Banuelos v. University of Wisconsin Hospitals and Clinics…, 406 Wis.2d 439 (2023) is best explained by the truism that lawyers have children in college. And tuition plus room and board is expensive.

The bills will get paid.

Beatriz Banuelos requested her medical records from University of Wisconsin Hospital. She submitted a signed request and asked for copies of her medical records in electronic format (pursuant to the HITECH Act). She authorized that the records be sent to her attorneys.

The Hospital complied with the request through its service provider, Ciox. Banuelos’ attorneys received the electronic copy.

And an invoice for $109.96.

The requested payment for copies included “per page” charges of $1.14 for the first 25 pages, $0.86 for the next 25 pages, $0.56 for the next 50 pages, and $0.34 for an additional 94 pages, which is consistent with the maximum rate for paper copies of patient health care records permitted under Wis. Stat. § 146.83(3f).

This invoice did not sit well with Banuelos’ attorneys.

Banuelos filed suit, seeking declaratory and injunctive relief, as well as damages. Her complaint alleged that because the copies of electronic patient health care records she requested do not fall into one of the enumerated categories contained within Wis. Stat. § 146.83(3f), none of the charges permitted under § 146.83(3f) applies to her electronic records request. Accordingly, she argued that UW Hospital’s charge of $109.96 was in violation of state law.

The Hospital filed a Motion to Dismiss alleging Banuelos’ claims were “fundamentally flawed” with respect to her interpretation of the Wisconsin statute.

The Hospital prevailed at the lower level.

The case was appealed and reversed.

Then, the Hospital appealed to the Wisconsin Supreme Court. Damn it. It was going to collect the $109.96.

The Hospital argued that the Wisconsin statute discussed what maximum charges could be for paper records, microfiche, X-rays, with additional charges if records were being requested by someone other than the patient or individual authorized by the patient. The Hospital argued that the statute was mute on electronic records. And the sky was the limit. Or at least a reasonable fee was the limit.

This was a cage fight with amicus curiae briefs filed for Aurora Health Care, Inc., Wisconsin Civil Justice Council, Inc., Wisconsin Association for Justice and Wisconsin Defense Counsel, the Wisconsin Medical Society, Inc., the Wisconsin Dental Association, Inc., LeadingAge Wisconsin, Inc., the Rural Wisconsin Health Cooperative, the Wisconsin Health Care Association/Wisconsin Center for Assisted Living, and the Wisconsin Health Information Management Association, Inc., and Association of Health Information Outsourcing Services.

The interested parties put their muscle behind the effort. The stakes could not be higher.

The Wisconsin Supreme Court affirmed the appellate decision. Banuelos won. Or more accurately, her attorneys, the individuals who wanted the records, won.

We conclude that although Wis. Stat. § 146.83(3f) provides for the imposition of fees for copies of medical records in certain formats, it does not permit health care providers to charge fees for patient records in an electronic format. Therefore, we determine that Banuelos’s complaint states a claim upon which relief can be granted.

The federal HITECH Act also addresses charges for electronic medical records.

Under the HITECH Act, the fee that any covered entity may impose for providing a copy of electronic health records “shall not be greater than the entity’s labor costs” in responding to the request. 42 U.S.C. § 17935(e)(2). The regulations make clear that the costs are limited to labor, the cost of supplies, and postage. See 45 C.F.R. 164.524(c)(4)(i)-(iii). The US Department of Health & Human Services permit you to charge $6.50 as a flat rate or calculate the average or actual cost for provided these electronic records, whichever is most appropriate for the circumstances. However, the fees charged must be “withing the boundaries of what is permissible under the Privacy Rule.” See https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/clarification-flat-rate-copy-fee/index.html.

The federal government notes three ways to determine charges for electronic records.

1. Actual Cost
2. Average Cost
3. $6.50 flat rate.

If “actual cost”, you will need to back up that number. How? Who compiled the records? How much time was spent on compiling the records? How much is that individual paid to perform their job?

If this cost is based on the average cost, you will need to back up that number. That number is likely the actual cost amortized over a year for similar requests.  

Of course, you can just charge the $6.50 flat fee. No calculations required.

Clearly, reproduction of electronic medical records is not going to be a revenue center.

Still, you can see that the issue of paying for electronic medical records triggers strong feelings.

I have no idea what the parties paid to litigate this issue to the Wisconsin Supreme Court. But it had to be steep.

As we have written before, some fights achieve momentum well beyond the stakes at play.

Remember the Falklands War. Argentine author Jorge Luis Borges, had his interpretation: “The Falklands thing was a fight between two bald men over a comb.” One journalist added, “The British still want the comb, if only to hand it over nicely.”

The Falklands War (Spanish: Guerra de las Malvinas) was a ten-week undeclared war between Argentina and the United Kingdom in 1982 over two British dependent territories in the South Atlantic: the Falkland Islands and its territorial dependency, South Georgia and the South Sandwich Islands. The conflict began on 2 April, when Argentina invaded and occupied the Falkland Islands, followed by the invasion of South Georgia the next day. On 5 April, the British government dispatched a naval task force to engage the Argentine Navy and Air Force before making an amphibious assault on the islands. The conflict lasted 74 days and ended with an Argentine surrender on 14 June, returning the islands to British control. In total, 649 Argentine military personnel, 255 British military personnel, and three Falkland Islanders were killed during the hostilities.

The population of the Falkland Islands today is 3,794. That said, there are about half a million sheep there.

This fight over invoices for copying electronic medical records seemed liked a fight between two bald men over a comb.

If I were to bet on the future, I expect the Wisconsin legislature to clarify the issue, and it will likely comport to what HITECH offers. But we’ll see.

What do you think?

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2023 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

Non-compete agreements are a double-edged sword.

For employers bringing on new employees, they invest in their new hires. They want their new hire to succeed. They do not want that person to build a practice, then leave, go across the street, and compete.

For employees, the non-compete agreement is very limiting. If the job does not work out, they have to leave. Often, they have to sell their house, yank the kids out of school, find a new dry cleaner. Moving is stressful. Doesn’t matter if you move 20 miles away or across the country.

Non-compete agreements are addressed by state law. Some states, like California, make physician non-compete agreements unenforceable. Other states, like Texas, incorporate a formula allowing a physician to “buy his way” out of the agreement. Other states, like Missouri, fully enforce such agreements.

In states where the agreement is enforceable, the terms must be reasonably necessary to protect the employer’s business interests. It cannot be more restrictive than necessary to protect the employer’s business interests. So, the geographic limitation cannot be too wide. The time restriction cannot be too long. Finally, if you are the only person providing services in the region, for example, pediatric oncology, special circumstances will likely apply. You cannot deprive an entire region of valuable follow-up care.

Over the past several months, the Federal Trade Commission has been considering a nationwide federal mandate. In January 2023, they issued a proposed rule that would ban all non-compete agreements. The proposed rule was published with the expectation that comments would be submitted.

26,000 comments were received. That’s a lot.

Under the proposed rule, not only will employers be prevented from entering into non-compete agreements with their workers, but they will also have to tell their former workers that their noncompetes are null and void.

Anyway, the Federal Trade Commission will address this again at a special meeting on April 23^rd. Importantly, there has been a lot of blowback. From the US Chamber of Commerce, the anti-trust section of the American Bar Association, and even the American Medical Association.

FTC will first vote whether to authorize the public disclosure the proposed final rule. If the vote clears, they will present the final rule to the public, and then will vote on whether to approve the final rule.

Even if the FTC approves the mandate, it will likely would take time to go into effect. And expect litigation to ensue in jurisdictions favorable to non-competes.

It’s too soon for employers or employees to break out the champagne and declare victory.

What do you think?

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2023 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

Semaglutide is a GLP-1 agonist (glucagon-like peptide 1), marketed by Novo Nordisk as Wegovy for weight loss and Ozempic for type 2 diabetes.

To say these medications are popular is an understatement. Novo Nordisk cannot keep up with demand. The same goes for Eli Lilly that markets tirsepatide (Zepbound for weight loss and Monjaro for type 2 diabetes.

The FDA publishes a drug shortage list. That list currently has 131 entries. It includes atropine sulfate injection, cefotaxime injection, and lidocaine injection. Drugs go in and out of this list. For example, the shortage of mannitol was resolved. Same with mepivacaine injection.

If a medication is on this list, federal law allows compounding pharmacies to make “essentially a copy.”

Semaglutide and tirzepatide are currently on that list. This allows compounding pharmacies to get in the game. But not without limitations.

The FDA sent warning letters to some entities selling compounds with similar sounding names – but a different compound. Such as semaglutide sodium salt. The sodium salt is probably effective, but that’s not how it was tested to gain FDA-approval. And there are some entities, particularly online, selling complete fakes.

But there are legal versions of GLP-1 agonists medications that can be and are purchased from reputable compounding pharmacies; pharmacies that follow state and federal laws, and only dispense via a health care provider prescription.

Some background. Compounding pharmacies come in two varieties. 503 A and 503 B.

503 A pharmacies are state licensed pharmacies and physicians.

503 B pharmacies are federally regulated outsourcing facilities regulated by the FDA.

The 503 B regulations emerged after 2012 meningitis / epidural abscess outbreak connected to compounded epidural steroid injections. 503 B pharmacies address medications for IV or intrathecal use.

Semaglutide is injected subcutaneously, so it does not require 503 B scrutiny.

The compounding pharmacies must obtain the active ingredients from FDA-registered facilities, which adhere to Current Good Manufacturing Practices (cGMP). This secures quality, efficacy, and safety.

So, the compounded versions are not “FDA approved.” But they are “FDA-allowed” as long as the medications are on the shortage list. And as long as the compounding pharmacy follows a number of rules.

Note, GLP-1 agonists can be addressed by either 503A or 503B compounding pharmacies. Notably, a 503 B pharmacy has an additional layer of regulation (by the FDA) and may provide an additional level of quality assurance.

What else can prescribing physicians do (or patients request)? They can request a Certificate of Analysis from the compounding pharmacy. This ensures the compound is what it purports to be. 

Also, some nomenclature. Some entities are marketing generic semaglutide. Generic semaglutide does not yet exist on the market. (A generic drug is one whose original patents have expired, allowing third parties to manufacture and sell it – the semaglutide patents and the others are still very much in force).

How is this stuff actually made?

Actual semaglutide for human use, as furnished by Novo Nordisk, is produced by first engineering yeast cells to make the underlying peptide. That product is quite similar to naturally occurring GLP-1, but with some key modifications. The first six amino acids at the N-terminus of GLP-1 are gone, and the alanine at position 8 is changed to the unnatural dimethyl version (Aib, 2-aminoisobutyric acid) – that’s to prevent enzymatic breakdown by the DPP-IV enzyme in vivo. A lysine at position 28 is switched out for an arginine, which leaves another lysine at position 26 free to be modified with a long fatty-acid/ethylene glyol-like chain, which improves the drug’s half-life in the blood even more (by binding to serum albumin). That side-chain modification is done chemically after purifying the underlying peptide from the fermentation step, and you can be sure that that process, along with the yeast expression DNA sequence, the fermentation conditions, and the purification steps have been pretty well tuned up by the Novo Nordisk folks. 

It’s certainly not an impossible process to duplicate, but it’s not a casual synthesis either, and you wouldn’t try it without the financial motivations that we see at the moment. And there are other ways to make the drug, likely somewhat more expensive or harder to scale, at least for now, as a look at the patent literature will show you. You don’t have to do the fermentation, for example, since peptides of this size can be made by straight synthesis, but if I were frantically trying to supply my most profitable product at the largest scale available I would certainly want cultured cells doing as much of the work as possible. I don’t know who’s making the sodium salt form or what process they’re using, although it’s surely very close to the regular semaglutide routes. 

The compounding pharmacy workaround to address a medication shortage is helpful, as long as it’s done properly. Derek Lowe, writing on science.org, summarized the conundrum eloquently.

So it’s a confusing landscape out there. My guess is that a significant amount of the stuff coming from the compounding pharmacies is not quite Ozempic, since there’s not enough of that to go around at the moment, and in some cases it may be even worse than that. There is truly no way for the patients involved to know what they’re getting in such cases, which is where the libertarian “let ’em try it” position starts to break down. The barriers to verification by the end users are just too high, which is why we have the bureaucratic, expensive, often infuriating supply chain regulations that we have. Because the alternative is you pay someone to send you a syringe full of stuff – cloudy, maybe a slightly different color than the last one, and with a different return address on the package this time – and you roll up your shirt and inject it under your skin anyway. And you see what happens.

What do you think?

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2023 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.