physicians should not sign contracts with restrictive covenants that “(a) unreasonably restrict the right of a physician to practice medicine for a specified period of time or in a specified geographic area on termination of a contractual relationship; and (b) do not make reasonable accommodation for patients' choice of physician” (31). What constitutes an unreasonable restriction requires case-by-case analysis; a 20-mile restriction may be considerable in an urban area but not a rural one, and large, geographically widespread health systems may pose unique challenges related to restrictions. Such clauses may be less likely to adversely affect patients when a practice is sold or when a physician retires (when issues of competition and patient choice are less relevant) (32).
Contracts should not prohibit outside activities that do not interfere with the physician's duties as an employee and should include due process (12). Physicians should scrutinize contracts that include unreasonable “hold harmless” clauses or lack remedy provisions if employers fail to meet their contractual obligations (12, 33). The ACP contracts guide (34) advises physicians to negotiate so as to limit a covenant's geographic and time restrictions and address specific remedies for violations in advance. Because restrictive covenants are a matter of state law and vary widely, consulting legal counsel on these and other contractual provisions is advised.
In the past, physicians were arguably in a stronger position to negotiate contract terms. Yet even today, physicians should feel empowered to negotiate and, if necessary, refuse to accept terms that do not align with ethics and professionalism.
ACP Recommendation 2: Contract provisions affecting practice should align with the ethical commitments of physicians and be subject to negotiation that recognizes that alignment.
Contract Clauses About Confidentiality
Contractual limitations on physician disclosures or speech (“gag clauses”) are, in general, ethically problematic. They can undermine trust in the patient–physician relationship, violate informed consent, and obstruct the physician's ethical duty of beneficence. Ethical analysis of clauses was extensive in the 1990s during the managed care era (35, 36). Recently, different types of clauses have arisen.
Clauses about EHRs can prevent disclosure of problems with EHRs or “hold harmless” (of liability) EHR companies (37, 38). Vendors say these clauses are narrowly focused and protect confidentiality and intellectual property. However, physicians and others worry that overly broad clauses stifle discussions about problems that affect patients or slow workflow (39, 40) and discourage error reporting (41). Clauses vary among technology vendors and may be difficult to oversee. Federal regulations now restrict some types of clauses (42).
Blanket confidentiality clauses or nondisclosure agreements could prevent physicians from discussing other safety, quality, or problematic practices for fear of legal action (43). Such clauses may make it difficult for safety and quality concerns to become known. They can compromise professional integrity and physician ethical obligations with regard to disclosure to both individual patients and the community (2). In addition, they permit few avenues for remediation, other than whistleblowing.
These clauses may seem removed from patient care, but their implications must be fully considered. The principles of transparency and honesty also require this. And, as ACP has reiterated during the COVID-19 pandemic, physicians should not be at risk of being fired for speaking out on patient welfare and patient and health professional safety (44).
ACP Recommendation 3: Confidentiality clauses should not interfere with patient well-being, respectful professional relations, or the individual and collective responsibility of physicians to promote patient best interests, community health, and quality improvement.
Contract Clauses About Termination
Some contracts allow for termination without cause, meaning an employer could terminate a physician's employment without having to provide justification. Physician employees may be “at will” employees, their employment subject to termination without cause unless other contract provisions govern termination. There may be advantages to these arrangements if the contract allows the employee to terminate the employment relationship or provides flexibility for parting ways on mutually accepted terms. Termination without cause may also avoid litigation costs.
However, abrupt terminations can interfere with the continuity of the patient–physician relationship, and the possibility of termination without cause may prevent physicians from addressing safety and quality issues or lead to their being labeled “disruptive” (43). Although truly disruptive behavior can negatively affect patients, physicians, other health care professionals, and the culture of health care (45–48), advocating for patient well-being is not only appropriate but also an ethical obligation (2). Physicians should also advocate for practice environments that foster physician well-being and safety, as has been done during the COVID-19 pandemic with advocacy for personal protective equipment and patient care resources, provided such efforts do not include joint actions that harm patient access to care or result in anticompetitive behavior (2).
The ACP contracts guide (34) recommends that any provisions related to termination without cause be reciprocal (meaning the physician has an equal right to terminate the employment relationship without cause) and time-limited (for example, during only the first year of employment). Employers may recognize that the potential adverse effects on their reputation for terminating without cause may outweigh the benefits.
ACP Recommendation 4: Physicians should consider carefully whether to sign an employment contract that permits termination without cause. Provisions related to termination should be reciprocal and time-limited.
Private Equity Ownership
Private equity firms are acquiring physician practices as part of a trend toward private equity investment in health care (49). Physician practices acquired by private equity increased from 59 in 2013 to 136 in 2016 (50). However, data are limited and lag behind the trend. Because of financial strain on practices during the COVID-19 pandemic, private equity interest may increase in its aftermath.
Typically, private equity firms purchase a large stake in a physician practice, invest resources to expand market share, increase revenue (for example, by adding services), decrease costs, and then sell the practice within a few years to generate returns for the firm's investors (51). The practice may be sold to another private equity firm, a large health care conglomerate, the public via an initial public offering, or an insurance company. This desire to sell the practice soon after acquisition can create the incentive to sell off parts of the practice or undertake drastic short-term cost-cutting measures, including staff layoffs, to make a potential sale more attractive. Insurance companies may further narrow their networks or restrict patient access to only their employed physicians (52). Because of their current value, relatively limited supply, and perceived future earning potential, dermatology, radiology, and ophthalmology practices particularly interest private equity firms (53–56).
The additional investment private equity provides can provide resources necessary to maintain practice solvency and promote practice innovation. However, firm ownership can limit physician control over the practice, and the need to generate returns in a short time frame can compete with other interests, such as long-term investments in safety and quality (57). In one high-profile case, Hahnemann University Hospital in Philadelphia, Pennsylvania, was purchased by a for-profit corporation and closed abruptly a year later; its closure within 4 weeks of announcement left patients without access to care and medical trainees and staff without positions (58).
The private equity firm might also limit practice populations, such as Medicaid or Medicare patients, due to lower rates of reimbursement or higher complexity (59). This can conflict with physicians' obligations to promote justice and fairness in health care and the ethical commitment to serve all patients. Private equity–owned practices have been accused of intentionally engaging in aggressive or surprise out-of-network billing practices that adversely affect patient financial well-being and foster distrust (60, 61).
Physicians who sell to a private equity firm must assess doing so with attention to potential effects on ethics and professionalism. At present, there is insufficient evidence comparing the clinical performance and ethical implications of private equity ownership versus other practice arrangements (partly because of nondisclosure agreements in some private equity agreements). Caution is needed.
ACP Recommendation 5: The net value of private equity investment in physician practices for patients, physicians, and medicine is unclear. Systematic studies of this trend on patients, medicine, and society are needed.
Clinical Priority Setting and Time
Clinical priorities at the practice level can be influenced by different parties, including government (for example, via regulations regarding quality measures), payers (for example, via value-based payments), health systems, and institutions. Together, these can influence which clinical conditions receive attention and how care is delivered. Ideally, these interests will align with those of individual patients and overall population health, but that is not always the case. Employed physicians may have less control over how employer organizations respond, which can create challenges for respect of patient autonomy, justice, physician professional integrity, and the primary obligation of beneficence.
Increased financial pressure on organizations to meet certain quality metrics or spending benchmarks at the aggregate level may be cost-effective and good for the overall health of a population, but there can be unintended consequences (23). Organizations may exclude or limit certain patients, including underinsured or uninsured patients, who are perceived to be more clinically challenging or to result in lower reimbursement. Denying care on the basis of the ability to pay can compromise physicians' commitments to ensuring all people receive care and honoring medicine's social contract with society (2).
Even high-quality metrics that support population health have varying benefit to individual patients. Patients and physicians may feel undue pressure to start use of new medications to meet a metric when doing so provides minimal benefit, especially for patients with complex comorbidities. Physicians may be prompted by EHRs to use certain diagnostic codes that are not entirely accurate but maximize reimbursement. Billing for services that are not provided is unethical (2). The very need to address such metrics and coding issues can shift physician focus to them.
These and other shifts in focus take time, which is a precious and limited resource that is valued highly by patients and physicians yet undervalued by existing health care payment structures (62, 63). Shrinking time for direct patient–physician interaction during visits has ethical implications (64). Effective communication, counseling, physical examination, and expression of compassion take time. Concerningly, women physicians may experience greater time pressures in practice and may be disadvantaged by existing reimbursement systems (65). Less time pressure exists where there is better alignment in values between clinicians and leaders, greater perceived clinician control over the work environment, and a stronger emphasis on quality over productivity (66). This may also have the positive effect of encouraging physicians who may otherwise retire to continue to share their expertise by practicing part-time. Although efficiency can be a legitimate goal, time is also an important, patient-centered metric of health care quality.
Health care payers and organizations increasingly engage in direct patient outreach about medications, health care maintenance, and other health issues. Even if motivated by financial gain, outreach can help improve care quality for individual patients. Nevertheless, these activities involve ethical questions of justice or resource allocation and potentially affect patient–physician relationships (67). Focusing on blood pressure control, for example, may mean that depression or substance use disorder is not addressed. When organizations reach out directly to patients without physician awareness, they may inappropriately capitalize on trust in the patient–physician relationship or disrupt that trust.
Employed physicians should ensure that patient and physician voices are heard in organizational priority setting; physician health care leaders should consider maintaining direct participation in patient care, which can be personally fulfilling and provide insights into frontline care (68). Integrated leadership models that include practicing physicians can foster organizational values that support patient-centered care (69). Some data suggest that organizations led by physicians may also be more successful at achieving quality and appropriate cost goals (70). Physicians should advocate for appropriate health care resources, including time and the value of a trusting patient–physician relationship. The physician should not allow specific quality, cost, or population-based goals “to diminish commitment to and advocacy for individual patients” (2), and medicine must maintain its collective voice on behalf of patients (1, 2).
ACP Recommendation 6: Organizations and employers should recognize and appropriately value time for patient–physician encounters and engage patients and physicians in priority setting across all aspects of health care.
Conclusion
Business practices can challenge the ethics and professionalism of individual physicians and the collective responsibility of the medical profession to patients. The social mission of institutions can be challenged as well.
Physicians, whether in training, newly graduated, or with decades of experience, must be aware of the effect business practices, employment terms, and contracts can have on ethics and professionalism. National organizations, such as the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education, and medical schools and residency programs should develop strategies for and educational materials on these issues. Because details matter, physicians must be prepared to ask questions about arrangements and feel empowered to advocate for practices that promote patient health and the patient–physician relationship. If a practice or policy harms or has the potential to harm patient care, the physician should speak out and “resist and even refuse to carry it out” (1).
It is also important for physicians to inform patients when these arrangements affect practice. Doing so preserves trust in the patient–physician relationship and helps make patients and society more aware of forces shaping the practice of medicine. Physicians should be actively involved as a major force.
The practice of medicine must be defined by the ethics of medicine. Efficiency and productivity are important but secondary to serving the needs of patients. Intrinsic motivations of service, professionalism, and clinical integrity must guide physicians and be respected by institutions and health systems. Trust in systems, individual clinicians, and the patient–physician relationship demands no less.
The challenges to care and medical practice during and after the COVID-19 pandemic underscore the need to reemphasize the ethical foundation of medicine. The commitment to ethics in the response of clinicians to COVID-19 has helped sustain the profession and society in the emergency. Some see in COVID-19 an important “lesson that the system can be reset” to better serve both patients and clinicians (27). Looking anew at the environment in which care is delivered, physicians should lead in ensuring that business relationships explicitly recognize and support the fundamental and timeless commitments of physicians and medicine to patients.
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