Off the Kuff Rotating Header Image

mifepristone

More on the Texas telemedicine lawsuit

Texas Monthly has a nice overview.

Imagine you’re sick, or you think you might be sick, and you want to talk to a doctor. Instead of waiting a week or two to see your primary care physician, you just open an app on your phone or computer and within minutes you’re video-chatting with a doctor or nurse. Maybe you even have a medical device, like a blood pressure monitor, that connects your computer and transmits images and data to your doctor in real time while you’re talking.

That’s not science fiction. It’s called telemedicine, an $18 billion worldwide industry and one of the fastest-growing sectors in health care. In many ways, telemedicine represents the future of health care, promising to do for medicine what Uber and Lyft have done for transportation. Across the country, the use of telemedicine is expanding as consumers realize how much more convenient it is to talk to a doctor when and where they choose. It’s also a lot cheaper. The average telemedicine visit costs between $40 and $50, compared to the average in-person doctor’s visit, which is about $100 more—not counting the cost of the time and effort it takes to travel to and from a brick-and-mortar doctor’s office.

But here in Texas, where we have an infamous shortage of doctors and nurses, telemedicine has hit a snag. New rules promulgated by the Texas Medical Board last year prompted Dallas-based Teladoc, the largest telemedicine firm in the country, to file a federal antitrust lawsuit against the board. Specifically, the medical board’s new rules (PDF), approved in April 2015 but blocked by a federal judge’s preliminary injunction just days before they were set to take effect, stipulate how physicians in Texas can establish a “doctor-patient relationship” with new patients before engaging in telemedicine. A patient must either visit the doctor in person or meet “face-to-face” over video conference. But the video conference must be at an approved medical site like a hospital, clinic, or a fire station, and there must be a “patient site presenter” on hand, like a nurse or a physician’s assistant. In other words, you can’t just turn on your computer at home, login to a telemedicine app and be connected with a doctor. Put another way, in Texas you have to go to a medical clinic to be seen by a doctor, even if the doctor isn’t there.

This presents a substantial obstacle for Texans who are interested in using telemedicine. Many people, especially younger folks, simply won’t go to a doctor’s office, either because they don’t have what doctors and policymakers call “a medical home,” or because they don’t have health insurance.

So in Texas, which has the highest uninsured rate in the nation, on-demand telemedicine could be a game-changer. It holds the promise that, instead of forgoing medical care, more people might actually seek out a doctor when they’re sick.

All of this is why the antitrust lawsuit Teledoc filed has sparked so much debate—and confusion. Teladoc, which says Texas was already among the most restrictive states in the country for telemedicine, claims the new rules will hamstring telemedicine firms and limit patients’ access to healthcare. The medical board claims just the opposite. It views its new regulations as an expansion of telemedicine, not a restriction of it. Meanwhile, as the case wends its way through federal courts, a consortium of health care and tech groups is calling on the Texas Legislature to step in and settle the matter when lawmakers convene in Austin early next year.

[…]

The Legislature seems at least somewhat aware that it needs to step in. Last session, both the Senate and House issued interim charges to study telemedicine and give recommendations about how to improve it. To date, most of these hearings have steered clear of the lawsuit and spent considerable time hearing testimony about how great telemedicine is in Texas. To be fair, Texas was one of the first states to invest in telemedicine technology in the 1990s, and since then has tried to encourage its use in rural areas where medical specialists are scarce. One pilot program, supported by state funds and run by the Texas Tech University Health Sciences Center in Lubbock, will equip ambulances in rural West Texas with technology that allows first responders to communicate with physicians at regional trauma centers on a secure internet connection and transmit patient data in real-time while en route to a trauma center or an emergency room.

Those are real advances, and will likely save some lives in rural communities. But the big gains from telemedicine will come from hundreds of thousands of consumers using the services for routine care—and doing so on their own initiative from their homes and offices. To make that possible in Texas, lawmakers might need to act. During the 2015 session, Representative Jodie Laubenberg filed several telemedicine bills, including one that would have prevented the medical board from issuing the rule requiring a face-to-face consultation if the physician had never seen the patient. The bill was introduced and referred to the House Public Health Committee, but after the board published its new rules in April and Teladoc sued, Laubenberg, pulled it. “If something’s going to court, we stand back,” she said—a line that’s since been repeated in interim hearings on telemedicine.

But Laubenberg, along with Teladoc and many other Texas-based healthcare firms, thinks the legislature should step in once the court case is settled. They think this is about something much larger than a single antitrust suit. “Over the last five to ten years, telemedicine changed from a promise to a reality,” says Gorevic. “Now we’re starting to see the benefits. Today it’s becoming part of the fabric of the healthcare delivery system.” Just how much a part of the fabric it becomes in Texas depends not only on the Fifth Circuit Court, but how well lawmakers can work with regulators once the dust settles. Right now, the tide seems to be turning in telemedicine’s favor. In September, Robinson, the medical board’s executive director since 2001, announced she’s leaving the board to direct the telemedicine program at University of Texas Medical Branch in Galveston.

For lawmakers like Laubenberg, the issue is about something yet greater than healthcare: the degree to which regulatory boards should make up rules for their industries. “I’ve never been a big fan of agency rulemaking. They tend to go rogue,” she said. “I think the medical board thought they could get ahead of it, but the issue’s too big, and they couldn’t do it.”

See here for the background, and be sure to read the whole thing. It seems likely that Teladoc will prevail in court, though one never knows for sure, and it won’t surprise me if the Lege decides to step in and attempt to settle the matter themselves. There is of course an irony in Jodie Laubenberg being so involved with this, since the omnibus anti-abortion HB2 from 2013 prohibits dispensing abortion-inducing drugs (mifepristone-misoprostol regimen) by anyone other than a physician and requires that the physician dispensing the drug first examine the pregnant woman, which is interpreted to mean “in person”, thus making HB2 itself a telemedicine ban. That provision wasn’t part of the lawsuit that led to much (but not all!) of HB2 being struck down, though it may well come later. Point being, Laubenberg considers regulating doctors to be her job, not the Medical Board’s. We’ll see who gets to make the next move, the Fifth Circuit or the Lege. Texas Association of Business President Bill Hammond, opining in the Chron, has more.

State finally releases abortion data

It’s exactly what you’d expect.

Right there with them

Right there with them

The Texas Department of State Health Services has released the state’s 2014 abortion data after weeks of allegationsthat the agency had been intentionally withholding the numbers.

The 2014 data is significant because it is the first year to reflect the impact of Texas’ anti-abortion law, House Bill 2, on abortion providers and patients across the state.

The U.S. Supreme Court struck downparts of HB 2 as unconstitutional this week, in part because the court could not find evidence for Texas’ justification for the law — that mandatory hospital admitting privileges for abortion providers and hospital-like renovations for abortion clinics would increase patient safety. In their challenge to the law, Texas abortion providers argued that HB 2 would instead reduce access to abortion and would have a disproportionately negative impact on Texas Latinas.

According to the newly released numbers, the providers were right.

One of the most striking revelations is the change in number of medical abortions — a two-pill regimen that, under HB 2, was heavily restricted and required many more clinical visits than a surgical abortion procedure. In 2013, 16,189 Texans got medical abortions; in 2014, that number dropped to almost 5,000. (Medication abortions became easier to access earlier this year, when an FDA label change enabled more providers to issue the drugs under the law.)

The 2014 DSHS data also suggest the law had a disproportionate impact on Texans of color. In 2013, over 24,000 of Texans who got abortions were Hispanic; in 2014, that number decreased by 18 percent to under 20,000. The numbers also show a 7.7 percent decrease among black Texans who got abortions.

Overall, the number of abortions in Texas decreased by 14 percent from almost 64,000 in 2013 to almost 55,000 in 2014. The data also show that the number of abortions performed in clinics dropped by 21 percent from 2013, and the number performed at ambulatory surgical centers increased by 12 percent, reflecting the closure of half the state’s non-surgical center clinics after parts of HB 2 took effect in 2013.

The new numbers also don’t show abortion was any safer post-HB 2. For both 2014 and 2013, complication rates were negligible; the complication rates were 0.04 percent and 0.05 percent, respectively.

See here for the background. On the matter of medical abortions, the Austin Chronicle explains:

While more than 16,000 women took medication to terminate their pregnancies in 2013, less than 5,000 did so in 2014 – a stunning 75% decrease. The number of women going in for surgical abortion, on the other hand, rose about 3,000. The likely reason? HB 2 included a provision that forced women to ingest abortion pills following outdated, more expensive, and potentially more harmful FDA protocol. Some providers responded by discontinuing the service and it was reported that women were less eager to opt for medication abortion, which had forced them to take the pill in the doctor’s office rather than their homes. The FDA has since updated its guidelines. Planned Parenthood Central Texas centers, including the Austin location, saw its medication abortion rates drop to less than 1% from 40% before HB 2.

See here for more on that. Since the FDA updated its guidelines, use of the abortion pill has risen sharply, which is exactly what you’d expect since taking a pill is safer, cheaper, and more convenient than going to a medical facility for an invasive procedure. Of course, women were still seeking medical abortions after HB2’s passage, they just were doing it on their own, without any assistance from a medical professional. Because HB2 was all about their safety, don’t ya know.

More women traveled out of state to obtain abortions as well.

The statistics also show a slight increase in the number of pregnant persons who traveled out of state to obtain abortion care. The number of abortions that took place “out of state” was 754 in 2014, compared to 681 in 2013.

However, data from other states suggest a much larger increase during that time period. As Rewire previously reported, statistics from Arkansas, Kansas, Oklahoma, and Louisiana appear to indicate at least 1,086 patients traveled to those states from Texas to obtain an abortion in 2014.

Basically, everything is as abortion rights activists said it would be under HB2, and whatever the reasons for the delayed release of this data, there’s no question that the timing was convenient for the state. Thanks for not buying the BS, Supreme Court. The Trib and the Chron have more.

Use of abortion pill rises

Until the Lege reconvenes, anyway.

Misoprostol

There’s been a sharp increase in the number of Texas women who are using the abortion pill to end their pregnancies now that federal officials have eased restrictions on the drug, according to officials at Planned Parenthood of Greater Texas.

Until recently, the number of women seeking medically induced abortions at Texas’ Planned Parenthood facilities had dipped to about 1 percent because of stringent guidelines put in place by state lawmakers, officials say.

That changed in late March, when the U.S. Food and Drug Administration relaxed guidelinesfor women taking mifepristone, a pill geared to induce abortion early in a pregnancy.

“We have seen a fourfold increase in the number of our patients choosing medication abortion since the FDA updated its protocol,” said Sarah J. Wheat, chief external affairs officer at Planned Parenthood. “From our perspective, it’s restoring options for women.

“It’s putting decisions back in the hands of women instead of politicians at the Capitol.”

No firm numbers are available yet, but Texas researchers and abortion providers say they see the increase and hope to have better estimates in the coming months.

[…]

Planned Parenthood continues to run clinics statewide, including the Southwest Fort Worth Health Center, a privately funded $6.5 million licensed ambulatory surgical center that opened in 2013.

A medical abortion has remained an option for patients at these facilities, but fewer women have used it because Texas law required them to visit the clinic four times for it, said Daniel Grossman, an investigator with the Texas Policy Evaluation Project and a professor at the University of California, San Francisco.

“In the six months after HB 2 went into effect, there was a 70 percent decline in medication abortions performed statewide,” said Grossman, who is working with researchers at the University of Texas at Austin to determine the impact of legislation on abortions. “Interviews with women … [showed they were] incredibly frustrated when they had a preference for medication abortion” and couldn’t get it.

Wheat said some women have had to travel 100 miles or more to reach a Planned Parenthood clinic, which put a hardship on them for multiple visits.

“That requirement alone created huge barriers for our patients,” she said.

Now that the FDA change has loosened restrictions in Texas — requiring a lower dose, 200 milligrams instead of 600 milligrams; fewer doctor visits; and allowing the medication up to 10 weeks in a pregnancy instead of seven weeks — more women are choosing the medical abortion option, Wheat and Grossman say.

Exact numbers won’t be available for weeks or months, but “many of the independent abortion providers who have already started using the new FDA regimen are saying their numbers are back up,” Grossman said. “Many women have a preference and prefer this.”

[…]

Now the question is whether Texas lawmakers will weigh in on the issue when they return to work in January.

Planned Parenthood officials say they hope not.

“The restrictions the Legislature put in place were not based in science,” Wheat said. “The FDA is the national expert in how medications are provided, and they approved these updates.

See here for the background. I’d laugh at the futility of hoping that science and rationality would prevail if it weren’t so painful. The best hope as I see it is for HB2 to be sufficiently gutted by the Supreme Court. That will surely only slow down the zealots, but it’s probably the best we can expect until we start electing different leaders.

FDA makes medical abortion safer

Good news, at least until the Legislature reconvenes.

Misoprostol

Texas women will be able to obtain medical abortions later into their pregnancies under newly approved changes by the federal Food and Drug Administration.

The FDA on Wednesday announced revised rules for drug-induced abortions — a method used early in a pregnancy — that will increase the number of days women can take medication to induce abortions from 49 days of gestation to 70 days. Other revisions to the original FDA label for medication that induces abortions include a lower dosage of the drug, known as mifepristone.

First approved in 2000, mifepristone, when taken with another drug called misoprostol, is used to terminate early pregnancies.

Doctors in many states already followed common, evidence-based protocols that strayed from the FDA’s previous label for the drug, but Texas doctors were prohibited from doing so by state law. Among the provisions of the 2013 abortion law known as House Bill 2, Texas doctors were required to follow the FDA’s protocol for drug-induced abortions rather than evidence-based protocols.

[…]

Abortion providers and representatives of the medical community had long asked for an update to the FDA rules, arguing the original FDA label for mifepristone was based on outdated evidence from the 1990s.

“Today, science has prevailed where the state legislature has failed,” said Yvonne Gutierrez, executive director of Planned Parenthood Texas Votes, the organization’s political arm in the state.

While the medication to end a pregnancy must still be administered in Texas by a physician, the FDA revisions also say the second drug can now be taken “at a location appropriate for the patient.” It’s unclear what that means for Texas women who under state law must take the pill in front of a doctor.

A spokesman for the Texas Medical Board, which regulates physicians, said it was “still in the process of analyzing the FDA’s updated regimen.”

Of course, plenty of women have taken matters into their own hands on this, so this is at least a small step in the direction of safety. Don’t expect the Lege to be deterred by this, of course. They will figure out a way to make this as burdensome and punitive as possible. We may get a favorable ruling from SCOTUS in the HB2 case, but this would be a separate matter that would have to be litigated all over again. So enjoy this while you can, it’s got a limited shelf life. Sorry to be such a drag. Think Progress, the Chron, the Press, Daily Kos, and the AusChron have more.