When Your "Free" Annual Check-up Isn't Free

A good reminder from the Kaiser Family Foundation (and broadcast on NPR's "Morning Edition" today: The ACA requires that insurers pay for an annual physical with no out-of-pocket payment by the insured patient, but that doesn't cover "extra" services that are offered during the same visit.

What's "extra." Like so much in health care, it depends.

One patient, Christine Rogers, answered her doctor's screening questionnaire honestly when it asked about depression. Her mother had unexpectedly died in a nursing home 13 hours away, and she answered the questionnaire with "It was a horrible year. I lost my mom." That triggered a 5-minute conversation about depression and an additional charge - not covered by her insurer - of $76.06.

Ms. Rogers felt a bit betrayed by a screening process that depends upon honest answers to questions about a patient's physical and emotional condition and then adds to her bill at the rate of $912.72 an hour.

The hospital and physician group stood behind the charge but -- perhaps to avoid being highlighted by KFF and NPR -- wrote off the extra charge.

The take-away: The ACA guarantees you one free physical per year, but what's included in that free service may vary from provider to provider, with precious little guidance to constrain billing practices.

Caveat emptor, indeed.

Abortion: Legislative Update

We* had our 36th Annual Conference of the Professions here in Dallas yesterday. The official title was "Governmental conflict with standards and professional judgment: Case studies in Texas." Our keynote speaker -- Prof. David Orentlicher, M.D., J.D. -- was great, as were our panelists from the clergy, law, and medicine -- Dr. Charles Brown, TAMU School of Medicine; Shelly Skeen, JD – Southern Regional Director, Lambda Legal; and Rev. Danielle Ayers, Pastor of Justice, Friendship-west -- and our panel moderator, Rev. George Mason, pastor emeritus of Wilshire Baptist Church & founder of Faith Commons.

It didn't take a lot of imagination to read our open-ended title and conclude that abortion and gender-affirming care would figure prominently in the discussion. We did cover a number of other subjects, but these two topics dominated the discussion.

Coincidentally, today's Washington Post ran an article on the abortion bans around the country, with a focus on the vague language state legislatures use to describe exceptions to the ban, e.g.:

(Click on images to enlarge.)

Predictably, that vague language leaves physicians and hospital guessing about whether any particular patient's condition qualifies for termination of her pregnancy. The Conference explored this effect in some detail yesterday. If you missed it, this article is a very good guide to the issue.

_____________________
*The organizers of the Conference are:  SMU Dedman School of Law, the Dallas County Medical Society, the Dallas Bar Association, the SMU Perkins School of Theology, The University of Texas Southwestern Medical Center at Dallas, Faith Commons, and SMU’s Maguire Center for Ethics and Public Responsibility.

J.D. Degree is a Lousy Way to Get to a Health Care C-Suite

Becker's CEO Report had an article on Tuesday about "The most common degrees for healthcare CEOs," based upon a report by C-suite consulting firm Crist|Kolder. Lawyers are well represented in the ranks of CEO at universities, nonproft organizations, and for-profits, but within healthcare organizations? Not so much:

Fifty percent of healthcare CEOs have a MBA and did not study beyond it, compared to a cross-industry average of 43 percent, according to the report. Another 21.2 percent received only a bachelor's degree. 

More healthcare CEOs hold a MD or PhD than chief executives of any other industries; over 15 percent can call themselves "doctor." 

In addition, 4.5 percent have their JD, and 9.1 percent hold a Master's in any field. 

Hospice Director Sentenced in $150+ Million Fraud Scheme

A hospice medical director was sentenced yesterday to 50 months in prison for his role in a scheme that involved the submission of over $150 million in false and fraudulent claims to Medicare for hospice and other health care services. According to DOJ's press release: 

According to court documents, from 2009 to 2018, Jesus Virlar-Cadena, 52, served as the medical director of the Merida Group, a large health care company that operated dozens of locations throughout Texas. Evidence at the trial of co-defendants Rodney Mesquias, Henry McInnis, and Francisco Pena, showed that the Merida Group marketed their hospice programs through a group of companies known as the Merida Group. They enrolled patients with long-term incurable diseases, such as Alzheimer’s and dementia, as well as patients with limited mental capacity who lived at group homes, nursing homes, and in housing projects. In some instances, Merida Group marketers falsely told patients they had less than six months to live. They also sent chaplains to the patients based on the false pretense they were near death. [emphasis added]

In order to bill Medicare for these services, the Merida Group hired Virlar and other medical directors, but made payment of their medical director fees contingent upon an agreement to certify unqualified patients for hospice. In addition to regular medical director payments, Virlar received luxury trips, bottle service at exclusive nightclubs, and other perks in exchange for his certification of unnecessary hospice patients. In exchange for these illegal kickbacks, Virlar himself certified over $18 million in unnecessary hospice services as part of the over $150 million conspiracy.   

Putting aside the financial crime involved in this case. Lying to these patients that they have a terminal illness is a gross violation of the interests of a vulnerable population. 

Tennessee Physician Sentenced in $1.88 Million Health Fraud Case

A Tennessee doctor will have 7 years in federal prison to contemplate his crimes against the Medicare program and his patients. 

He was convicted on a 36-count indictment in the following scheme, as described by the U.S. Attorney for the Middle District of Tennessee:

The defendant, through his medical clinic in Clarksville, billed federal health insurance programs for hundreds of medically unnecessary services, including unnecessary office visits and steroid injections. The evidence at trial showed that he required Medicare beneficiaries and other patients to visit his clinic as many as six times each month and to undergo unnecessary steroid injections in order to obtain their prescriptions. The evidence also showed that the defendant altered progress visit notes in his patients’ medical records to justify higher billing rates.

The physician was ordered to pay over $1 million in restitution and serve three years of supervised release.  He was also fined $195,000 and must forfeit previously seized assets worth approximately $900,000.

This isn't the physician's first encounter with the legal system. In 2022 the Administrator of DEA revoked his authorization to prescribe controlled substances, based upon findings that he indiscriminately and dangerously prescribed large amounts of oxycodone and other controlled substances. See Fed. Reg., Jan. 19, 2022, at 2986. 

Health care fraud is as health care fraud does.

Chamber of Commerce Is Denied an Injunction to Halt Medicare Drug Price Negotiations

Happy to do the bidding of Big Pharma, the US Chamber of Commerce sued the Biden Administration to stop the Drug Price Negotiation Program created by the federal Inflation Reduction Act,  42  U.S.C.  §§ 1320(f), et  seq in its tracks on the theory that this program violates due process. The Chamber was joined by a handful of affiliates -- along with AbbVie, Inc., manufacturer of the lucrative Imbruvica (used to treat Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)) and is one of eight such suits filed around the country.

On Friday a Trump appointee in the Southern District of Ohio denied the Chamber's motion for a preliminary injunction, as well as the government's motion to dismiss. The opinion is a Civil Procedure teacher's dreams, covering such juicy first-years topics as:

• subject-matter jurisdiction
• standing, especially associational standing
• ripeness
• the standards for a preliminary injunction, especially irreparable harm if denied and likelihood of prevailing on the merits.

Dayton Area Chamber of Commerce v. Becerra, S.D. Ohio, September 29, 2023, No. 323cv00156SDOh/5.

It's hard to say how long this victory for HHS will last. Plaintiffs were ordered to file an amended complaint by October 13, and HHS will have until October 27 to respond, so it will be at least November before there's another ruling. Meanwhile, discovery will continue.

AHLA Podcast on Tax-Exempt Joint Ventures

AHLA has a nice, 19-minute podcast that offers a useful overview of the types of issues that arise when a tax-exempt entity enters into a joint venture (mostly ancillary jv's rather than whole-hospital jv's) with a for-profit entity. The participants include the indefatigable Gerry Griffith, Partner, Jones Day (Detroit), as well as Jennifer Noel, Corporate Director of Tax, Christiana Care Health System, and Robert Friz, Partner, PricewaterhouseCoopers. Nerd that I am, I love these tax issues and look forward to teaching them in my Health Law course each year. 

This podcast is actually a teaser for AHLA’s upcoming "Tax Issues for Health Care Organizations" program in Washington, DC on October 23-24. The program and faculty all look great.

Disclaimer: AHLA didn't ask me to post this plug for the program. 

Fourth Circuit Reinstates ERISA Claim Against Administrator (and Contractors) of Self-Insured Plan

Here are the facts as stated in the Fourth Circuit's opinion in Rose v. PSA Airlines et al., (4th Cir. 9/11/2023):

The Employee Retirement Income Security Act's § 502(a)(1)(B) allows a beneficiary to “recover benefits due to him under the terms of his plan.” And ERISA's § 502(a)(3) allows a beneficiary to sue for “other appropriate equitable relief.” This case requires us to answer when—and under what conditions—a plaintiff may seek monetary relief under one of those provisions.

Jody Rose's son had a rare heart condition. He died at the age of twenty-seven, awaiting a heart transplant, which Rose says that Defendants—who administered her son's employer-based health benefits program—wrongfully denied. So she sued on behalf of his estate, seeking monetary relief under both § 502(a)(1)(B) and § 502(a)(3). The district court dismissed both claims. As to Rose's (a)(1)(B) claim, the court held that money was not one of the “benefits” that her son was owed “under the terms of his plan.” And, as to her (a)(3) claim, the court held that her requested monetary relief was too similar to money damages and was thus not “equitable.”

We now affirm in part and vacate in part. The district court correctly held that money was not one of the “benefits” that Rose's son was “due” “under the terms of his plan.” So it was right to dismiss her (a)(1)(B) claim. But we must vacate its complete dismissal of Rose's (a)(3) claim. While the district court correctly noted that compensatory, “make-whole” monetary relief is unavailable under § 502(a)(3), it did not consider whether Rose plausibly alleged facts that would support relief “typically” available in equity. Montanile v. Bd. of Trs., 577 U.S. 136, 142, 136 S.Ct. 651, 193 L.Ed.2d 556 (2016). We thus remand for the district court to decide in the first instance whether Rose can properly allege such a theory based on a Defendant's unjust enrichment, including whether an unjust gain can be followed to “specifically identified funds that remain in the defendant's possession” or to “traceable items that the defendant purchased with the funds.” Id. at 144–45, 136 S.Ct. 651.

So the district court will now decide whether unjust-enrichment damages are available under § 502(a)(3). And unless the case settles, there will be the inevitable appeal to the Fourth Circuit no matter which way the lower court rules. And then cert.?

This case is worth watching. The Supreme Court ruled 30 years ago that § 502(a)(3) does not authorize damage actions, at least under the narrow facts of that case. See Mertens v. Hewitt Assocs., 508 U.S. 248 (1993). Yale law professor John Langbein has written that the Court got it wrong in Mertens. The Court has repeated its no-damages refrain in later cases over the decades. Is an unjust-enrichment claim the way to crack open that ruling? 

Texas Attorney Convicted for Role In Kickback Scheme

It's relatively rare for an attorney to be such an integral part of a kickback-for-referrals scheme that he gets convicted of money-laundering (as well as a charge of perjury for lying about the scheme under oath), but that's what happened this summer to Houston lawyer Peter Bennett. See Law360, 7/17/2023. Bennett was convicted on charges that he created sham corporations and sham trusts to launder money paid for referrals to a local hospital. His motion for acquittal or a new trial is pending before District Judge Jeremy Kernodle in the Eastern District of Texas. See Law360, 9/11/2023.

If there's ever an opinion in this case, it would provide a cautionary tale for my health law students . . . 

How Many Separate Fraud Schemes Can You Spot in This Picture?

This doesn't quite match the $200 million health care fraud scheme I reported on yesterday, but it could still be a great final exam "issue spotter" in my Health Care Law class. It reminds me of those children's puzzles that have 10 or 15 errors partially hidden in a picture. Here's the picture (from the DOJ press release; emphasis added):

[T]he United States has filed and settled a civil fraud lawsuit against KLAUS PETER RENTROP and his medical practice GRAMERCY CARDIAC DIAGNOSTIC SERVICES P.C. (“GRAMERCY CARDIAC”) for paying millions of dollars in kickbacks to physicians and their practices for patient referrals.

RENTROP and GRAMERCY CARDIAC offered and paid physicians and their practices millions of dollars in kickbacks in the form of inflated “rental payments” and referral fees to induce them to refer patients to Gramercy-contracted cardiologists and to Gramercy Cardiac for diagnostic tests and procedures, in violation of the Anti-Kickback Statute and the Stark Law. 

RENTROP and GRAMERCY CARDIAC’s scheme worked as follows.  RENTROP and GRAMERCY CARDIAC entered into office space rental agreements, often in excess of fair market value, with primary care and other physicians or their medical practices (the “Rental Practices”).  These agreements typically provided for the use of an exam room once or twice a month, as well as for the use of basic equipment (e.g., a telephone and a computer) and front desk staff to assist with scheduling.  The defendants often agreed to pay thousands of dollars each month in rent.  RENTROP and GRAMERCY CARDIAC also entered into independent contractor agreements with dozens of cardiologists (the “Gramercy-Contracted Cardiologists”) who were sent to see patients at the Rental Practices.  In exchange for the purported “rental payments,” the Rental Practices referred patients to the Gramercy-Contracted Cardiologists, who in turn referred many of these patients to a GRAMERCY CARDIAC office to undergo cardiac diagnostic tests and procedures.  RENTROP and GRAMERCY CARDIAC paid the Gramercy-Contracted Cardiologists a flat fee for each test or procedure performed on referred patients at a Gramercy Cardiac location, with larger fees paid for tests and procedures for which GRAMERCY CARDIAC received a greater reimbursement.  These per-procedure fees were the only compensation paid to some Gramercy-Contracted Cardiologists.

To ensure the kickbacks paid to the Rental Practices were working, RENTROP directed his staff to calculate GRAMERCY CARDIAC’s return on investment from the “rental payments” paid to each Rental Practice.  RENTROP insisted on a minimum return on investment of at least 300% from the kickbacks. 

These Rental Practices referred tens of thousands of patients to the Gramercy-Contracted Cardiologists, who in turn referred more than 23,000 patients for PET and SPECT scans at GRAMERCY CARDIAC.  A significant proportion of these patients were Medicare or Medicaid beneficiaries: GRAMERCY CARDIAC billed Medicare or Medicaid for tests or procedures provided to tens of thousands of Medicare or Medicaid beneficiaries who were referred by the Rental Practices, including for PET and SPECT scans for many thousands of these beneficiaries.  As a result, the claims submitted for payment for these tests and procedures were false and violated the federal False Claims Act. 

As part of the settlement, RENTROP and GRAMERCY CARDIAC each admits, acknowledges, and accepts responsibility for the following conduct:

From 2010 through 2021, GRAMERCY CARDIAC, at RENTROP’s direction, entered into rental agreements (the “Rental Agreements”) with more than 130 physicians and medical practices (the “Rental Practices”) under which GRAMERCY CARDIAC leased a portion of the practice’s office space, usually one or two exam rooms for certain days or hours each month.  RENTROP took part in the negotiation of the Rental Agreements and signed them on behalf of GRAMERCY CARDIAC.  GRAMERCY CARDIAC paid a total of more than $11 million to the Rental Practices pursuant to the Rental Agreements. 

From 2010 through 2021, GRAMERCY CARDIAC, at RENTROP’s direction, entered into independent contractor agreements (the “Independent Contractor Agreements”) with more than 50 cardiologists (the “Gramercy-Contracted Cardiologists”) or their medical practices.  RENTROP took part in the negotiation of the Independent Contractor Agreements and signed them on behalf of GRAMERCY CARDIAC. 

GRAMERCY CARDIAC sent the Gramercy-Contracted Cardiologists to the rented office space one or more times each month to see patients who were referred for an assessment by the healthcare providers at the Rental Practice.  The Gramercy-Contracted Cardiologists in turn referred these patients to GRAMERCY CARDIAC to undergo diagnostic tests and procedures, such as PET and SPECT scans.

GRAMERCY CARDIAC paid many of the Gramercy-Contracted Cardiologists a flat fee for each diagnostic test or procedure which the cardiologist referred to GRAMERCY CARDIAC provided that the patient received the test or procedure at a GRAMERCY CARDIAC location.  These “per procedure” fees were the only compensation GRAMERCY CARDIAC provided to the Gramercy-Contracted Cardiologists.

Certain versions of Independent Contractor Agreements stated that the Gramercy-Contracted Cardiologist was to be paid not for the referrals to GRAMERCY CARDIAC, but rather for the “[a]dministration and supervision” of the PET and SPECT scans to be performed at GRAMERCY CARDIAC.  However, in many cases, the Gramercy-Contracted Cardiologists did not, in fact, administer and supervise the PET and SPECT scans and were nonetheless paid by GRAMERCY CARDIAC based solely on the number of tests and procedures referred.

At the time the Rental Agreements were executed, it was understood that the Rental Practices would refer their patients to the Gramercy-Contracted Cardiologists.  Indeed, GRAMERCY CARDIAC calculated the number of hours per month that GRAMERCY CARDIAC leased the office space based on the volume of expected patient referrals.

GRAMERCY CARDIAC calculated its return on investment from its Rental Agreements — which it internally referred to as the “efficiency” of the Rental Agreements — by comparing the revenue GRAMERCY CARDIAC generated from the patient referrals to the payments it made to the Rental Practice.  

When a Rental Agreement’s return on investment fell below the minimum threshold, GRAMERCY CARDIAC, at RENTROP’s direction, would often refuse to pay the Rental Practice the amounts due under the Rental Agreement.  In addition, at RENTROP’s direction, GRAMERCY CARDIAC Physician Liaisons advised Rental Practice physicians that if the volume of referrals to Gramercy-Contracted Cardiologists did not increase, rent would be decreased, or the Rental Agreement would be terminated.  GRAMERCY CARDIAC terminated a number of Rental Agreements because the return on investment through patient referrals was too low.

When negotiating or re-negotiating the monthly rental payment to be made under a Rental Agreement, GRAMERCY CARDIAC took into account the expected or historic return on investment based on the volume of patient referrals generated from the Rental Practice.

The rental fees paid by GRAMERCY CARDIAC under the Rental Agreements were in excess of fair market value for at least some Rental Agreements.

That's a whole lotta kickback-payin' goin' on! How much fraud are we talking about? The defendant physician and his practice are paying $6.5 million to settle the charges, but if they fail to pay, there is "a Consent Judgment in the amount of $64,416,515, which may be enforced if Defendants do not make the payments required under the settlement agreement." 

Health Care Fraud Case of the Week

 

Here's the headline from the DOJ news release on this conviction: "Nurse Practitioner Convicted of $200M Health Care Fraud Scheme." There were a few other parties involved, as you might imagine, but this one NP was at the center of a $200 million fraud scheme. As audacious as that sounds, the facts are equally breathtaking:

According to court documents and evidence presented at trial, [the defendant] signed thousands of orders for medically unnecessary orthotic braces and genetic tests, resulting in fraudulent Medicare billings in excess of $200 million. As part of the scheme, telemarketing companies would contact Medicare beneficiaries to convince them to request orthotic braces and genetic tests, and then send pre-filled orders for these products to Hernandez, who signed them, attesting that she had examined or treated the patients. In reality, she had never spoken with many of the patients.

There's more: 

In 2020, Hernandez ordered more cancer genetic tests for Medicare beneficiaries than any other provider in the nation, including oncologists and geneticists. She then billed Medicare as though she were conducting complex office visits with these patients, and routinely billed more than 24 hours of “office visits” in a single day. Hernandez personally pocketed approximately $1.6 million in the scheme, which she used to purchase expensive cars, jewelry, home renovations, and travel.

The truly astonishing thing about this is the defendant's apparent confidence that the CMS computers wouldn't pick up on the fact that she ordered more cancer genetic tests than any other Medicare provider in the entire country. 

Love is blind, and so is greed.

Nonconsensual Pelvic Exams

Over the years (decades, actually), I've heard reports from med students who were disturbed by what they witnessed during their ob-gyn clinical rotation: pelvic exams performed on sedated women who had not consented to the exam. Following up, I've been told repeatedly that this doesn't happen, that consent was obtained from all women who experienced pelvic exams, but the med students didn't know about the consent. That sounds kind of sketchy. Why wouldn't the consent process be included as an essential part of the med students' training? 

That's certainly not the story by way of NBC News (courtesy of the Hastings Center):

NBC TV Nightly News featured a Hastings Center Report study estimating that more than 3.5 million patients in the U.S. may have been given pelvic exams without consent, often while sedated for surgery. Doctors interviewed by NBC called the practice a “violation of medical ethics” and of “patient autonomy.” Watch the NBC segment. 

Labor Day Weekend Post #2: Hospital Cancels Bargaining Session After Nurse 'Walk-in'

  The Ascension hospitals in Austin and Kansas have been stuck in place for months in contract negotiations with the National Nurses Union. "Ascension Seton Medical Center in Austin, Texas, said it canceled a recent bargaining session after members of the National Nurses Organizing Committee, an affiliate of National Nurses United, held a "walk-in" [on Aug. 31] to hand deliver their staffing proposal to leaders." (Becker's Hospital Review (9/1/2023)). 

The nurses claim that current conditions in their hospital -- including a 1:6 nursing ratio in critical-care settings -- are unsafe for patients. There is a nationwide nursing shortage -- partly, but only partly, the result of COVID -- that has driven up salaries to retain nurses and attract new ones. Seton's reason for cancelling the bargaining pales somewhat in comparison: "Ascension Seton condemned the union's actions Aug. 31 as 'unprofessional, disrespectful and in blatant violation of the decorum by which negotiations are managed' and said they canceled the day's bargaining session to protect the well-being of the bargaining team." Right. I guess they'd have preferred a walk-out?

Labor Day Weekend Post #1: Hospitals Need to Do More to Protect Workers from Rudeness

There's a growing sense out there that we are experiencing a worldwide uptick in rudeness, probably brought on or at least exacerbated by COVID-related stress and isolation. It's a labor-and-employment issue for hospital managers, who have also seen an increase in workplace violence. Becker's Hospital Report picked up on a recent post in The Atlantic by Olgha Khazan in March 2022 ("Why People Are Acting So Weird") (may be free, but might be behind a paywall).

Mass General Brigham exemplifies the way back and the problem, in that order. They have enacted an explicit code of conduct for patients (and visitors?) to protect employees from rude and discriminatory behavior. Good. But: "On rare occasions, patients who violate this code may be asked to seek care elsewhere, the Somerville, Mass.-based health system said." On rare occasions . . . may be asked. Presumably only the worst behaviors will provoke the administrators to use the policies on their books to address unacceptable conduct.

The problem is a messy one. Hospitals tend to be places that can, and often do, bring out the worst in people. Pain, uncertainty, anxiety, loss of control . . . some folks deal with these stressors by lashing out. Health care professionals typical try to counsel patients and families unless there's a credible threat of violence. And safety-net hospitals are often loathe to evict patients because these institutions are the only option the patients have. 

On the other hand, a marked increase in rude and threatening and violent behaviors can't be treated in a business-as-usual manner. COVID-related stress and isolation is everywhere. We all need to have effective coping mechanisms. Hospitals are no different. 

Maternal Mortality: New JAMA Article and Video

JAMA has published a free online article, "Maternal Mortality Crisis and Extension of Medicaid Postpartum Coverage", but before reading this valuable article, I strongly recommend the accompanying video that explores the reasons for this country's dismal record and the resulting tsunami of individual and family suffering and misery. For an investment of a mere 30 minutes, this video offers a lot of lessons, busts dangerous myths that surround maternal mortality. It's a deep and subtle dive into causes and possible solutions. For starters, JAMA's Editor-in-Chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, introduces three take-aways with this comment: "A recent release from the National Center for Health Statistics in March of 2023, covered by JAMA Medical News, makes the case for the importance of this issue with the numbers in the US from 2021. There are three things that are striking in the numbers on maternal mortality in the US."

1. The first is that they're high. The US rate for 2021 was 32.9 maternal deaths per a hundred thousand live births. This is a number more than 10 times the estimated rates for other high income countries. Countries like Australia, Austria, Israel, Japan, and Spain, all hover between two to three deaths per a hundred thousand live births. 
2. The second important point is that the numbers are strikingly high in particular populations in the US, most notably Black women whose mortality rates are more than two and a half times that of white women. Hispanic women's mortality rates are at an all time high and surpassing those of white women. For other populations without appropriate data collection, we can't quantify the disparities accurately, and this is needed if we are to design interventions and allocate resources across all communities and populations. For example, data regarding American Indian women are rarely highlighted even though they have a high prevalence of poor outcomes. And in Asian populations, data disaggregation is needed to understand and interpret the true trends. 
3. The third important point, the one that really got to me in this new report, is that the trends are getting worse. More than 1200 people died of maternal causes in the US in 2021, a 40% increase from the previous year. And in every group examined in this new report across all races and ethnicities, across all ages of pregnant people, the trends are getting worse over time. 

The Q&A that follows brings together three women who are practicing physicians, researchers, or both. It's an incredibly insightful colloquy.

This is prelude to the article cited above by Eli Y. Adashi, MD, MS; Daniel P. O’Mahony, MSLS; I. Glenn Cohen, JD. The point I want to emphasize is the connection between the mortality crisis and the law, specifically Medicaid.

The video panelists all seem to agree that the post-partum period is the most lethal yet the one where our healthcare "system" fails women:

One in 3 pregnancy-associated deaths occur within 1 year of childbirth. Thus the extension of Medicaid postpartum coverage from 60 days (the duration required by federal law) to 12 months has emerged as a key strategy to address the US maternal mortality crisis.2 This Viewpoint assesses the maternal mortality crisis in the US, calls for an extension of Medicaid postpartum coverage, and discusses the residual challenges across the US related to maternal health.

States are currently free to extend post-partum coverage of their Medicaid programs, but not many have done so. Of particular interest to Texans and others who live in states whose legislatures and governors have not expanded Medicaid eligibility pursuant to Obamacare's generous federal match, the situation is even worse:

Although some individuals may qualify for extended postpartum Medicaid coverage because of their economic circumstances (ie, those with incomes ≤138% of the federal poverty level), many others are likely to no longer be eligible for Medicaid coverage, especially in the states that have not expanded Medicaid coverage.3 Postpartum individuals who reside in nonexpansion states can only qualify for Medicaid as parents.3 However, Medicaid income eligibility levels for parents are much lower than those for pregnant people.3 It follows that many individuals living in nonexpansion states become uninsured after their pregnancy-related coverage ends at 60 days’ postpartum.

How on earth can this continue?

5th Circuit Affirms District Court's Decision re: Mifepristone

This is complicated, but the bottom line is this: The FDA's loosened rules for access to mifepristone remain in effect, at least until the case gets to the Supreme Court. Here's the breakdown:

1. In April, U.S. District Judge Matthew J. Kacsmaryk ruled that the FDA failed to consider important safety issues when it (in 2023) approved a rule change that permanently lifted a restriction requiring in-person dispensing of the abortion pill and permitted pharmacies to fill mifepristone prescriptions for customers directly, as well as various FDA approvals of mifepristone dating back to the agency's initial decision to greenlight the drug in 2000. The district judge granted an injunction against sales under the FDA's new rule pending an appeal to the Fifth Circuit.

2. On August 16 the Fifth Circuit Court of Appeals disagreed with a few of the trial court's conclusions and orders, but unsuprisingly affirmed others. Here's their summary:

After extensive briefing and oral argument, we hold that the district court’s stay order should be VACATED in part and AFFIRMED in part.  We conclude that the Medical Organizations and Doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations.  Accordingly, that component of the district court’s order must be VACATED.  This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016.

 

We also VACATE the portion of the order relating to the 2019 Generic Approval because the Medical Organizations and Doctors have not shown that they are injured by that particular action.  The generic version of mifepristone will also be available under the same conditions as Mifeprex.

 

We AFFIRM the components of the stay order that concern the 2016 Amendments and the 2021 Non-Enforcement Decision.  Those agency actions—which generally loosen the protections and regulations relating to the use of mifepristone—will be stayed during the pendency of this litigation.

 

Finally, we note that our holding is subject to the prior order of the Supreme Court, which stayed the district court’s order pending resolution of this appeal and disposition of any petition for writ of certiorari.  Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).  

 3. Bottom line, mifepristone will remain available without restrictions imposed by the trial judge and affirmed by the appellate court. 

Expect intense motion practice in the Supreme Court to modify or rescind their stay earlier this year. And on the merits of the case, this will go to the same conservative Supreme Court that wiped out Roe v. Wade last year. This is also a case with a serious administrative law overlay, and this is a Court that has been skeptical of agencies' expertise and increasingly skeptical of tradition doctrines (like Chevron) that call for judicial deference to many if not most agency determinations.

Health Insurers' Tactic Resurfaces With a Vengeance: Deny, Deny, Deny

I once had a Health Law student who had been an HMO employee in a previous life. She was the one who answered the phone when a provider (hospital, clinic, physician, etc.) dialed 1-800 for pre-authorization for a procedure, hospitalization, or prescription item (medication, wheelchair, PT, etc.). Her standing order was simple: Always deny the request first time around. In Texas, we call that "bad faith claims handling" and it's a tort that can result in compensatory and punitive damages. So much for the deterrence effect of tort law!

A lot has changed in health care in the intervening two decades, byt "deny, deny, deny" is still with us. It's frustrating for policy holders (a/k/a patients and human beings), and it's aggravating for the providers. It's also a form of Russian roulette that results in dangerous delays in providing needed health care goods and services.

A recent article in Becker's CFO Report (Aug. 14, 2023) highlights the problem. As described by a hospital CEO with 37 years of experience in health care, bare-knuckle negotiations over reimbursement rates get all the media attention when providers and a payor appear to be at impasse and termination of the contract is a looming reality for thousands of patients whose providers are about to be "out of network." Reimbursement rates are the "above the surface" story in these negotiations, but eventually both sides compromise and crisis is averted.

The "below the surface" issues, though, have an outsized effect on providers. These issues stem from denials of payment for any of the myriad reasons insurers can cite: service or medication not covered, no pre-authorization or referral from a gatekeeper, DRG down-coding, difference in clinical judgment about medical necessity . . . . The list goes on. Here's the eye-popping heart of the article:

Data and numbers on denial rates are not easy to find, but some examination paints a picture rich with variation. An analysis of 2021 plans on Healthcare.gov conducted by KFF found nearly 17 percent of in-network claims were denied, with rates varying from 2 percent to 49 percent. The reasons for the bulk of denials are unclear. About 14 percent were attributed to an excluded service, 8 percent to lack of pre-authorization or referral and 2 percent to questions of medical necessity. A whopping 77 percent were classified as "all other reasons." 

Adding to the inconsistency is the fact that health plan denial rates fluctuate year over year. In 2020, a gold-level health plan offered by Oscar Insurance in Florida denied 66 percent of payment requests; in 2021 it denied 7 percent.

And here's a refrain I hear from physician friends from all over:

"Nobody becomes a physician because they hope to feel like a cog in a factory," Michael Ivy, MD, deputy chief medical officer of Yale New Haven (Conn.) Health, told Becker's. "However, between meeting the demands of payers for referrals, denials of payment and increased documentation requirements in order to assure proper reimbursement and risk adjustment, as well as an increasing number of production metrics, it can be difficult not to feel like a cog." 

As for the government's role in policing the conduct of these insurers:

Authors of the 2010 Affordable Care Act worried that provisions to expand health insurance access — such as barring health insurers' refusal to cover patients with preexisting conditions — could cause them to ratchet up other tactics to make up for the change. With this in mind, the law charged HHS with monitoring health plan denial rates, but oversight has been unfulfilled, leaving denials widespread.  

When you consider insurance company profits and their executive salaries, it's apparent that the "middle men" in these transactions are getting rich at the expense of providers and patients alike. Where's a good, old-fashioned congressional or FTC hearing when you need one? 

RFK, Jr., Public Health Law & Policy

Robert F. Kennedy, Jr. is running for the Democratic Party's 2024 presidential nomination. He is a prominent member of one of this country's most prominent political families, at least since the Adamses, the Roosevelts, the Buckleys, and . . . oh, we do love our dynasties, don't we?

In a past life, he was an environmental activist (although Dan Farber, whose work I admire, is a skeptic on that count, as well). But RFK, Jr. is also a prominent spreader of misinformation about Covid, vaccines, and Covid vaccines in particular. If his dangerous positions on these public health basics had been the official government policy, countless more people in this country would have died than the 1,137,057 who have died so far. Period. (Interestingly, there isn't a whisper about these issues on his official campaign website. Perhaps because media coverage has been dominated by questions about these issues to exclusion of much else on his issues list, and because just about the entire Kennedy family seems to be opposed to his positions. NYT, Aug. 6, 2023; Politico, April 19, 2023.)

FactCheck.org's SciCheck team has a three-part series on Kennedy's Covid and vaccine errors:

In our first article, Jessie addresses several of Kennedy's key talking points about vaccines in general. (See "FactChecking Robert F. Kennedy Jr.")

In a second article, Staff Writer Kate Yandell goes deep into some of his go-to arguments about vaccines and autism. (See "What RFK Jr. Gets Wrong About Autism.")

[In] the third and final article, Staff Writer Catalina Jaramillo and Kate tackle Kennedy's numerous claims about the COVID-19 pandemic, many of which we’ve written about before and may be familiar to you already.

All three articles can be found on this page. 

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.)