Physician Discipline: Covid Denier's License Suspended, but Not For Lying

Sherri Tenpenny, D.O., testified before the Ohio legislature that the Covid vaccine "magnetizes" recipients and interfaces with 5G cellphone towers. Soon after, her medical license came up for renewal and the Ohio Medical Board renewed it, no muss, no fuss, despite the good doctor having been named as "one of the 12 most prolific spreaders of COVID-19 misinformation on social media, according to research from the Center for Countering Digital Hate." (Becker's Hospital Review, Sept. 20, 2021).

At the time of the renewal, the Board said that renewal was an automatic process and did not foreclose a future investigation. After receiving approximately 350 complaints, the Board did start an investigation. Dr. Tenpenny, however, unwisely blew off the Board's discovery requests and a subpoena to testify, and for that she got her license suspended until she starts to cooperate with the Board's investigation. (Becker's Hospital Review,  Aug. 9, 2023).

This case offers two teaching points: (1) many licensing boards are slow to react to quackery, and (2) turning your back on a board’s investigation never pays off  

Meanwhile, Dr. Tenpenny's anti-vaccine and conspiracy-spewing firm rakes in an estimated $4.04 million in annual sales. There's gold in them thar lies!

Health Care M&A Activity Hits 3-year Low . . . Or Not

Becker's Hospital Review has a story (Aug. 9) about a KPMG report that describes a three-year decline in merger-and-acquisition activity in the health care sector. Apart from a couple of large deals in May (CVS Health's closing on Oak Street Health for $10.6 billion) and June (UnitedHealth Group's $3.3 billion agreement to take over Amedisys), second-quarter M&A activity was the lowest since the same quarter in 2020. (Health consultants Kaufman Hall paint a rosier picture of M&A activity in Q2 2023.)

I don't know how this compares to M&A activity in other parts of the economy, but the reasons cited by KPMG sound pretty generically applicable throughout the economy:

"Ongoing pressures could keep second-half M&A near first-half levels," Kristin Pothier, leader of healthcare and life sciences for KPMG and principal of deal advisory, said. "Additional interest-rate hikes even amid an economic downturn, political divisions in advance of a presidential election year, and uncertainty about the valuations of potential acquisition targets may combine to postpone a rebound in deal making. But we expect at least some of those headwinds to moderate toward the end of the year, and that could begin to release long-pent-up demand." 

To this list I would add recent M&A policy revisions from the FTC & DOJ, making Hart-Scott-Rodino review more of a toss-up than the market is used to. (See posts here and here.) 

Texas Case Highlights the Human Cost of Texas's Abortion Ban

After the Supreme Court's Dobbs decision, much was written about the human suffering that will result once states ban or seriously restrict abortion services. The recent Austin case put four faces on that suffering through the testimony of four women plaintiffs. The trial judge's opinion alluded to the nature of their testimony but didn't provide details.  A recent KFF Health News article (August 7) highlighted their testimony and illuminated the risk to women's health as a result of Texas's abortion ban. 

The article should be required reading for members of the legislature and Governor Abbott, but I'm not holding my breath.

SCOTUS Agrees to Review Proposed Opioid Settlement

From Bloomberg's USLW email teaser:

The US Supreme Court agreed to consider scuttling Purdue Pharma LP’s $6 billion opioid settlement, taking up a Biden administration appeal that contends the accord improperly shields the Sackler family members who own the company.

High court review threatens Purdue Pharma’s bankruptcy reorganization plan, which includes the opioid settlement as well as an agreement by the Sacklers to give up ownership of the company.

The plan would end a mountain of litigation against the OxyContin maker and funnel billions of dollars toward efforts to abate the opioid crisis. Family members have agreed to pay as much as $6 billion to those suing.

The high court also halted implementation of the settlement while the justices consider the case. The court said it will hear arguments in December.

See also CNN.

The Justice Department had multiple objections to the proposed settlement, the central one of which was included in the Supreme Court's order granting certiorari today:

Application (23A87) granted by the Court. The application for stay presented to Justice Sotomayor and by her referred to the Court is granted. The mandate of the United States Court of Appeals for the Second Circuit in case No. 22-110 and the consolidated cases is recalled and stayed. Applicant suggested this Court treat the application as a petition for a writ of certiorari; doing so, the petition is granted. The parties are directed to brief and argue the following question: Whether the Bankruptcy Code authorizes a court to approve, as part of a plan of reorganization under Chapter 11 of the Bankruptcy Code, a release that extinguishes claims held by nondebtors against nondebtor third parties, without the claimants’ consent. The Clerk is directed to establish a briefing schedule that will allow the case to be argued in the December 2023 argument session. The stay shall terminate upon the sending down of the judgment of this Court. (emphasis added)

As the Justice Department put it in their request to the Court for a stay of enforcement of the settlement:

Until recently, Purdue was controlled by members of the Raymond and Mortimer Sackler families.  Members of those families, who withdrew approximately $11 billion from Purdue in the eleven years before the company filed for bankruptcy, App., infra, 19a, have now agreed to contribute up to $6 billion to fund Purdue’s reorganization plan, id. at 40a, but only on the condition that the Sacklers and a host of other individuals and entities -- who have not themselves sought bankruptcy protection -- receive a release from liability that is of exceptional and unprecedented breadth.  The plan’s release “absolutely, unconditionally, irrevocably, fully, finally, forever[,] and permanently release[s]” the Sacklers from every conceivable type of opioid-related civil claim -- even claims based on fraud and other forms of willful misconduct that could not be discharged if the Sacklers filed for bankruptcy in their individual capacities.  Id. at 25a (quoting C.A. SPA 920). 

 

The Sackler release extinguishes the claims of all opioid claimants except the United States, and therefore applies to an untold number of claimants who did not specifically consent to the release’s terms. The Sackler release is not authorized by the Bankruptcy Code, constitutes an abuse of the bankruptcy system, and raises serious constitutional questions by extinguishing without consent the property rights of nondebtors against individuals or entities not themselves debtors in bankruptcy.  The Bankruptcy Code grants courts unusual powers specifically authorized by the Constitution for addressing true financial distress.  Allowing the court of appeals’ decision to stand would leave in place a roadmap for wealthy corporations and individuals to misuse the bankruptcy system to avoid mass tort liability.  That is not what Congress enacted the Bankruptcy Code to accomplish.  And if such abuses are permitted, the gamesmanship that is sure to follow will only amplify the harms to victims by redistributing bargaining power to tortfeasors.  

Considering the vast stakes involved in this case, every sentence of that last paragraph will be hotly contested between now and December.

 

Noncompete Clauses, the FTC, and the Health Care Industry

As described in an excellent paper on the American Bar Association's website (sorry, but you need to be an ABA member -- or know one -- to get access), states are all over the map when it comes to noncompete clauses. They've been unenforceable in California for 150 years. A few other states have banned them, some with limited exceptions. For physicians, state law is a big deal. According to the paper, Medscape reports that 87% of physicians report being subject to a noncompete clause sometime during their careers.

State law may become irrelevant in light of a rule proposed by the Federal Trade Commission this year, that would prohibit many firms from including noncompetes in their contracts with employees and independent contractors (press release, FTC (Jan. 5, 2023).  

There are some limits to the scope of the proposed rule:

• As written, it does not apply to noncompetes that are written into contracts for the sale of a business.
• The FTC generally doesn't regulate nonprofits, unless they are "organized to carry out business for its own profit or that of its members.” Under most states' laws and § 501(c)(3) of the Internal Revenue Code, nonprofits (and tax-exempts) must be organized primarily for public as opposed to private benefit. It is a sketchy distinction in some cases, but it endures.
• There's no private cause of action under § 5 of the FTC Act, so enforcement of the prohibition (if it is adopted as a final rule) will be up to the FTC and DOJ.

I say "if it is adopted" because over 21,000 comments have been filed for and against the proposed rule. Former FTC Commissioner Christine Wilson dissented from the Notice of Proposed Rulemaking, noting that the proposed rule would prohibit conduct that is permitted in 47 states. If the rule is adopted, expect (1) lots of work for lawyers revising work contracts and (2) a court challenge. It's likely that any case would wind up in the Supreme Court. And if that happens, expect a tug of war among the justices over the recently discovered "major questions doctrine."

The Hidden Harms of CPR

In a truly great article this past weekend in The New Yorker, Dr. Sunita Puri describes the conundrum around the use of cardiopulmonary resuscitation, especially in hospitals, and most especially for patients with terminal diagnoses (limited free access is available). 

The thing is, CPR is ineffective at treating the underlying condition that is bringing about the patient's death. And even as a stop-gap to allow treatments to take effect, it mostly works in a small cohort of patients:

CPR can save lives when patients are relatively healthy, and when the cause of their death is reversible or unclear. Damar Hamlin, the Buffalo Bills player whose heart stopped during a nationally televised game in January, typifies the person for whom CPR was invented: young and fit, and the victim of a sudden, treatable injury rather than a progressive disease. Still, less than ten percent of people who receive CPR outside a hospital survive. Inside hospitals, where CPR begins quickly, the odds are slightly better, but only for those who aren’t in the last stages of life. A mere two per cent of adults over sixty-seven with severe chronic disease, including cancer, are alive six months after CPR, and they often deal with pain, physical debility, and post-traumatic stress disorder. Reversing a death is not the same as restoring a life.

And yet doctors, including a younger version of the author, often give families the choice of performing CPR or not without offering the grim statistical chance of failure, giving the impression that they are choosing between life or death. Families and physicians alike are traumatized in these situations because the truth is not easy to discuss. 

Texas is one of the few states in the country that offers legal protection for physicians who resist requests for medically inappropriate treatment (Ch. 166, Tx. Health & Safety Code). It was amended in 2017 to add Subchapter E, which may fairly be characterized as hostile to do-not-resuscitate (DNR) orders. The unfortunate result has been to sow confusion and doubt about when a hospital DNR order may be written and, once written, when it may or may not be followed. The need for such a law was dubious at the time, and although amendments have provided some clarity, Subchapter E stands as a prime example of the unwisdom of legislatures prescribing standards of care.

SEC's Final Cybersecurity Rule and the Health Care Industry

Rachel Rose and Bob Chaput have written a helpful guide to the SEC's new final rule on cybersecurity and related issues (most especially reporting cyber breaches): "The Nexus Between the SEC’s Final Rule and the Health Care Industry" in the American Health Law Association's Health Law Weekly (Aug. 4, 2023). The first couple of paragraphs serve as an abstract for the piece (footnotes omitted):

In March 2023, we wrote the article, Why ALL Health Care Organizations Must Care About SEC Proposed Cybersecurity Rule Changes, which highlighted the U.S. Securities and Exchange Commission’s (SEC’s) March 9, 2022 announcement of its proposed rules related to cybersecurity requirements (i.e., risk management, corporate governance, and incident disclosures).

While testifying in front of the U.S. Senate Committee on Banking, Housing, and Urban Affairs, SEC Chairman Gary Gensler stated, “[t]he proposed amendments are intended to better inform investors about a registrant’s risk management, strategy, and governance and to provide timely notification of material cybersecurity incidents.” The wait is over. On July 26, 2023, the SEC released its final rule related to cybersecurity. Specifically, the final rule requires registrants and foreign issuers alike “to disclose material cybersecurity incidents they experience and to disclose on an annual basis material information regarding their cybersecurity risk management, strategy, and governance.”

This article highlights some of the key areas that health care sector participants—public, private, and not-for-profit—should consider in relation to enterprise risk management and policies and procedures.

Before those of you who don't represent clients whose shares are registered with the SEC conclude this article doesn't apply to those companies, NOT SO FAST. One of the major takeaways of this article -- which is brief and to the point -- is that there is enough potential liability to go around.

The article is available to AHLA members only, which is reason enough to join if you haven't already!

Mental Health and the Criminal Justice System

Much has been written about the shockingly low level of mental health facilities and services in Texas, especially if you are poor or uninsured or incarcerated. And much has been written about months and years of incarceration that may befall a defendant who cannot make bail. The combination of inadequate services and long-term incarceration is a prescription for disaster.

PBS's "Frontline" (with its local affiliate, KFAE, in Charlotte, NC) took a look at this situation through the lens of one prisoner who cycled between jail and the mental health system, such as it is, for five years while waiting for his trial. Text and audio are here.

Medical Error & AI: Who Is Liable?

"Locating Liability for Medical AI" [SSRN Download (requires subscription)]
DePaul Law Review, Forthcoming

W. NICHOLSON PRICE II, University of Michigan Law School
Email: wnp@umich.edu

I. GLENN COHEN, Harvard Law School
Email: igcohen@law.harvard.edu

Abstract:

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed for adaptation and monitoring. If that information is unavailable, we suggest that liability should shift from hospitals to the developers keeping information secret.

Abortion Litigation: Texas Trial Judge Enjoins Enforcement of SB 8 Under Limited Circumstances

In a nutshell: "A Texas judge ruled Friday [Aug. 4] the state’s abortion ban has proven too restrictive for women with serious pregnancy complications and must allow exceptions without doctors fearing the threat of criminal charges" (Associated Press). 

First, the opinion. It's not long and is worth reading.

Or, go straight to the BBC's excellent coverage of yesterday's ruling. Or the Texas Tribune:

State District Court Judge Jessica Mangrum of Austin wrote that the attorney general cannot prosecute doctors who, in their “good faith judgment,” terminate a complicated pregnancy. Mangrum outlined those conditions as a pregnancy that presents a risk of infection; a fetal condition in which the fetus will not survive after birth; or when the pregnant person has a condition that requires regular, invasive treatment.

Predictably, the state took a same-day appeal to the Texas Supreme Court, which had the effect of immediately staying Judge Mangrum's order. 

For part of one day, women in Texas had their right to potentially life-saving treatment restored. Texas, though, continues to follow its preferred policy of death, disability, and denial of reproductive autonomy.

Is Common-Law Contract Theory Superior to the No Surprises Act?

A new article from David Orentlicher et al.:

"Limiting Overall Hospital Costs by Capping Out-of-Network Rates" [Free Download]
Annals of Health Law, Vol. 32, No. 2 (2023)

DAVID ORENTLICHER, University of Nevada, Las Vegas, William S. Boyd School of Law
Email: david.orentlicher@unlv.edu

KYRA MORGAN, Nevada Department of Health and Human Services

BARAK D. RICHMAN, Duke University, School of Law, CERC, Stanford Univ. School of Medicine
Email: richman@law.duke.edu

Abstract:

Contract theory offers a simple and wildly effective solution to surprise bills: Hospital admissions contracts are contracts with open price terms, which contract law imputes with market rates. This solution not only obviated the costly, time-consuming, and complicated (and still unimplemented) legislative fix in the No Surprises Act, but it also is a superior solution since it introduces superior incentives to disclose, compete, and economize. 

Using data from the Nevada Department of Health and Turquoise Health, this paper explores the theory and empirics of employing contract law's solution to hospital surprise bills and its superiority over other legislative interventions.

Reproductive Rights after Dobbs: New Article in SMU Law Review

"Pregnancy Risk and Coerced Interventions after Dobbs" [Free Download]
SMU Law Review, Vol. 76, No. 1 (2023)

ELIZABETH KUKURA, Drexel University Thomas R. Kline School of Law
Email: kukura@drexel.edu

Abstract:

Only nine months after the Supreme Court eliminated the federal constitutional right to abortion in Dobbs v. Jackson Women's Health Organization, fourteen states had banned abortion entirely, and experts estimate the ultimate number of states imposing complete or near-complete restrictions on abortion care will likely rise to twenty-four. Millions of people with the capacity for pregnancy now (or will soon) live in places where getting pregnant means there is no choice other than to carry the pregnancy to term and give birth. One underappreciated, though critically important, impact of Dobbs is the extent to which newly enacted abortion restrictions will increase both the number of people with high-risk pregnancies and, relatedly, the number of people who are coerced into medical treatment during labor and delivery. Such mistreatment in the form of coerced interventions will compound the harm of forced pregnancy after Dobbs with negative consequences for the physical and emotional well-being of birthing people and their babies.

Public Health Law Priorities to Pursue While Congress Recesses

The American Public Health Association (APHA) sent out its call to action during the current Congressional recess. In addition to providing advice on how to press your views on public-health issues while the Senators and Representatives are away, the APHA missive provides links to a wealth of policy papers, reports, and the like across a broad spectrum of public health. And its not only about Congress. As the APHA suggests, state and local officials -- traditional wielders of "police powers" -- also need to be educated about public health, about which so much misinformation and disinformation emerged during COVID. And there are op-ed opportunities. The list goes on . . . .

Congressional recess is here (July 31 – Sept. 11 for the House and July 31 – Sept. 4 for the Senate) which makes this month the perfect time to raise your public health voice and urge your members of Congress to take action. Join the Speak for Health campaign with APHA’s suggested advocacy activities:

•  Got a minute? Head over to APHA’s action alerts and send a quick message to your elected officials on a variety of topics including environmental health, reproductive rights, gun violence and public health funding.
• Schedule a meeting with your members of Congress, virtually or in person, to discuss public health priorities. You can call their local offices for details on scheduling a meeting.
• When speaking to elected officials, point to APHA’s 2023 advocacy priorities as key areas for action.
• Boost your advocacy efforts with issue fact sheets that summarize priority advocacy issues and state fact sheets that break down public health in each state.
• Write and submit an op-ed to your local paper. APHA offers op-ed writing tips and sample op-eds on gun violence, climate change, public health funding and reproductive health which you can request by emailing speakforhealth@apha.org.
• Engage elected officials on social media about their support for public health. You can include social media shareable images found on the Speak for Health page, and make sure you use the hashtag #SpeakForHealth!
• Attend a town hall and ask your elected official key questions about their commitment to supporting public health. You can contact their office to ask when the next town hall is scheduled.

Your voice helps shape how members of Congress view critical public health issues, and your community’s public health concerns deserve to be heard by our nation’s leaders. Join us and Speak for Health — for today and for future generations.

The APHA 2023 advocacy priorities cover a lot of territory and offer something for everybody:

• Increase and protect funding for vital public health agencies and programs and strengthen the nation’s public health infrastructure. 
• Uphold the Affordable Care Act and expand access to health coverage and services. 
• Address the health impacts of climate change. 
• Protect access to reproductive health care. 
• Pass a 2023 Farm Bill to protect nutrition security. 
• Protect nutrition standards for children. 
• Uphold and strengthen critical public health laws and regulations and reverse damaging rollbacks. 
• Address the nation’s gun violence epidemic.

For more information on APHA’s advocacy priorities, visit https://www.apha.org/advocacy or contact Don Hoppert at Donald.Hoppert@apha.org or Jordan Wolfe at Jordan.Wolfe@apha.org.   

Henrietta Lacks -- Still Immortal -- Family Settles Suit Against Thermo Fisher Scientific

Anyone who has read The Immortal Life of Henrietta Lacks is familiar with the story. Cancer cells from Henrietta Lacks's cervix were grown in a lab in the 50s after it was shown that, unlike most cells, they could reproduce in vitro. This made them incredibly valuable for biologic research:

Research using the HeLa cells has led to the development of vaccines treatments for diseases including cancer, Parkinson’s and the flu. The cells have also been used by researchers around the world and have been cited in more than 110,000 scientific publications, according to the National Institutes of Health. (NY Times, Aug. 1, 2023)

But Ms. Lacks -- who was black and being treated in a segregated ward at Johns Hopkins -- wasn't informed that her cells were harvested for research and didn't consent to their use. And for more than 70 years biotech firms have reaped millions in profits from the use of her cells.  

The NY Times reports (above) that the family has settled its suit against one of the biotech firms for an undisclosed amount. In a news conference yesterday, a spokesman for the family said the fight for justice will go on.

Her story is a perfect storm of racialized medicine, immature research ethics, and money. I'd like to think it couldn't happen in this day and age, but with U.S. and European firms exporting ethically sketchy research to Third-World countries, that is more of a hope than a prediction.

House & Senate Pass Bipartisan Bill to Reform Organ Procurement Transplantation Network

Last Thursday evening (7/27), in a rare bipartisan move, the Senate passed H.R. 2544 (entitled the “Securing the U.S. Organ Procurement and Transplantation Network Act”) without change, and the bill is now on President Biden's desk for his signature. The bill amends 42 U.S.C. § 274 for essentially one purpose.

Federal law currently authorizes the Secretary of HHS to contract with "a private nonprofit entity that has an expertise in organ procurement and transplantation" to operate the OPTN. Since the creation of the Network in 1984, that entity has been UNOS, a Virginia nonprofit. There has been growing unhappiness with UNOS's operation of the network, which led Congress to pass H.R. 2544. It strikes the language quoted above and replaces it with language that says the OPTN "shall . . . be operated through awards to public or private entities made by the Secretary." 

One group -- representing nephrologists and transplant professionals who have had to to work under UNOS's rules for nearly 40 years -- seem pretty happy:

"The American Society of Nephrology (ASN) is grateful for steadfast, bipartisan leadership on behalf of transplant patients demonstrated by tonight's passage of the Securing the U.S. OPTN Act," said Michelle A. Josephson, MD, FASN, ASN President. "The United States transplant system was put into place nearly 40 years ago. As the transplant field has changed over time, Congress' establishment of a modern policy infrastructure to support transplant care means that our field can continue to grow, meeting the needs of the thousands of Americans who would benefit from a kidney transplant."

Roll Call has done some interesting background reporting (7/28/2023) on the concerns that led to the passage of this bill:

 A Senate Finance Committee investigation released last year found that hundreds of people have developed diseases from transplanted organs, and 70 people died between 2008 and 2015 from those illnesses.

The committee argued that such mistakes were allowed to happen because of UNOS’s lack of oversight of organ procurement organizations

A record-high 21.3 percent of procured kidneys were not transplanted in 2020, according to the Scientific Registry of Transplant Recipients. 

More than 100,000 Americans are currently waiting for an organ — mainly kidneys — and an estimated 17 people die each day on the waiting list.

I'm not 100% convinced that UNOS was responsible for all of these lapses. We'll see if bringing in a new company, based on a competitive bid process, makes a difference.

Provider Screws Up its Bill to Medicare, Tries to Stick Patient with 100% of Charge

Today's featured Surprise Bill of the Month (KFF Health News, NPR (July 27, 2023)) involves a 74-year-old gentleman who needed vascular surgery in his leg to relieve pain caused by low circulation. He got the surgery, and it provided him with some relief. The relief was short-lived, though, when a collection agency started sending notices of delinquency in pay for the anesthesia services to the tune of $3,000. The patient is on Medicare and is a long-time owner of a supplemental policy from Humana. His reasonable expectation was that Medicare would be the primary payer and Humana the secondary, and that his out-of-pocket payment would be $0.

After much effort, the patient -- his wife, actually, who worked tirelessly to get a little justice -- discovered that the anesthesiology firm (private-equity-owned North American Partners in Anesthesiology, with thousands of providers in 21 states) failed to bill Medicare until 17 months after the surgery. Medicare requires all bills to be submitted within 12 months and refused to pay. Humana's supplemental policy doesn't pay if a service isn't covered by Medicare. Also, the bill submitted to Medicare, in addition to being late, show that a nurse anesthetist and an anesthesiologist were both present for the entire duration of the surgery, which is a red flag for Medicare and required explanation before Medicare will pay. According to the story, "A [Medicare] quarterly summary notice said while the time limit for filing the claims had expired, [the patient] also could not be billed." That should have been the end of it, right?

Instead of simply eating the charge, NAPA billed the patient for the full $3,000. (The patient says the first he knew of the bill was when he was contacted by a collection agency.) To noöne's surprise, the "News & Insights" page on NAPA's website has no mention of this national story. Meaning no disrespect for Mom-and-Pop businesses everywhere, this is the kind of screw-up that you might expect from a small, family-owned practice that struggles to keep up with the paperwork demands of a busy medical practice. But NAPA is one of the big boys. It has computers and presumably employs billing specialists to keep track of its "thousands of providers in 21 states." 

Pharmaceutical Firms Seek to Block Price Negotiations with Medicare

The New York Times has an excellent piece (23/24 July) on the drug industry's efforts to derail drug-pricing negotiations with Medicare that are authorized by the Inflation Reduction Act. As the deadline for starting negotiations nears, lawsuits have been filed by Johnson & Johnson; Bristol Myers Squibb;  Astellas Pharma; the National Infusion Center Association (NICA), the Global Colon Cancer Association (GCCA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) (read here); and Merck. 

As the Times piece points out, the policy arguments for and against  price negotiations focus on (1) how much of a financial hit the firms will take as a result of lower prices for drugs covered by Medicare and (2) the impact of those reductions on R&D and ultimately on the number of new drugs that will not get to market over the next decade:

A study released last month that was funded by the Biotechnology Innovation Organization . . . warned that the pricing provisions would discourage innovation, resulting in as many as 139 fewer drug approvals over the next 10 years.

But that assessment is at odds with an analysis by the [nonpartisan] Congressional Budget Office, which estimated that the law would result in only one fewer drug approval over a decade and about 13 fewer drugs over the next 30 years. 

The calculations are actually quite difficult to nail down. Consider, for example, that we don't know which drugs will be included in future negotiations (and therefore what the projected savings to Medicare will be). And then there's the spillover effect. Most if not all the most expensive drugs whose prices will be negotiated have competitors, and there is likely to be an effect on the competitors' drug prices. Modeling all these variables can account for much if not all of the difference between the two estimates, but I will take any estimate from a pharma trade group with a large dose of salt.

Price Transparency Rules: 2/3 of Hospitals are Not Complying

According to a recent story from The Hill, Patient Rights Advocate.Org (PRA.Org) has issued a report (July 20) that details a shocking (but not surprising?) level of noncompliance with the requirements of the No Surprises Act, which was intended to eliminate surprise medical bills, with a particular focus on disputes arising from the use of out-of-network providers. (I've posted on this subject here (2021), here (same), and here (2023).)

According to the report -- the fifth semi-annual report published by PRA.Org -- compliance has improved steadily since CMS issued its final rule implementing the Act in August 2022, but 64% of the 2,000 hospitals and health systems surveyed remain partially or totally out of compliance. 

One might expect the largest providers to have the resources to implement billing reforms, but the results among that group are pretty dismal:

Compliance varied widely among the largest hospital systems we reviewed. 

•  None (0%) of the hospitals we reviewed which were owned by HCA Healthcare, Tenet Healthcare, Providence, Avera Health, UPMC, Baylor Scott & White Health, and Mercy were found to be fully compliant.
•  Consistent with prior reports, none of the hospitals owned by the largest hospital system in the country, HCA Healthcare, were found to be in full compliance, with a significant amount of its hospitals posting illegible, nonconforming files.
•  Substantial improvements since our last report include: 88% of hospitals owned by CommonSpirit Health, 97% of hospitals owned by Community Health Systems, and 98% of hospitals owned by Kaiser Permanente were found to be in full compliance. 
• Forty hospitals exhibited 'backsliding,' with an assessment of Noncompliant in the current report after having been assessed as Compliant in our prior report. 

Maybe people of a certain age should stay off social media altogether

The president of Thomas Jefferson University and dean ad interim of TJU's medical school, stepped down this past week, three months after (in the words of a Philadelphia Inquirer article) "liking controversial tweets about COVID-19 vaccines and gender reassignment surgery for children on his official presidential Twitter account." 

The tweets are quoted in the Inquirer article and are straight out of the MAGA playbook. Mark Tykocinski, 70, claimed he used the "like" function to bookmark tweets that he wanted to revisit and research. 

I don't know about that.

On every Twitter message, there's a heart icon to "like" and a flag memo to "bookmark." They are side-by-side; it's hard to see one and not also see the other, though understanding their differences requires an internet search. One crucial difference is that "likes" are public and "bookmarks" remain private. There are lots of sources for this information, including Twitter itself. 

This sounds easy, but for someone old enough to be enrolled in Medicare, it might still be confusing, just as most social media platforms are to me. I am an incredible doofus when it comes to Twitter and Facebook and absolutely hopeless trying to navigate Instagram. TikTok frightens me, so I don't even contemplate going there. In my defense, I will turn 74 in a little over a month. "Influencers" in my world suggest ways to mix a better martini. When it comes to Barbenheimer, I am more comfortable on the "heimer" part of that meme. (It it a "meme"? What, exactly, is a meme? Does something have to move or make noise to be a meme, or can a word or phrase be a meme?)

The bottom line for Tykocinski is that he either agreed with the tweets, which is baffling for a competent molecular immunologist, or he is reckless in his untutored approach to Twitter. There is a reason TJU and every other university and college has professionals who manage institutional social media.

The lesson is an important one for all of us in the health care field, from pre-med college students to med students to residents to doctors and allied health professionals. Be very sparing and very careful in what you post. "Unprofessional conduct" is a subjective judgment, and the beholder whose eyes matter is not, at the end of the day, the person who posts.

Q: When is a Doctor not a "Doctor"?

A: When she (and the nursing field is still predominately women) has a doctorate (could be a D.N.P. or a Ph.D. or . . .  It really doesn't matter, as long as it's not a medical doctorate). That's how California sees it anyway. 

Becker's Hospital Review (July 18) reports on a challenge to California's law: 

Under California law, only physicians and surgeons can use the word "doctor" or the prefix "Dr." In November, Sarah Erny, a nurse practitioner with a doctorate, was found violating the law by allegedly describing herself as a doctor on professional websites and social media. She was fined $20,000 by the state and another $2,500 by the state medical association.

In June, three nurse practitioners with doctorates of nursing sued the California attorney general, leaders of the medical board of California and leaders of the state board of registered nurses, arguing they have a right to call themselves doctors. 

States have a legitimate interest in avoiding deceptive practices, such as deceiving patients about whether they are consulting a medical doctor (M.D. or D.O.) or some other person with a doctorate. And nurses have an interest in honestly and accurately informing the public about their advanced practice credentials. A number of states prohibit the use of the term "Doctor" by non-physicians, so the outcome of this litigation is a matter of national interest. It's actually an international issue, as described by a 2016 article in the Canadian Association of Medicine Journal. 

There's a First Amendment issue here. The strict scrutiny accorded to state-imposed content-based restrictions on speech requires that the state's use of its police powers be the least restrictive means possible. Wouldn't California accomplish its goal by  requiring that anyone using the prefix "Dr." add their doctoral degree(s) after their name? This appears to be how it is handled in Texas. If the degree isn't a medical degree, how likely is it that patients would be deceived? I'm on the side of the nurses on this one.

Contra: When speech is deemed to be "commercial speech," the level of judicial scrutiny is "intermediate," not "strict." A claim by California that the nurses are engaged in commercial speech would require an inquiry into the circumstances surrounding their use of the title "Doctor." Business cards? Professional listings on a job board? Letterhead? 

Medical boards and professional associations are constantly fighting to protect the boundaries of their profession against interlopers. They traditionally do so in the name of good patient care. This dispute has that feature, as well. It should be interesting. 

New Proposed Merger Guidelines from FTC & DOJ

 

In a previous post (May 25, 2023), I featured some of the criticisms leveled by Daniel Sokol and Dick Pierce against the emerging M&A policy at the FTC under the leadership of Lina Khan. It's not likely that the revised merger guidelines released by DOJ and FTC on July 19 will do much to soften their criticism. 

Of particular interest for health lawyers, consider these more or less parallel developments:

• July 14: the two agencies withdrew the Statements of Antitrust Enforcement Policy in Health Care and the Statement of Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program. ACOs represent a major innovation in the 2010 Patient Protection and Affordable Care Act, and a major part of ACO-related policy was the antitrust protection issued by the FTC and DOJ. The ACO initiative hasn't been a roaring success, and if the FTC and DOJ tighten the enforcement screws on ACOs, that could be the end of the road for them.
• July 20: at an open meeting, the FTC voted to issue a statement that discourages reliance on 11 prior advocacy letters and reports issued between 2004 and 2014 related to pharmacy benefit managers.

These are interesting times, indeed, for health-care antitrust counsel and their clients.

American Indian/Alaska Native Health Equity; Private Sector Opportunities

Health Affairs' fourth installment (July 21) of the past week in its Forefront series, "Private Sector Solutions For Health Equity," is written by two principals in Indigenous Pact, a public-benefit corporation whose mission is "[to] provide health care benefits and reimbursement to American Indians and Alaska Native and promote the autonomy and sovereignty of American Indian tribal government over the health of their people.”

The article is a comprehensive review of the hurdles currently faced by indigenous peoples in obtaining health care goods and services, which they introduce with this observation:

The story of American Indian/Alaska Native (AI/AN) health is fractured by genocide and systematic, forced migration away from lands that nourished good health. What existed unsullied for thousands of years was essentially wiped away when colonial settlers stepped foot onto the land that is now called the United States. And what exists now are pieces of brokenness and transgenerational trauma that pervade nearly every aspect of indigenous health.

There’s a well-known, albeit sardonic, pronouncement in Indian Country that admonishes, “You’d better get sick by June or there won’t be any money left—and if you do need medical intervention, it’d better be life or limb because those are the only things that will get authorized.” Unfortunately, it’s funny because it’s true.

The solutions are broad, ambitious, and unflinching. It's way past time to address the needs of this country's original occupants. 

Employers Can Improve Reproductive Health Equity

This is the third in this week's Health Affairs short series on Private Sector Solutions For Health Equity: "Employers Can Help Raise The Bar For Reproductive Health Equity" (July 20) by Sinsi Hernández-Cancio, JD,  vice president for health justice at the National Partnership for Women & Families.

The main focus of the article is on maternal health, which the author frames this way:

We need to solve the maternal health crisis for three main reasons. First and foremost, we must put an end to our status as the most dangerous place to give birth among high-income countries. Second, this crisis is the clearest example of the impact of racism and other structural inequities on the lives and well-being of women and their families. Finally, we know that the healthiest start possible for every person supports a positive life trajectory, while poor maternal and infant health can have long-reaching negative consequences on the health and well-being of both mom and baby.

 Her solutions are multi-tiered, mostly long-term, and hard to read without feeling some despair, e.g.:

• "expand[] their employee health coverage to include out-of-state services for those seeking reproductive care, and also gender-affirming care"
• "invest[] philanthropic dollars in reproductive health advocacy groups such as Planned Parenthood" and in general increase advocacy efforts aimed at improving, not destroying, their employees health care option
• "focus on improving clinical care–especially providing culturally centered, whole-person care that considers the patient’s life context. But health care institutions can and should do more, including aligning their hiring and workplace policies with equity goals, collaboratively partnering with community-based organizations, and pushing for improved policies at various decision making tables"
• diversify "their workforce, especially at leadership levels. According to a 2020 report from Mercer, a business consulting company, 64 percent of corporate entry-level positions were held by white employees; at the executive level that number jumped to 85 percent. The health care industry is no exception. Roughly nine out of ten hospital CEOs are white. Only 15 percent of health care CEOs are women, despite women comprising a large majority of health care workers, including the maternal health workforce."
• "focus[] on the dignity, personal agency, and bodily autonomy of birthing people. Among the recommendations: screening for and helping to meet patients’ physical, mental, and social health needs, and measuring respectful care for internal improvement and accountability. This includes understanding and addressing how structural inequities undermine people’s health."
• "collaborate and co-create with community-based partners"

The basic lesson here is that maternal health won't get significantly better if we wait for initiatives and funding to come from the public sector, nor can it happen without the public sector. One engine for change is companies that are willing to put resources -- including time and money -- into improving health for their employees.

Almost four years ago, Texans Care for Children (TCC) issued a report, Healthy Moms Raising Healthy Babies: Central Texas and Statewide Challenges and Opportunities to Support Maternal Behavioral Health During the First Year After Childbirth (Oct. 2019). One section addressed "What Factors Contribute to Racial Disparities in Maternal Health Outcomes?" The factors include:

• Implicit biases in our health care system can affect the quality of health care provided, decision making, and how health programs are carried out. 
• Chronic stress, including the physical toll of stress related to structural racism, increases health risks for mothers and babies. 
• Discrimination, both past and present, negatively affects social determinants of health — such as housing, food scarcity, and education, among others. 
• Lack of access to health insurance disproportionately affects people of color and limits the ability to manage health conditions before and after pregnancy. 

The depth and complexity of social and cultural roots of the problem reinforce the conclusion I drew from Ms. Hernández-Cancio's article: It's going to take a lot of work, a lot of investment, and a lot of time to improve maternal health in this country. 

One thing the legislature and Governor Abbott could do with the stroke of a pen and at almost no cost to the state is take up the federal government's invitation to expand Medicaid eligibility and let the United States pay for nearly all of the additional cost. As the TCC report noted:

In Texas, Black and Hispanic women are more likely to be uninsured than White women. Seventeen percent of nonelderly Black adults in Texas, 29 percent of nonelderly Hispanic adults, and 12 percent of nonelderly White adults in the state were uninsured in 2017.

Recent research found that states that offer Medicaid insurance to cover low-wage adults who do not have insurance through their job experienced a decrease in disparities for Black families with respect to maternal mortality, infant death, preterm birth, and low birth weight babies. Specifically:

Analysis of data from 2010 to 2016 found that infant deaths have declined across most states, but the decline was more than 50 percent greater in states that offer health coverage before, during, and after pregnancy — with the decline in infant deaths greatest among Black infants.

Research found that coverage for low-wage workers before, during, and after pregnancy was associated with “significant improvements in disparities for black infants relative to white infants for the four outcomes studied: preterm birth, very preterm birth, low birth weight, and very low birth weight.” 

Is a drop of empathy too much to ask of our state leaders? This is the question I've been asking on this blog for years (here, here, here, here, and here). When we find that our leaders are unmoved by the deaths of women who need life-saving abortions and women dying during and after childbirth, it ought to be a question that decides elections.

U.S. Child and Teen Firearm Mortality is Off the Chart. Literally.

Following up on my Father's Day post about firearms.  The Kaiser Family Foundation has released a new issue brief: "Child and Teen Firearm Mortality in the U.S. and Peer Countries". One graphic tells the story:

It's the #1 cause of death (by a pretty wide margin) for minors (ages 1-17), ahead of motor vehicles, cancer, and all other causes.

It's a short paper with an important message. The concluding paragraph raises an issue that doesn't get a lot of coverage in the popular press:

Exposure and use of firearms also have implications for mental health. Research suggests that youth may experience symptoms of post-traumatic stress disorder and anxiety in response to gun violence. Specifically, survivors of firearm-related injuries, including youth survivors, may be at increased risk of mental health conditions and substance use disorders. Furthermore, gun violence disproportionately affects many children of color, particularly Black children, and children living in areas with a high concentration of poverty.

This is a public health issue and ought to be understood as a public health law issue as well. When will legislatures wake up?

Gene Editing: New Report from Third International Summit

This is a must-read document for students of bioethics, teachers, and practitioners. Here are the details:

NEW PROCEEDINGS OF A WORKSHOP—IN BRIEF

Third International Summit on Human Genome Editing: Expanding Capabilities, Participation, and Access

The proceedings of the Third International Summit on Human Genome Editing, which took place on March 6-8, 2023 in London, are now available in a free PDF (readable and downloadable).

Building on previous events held in Washington, D.C. (2015) and Hong Kong (2018), the third summit examined scientific advances that have occurred since the previous summits and the need for global dialogue and collaboration on the safe and ethical application of human genome editing.

The first two days of the summit focused largely on somatic human genome editing, where the cells being altered are non-reproductive cells - as a result genetic changes cannot be passed on to future generations.

The third day of the summit broadened the discussion to include heritable human genome editing, in which genetic changes could be passed on to descendants.

The summit proceedings highlight the presentations and discussions of the event. 

The summit was organized by the UK Royal Society and Academy of Medical Sciences, the U.S. National Academy of Sciences and National Academy of Medicine, and UNESCO-The World Academy of Sciences for the advancement of science in developing countries (TWAS).  

For fogies like me, I assumed the conference would be all about CRISPR-Cas9 (the technique that garnered its co-inventors a Nobel Prize), but that gene-editing technique is yesterday's news:

The CRISPR-Cas9 system discovered by Doudna and Emmanuelle Charpentier is still a widely used tool in genome editing, but newer systems are even more powerful and precise. Techniques known as base editing and prime editing enable efficient and precise gene correction in a wide variety of cell types without requiring that both strands of the DNA molecule be broken, minimizing the possibility of DNA deletions, insertions, or rearrangements that can result from double-stranded DNA breaks. Many laboratories have used prime editing to treat diseases in animal models of human disease, and some of these techniques have been applied in clinical trials. [Proceedings, p. 4]

The ethical concerns, like the Dude, abide: accessibility and affordability of somatic gene editing, the lack of infrastructure and expertise in developing countries, the difficulty and complexity of determining the value of new therapies, the need to engage the public in sophisticated policy discussions, appropriate oversight of experiments, and probably the most polarizing topic of all: germline and heritable gene editing. 

Private-Sector Strategies to Address Disparities in Access to Mental Health Resources

Health Affairs just published the second of four articles on private-sector strategies to address disparities in access to health care: "Addressing The Mental Health Equity Crisis: Can The Private Sector Lead?" The author is Wizdom Powell, Ph.D., M.P.H. (recently named one of the 25 Essential Voices on Black Mental Health). 

"Crisis" is not hyperbole. As inequitable as access to health care is in general, access to mental health care is even more problematic. Helping a friend or family member to be seen, evaluated, and into appropriate treatment is the medical equivalent of banging your head against a brick wall over and over again. As Dr. Powell writes, "By any measure, an all-hands-on-deck approach is needed." She continues:

Health disparities, or preventable differences in the burden of chronic disease and health outcomes, are a driving force behind mental health inequities. Our health equity problem is of our own making, created by artificial caste distinctions, persistent racism, and how we structure our economy and investments in health care; the status of health care disparities is determined, largely, in the ways that the private sector either confronts them or looks away. It is also valuable to recognize that the wicked problem of health inequity is not immutable and that our lack of sustained advancement has more to do with internalized myths of complexity than with our societal capacity.

Wicked problems aren’t unsolvable; instead, they offer many paths to a solution. Just as we have created the problems, we can create the solutions as well. This requires the private sector to do what can prove difficult for public sector leaders—invest resources in pursuing a mental health equity moonshot. The private sector is uniquely positioned and resourced to take the lead in marshaling solutions that will deliver the rapidity and scale necessary to address these troubling trends and ultimately advance health equity. 

Read the article and learn about DEIBJ (Diversity, Equity, Inclusion, Belonging & Justice) and SDGs (the United Nations' Sustainable Development Goals). The article is a quick read and well worth your time. 

JAMA: SCOTUS Decision on Race in College Admissions Will Worsen Health Care Inequities

New online and free article in JAMA: "The Supreme Court’s Rulings on Race Neutrality Threaten Progress in Medicine and Health," by public health scholars Harald Schmidt, Lawrence O. Gostin, and  Michelle A. Williams.

The first paragraph should whet your appetite for more:

In landmark rulings, the US Supreme Court significantly restricted race-conscious admissions policies in higher education, a chilling echo of its evisceration of settled law on abortion. In principle, race neutrality is desirable—but it is one thing to set aside race in a society with genuine equal opportunity, and another to do so where stark differences persist in opportunities and outcomes, fueled by a 400-year history of systemic racism. While the Court focused on education, its rulings could have broad and pernicious implications for health. They could upend programs designed to achieve equity and actively harm population health.