Atul Gawande Nominated for Global Health Role at USAID

Good news for fans of Atul Gawande (books: Amazon author's page) who will be pleased to know Pres. Biden has nominated the author/surgeon/health policy wonk to be  assistant administrator of the United States Agency for International Development's Bureau for Global Health. One of the hottest pandemic-related issues confronting the developed world is how to meet the need for vaccines and vaccination resources (human and otherwise) in the 90% of the world that is less than 10% immunized. It's an enormous challenge and one that falls squarely within Dr. Gawande's portfolio (assuming Senate confirmation).

SCOTUS grants review in 4 health law cases

The 2021 Term will be a lively one for health lawyers in light of yesterday's grant of four petitions for review (two Medicare cases, one Medicaid case, and a PPACA case that doesn't involve a challenge to the constitutionality of the law):

• American Hospital Association v. Becerra, No. 20-1114, a challenge to a Department of Health and Human Services rule that cut Medicare reimbursement rates for prescription drugs for hospitals that participate in a program for underserved communities. The U.S. Court of Appeals for the District of Columbia Circuit ruled that the reimbursement cut was a reasonable interpretation of the Medicare statute; the justices on Friday agreed to weigh in on whether that deference is appropriate in this case. The court also asked both sides to discuss whether the challenge is barred by a provision of federal law that limits judicial review of certain Medicare-related calculations.
• Gallardo v. Marstiller, No. 20-1263, in which the court will decide whether a state Medicaid program can get reimbursed for past medical expenses that it has paid by taking money from a settlement or jury award that is intended to compensate for future expenses.
• Becerra v. Empire Health Foundation, No. 20-1312, a dispute over how to calculate additional payments under the federal Medicare program for hospitals with a large number of low-income patients.
• CVS Pharmacy v. Doe, No. 20-1374, in which the court will consider whether the Rehabilitation Act, which bars discrimination on the basis of disability by any program or activity receiving federal funding, and the Affordable Care Act allow plaintiffs to bring claims alleging that a policy or practice disproportionately affects people with disabilities.

CMS Proposes Final Interim Rule to Implement the No Surprises Act

Surprise medical bills are horrific events for patients and their families, throw insurance underwriting into disarray, and create or reinforce barriers to entry into the medical-industrial complex. The federal No Surprises Act (a relatively small part (32 pages) of H.R. 133, the 2,124-page Omnibus Reconciliation Act of 2021) was supposed to address the problem, but the new law needed a regulation to implement it. That rule -- in the form of a 411-page "interim final rule" with a request for comments -- dropped today.  CMS has provided a reasonably helpful fact sheet if you don't have time to wade through the rule's preamble. The rule is supposed to have an effective date of January 1, 2022, but don't be surprised if that date gets bumped. This rule will undoubtedly attract a ton of comments. The comment period closes 60 days after publication of the interim final rule in the Federal Register.

Hospitals Now Employ 50% of all U.S. Physicians

Once upon a time, it was a virtually universal no-no for a corporation or other lay entity or person to own, or even have an ownership interest in, a physician's practice. There were various rationales for the so-called "corporate practice prohibition," including:

• only natural persons could meet the requirements for medical licensure,which ruled out corporations, trusts, partnerships, etc.
• a corporate or other lay owner created at least the potential for dual loyalties, putting doctors in the impossible position of choosing between his or her patient and corporate overlords; and
• allowing non-physicians to get in on a medical practice's action represented an unseemly commercialization of medical practice.

Not all states bought into the corporate practice prohibition. Some did, at least formally, but in many states the prohibition was under-enforced, to say the least. By the 1990s about a dozen states still recognized and enforced the prohibition, some with more or less enthusiasm than others.

Over time a couple of things changed. First and foremost, the three rationales for the prohibition -- always somewhat sketchy -- became increasingly suspect.

Second, state legislatures, and occasionally state supreme courts, created exceptions to the prohibition, allowing corporate ownership, for example, by nonprofit hospitals or by staff-model HMOs. Texas -- often cited as having one of the strongest corporate practice prohibition doctrines, even created the "5.01(a)" workaround, now codified at Texas Occupations Code §§ 162.001-.006. This law allows for the creation of a "certified nonprofit organization" -- subject to a plethora of requirements and limitations -- created to employ physicians to carry on the practice of medicine. And pursuant to Texas's Business Organizations Code, nonprofit corporations may have one or more "members" [§§ 22.151 et seq.]. This opened the door for certified nonprofits to have as their sole member a hospital or health care system that, in turn, provided much of the working capital and assets for the medical practice. Call it "virtual ownership" of medical practices.

As it turned out, many of the single-member 501(a)'s weren't very good investments for the hospitals, not even for those hospitals who were willing to lose some money as an investment in future referrals by the doctors who were employed by the 5.01(a). Not to mention that intentionally losing money in support of a medical practice that employs physicians who refer patients to the hospital raises questions under federal and state fraud and abuse laws and (if the hospital is tax-exempt) under § 501(c)(3) of the Internal Revenue Code (see IRS Gen. Couns. Mem. 39,862: "We question whether the Service should ever recognize enhancing a hospital's market share vis-a-vis other providers, in and of itself, as furthering a charitable purpose").

All of this is to say, today's news (Becker's Hospital CFO Report, 6/29/21) that hospitals employ 50% of U.S. physicians and that percentage continues to increase at a fast clip is further evidence of the break from past understandings of the corporate practice prohibition. May it rest in peace.

Surprise billing: It's still a thing

From the Kaiser Family Foundation's news service:

In Alleged Health Care ‘Money Grab,’ Nation’s Largest Hospital Chain Cashes In on Trauma Centers

After falling from a ladder and cutting his arm, Ed Knight said, he found himself at Richmond, Virginia’s Chippenham Hospital surrounded by nearly a dozen doctors, nurses and technicians — its crack “trauma team” charged with saving the most badly hurt victims of accidents and assaults. But Knight’s wound, while requiring about 30 stitches, wasn’t life-threatening. Hospital records called it “mild.” Nevertheless, Chippenham, owned by for-profit chain HCA Healthcare, included a $17,000 trauma team “activation” fee on Knight’s bill, which totaled $52,238 and included three CT scans billed at $14,000. His care should have cost closer to $3,500 total, according to a claims consultant which analyzed the charges for KHN. (KHN, Richmond Times-Dispatch)

The federal No Surprises Act (signed Dec. 27, 2020) was supposed to curb billing abuses. The KHN link has an exhaustive analysis of the problem, but it doesn't say whether Mr. Knight's trip to the ER was before or after the effective date of the new law. (And the Richmond Times-Dispatch link didn't work for me; I've included it here in case it works for you.) 

 

Free Webinar: Pres. Biden's First 100 Days of Health Policy

This looks like a good webinar:

Boston University's Center for Health Law, Ethics & Human Rights faculty discuss the first 100 days of President Biden’s term:

• Executive Orders,
• proposed bills, and
• other steps to tackle COVID, climate, and economic crises affecting health.

What has happened? What comes next? 

Thursday, March 11, 2021
1:00 - 2:30 p.m. EST

SPEAKERS
George Annas
Nicole Huberfeld
Wendy Mariner
Michael Ulrich

JOIN ZOOM MEETING
https://bostonu.zoom.us/j/93372687004?pwd=NXpoNm5wZW1YOEljeENyeWY2V3dVUT09

Meeting ID: 933 7268 7004
Passcode: 331167

Welcome to the Wacky World of Hospital Pricing Practices

Today's Wall Street Journal (02-12-21) has a good piece on the incredible range of charged prices for hospital services. We are accustomed to articles highlighting differences from region to region, rural vs. urban, and even within the same city. This article looks at the prices charged for the same procedure at a single institution:

When a woman gets a caesarean section at the gleaming new Van Ness location of Sutter Health’s California Pacific Medical Center, the price might be $6,241. Or $29,257. Or $38,264. It could even go as high as $60,584.

Sutter Health isn't doing anything illegal or even unique. It bills different amounts based on whether the patient is uninsured, insured, a subscriber to the Sutter Health HMO, or (worst-case scenario) out-of-network. There is a historical and economics-based rationale for the way serves are priced in the hospital's ChargeMaster and ultimately billed to patients and payers of various stripes. Unfortunately, the history and accounting rationales conspire to hurt the patients least able to protect themselves with health insurance, Health Savings Accounts, and the like. I hope everyone has a chance to read this article.

Beyond the Health Policy "Iron Triangle" of Cost, Quality, and Access"

 

There's a new article that builds on our experience with pandemic response to make the case for increasing emphasis upon health justice -- equity and public health. "Health Reform Reconstruction" is a free download on SSRN and is well worth the time to read and reflect on its message. Authors Lindsay F. Wiley, (American University - Washington, College of Law), Elizabeth Y. McCuskey (University of Massachusetts School of Law, Center for Health Law Studies), Matthew B. Lawrence (Emory University School of Law, Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics), and Erin C. Fuse Brown (Georgia State University College of Law) provide this Abstract:  

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades – and calls for reconstruction. For more than a half-century, an intellectually cramped “iron triangle” ethos has constrained health reform conceptually. The iron triangle centered individual interests in access to, quality of, and cost of medical care, while marginalizing equity and public health. In the iron triangle era, reforms unquestioningly accommodated four entrenched fixtures of American law—individualism, fiscal fragmentation, privatization, and federalism—that distort and diffuse any reach toward justice and solidarity. The profound racial disparities and public health failures of the U.S. pandemic response in 2020 agonizingly manifested the limitations of pre-2020 health reform and demand a reconstruction. 

Health reform reconstruction begins with the replacement of the iron triangle era with a new era in which reforms aim to realize health justice. Health justice does not itself overcome the fixtures of American law that constrain reform and propagate subordination. But it reveals the importance of doing so, despite the fixtures’ stubborn legal and logistical entrenchment. Because health reformers can no longer accept any conceptual goal short of health justice, incremental reforms must be measured chiefly by whether they confront or accommodate individualism, fiscal fragmentation, privatization, and federalism in health care. Through an uncompromising conceptual aspiration and a method of confrontational incrementalism focused on dismantling the legal structures that stand in the way of health justice, health reform reconstruction is possible. The Article describes how health reform reconstruction can chart the path of legal change and reflects on the usefulness of its methodology of confrontational incrementalism in other fields which recognize the necessity of reconstructive reform, along with its near impossibility, such as policing and drug policy.

Ten Lessons from Health Affairs

The esteemed health-policy journal Health Affairs has published its list of "Ten Lessons from COVID-19  Research Published in Health Affairs" (12/30/20). Number 10 shouldn't have surprised me, but it did:

1. Mandating face masks in public is associated with a decline in the daily COVID-19 growth rate.
2. COVID-19 emergency sick leave has reduced confirmed cases.
3. Increased testing and isolation may be the most effective, least costly alternative—in terms of money, economic growth, and human life—for controlling COVID-19.
4. Shelter-in-place orders reduce both daily COVID-19 hospitalizations and mortality growth rates within weeks of enactment.
5. Blacks and Hispanics are more likely to screen positive, be hospitalized, and die due to COVID-19 relative to non-Hispanic Whites.
6. Vaccine implementation, including the pace of vaccination and the percent of the population ultimately vaccinated, will contribute more to the success of vaccination programs than a vaccine’s efficacy determined in clinical trials.
7. Hospitals reinvented patient and staff support systems during the COVID-19 pandemic to better cope with trauma.
8. Expanded Medicaid coverage and insurance reimbursement for telehealth played a pivotal role in the rapidly increased use of these services during the pandemic.
9. The majority of school employees and school-age children live in households including at least one adult with increased risk for severe COVID-19, and about half of all school employees have increased risk themselves.
10. Unionized health care workers in nursing homes were associated with a decrease in COVID-19 mortality rates and greater access to personal protective equipment for workers.

I've been considering my coverage decisions for Health Law next semester, and unionization -- not much of a force in health-care settings in the South and Southwest -- seemed like an easy topic to cut. Now I am reconsidering that decision.

Pres. Obama's Inside Story on the Rocky Road to Obamacare

Here's a story worth reading: how the U.S. got -- if not universal health care -- something close after a century of trying and failing. For fans of sausage-making, it's a fascinating glimpse inside the factory, excerpted in the 11/02/20 issue of The New Yorker. The general story is well-known, but it is worth remembering how close we came to not getting an Affordable Care Act at all. 

With "about six in ten of the public say[ing] they or someone in their household suffers from a pre-existing or chronic medical condition, such as asthma, diabetes, or high blood pressure," the most popular provision remains the prohibition against discrimination by health insurers based upon preëxisting conditions. (Kaiser, 12/18/20) And now that the wildly unpopular individual mandate has been rendered completely toothless by the tax reform legislation in 2017, the favorable-over-unfavorable gap in public opinion is 19%, the largest it's been since enactment. 

Top 10 Health Stories of 2020: Nearly All Are Healthlaw-Related

 From The Commonwealth Fund (more details are here):

1. "COVID-19 hits the United States." The greatest public health (and public health law) crisis in a century.
2. "Pandemic takes a devastating toll on health." Public health measures alone don't protect against the virus. Compliance matters. 
3. "Economic fallout." COVID-19 has put pressure on every level of government. Some performed brilliantly, a few failed miserably, and for the rest the report card was mixed. 
4. "FDA authorizes coronavirus vaccine and distribution begins." A stunningly successful public-private partnership produced unprecedented results, though Pfizer -- the first to get FDA approval -- turned down federal funding. 
5. "Dramatic leapfrogging in telehealth." Regulators at both the federal and state levels proved to be fairly nimble in providing authorization and reimbursement for greatly expanded telemedicine services. This is probably one of many developments that won't go away after the virus has been controlled. Telemedicine will be part of the "new normal."
6. "Racial injustice protests draw attention to health disparities." It's not as if there are plenty of federal and state laws on the books to deal with discrimination in health care, but health disparities remain. There's a lot more work to do on this front.
7. "The future of the Affordable Care Act is still unknown." It is, once again, in the hands of SCOTUS. Chief Justice Roberts was the architect (and principal author) of the Court's two previous encounters with potentially ACA-killing litigation. With a revised lineup of Justices, will he provide the saving grace in Texas v. U.S.?
8. "Medicaid expansion continues at a slow and steady pace." Three states voted to expand Medicaid eligibility pursuant to the ACA; twelve continue to impede the ACA's promise of expanded coverage at virtually no cost to the states. Texas -- with the largest number and percentage of uninsured citizens in the U.S. -- remains a notable holdout. Consider the billions of federal dollars Texas providers have been denied during the COVID-19 crisis, which has seen provider and after provider, especially in rural areas, close up shop
9. "Joe Biden is elected president." We will soon have a resident in the White House who isn't trying to hobble the ACA and cast doubt on the bona fides of public-health authorities at every turn. 
10. "Biden appoints new health care team." With a few exceptions, the Trump cabinet was filled with amateurs with either no experience or a predisposition to cut back on enforcement of federal programs or both. The new cabinet and sub-cabinet appointees look to reverse the trend. 

Early Indications Are Leaning Toward a Favorable SCOTUS Decision for the ACA

One thing I learned as a Constitutional Law prof many years ago is to not give full faith and credit to the comments and questions of Justices during oral argument. Sometimes they are simply testing out ideas that they plan to write against when the dust settles. All that said . . . 

Early reports from today's oral argument in the Supreme Court suggest that Justices Sotomayor, Kagan, and Breyer may be joined by Chief Justice Roberts and Justice Kavanaugh in upholding the ACA against the attack mounted by 20 GOP-led states. Policy wonks decry the possibility that 20 million people in this country could lose their health insurance if the ACA is struck down, and millions more will lose coverage if other underwriting reforms go down the tubes, including the prohibition against discriminating on the basis of pre-existing conditions, the ban on annual and lifetime caps, and the option for children to be covered by their parents' health insurance until they turn 26. The Supreme Court doesn't get to make health policy, but consequences as Draconian as these have to figure into their reading of the law, especially in a case in which congressional intent controls the issues. 

There are two issues in play. The first is whether the individual mandate can survive Congress's decision in the 2017 tax law to reduce the penalty tax for failing to secure health insurance all the way down to $0. Without a tax, the plaintiffs have argued, the constitutional basis for the mandate disappears. Maybe. I seem to remember from Income Tax I (Summer 1975) that Congress has from time to time elected not to collect a tax, and the Court has upheld the regulation attached to the tax nonetheless. Even if I recollect incorrectly, it should be at least a close question whether Congress intended to wipe out the individual mandate when they reduced the tax. It seems supremely silly to me 

If the Court answers the first question in the affirmative, the second question shouldn't be close at all: whether the end of the individual mandate means the entire ACA should be tossed out as well. The question is one of severability, and it shouldn't even pass the smile test, although the district court and the Fifth Circuit opined that the ACA could not be saved if the individual mandate were taken out. 

Stay tuned . . . 

Senate Report on Health Inequities and COVID-19

It's a report from the Democratic staff of the Senate Health, Education, Labor, and Pensions Committee: "COVID-19 & ACHIEVING HEAL TH EQUITY: Congressional Action Is Necessary To Address Racism And Inequality In The U.S. Health Care System" (Sept. 2020).

From the summary:

COVID-19 has had a disproportionate impact on Black people across urban, suburban, and rural communities. As of September 2020, Black people were nearly 3.5 times as likely to die from COVID-19 as white people when age is accounted for.

Latinx people have experienced some of the highest rates of infection from COVID-19 in the country. As of June 2020, counties where more than a quarter of the population is Latino saw infection rates increasing at higher rates than in counties with smaller Latino populations, and as of July 2020, the infection rate among Hispanic patients was more than three times the rate among white patients. Over the same time period, Hispanic patients were hospitalized at a rate that was more than four times higher than white patients, and COVID-19 accounted for approximately one in five deaths among Hispanic people.

Data are not consistently available from states for other minority groups, but what is known supports similar conclusions about the risk of serious COVID-related complications and death among Asians, Native Americans, and LGBTQIA+ individuals.

Contributing factors include underlying health conditions, a lack of adequate insurance, increased likelihood of exposure to COVID-19 at work, mistrust of the health care system based upon a history of racial bias and exploitation, present-day explicit and implicit bias in the health care system, underrepresentation of physicians of color, bias in medical research and pharmaceutical clinical trials, limited access of patients of color to high-quality medical care, and a long list of social determinants of health that have disproportionately disadvantaged persons of color.

This is an important report, and not only for the fifteen pages of endnotes. The report ends with thirty recommendations for congressional action. Ask your representative or senator if they've read the report. We all should. 

KFF Report on Trump's Health Care Record

We can expect health care (and HC reform) to be a major policy focus of the fall presidential campaign. The president's record is long and complex, including (quoting a press blurb from the nonpartisan Kaiser Family Foundation):

his response to the COVID-19 pandemic, his early and ongoing efforts to repeal and replace the Affordable Care Act (ACA), his annual budget proposals to curb spending on Medicare and Medicaid, his executive orders and other proposals to lower prescription drug prices, and his initiative on hospital price transparency.

This is from an issue brief published by KFF  -- "President Trump's Record on Health Care" -- with all the details. It is the fairest and most comprehensive summary I've seen.