Under the “third party” arrangements, nonprofit organizations work as a front for medical care providers trying to win higher payments from private insurers that pay more than government programs like Medicaid, insurers say. For example, UnitedHealth Group last month sued a dialysis chain, American Renal Associates, alleging fraud. In its suit, UnitedHealth said American Renal hooked patients up with a charitable organization that helped patients pay their premiums, according to media reports.

Even though patients were eligible for Medicaid coverage for the poor, according to this New York Times report, the kidney care company wanted them to be covered by a private insurer so the dialysis providers could be paid a higher reimbursement.

Here is more, via Megan McArdle.  And here is Megan on who is gaming Obamacare — everyone.

The Right to Try

by on August 7, 2016 at 7:36 am in Economics, Law, Medicine | Permalink

Right to Try legislation permits patients fighting a terminal illness to get access to not-yet-FDA-approved drugs. Thirty-one states have passed Right to Try legislation with massive shows of support but so far these laws are untested by the courts so it’s not clear whether they are anything but expressive. The massive support for Right to Try laws, however, suggests that there is demand for a better FDA as Bartley Madden writes:

Freedom is a powerful rallying call and 31 states have now passed Right To Try legislation with sky-high approval ratings by citizens.

…[But] the states do not have the legal authority to circumvent the FDA. Moreover, drug developers have a major disincentive to participate because, to survive, drug developers need to secure FDA approvals for their new drugs. And circumventing the FDA by providing not-yet-approved drugs to terminally-ill patients could easily slow or prevent FDA approvals.

…A better solution is Free To Choose Medicine (FTCM). It would solve the dilemma facing politicians who are pulled in one direction by citizens’ demands for more freedom and in the opposite direction by FDA proponents with demands for a highly-controlled process. A clear, brief explanation of FTCM is available on the Internet in the PowerPoint presentation, “Free To Choose Medicine and Right To Try.” It explains how we will all benefit from more freedom of choice.

First, the Free To Choose track (separate from the FDA’s conventional clinical testing track) enables patients and their doctors to make informed decisions about the use of FDA-approved drugs or not-yet-FDA-approved drugs. Patients, under the guidance of their doctors, would learn about initial safety results and up-to-date treatment results of FTCM drugs. FTCM drugs for a wide range of illnesses (not just terminal illnesses addressed by Right To Try) would be available up to seven years before conventional FDA approval.

Second, FTCM legislation would provide for government oversight of an open-access, Internet-accessible database. It provides up-to-date information for patients and doctors about a FTCM’s drug’s potential benefits and risks before they choose to use it. This is a self-adjusting system wherein more patients use FTCM drugs that work well and vice versa.

The open-access database would contain treatment results of FTCM patients including their genetic makeup and relevant biomarkers. This database (not part of Right To Try legislation) would reveal subpopulations of patients who do extremely well or poorly with the new drug. Pinpointing such groups of patients is a huge benefit to, not only patients, but to biopharmaceutical researchers working on new breakthroughs in medicine.

Third, FTCM federal legislation needs to provide a new type of drug approval – Observational Approval – based on treatment results for real-world patients who receive the FTCM drugs. This would motivate drug developers to participate as well as expedite insurance reimbursement for patients.

Naturally, I agree with Bart on the need for FDA reform.

Richard “Scott” Silverthorne, the mayor of the City of Fairfax, has been arrested after he allegedly gave methamphetamine to an undercover detective in exchange for a sexual encounter, Fairfax County police say.

Story here.  It is nonetheless a wonderful place to work and live!

For the pointer I thank Yana and Scott.

The first home pregnancy tests were controversial because it was believed that women could not be trusted to do the tests correctly or to use the results appropriately:

NYTimes: When a mail-order New York firm tried to sell Organon test kits to American consumers in 1971, it faced opposition from the United States Public Health Service. In 1973, a New Jersey drugstore bought kits made by the drug company Roche and offered fast and private tests to their customers, and though the technology was similar to that available in medical clinics, the state medical examiner questioned the legality of the service.

Why so much opposition? Some regulators worried that “frightened 13-year-olds” would be the main users of the test kits. But after the product did become available in the United States in 1977, it appealed instead to college-age and married women — many of whom desperately hoped for children.

Even so, the Texas Medical Association warned that women who used a home test might neglect prenatal care. An article in this newspaper in 1978 quoted a doctor who said customers “have a hard time following even relatively simple instructions,” and questioned their ability to accurately administer home tests. The next year, an article in The Indiana Evening Gazette in Pennsylvania made almost the same claim: Women use the products “in a state of emotional anxiety” that prevents them from following “the simplest instructions.”

The tale of the home pregnancy test is not unique. Breakthroughs that give patients control over their bodies are often resisted. Again and again, the same questions come up: Are patients smart enough? Can they handle bad news? And do they have the right to private information about their bodies?

I wrote about these issues in Our DNA, Our Selves which discussed the FDA’s unconstitutional over-regulation of DNA tests. The legal questions in that case are yet to be fully resolved but the technology is pushing towards the freedom to know our own bodies.

Chinese scientists are on the verge of being first in the world to inject people with cells modified using the CRISPR–Cas9 gene-editing technique.

A team led by Lu You, an oncologist at Sichuan University’s West China Hospital in Chengdu, plans to start testing such cells in people with lung cancer next month. The clinical trial received ethical approval from the hospital’s review board on 6 July.

…The Chinese trial will enroll patients who have metastatic non-small cell lung cancer and for whom chemotherapy, radiation therapy and other treatments have failed. “Treatment options are very limited,” says Lu. “This technique is of great promise in bringing benefits to patients, especially the cancer patients whom we treat every day.”

On this one, they’re ahead of us.  There is much more information at the link, including a discussion of where the U.S. is at and also the FDA.

A central Pennsylvania man is accused of spraying fluid used to embalm a human brain on marijuana that he then smoked.

State police in Carlisle on Thursday charged Joshua Lee Long, 26, with abuse of a corpse and conspiracy.

WGAL-TV says court records indicate Long’s aunt discovered the brain in a department store bag while cleaning out a trailer.

…Court records indicate a coroner concluded the brain was real and that Long supposedly named it Freddy. According to the arrest affidavit, the coroners who examined the brain believe it is “most likely” a stolen medical specimen.

Here is more, via Tim B.

The FDA versus the Tooth

by on July 15, 2016 at 7:20 am in Economics, Law, Medicine | Permalink

The NYTimes has an incredible story on a simple, paint-on liquid that stops tooth decay and prevents further cavities:

Nobody looks forward to having a cavity drilled and filled by a dentist. Now there’s an alternative: an antimicrobial liquid that can be brushed on cavities to stop tooth decay — painlessly.

The liquid is called silver diamine fluoride, or S.D.F. It’s been used for decades in Japan, but it’s been available in the United States, under the brand name Advantage Arrest, for just about a year.

The Food and Drug Administration cleared silver diamine fluoride for use as a tooth desensitizer for adults 21 and older. But studies show it can halt the progression of cavities and prevent them, and dentists are increasingly using it off-label for those purposes.

Ari Armstrong has the right reaction:

So the Japanese have been using this drill-free treatment for “decades,” yet we in the United States have had to wait until last year to get it. And the only reason we can get it now to treat cavities is that it happens to be allowed as on “off-label” use for what the FDA officially approved it for.

The NYTimes continues:

Silver diamine fluoride is already used in hundreds of dental offices. Medicaid patients in Oregon are receiving the treatment, and at least 18 dental schools have started teaching the next generation of pediatric dentists how to use it.

…The main downside is aesthetic: Silver diamine fluoride blackens the brownish decay on a tooth. That may not matter on a back molar or a baby tooth that will fall out, but some patients are likely to be deterred by the prospect of a dark spot on a visible tooth.

…[But] “S.D.F. reduces the incidence of new caries and progression of current caries by about 80 percent,” said Dr. Niederman, who is updating an evidence review of silver diamine fluoride published in 2009.

Fillings, by contrast, do not cure an oral infection.

But as Armstrong writes the craziest part of the story is this:

American dentists first started using similar silver-based treatments in the early 1900s. The FDA is literally over a century behind the times.

It seems that the future of dental treatment has been here all along but a combination of dentists wanting to be surgeons, lost knowledge, and FDA cost and delay prevented it from being distributed. Incredible.

For some time now I have had mixed feelings about the move to electronic medical records, here is another reason why:

On the dark web, medical records draw a far higher price than credit cards. Hackers are well aware that it’s simple enough to cancel a credit card, but to change a social security number is no easy feat. Banks have taken some major steps to crack down on identity theft. But hospitals, which have only transitioned en masse from paper-based to digital systems in the past decade, have far fewer security protections in place.

…These records can sell for as much as (the bitcoin equivalent) of $60 apiece, whereas social security numbers are a mere $15. Stolen credit cards sell for just $1 to $3. During the tour, we spotted one hacker who claimed to have a treasure trove of just shy of 1 million full health records up for grabs.

As IBM’s Kuhn explained in a follow-up interview, these medical records can be leveraged for a wide variety of nefarious purposes. In some cases, it’s about stealing a person’s identity and billing them for a surgery or a prescription, and in others it’s about opening a new line of credit. Security researcher Avi Rubin told Fast Company in an recent interview that he suspects hacked medical records are often routinely used for blackmail and extortion.

Such hacking is indeed a trend:

More than 113 million medical records were hacked in 2015 alone, according to data compiled by the Health and Human Services. A newly released report from the Institute for Critical Infrastructure Technology, a cybersecurity think tank, found that some 47% of Americans have had their medical record hacked in the past 12 months.

That is from Christina Farr.

Kidney Gift Vouchers

by on July 13, 2016 at 9:20 am in Economics, Medicine | Permalink

I am not expecting a market in kidneys anytime soon but ever more sophisticated barter is slowly improving kidney allocation. Most recently, UCLA has started a program where a kidney donation may be swapped for a kidney gift certificate good for a kidney transplant at a time of the recipient’s choosing.

The program allows for living donors to donate a kidney in advance of when a friend or family member might require a kidney transplant.

…“It’s the brainchild of a grandfather who wanted to donate a kidney to his grandson nearing dialysis dependency, but the grandfather felt he would be too old to donate in a few years when his grandson would likely need a transplant.”

Nine other transplant centers across the U.S. have agreed to offer the gift certificate program, under the umbrella of the National Kidney Registry’s advanced donation program. Veale anticipates that more living donors will come forward to donate kidneys, which could trigger chains of transplants. Then, when a patient redeems his or her gift certificate, the last donor in the chain could donate a kidney to that recipient.

Improving allocation is important but the real constraint today is supply. This program may help with that on the margin, however, because altruistic donors could donate and keep a gift certificate as insurance in case any of their family members one day needed an transplant. More fundamentally, however, increasing supply will require some form of compensation or incentive such as no-give, no-take.

From Sunita Sah (NYT):

Disclosure can also cause perverse effects even when biases are unavoidable. For example, surgeons are more likely to recommend surgery than non-surgeons. Radiation-oncologists recommend radiation more than other physicians. This is known as specialty bias. Perhaps in an attempt to be transparent, some doctors spontaneously disclose their specialty bias. That is, surgeons may inform their patients that as surgeons, they are biased toward recommending surgery.

My latest research, published last month in the Proceedings of the National Academy of Sciences, reveals that patients with localized prostate cancer (a condition that has multiple effective treatment options) who heard their surgeon disclose his or her specialty bias were nearly three times more likely to have surgery than those patients who did not hear their surgeon reveal such a bias. Rather than discounting the surgeon’s recommendation, patients reported increased trust in physicians who disclosed their specialty bias.

Remarkably, I found that surgeons who disclosed their bias also behaved differently. They were more biased, not less. These surgeons gave stronger recommendations to have surgery, perhaps in an attempt to overcome any potential discounting they feared their patient would make on the recommendation as a result of the disclosure.

Surgeons also gave stronger recommendations to have surgery if they discussed the opportunity for the patient to meet with a radiation oncologist. This aligns with my previous research from randomized experiments, which showed that primary advisers gave more biased advice and felt it was more ethical to do so when they knew that their advisee might seek a second opinion.

The piece is…self-recommending!

…I work occasionally at the VA as a psychiatrist in both inpatient and outpatient settings. My impression is that the men going into the recent wars are far less psychologically healthy then the men who went to WWI, WWII, or Korea. The prior longitudinal studies of the wars of the first half of the 20th century, such as they are, do indeed suggest that most men exit war with similar psychological profiles as to when they entered. Could the recently documented ‘sense of loss’ so many returning veterans express reflect something similar to inner city youths and gangs, namely, that the camaraderie of combat and order of military life provided the paternal presence they lacked growing up? Military life and combat provided what communities and families had provided similar men when they returned from WWI and WWII. Take away the military life and combat, and they are left where they were prior to joining.

That is from a recent post on reading.

“These are black boxes,” said Dr. Steven Joffe, a pediatric oncologist and bioethicist of the University of Pennsylvania, who serves on the FDA’s Pediatric Ethics Committee. “IRBs as a rule are incredibly difficult to study. Their processes are opaque, they don’t publicize what they do. There is no public record of their decision or deliberations, they don’t, as a rule, invite scrutiny or allow themselves to be observed. They ought to be accountable for the work they do.”

That is part of a longer and very interesting article on whether IRBs should be for-profit, or if we even at this point have a choice:

“This shift to commercial IRBs is, in effect, over,” said Caplan, who heads the division of bioethics at New York University Langone Medical Center. “It’s automatic and it’s not going back.”

Institutional review boards — which review all research that involves human participants — have undergone a quiet revolution in recent years, with many drug companies strongly encouraging researchers to use commercial boards, considered by many more efficient than their nonprofit counterparts.

Commercial IRBs now oversee an estimated 70 percent of US clinical trials for drugs and medical devices. The industry has also consolidated, with larger IRBs buying smaller ones, and even private equity firms coming along and buying the companies. Arsenal Capital Partners, for example, now owns WIRB-Copernicus Group.

But even if the tide has already turned, the debate over commercial review boards — and whether they can serve as human subject safety nets, responsible for protecting the hundreds of thousands of people who enroll in clinical trials each year — continues to swirl.

I am not well-informed in this area, but if you refer back to the first paragraph, perhaps nobody is.  That’s worrying.

For the pointer I thank Michelle Dawson.

Critics attribute such medical experimentation in China to national ambition, generous state funding, a utilitarian worldview that prioritizes results, and a lack of transparency and accountability to the outside world.

If that is the critics, I wonder what the defenders say!  That concerns transplanting one person’s head onto the body of another.  From that NYT article, the procedure still seems impossible.  Nonetheless I am not sure the NYT’s articulation of the critical charges sounds as damning as many biomedical ethicists might wish to think…

The robot administers a small pin prick at random to certain people of its choosing.

The tiny injury pierces the flesh and draws blood.

Mr Reben has nicknamed it ‘The First Law’ after a set of rules devised by sci-fi author Isaac Asimov.

He created it to generate discussion around our fear of man made machines. He says his latest device shows we need to prepare for the worst

‘Obviously, a needle is a minimum amount of injury, however – now that this class of robot exists, it will have to be confronted,’ Mr Reben said on his website.

Here is more, with pictures of (slightly) injured humans, via the excellent Mark Thorson.

I study the effect that expanding Medicaid eligibility has on labor force participation of childless adults. The Affordable Care Act provided federal funding for states to expand public health insurance to populations that had never before been eligible for the benefit on a large scale, among those are adults without dependent children. A 2012 Supreme Court decision allowed states to choose whether or not they wanted to accept federal funds to expand Medicaid eligibility, resulting in a situation where roughly half of the population resided in states that had expanded Medicaid eligibility in 2014 and half did not. I exploit this variation by conducting a series of difference-in-differences and triple differences analyses both at a local level within one labor market, and nationwide to determine the relationship between Medicaid expansion and labor force participation. I find a significant negative relationship between Medicaid expansion and labor force participation, in which expanding Medicaid is associated with 1.5 to 3 percentage point drop in labor force participation.

That is from a Georgetown thesis by Tomas Wind, via Ben Southwood.  Given the possibility of paternalistic judgments in health care policy, the simplest question here is whether this class of individuals is better off as a whole, as a result of some of them choosing this trade-off.  Work is good for most people, and it is even better for their future selves, and their future children too.