West Virginia's Constitutional Amendment Prohibiting Physician-Assisted Suicide

Prof. Austin Sarat (Amherst College) has posted an excellent op-ed on the website of The Hill that describes and decries the autonomy-crushing West Virginia constitutional amendment that voters passed last week by a 1% margin (50.5% yes-49.5% no). In the 40 states where physician-assisted suicide (a/k/a Medical Aid-in-Dying) is illegal, the prohibitions are statutory. As Sarat points out, by embedding a ban in its constitution West Virginia has made it exponentially more difficult to reverse course in future years. 

Major arguments for and against the ballot measure are summarized by Ballotpedia:

In opposition:

Death with Dignity: "While Death with Dignity is already illegal under current West Virginia law, this constitutional amendment would mark the first time any state amended its constitution to explicitly prohibit aid in dying. Never before has a legislature in this country mobilized an attack like this on terminally ill patients. And to make matters worse, proponents of the ban are on a press tour spreading malicious lies about how Death with Dignity works in states where it’s legal." 

Eli Baumwell, interim executive director for ACLU West Virginia: "'Mountaineers are always free' is a promise that the ACLU of West Virginia works every day to ensure is kept. Amendment One runs counter to that promise by enshrining a prohibition into the state constitution designed to take away the last free choice Mountaineers can make. West Virginians, like most Americans, do not believe that the government should interfere in personal medical decisions. As shown by the Legislature going zero for four last year in seeking permission from the people to modify our Constitution, they do not represent the will of the people. Instead, they represent a dangerous and out of touch minority: lawmakers who want to take the last medical decision you can ever make about yourself." 

In support:

State Del. Pat McGeehan (R-1): "There’s this phenomenon of nihilism that’s sort of spreading across the country, and I think it’s an important issue we need to address. To the best of my knowledge, we’ll be the first to place this and take a stand in the state constitution." 

State Del. Pat McGeehan (R): "That’s why it is vital to vote for Amendment One this November. It secures our state from medically-assisted suicide and the culture of indifference and carelessness it promotes. It affirms the goodness of suicide prevention. And it sends a clear and confident message that West Virginia is not a place of fear and despair, but a state of courage and hope." 

Mary Tillman, legislative coordinator for the West Virginia alliance for Ethical Health Care: "If there is a fear of pain at the end of life, good palliative care and hospice care are ways to provide comfort and care until a person’s life ends naturally. A vote FOR Amendment One will protect all West Virginians from physician-assisted suicide. This November, please vote to keep West Virginia a state where all lives are valued and protected." 

Ms. Tillman's point about "good palliative care and hospice care" is only half right. Palliation and hospice care are designed to provide relief from suffering, but relief is far from inevitable. In a pioneering article in the New England Journal of Medicine, Dr. Tim Quill (coincidentally, a graduate of Amherst College, Class of 1971) wrote about the last days of his patient, Diane, who was dying of leukemia:

Bone pain, weakness, fatigue, and fevers began to dominate her life. Although the hospice workers, family members, and I tried our best to minimize the suffering and promote comfort, it was clear that the end was approaching. Diane's immediate future held what she feared the most — increasing discomfort, dependence, and hard choices between pain and sedation. . . .

Although I know we have measures to help control pain and lessen suffering, to think that people do not suffer in the process of dying is an illusion. Prolonged dying can occasionally be peaceful, but more often the role of the physician and family is limited to lessening but not eliminating severe suffering. [italics added]

"Death and Dignity — A Case of Individualized Decision Making," N Engl J Med 1991;324:691-694 (March 7, 1991). Any argument that ignores this harsh reality lacks scientific, medical, and moral authority.

Finally, I want to end with the point that Prof. Sarat makes at the outset of his op-ed:

Donald Trump’s surprisingly decisive electoral victory was a serious blow to those who value freedom and human dignity. . . .

His version of freedom does not include respecting the choices that individuals make about their own bodies. . . .

And while our attention was focused on those assaults on bodily autonomy, voters in West Virginia, where the MAGA ethos reigns supreme, passed a ballot measure amending their state constitution to prohibit people from participating in “the practice of medically assisted suicide, euthanasia, or mercy killing of a person.”   

Passage of West Virginia's ballot measure represents a victory for MAGA-types and MAGA-adjacent pro-life absolutists like the National Right to Life Committee and its various state affiliates. They added end-of-life decision-making to their traditional focus on reproductive decision-making three decades ago and have advocated relentlessly and quite successfully to curtail patient rights ever since.

Health Care Fraud: Texas Style

On Oct. 15 a federal jury in Houston convicted the owner of a firm that operated 14 pharmacies, on fifteen counts including conspiracy to commit mail fraud, conspiracy to violate the anti-kickback statute, bribery concerning programs receiving federal funds, conspiracy to commit bribery, five counts of healthcare fraud, and six counts of money laundering, resulting in $160 million in fraudulent claims that were paid by Medicare. 

As described by the Office of the U.S. Attorney for the Southern District of Texas:

From 2014 through 2021, Mohamad Mokbel led a company called 4M Pharmaceuticals which operated 14 pharmacies with straw owners. The jury heard evidence that Mokbel illegally purchased thousands of Medicare beneficiaries, including their identification number, personal health and physician information. Mokbel targeted elderly diabetic patients who are dependent on diabetic testing supplies to manage their blood sugar levels. Mokbel paid $16 to $40 per Medicare beneficiary.  

To maximize reimbursements and without regard for medical necessity, Mokbel then directed 4M employees to use the Medicare beneficiaries’ patient data to run insurance claims to determine if Medicare or other insurance plans would cover and reimburse at a high rate for the topical creams, Omega-3 pills and other medications that Mokbel intended to sell through 4M pharmacies.

At Mokbel’s direction, 4M employees would then fax pre-filled prescription requests to the patients’ doctors appearing to be for diabetic testing supplies with topical creams added at the bottom. They also included false representations that the patient was requesting a 4M Pharmacy fill their medications. In reality, Mokbel had previously purchased the patient’s personal information, the patient had not selected a 4M Pharmacy and the patient was often unaware the request was being made on their behalf. 

Many doctors apparently took the representations in the fax at face value and did sign and send back the prefilled prescription requests to 4M. Mokbel’s call center in Houston and later in Egypt then contacted the patients and made false and misleading statements about the topical cream and their doctor’s order. Mokbel’s pharmacies then shipped out numerous topical creams, often on auto-refill, and excessively billed Medicare, Medicaid and private insurance plans. 

Mokbel made over $200 million as a result of the scheme. 

The money value of the fraud is considerably less than the record for Medicare fraud, but what caught my eye was the complexity of the scheme and the lineup of law-enforcement agencies involved in the case: Homeland Security Investigations (HSI) Houston, the FBI, IRS Criminal Investigation, the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, and the Texas Attorney General’s Medicaid Fraud Control Unit. This was a big, big deal for these investigators.

HIPAA Violation Alleged Against Texas Physician

We all know HIPAA, the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), because seemingly every visit to every doctor starts with an HIPAA authorization form that allows patients to designate persons with whom personal health information (PHI) can be shared. The statute is pretty bare-bones, but it authorizes HHS to issue rules, which it did from 2000 to 2013 (summarized at the bottom of this post*). 

The cardinal rule for health care professionals is pretty simple: Don't access or spread the PHI of patients unless there's a need to know (with respect to the person accessing the PHI and the person on the receiving end). There are a gazillion technical aspects to the rule, but my version will cover the vast majority of situations in which a person who is covered by the rule (including health care professionals) seeks access to PHI.

A violator of HIPAA faces civil and criminal prosecution that may result in fines or even jail time. A medical resident at Baylor College of Medicine has been indicted for alleged HIPAA violations and if convicted faces the possibility of a $250,000 penalty and up to ten years in prison. Here's DOJ's summary of the case:

A Houston doctor has been indicted for obtaining protected individual health information for patients that were not under his care and without authorization, announced Alamdar S. Hamdani.

The four-count indictment alleges [Ethan] Haim[, Dallas,] obtained personal information including patient names, treatment codes and the attending physician from Texas Children’s Hospital’s (TCH) electronic system without authorization. He allegedly obtained this information under false pretenses and with intent to cause malicious harm to TCH.

 According to the indictment, Haim was a resident at Baylor College of Medicine and had previous rotations at TCH as part of his residency.

In April 2023, Haim allegedly requested to re-activate his login access at TCH to access pediatric patients not under his care. The indictment alleges he obtained unauthorized access to personal information of pediatric patients under false pretenses and later disclosed it to a media contact.

According to Becker's Hospital Review (June 17),  

[Haim] is accused of violating HIPAA by leaking internal documents from Houston-based Texas Children's Hospital concerning gender-affirming services. . . . 

This unauthorized access allegedly allowed him to obtain patients' personal health information, including names, treatment codes and details of the attending physicians. . . . 

In May 2023, Dr. Haim shared these internal documents with Christopher Rufo, a senior fellow at the Manhattan Institute in New York City. . . .

Although a HIPAA violation is a violation, not all violations are created equal. Inadvertence, carelessness, a desire to be helpful -- none of these excuses a violation of HIPAA, but the key to this case is likely to be the apparently political nature of Dr. Haim's alleged breach and this sentence in the DOJ press releasee: "He allegedly obtained this information under false pretenses and with intent to cause malicious harm to TCH." If true, not a good way to start a career in medicine!
____________________________

*HHS's HIPAA rules (source):

• HHS published a final Privacy Rule in December 2000, which was later modified in August 2002. This Rule set national standards for the protection of individually identifiable health information by three types of covered entities: health plans, health care clearinghouses, and health care providers who conduct the standard health care transactions electronically.  Compliance with the Privacy Rule was required as of April 14, 2003 (April 14, 2004, for small health plans).
• HHS published a final Security Rule in February 2003. This Rule sets national standards for protecting the confidentiality, integrity, and availability of electronic protected health information. Compliance with the Security Rule was required as of April 20, 2005 (April 20, 2006 for small health plans).
• The Enforcement Rule provides standards for the enforcement of all the Administrative Simplification Rules.
• HHS enacted a final Omnibus rule that implements a number of provisions of the HITECH Act to strengthen the privacy and security protections for health information established under HIPAA, finalizing the Breach Notification Rule.
• View the Combined Regulation Text - PDF (as of March 2013). This is an unofficial version that presents all the HIPAA regulatory standards in one document. The official version of all federal regulations is published in the Code of Federal Regulations (CFR). View the official versions at 45 C.F.R. Part 160 - PDF, Part 162 - PDF, and Part 164 - PDF.

NEWS FLASH: Telehealth Fraud is Health Fraud. Full Stop.

Here's the headline from DOJ, along with excepts from the news release announcing the arraignment of two principals of a telehealth company in California:

Founder/CEO and Clinical President of Digital Health Company Arrested
for $100M Adderall Distribution and Health Care Fraud Scheme

The founder and CEO (He) of a California-based digital health company and its clinical president (Brody) were arrested today in connection with their alleged participation in a scheme to distribute Adderall over the internet, conspire to commit health care fraud in connection with the submission of false and fraudulent claims for reimbursement for Adderall and other stimulants, and obstruct justice. . . .

“The individuals charged today allegedly disregarded the first rule of medical care—do no harm—in order to maximize profits, and there is no place for such fraud in our healthcare system,” said Secretary of Homeland Security Alejandro N. Mayorkas. . . . 

“As alleged in the indictment, the defendants provided easy access to Adderall and other stimulants by exploiting telemedicine and spending millions on deceptive advertisements on social media. They generated over $100 million in revenue by arranging for the prescription of over 40 million pills,” said Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division. “These charges are the Justice Department’s first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company. As these charges make clear, corporate executives who put profit over the health and safety of patients—including by using technological innovation—will be held to account.”

According to court documents, He and Brody allegedly conspired with others to provide easy access to  Adderall and other stimulants in exchange for payment of a monthly subscription fee. The indictment alleges that the conspiracy’s purpose was for the defendants to unlawfully enrich themselves by, among other things, by increasing monthly subscription revenue and thus increasing the value of the company. Done allegedly arranged for the prescription of over 40 million pills of Adderall and other stimulants, and obtained over $100 million in revenue. 

He and Brody allegedly obtained subscribers by targeting drug seekers and spending tens of millions of dollars on deceptive advertisements on social media networks. They also allegedly intentionally structured the Done platform to facilitate access to Adderall and other stimulants, including by limiting the information available to Done prescribers, instructing Done prescribers to prescribe Adderall and other stimulants even if the Done member did not qualify, and mandating that initial encounters would be under 30 minutes. To maximize profits, He allegedly put in a place an “auto-refill” function that allowed Done subscribers to elect to have a message requesting a refill be auto-generated every month. He wrote that Done sought to “use the comp structure to dis-encourage follow-up” medical care by refusing to pay Done prescribers for any medical visits, telemedicine consultation, or time spent caring for patients after an initial consultation, and instead paying solely based on the number of patients who received prescriptions.

“The defendants in this case operated Done Global Inc., an online telehealth website that prescribed Adderall and other highly addictive medications to patients who bought a monthly subscription. The defendants allegedly preyed on Americans and put profits over patients by exploiting telemedicine rules that facilitated access to medications during the unprecedented COVID-19 public health emergency,” said DEA Administrator Anne Milgram. “Instead of properly addressing medical needs, the defendants allegedly made millions of dollars by pushing addictive medications. In many cases, Done Global prescribed ADHD medications when they were not medically necessary. In 2022 the FDA issued a notice of shortages in prescription stimulants, including Adderall. Any diversion of Adderall and other prescription stimulant pills to persons who have no medical need only exacerbates this shortage and hurts any American with a legitimate medical need for these drugs. The DEA will continue to hold accountable anyone, including company executives, that uses telehealth platforms to put profit above patient safety”. . . .

He and Brody allegedly persisted in the conspiracy even after being made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, and that Done members had overdosed and died. They also allegedly concealed and disguised the conspiracy by making fraudulent representations to media outlets to forestall government investigations and action and induce third parties to continue doing business with Done. . . .

This isn't just about money. It's about enabling addiction and about killing patients. I am amazed at the sociopathic conduct alleged here, and even more amazed that a digital company thought it could (allegedly) engage in massive on-line health fraud without leaving a digital trail  that would lead directly back to the company and its leaders. Hubris? Stupidity? Both?

More Healthcare Fraud Enforcement Actions: The Beat Goes On

  It's hard to know who is winning the battle against healthcare fraud -- the fraudsters or the enforcers. The list of enforcement outcomes (charges, verdicts, sentencing) is pretty darned impressive, both for the brazenness of the crimes and the success of the prosecutors. 

The HHS Office of Inspector General has a useful website that list 9,232 enforcement actions over the past decade. For my purposes, it's over-inclusive, because it lists "[c]riminal, civil or administrative legal actions relating to fraud and other alleged violations of law, initiated or investigated by OIG and its law enforcement partners" -- in other words, way more than only criminal prosecutions for health care fraud. The site does have some filters, but none are specific to health care. The listings for the past week alone, however, show the heavy concentration of health care fraud and the use of the criminal-justice system to punish wrongdoers:

• Florida Felon Sentenced to Prison for Role in Multi-Million Dollar Health Care Kickback Scheme After Pleading Guilty to COVID-19 Fraud and Unlawfully Possessing Firearm (May 30, 2024)
• Attorney General Ken Paxton Secures 84-Month Prison Sentence for Clinic Owner in $15 Million Medicare Fraud Scheme (May 30, 2024) (Note: Paxton's a terrible model of a public servant, but his fraud task force has done admirable work over the years going after healthcare fraudsters)
• Medical Device Manufacturer Innovasis Inc. and Two Top Executives Agree to Pay $12M to Settle Allegations of Improper Payments to Physicians (May 29, 2024) 
• Wisconsin Attorney Sentenced To Five And A Half Years In Federal Prison For $2.3 Million Fraud And Tax Evasion Schemes (May 28, 2024) 
• Penn Highlands Healthcare To Pay $735,000 To Settle False Claims Act Allegations (May 28, 2024) 
• Doctor Convicted Of $70M Medicare Fraud Scheme (May 24, 2024)
• Florida Businessman Daniel Hurt To Pay Over $27 Million For Medicare Fraud In Connection With Cancer Genomic Tests (May 24, 2024) 

Is it characteristic of fraudsters that, in their heart of hearts, they really believe they won't be found out by the authorities? Of do they take a (misguided) risk/reward calculation? 

$100 Million Medicare Fraud => 9-Year Sentence

Defendant Andrew Chmiel got a one-way ticket to federal prison for 9 years following his conviction for Medicare fraud, courtesy of the U.S. Attorney's office in the District of South Carolina. He was also ordered to pay $98,935,533.00 in restitution.

Touting this as one of the biggest Medicare fraud cases ever, the press release on this case described the essentials of the scheme (emphasis added): 

Chmiel’s charges were brought in 2019 as part of Operation Brace Yourself, an investigation that originated in South Carolina. Operation Brace Yourself, which was prosecuted in conjunction with the Department of Justice’s Criminal Division Fraud Section, was a multi-jurisdictional investigation that involved the execution of more than 80 search warrants in 17 federal districts.

As for Chmiel’s criminal conduct, evidence presented to the court showed that Chmiel controlled and operated at least 10 DME companies, which were located throughout the United States. These DME companies were used by Chmiel and his co-conspirators to submit false and fraudulent claims to Medicare for braces that were not medically necessary and/or were obtained through the payment of kickbacks and bribes. 

To effectuate the scheme, these DME companies entered into agreements with an offshore call center to purchase completed doctors’ orders so the DME companies could bill Medicare. This offshore call center was advertising through television and internet advertisements.  Once a Medicare beneficiary called a 1-800 number that was on the advertisements, that Medicare beneficiary would be screened for eligibility and then convinced that he or she needed a brace, and oftentimes upsold on other braces.  The call center would then contact a telemedicine company whose physician and/or or nurse practitioner would issue a prescription without regard to the medical necessity.  Throughout the investigation the evidence revealed that beneficiaries were prescribed braces without ever being examined by, seeing, or, in some instances, even speaking to a medical professional. Evidence presented showed that Chmiel was attempting to hide that he was purchasing completed doctors’ orders by creating fraudulent and false invoices for alleged marketing and business processing services.

Throughout the health care fraud scheme, Chmiel’s companies, which included 10 DME companies, two dropship companies, and two additional companies that were used to facilitate the fraud – D.O. Delivery and Pain Center – billed Medicare in excess of $200 million and Medicare paid Chmiel’s companies in excess of $95 million.

For the past two decades, durable medical equipment has been a fertile field for fraud and, correspondingly, for federal fraud prosecutions. The perpetrators of these schemes apparently fail to take into account the investigatory tools available to the Department of Justice and the fact that the government has computers that can crunch a lot of Medicare claims. $200 million worth of DME orders from 10 DME companies was bound to be picked up by some computer's filter or algorithm. 

Criminal Liability of Health Care Providers

Some types of criminal prosecutions of health care providers are rare, while others are not.

1. Not-so-rare. This category includes fraud (against private insurers and public health programs like Medicare, Medicare, and Tricare); criminal prosecutions involving violations of the Anti-Kickback Law are announced by DOJ and state AGs every week (if not every day). Last Friday, for example, the Massachusetts Attorney General announced indictments against a dentist and his dental practice for billing the Medicaid program for services that were never rendered or were not rendered by the dentist. The charges included multiple counts of Medicaid False Claims and Larceny Over $1,200. 

Violations of state and federal Controlled Substances Acts often have a provider -- a physician, nurse, or pharmacy worker -- with access to drugs in the middle of the scheme. A recent example comes from the U.S. Attorney for the Northern District of New York. whose office announced on March 1 that a nurse practitioner received a 70-month sentence "for distributing controlled substances outside the course of professional practice and for no legitimate medical purpose." In her plea agreement, the defendant admitted that she 

unlawfully prescribed controlled substances to a total of 54 patients.  Simonson issued hundreds of unlawful prescriptions, including for the opioids hydrocodone and oxycodone, benzodiazepines (clonazepam, diazepam, and lorazepam), and the stimulants amphetamine (e.g. Adderall) and methylphenidate.  For instance, Simonson admitted that she issued a total of 63 oxycodone prescriptions to two residents of Suffolk County, New York, without treating either of them for a medical condition. The Suffolk County residents usually paid Simonson by mailing her packages of cash concealed within DVD cases.

To settle the government's civil case against her, the defendant "admitted that she improperly prescribed controlled substances to 105 patients (including the 54 listed in her criminal plea agreement), often without ever examining patients and maintaining medical records justifying her decision to prescribe controlled substances."

2. Very rare. This category involves provider errors that result in iatrogenic injury. Most such cases, of course, are handled on the civil side by medical-malpractice and medical-negligence claims. In a small percentage of cases, though, a provider will be indicted. Most such cases involve extreme departures from the standard of care resulting in a patient's death. An example was reported by the NY Times earlier this month:

A Colorado paramedic convicted in the 2019 death of Elijah McClain, a young Black man whose case helped drive the national police reform movement, was sentenced on Friday to five years in prison.

The case was a rare criminal prosecution of emergency medical personnel, and stirred outrage among paramedics and firefighters across the nation who worry that urgent decisions made as part of their jobs can be criminalized.

The paramedic, Peter Cichuniec, 51, a former lieutenant with Aurora Fire Rescue, was convicted in December of criminally negligent homicide and second-degree assault for the unlawful administration of drugs. He was one of five police officers and paramedics prosecuted in state district court over three consecutive trials. . . .

In August 2019, Mr. McClain, a 23-year-old massage therapist, was returning home from a store when he was confronted by police who were responding to a 911 call about a suspicious person. During a quickly escalating encounter, Mr. McClain was forcefully restrained by police and placed in a carotid chokehold, a neck restraint that has since been banned in Aurora and other police departments. Paramedics then injected him with an overdose of the powerful sedative ketamine. He died in a hospital several days later.

Top Four Kick-the-Can Issues in Health Care

Becker's is an incredible daily resource through various newsletters aimed at hospital management, CFO's, and policy makers. From their vantage, they have a good feel for the recurring issues that government ignores and that might yield at least somewhat to public-private partnerships. Here are their top four:

1. Hospital closures. It seems lawmakers only start to take notice of hospital financial solvency when closure announcements are made. Lost in this 11th-hour dynamic is concern for patient safety and care quality. The closure of a hospital is one thing. But just as important — and often neglected — is scrutiny of the quality of care patients receive in the period leading up to the announcement of closure. 

2. Hospital staff safety. The Safety from Violence for Healthcare Employees Act was introduced in the House last April and in the Senate last September. The bipartisan legislation would make it a federal crime to knowingly assault hospital workers and enact federal protections for healthcare workers like those in effect for aircraft and airport workers. 

Since the legislation's introduction, individual acts of violence in hospitals continue to unfold and make headlines as more longitudinal data is released showing just how much more hostile healthcare settings have become. More than double the number of health workers reported harassment at work in 2022 than in 2018, including threats, bullying, verbal abuse, or other actions from patients and co-workers that create a hostile work environment, according to CDC data. More than 5,200 nursing personnel were assaulted in the second quarter of 2022, according to data from Press Ganey, amounting to about 57 assaults per day. 

3. Healthcare workforce shortages. Much attention is paid to technology solutions and AI support systems to augment the healthcare staff and workers who are in short supply. But look more closely, and the foundation of data about the U.S. workforce looks like Swiss cheese. 

There are more than 8,300 designated primary care shortage areas in the U.S., and nearly 200 of them have been federally designated as such for at least 40 years. This finding stems from an analysis that KFF Health News published last month. One area on the far south side of Chicago has been designated as a shortage area since 1978. Another area in the Baton Rouge metro area in Louisiana, has been named a shortage area since 1979, most recently with 22 full-time primary care physicians for nearly 140,000 people. 

4. Hospital cybersecurity. Becker's covered one of the earliest hospital ransomware attacks on a small hospital in Kentucky in 2016. Methodist Hospital in Henderson, Ky., operated in an internal state of emergency for five days and did not pay the ransom. Since, we've seen cybergangs and criminals grow more savvy, emboldened and nefarious in their targeting of hospitals. Health system ransomware attacks nearly doubled in 2023, with 141 U.S. hospitals affected last year and data stolen in 32 of 46 of the events. 

These attacks can wreak havoc and cause harm to entire healthcare infrastructures across state lines. Last November, the hack of 30-hospital Ardent Health Services, based in Nashville, Tenn., caused ambulances to be diverted across six states. The actors behind these attacks have also grown more cruel, hitting children's hospitals (most recently Lurie Children's, a level 1 pediatric trauma center in Chicago), demanding $900,000 from a safety-net hospital in 48 hours, publishing data about hospital staff, or activating other hospital equipment mid-attack.

Physician Acquitted in $15M Healthcare Fraud Prosecution

A federal jury in Maryland convicted the physician on five counts of healthcare fraud in connection with his billing practices for level 4 CPT codes for evaluation and management services (E/M) for Covid patients. According to Becker's Hospital Review:

Ron Elfenbein, MD, 49, owned First Call Medical Center and Chesapeake ERgent Care, which operated multiple drive-thru COVID-19 testing sites. He instructed employees, in addition to billing for COVID-19 tests, to bill for high-level evaluation and management visits, according to an Aug. 4 Justice Department news release. Dr. Elfenbein ordered the high-level visits to be billed for all patients, including those who were asymptomatic, getting tested for their employment requirements or being tested so that they could travel, according to the release. Dr. Elfenbein was accused of submitting false claims for tens of thousands of high-level visits that were ineligible for reimbursement. 

As analyzed by Husch Blackwell:

[U]nlike some CPT codes, E/M CPT codes are imprecise. There is purpose in E/M CPT codes’ imprecision in that it allows physicians flexibility to exercise their best judgment given the multitude of factors that go into medical decision-making.

But that imprecision in E/M CPT codes makes for difficult federal prosecutions. As the court held in overturning Dr. Elfenbein’s convictions, CPT codes’ “imprecision does not necessarily integrate well with the clear notice and due process guarantees of our criminal law” and “where the relevant CPT codes and related definitions are ambiguous and subject to multiple interpretations, problems clearly arise.” 

Does this mean DOJ can't win ambiguous-CPT code cases? Not at all (from Husch):

The court was careful to make clear that it is possible for the Justice Department to successfully prosecute defendants who take advantage of ambiguous CPT codes, but that such prosecutions must show objective falsity in a way the prosecutors failed to do in Dr. Elfenbein’s trial. The “Government sails in shallow waters when it prosecutes a case of this type; these cases require careful navigation,” wrote the court.

To make its point, the court pointed to several cases in which the Justice Department was able to navigate ambiguous waters, including one E/M CPT case in which the prosecution’s expert testified the medical judgment was “not even close to being properly classified” at the code’s level. And so, while prosecutions based on ambiguous CPT codes are clearly an uphill battle for the Justice Department, they are not insurmountably uphill. 

The district court's 90-page opinion is here. 

Latest Fraud Enfocement Actions include $148 Million Scheme

Here's the latest rundown from USDOJ, with some details on a couple of the most notable actions:

Lab Owner Pleads Guilty To $1.7 Million COVID-19 Test Fraud Scheme (December 1, 2023; U.S. Attorney's Office, Northern District of Texas)

Physician Sentenced For $1.2M Pill Mill Scheme (November 30 2023; U.S. Department of Justice)

Philadelphia Pharmacy Pleads Guilty To More Than $500,000 In Fraudulent Insurance Claims As Part Of Prescription Medication Scam (November 28, 2023; Pennsylvania Attorney General)

▶︎Man Charged In $148M Medicare And Medicaid Fraud Scheme (November 30 2023; U.S. Department of Justice)

A federal grand jury in Baton Rouge, Louisiana, returned an indictment today charging a Louisiana man for his role in a scheme to defraud Medicare and Medicaid of over $148 million in medically unnecessary definitive urine drug testing services.   

According to court documents, Brad Paul Schaeffer, 48, of Zachary, was a co-owner and chief executive officer of MedComp Sciences LLC (MedComp), a diagnostic laboratory located in Zachary. From approximately January 2013 through approximately August 2022, MedComp, at the direction of Schaeffer, allegedly billed Medicare and Medicaid for definitive testing of at least 15 substances in urine specimens it received, regardless of the patient’s treatment plan and history, or the request of the referring provider. 

To perpetuate the fraud, Schaeffer, through MedComp, allegedly took several actions, among them, writing off patient co-pays, directing MedComp staff to fill out and submit order forms on providers’ “behalf,” concealing the true nature, permissibility, and extent of testing from providers, orchestrating a pass-through billing scheme using hospitals, and paying kickbacks to physicians disguised as laboratory ownership interests. Schaeffer then allegedly used the fraudulent proceeds for his own benefit, including spending thousands of dollars to renovate a pool and on a pool house in his backyard, and to restore a truck. 

▶︎Caretaker Charged With Involuntary Manslaughter, Neglect For Failure To Renew Patient’s Medications Which Led To Fatal Seizure Episode (November 29, 2023; Pennsylvania Attorney General)

Kelly Gonzales, 48, was the administrator at ARC of Lawrence County, a personal care home in New Castle, when she failed to renew a prescription for the patient’s anti-seizure medication. Gonzalez then altered medical records to indicate that a health care provider discontinued the medication — which was not true.

As the administrator of the personal care home, Gonzales was responsible for the administration and management of the home, including the health, safety, and well-being of the residents. This included ensuring the residents’ paperwork was complete, that they attended all medical appointments, and received their prescribed medication in a timely manner.

According to the complaint, the resident was diagnosed with a seizure disorder and was prescribed anti-seizure medication to control his seizures. He died at the care home on Dec. 2, 2021 after not receiving his medication for over 10 days. Upon autopsy, it was discovered that the seizure disorder caused his death and that the levels of anti-seizure medication in his system were well below therapeutic levels.

Gonzales was charged Tuesday with felony counts of neglect of a care dependent person and tampering with records, and misdemeanor involuntary manslaughter. Gonzales surrendered Tuesday, was arraigned and released on her own recognizance.

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.

Violent attacks on hospital staff: What's the solution?

The reports of violent attacks on doctors and nurses in hospitals, clinics, medical offices, and other health care settings keep coming in. From The Hospitalist (Mar. 1, 2023):

Even before the onset of the COVID-19 pandemic, health care workers suffered more workplace injuries as a result of violence than any other profession, with approximately 654,000 harmed annually, according to American Hospital Association studies. Since the pandemic began, violence against hospital employees alone has markedly increased. For example, 44% of nurses reported an increase in physical violence and 68% reported an increase in verbal abuse. (emphasis added)

The weapons tend to be knives and guns. Maybe it's a sign of the times, with random violence increasing all around us each year, there seems to be a steady stream of stories of violent attacks against health care personnel. (See, e.g., American Association of Critical-Care Nurses (blog)). I have further thoughts, but first, consider a recent example: "Man charged in fatal shooting of Tennessee surgeon" (Becker's Hospital Review, July 13). The shooter had reportedly been seen in this orthopedic surgery clinic earlier in the day, returned to the clinic, and shot the orthopedic surgeon.

It goes without saying that violence against doctors, nurses, and other health care workers simply shouldn't be a thing. We remember the political assassination of Dr. George Tiller 14 years ago while he was ushering in a worship service at his church in Wichita, Kansas. The killer was described as an "anti-abortion extremist." But much more violence and threats of violence occur every day in ordinary clinical settings. The work of clinical staff is performed with often emotionally fraught individuals (patients, family members), and then there are others with perceived grievances against the health care system or the world. The CDC has a useful list of risk factors:

The clinical setting is one of intensified emotions. Patients who are at risk of perpetrating violence include those who:

• are under the influence of drugs or alcohol
• are in pain
• have a history of violence
• have cognitive impairment
• are in the forensic (criminal justice) system
• are angry about clinical relationships, e.g., in response to perceived authoritarian attitude or excessive force used by the health provider
• have certain psychiatric diagnoses and/or medical diagnoses.

Clinics are designed to be open and welcoming, not armed fortresses. Doctors and nurses don't pack heat, and possession of a firearm on hospital property is universally prohibited (except in states where such prohibitions are themselves prohibited). They are vulnerable professionals -- first responders and health care workers -- who spend their careers comforting and healing. Violence is obscene and should be unthinkable in any workplace, including elementary schools, places of worship, and health care settings. 

There is no shortage of resources for dealing with violence in hospitals and clinics, including programs and best practices suggested or endorsed by the following:

• the American Hospital Association (Hospitals Against Violence; 2022 fact sheet)
• the federal Occupational Safety and Health Administration (OSHA) (report)
• the Centers for Medicare and Medicaid Services (CMS) (report)
• the Centers for Disease Prevention and Control (CDC) (course materials)

Health care settings are especially risky places to work, as many of the resources quoted and cited above establish. While we're at it, let's not forget the gun culture, the threat of which permeates every aspect of our lives. I wrote about this on Father's Day. The insanity has to stop.

Plastic surgeon to be sentenced after manslaughter conviction

It is rare, but not unheard of, for a physician to be prosecuted criminally for conduct that would otherwise be treated as medical malpractice and tried in a civil courtroom. Even egregious departures from the applicable professional standard of care will usually be treated as gross negligence or, rarely, an intentional tort (like assault), either of which may give rise to liability for punitive damages, usually multiples of the compensatory damage award. Again, even in most of these extreme-negligence/intentional-tort cases, prosecutors seldom seek criminal charges.

So when Beckers Hospital Report picked up a story from Colorado about a plastic surgeon who has been convicted of attempted reckless manslaughter and obstruction of telephone service (both felonies), a couple of questions occurred to me:

1. How bad was the surgeon's conduct to expose him to criminal liability?
2. "Obstruction of telephone service"? What on earth?

The surgeon was performing a breast augmentation procedure on an 18-year-old patient who, while under anesthesia, suffered a cardiac arrest and went into a coma. Staff members asked the surgeon for permission to call 911, and the surgeon said no. (Interference with telephone service?) 

Instead, the surgeon performed CPR himself and didn't allow a call to emergency responders until 5 hours after the cardiac arrest. The patient died 1 year later in a nursing home (NBC News, June 15, 2023).

More questions:

1. "Attempted" manslaughter? I am guessing the charge was negotiated down to attempt, despite the fact that the surgeon surely caused the patient's eventual death. The one-year delay before the patient died may have made it at least questionable that the state could prove causation in a manslaughter case. I'm not a Colorado attorney, but there also may be a statute or case law that bears on the issue of causation when there's a substantial delay between the injury and the death -- unlikely, but possible.
2. What were the clinic's staff thinking? That they might be fired if they disobeyed the surgeon's instruction not to call for help? I hate to be a Monday-morning quarterback, but this is really unconscionable.

The press version of legal cases often raise more questions than they answer and frequently get details wrong. But from what's available in NBC's reporting, this looks like a case that deserved to be scrutinized by the criminal justice system.

Hellacious Health Care Fraud Cases of the Week (III)

A fresh crop of miscreants -- some charged, some convicted, some sentenced. It's hard to quantify, but the continuing tidal wave of fraud enforcement actions leads me to question the deterrent effect claimed by criminal law theorists. Or it may be that criminal liability deters penny ante stuff but when the payoff is in the millions, the possibility of some time in jail may pale in comparison the the potential gain.

Two Jacksonville Compounding Pharmacies And Their Owner Agree To Pay At Least $7.4 Million To Resolve False Claims Act Allegations (June 15, 2023; U.S. Department of Justice) Three Defendants Plead Guilty In Personal Care Attendant Fraud Cases (June 15, 2023; Massachusetts Attorney General) Attorney General Josh Stein Announces $4.7 Million Health Care Conviction (June 14, 2023; North Carolina Attorney General) Carr: Hart County Man Indicted For Elder Exploitation (June 14, 2023; Georgia Attorney General) Office Of The Attorney General’s Medicaid Fraud Control Unit Sends Owner Of Home Health Company To Prison For 57 Months For $1.4 Million Fraud Scheme (June 13, 2023; Texas Attorney General) Attorney General Alan Wilson Announces Arrest Of Kershaw Co. Man For Exploitation Of A Vulnerable Adult (June 13, 2023; South Carolina Attorney General) TennCare Fraud Investigation Leads To Arrest In Memphis(June 9, 2023; Tennessee Attorney General)

Massive HHS settlements & judgments in 2020 for false and fraudulent claims

The gory details are contained in a report of the Inspector General released this month. Becker's Hospital CFO Report has a summary (emphasis added): 

HHS' watchdog agency, the Office of Inspector General, recovered $3.1 billion in false and fraudulent claims in 2020, according to a July report. 

OIG won or negotiated more than $1.8 billion in judgments and settlements in 2020, which, combined with efforts from previous years, led to 2020's $3.1 billion recovery. Of the $3.1 billion, $2.1 billion was transferred to the Medicare Trust Fund, and $128.2 million in Medicaid funds was transferred to the Treasury. 

A total of 440 people were convicted of healthcare fraud and related crimes in 2020, the OIG said. The Department of Justice opened 1,148 healthcare fraud investigations in 2020, according to the report.

Even after teaching health law (including fraud and abuse) for 33 years, I am still gobsmacked by the amount of thievery and other forms of law-breaking that goes on in the healthcare industry. I am reminded of Willie Sutton's reported response to a reporter's question why he robbed banks: "Because that's where the money is."  The health care sector represents 18% of GDP, more than defense and all levels of education combined. Yep, that's where the money is all right.

 

Grand Jury Declines to Indict Houston Doctor Accused of Stealing COVID Vaccine

As reported by The NY Times, The Associated Press, KHOU-TV, the Houston Chronicle, and Forbes, Dr. Hasan Gokal will not be indicted by the Harris County grand jury on charges that he stole vials of COVID-19 vaccine for family and friends. His defense consisted of the following:

1. The doses were about to be destroyed due to nonuse and aging.
2. It was his duty as a physician -- and one employed by the Harris County health department -- to maximize health and protect life.
3. Allowing the doses to be destroyed would have been a violation of his professional duties and sacred oath.

In short: "In an interview with The Associated Press, Gokal, 48, said when he was confronted with the possibility that a life saving vaccine could be lost, he made the decision to find eligible people late at night who could be given the expiring doses."

Although Harris County Public Health fired Gokal over the incident, the defense worked with the Texas Medical Board, which dismissed charges against him, as well as with a Harris County Court-at-Law Judge, who dismissed the theft charges against him. Prosecutors then turned to the grand jury, which rejected the case on June 30.

I'm searching for the right analogy to capture what was wrong with the prosecutor's case. Is this an "inverse Jean Valjean" situation, where the loaf of bread (vials of vaccine) would have been stolen not to feed Gokal's family (though his wife did get one of the doses) but the family of others? 

It's difficult to criticize Gokal's action if [1] the vaccine was going to be destroyed unless he acted, [2] noöne would be harmed if he did act (so this is not a variation on The Trolley Problem), [3] 9 otherwise at-risk individuals acquired some protection from infection at a time (late December 2020) when COVID-19 was still running rampant, and [4] Gokal himself wasn't responsible for creating the dilemma in the first place.