Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Tuesday, September 07, 2021
The latest surge: It's real and it was avoidable
Sunday, July 25, 2021
DFW's COVID-19 Hospitalizations Have Tripled in the Past Month
We have 1,126 COVID-19 patients in our hospitals in TSA-E which is an increase from 1046 yesterday and we are sorry to see this number spike over 1,100 COVID-19 hospitalized patients. This represents 8.28 percent of bed capacity and 23.91 percent of adult ICU patients which means we are approaching one in four of our adult ICU patients has COVID-19. Tarrant county has 401, Dallas 336, Collin 162, Denton 53, Hunt 28, Grayson 30 and Rockwall 35. As we have said before, the majority of the patients are not vaccinated. As a point of reference, we had 387 COVID-19 patients in the hospitals on June 25 so as you can tell, our hospitalizations have increased significantly in 30 days. Currently, we have 118 available adult staffed ICU beds . We have 135 adults on ventilators.
As nearly as anyone can tell, with the exception of a relative handful of "breakthrough" infections among the fully vaccinated (to be expected, because no vaccine is 100% effective), this increase is almost entirely among the unvaccinated population.
I am not inclined to be judgmental when it comes to choices people make for themselves, but refusing vaccination puts family and loved ones and the rest of the community at increased risk, and as the above numbers indicate, stress the critical care capacity to the detriment of other patients who also need treatment. Without a truly compelling reason (e.g., a validated medical reason) to skip vaccinations, failing to be vaccinated at this point is simply incomprehensible. And compelling reasons do not include cost (it's free), inconvenience (shots are available everywhere), or doubts about efficacy and safety (both of which have been amply demonstrated by the millions of individuals who have been vaccinated after the FDA granted emergency approval).
Friday, July 16, 2021
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.
Wednesday, July 14, 2021
Atul Gawande Nominated for Global Health Role at USAID
Tuesday, July 13, 2021
The High Costs of Non-Beneficial Treatments in the ICU
Thad Pope has a useful post on this subject. There are direct medical costs (estimated at $2,700/day (Ottawa study) to $4,000/day (UCLA study)), but equally if not more concerning "may be (a) the opportunity cost when other patients are denied ICU care, (b) moral distress of the nursing staff, and (c) suffering inflicted on the patient."
None of this seems to matter to the legislators in Texas who try, every legislative session, to gut the provisions of the Texas Advance Directives Act that were added in 1999 to deal with disputes over medically inappropriate treatment. The provisions are at Tex. Health & Safety Code § 166.046. The purpose of the law was to provide a nonjudicial mechanism for resolving these disputes. The key provision is in subsection (d), which -- after reasonable efforts over a 10-day period to find a provider willing to provide the treatment requested by the surrogate decision-maker fail to identify a provider willing to accept transfer of the patient -- permits the disputed treatment to be withheld or withdrawn.
The objectors in the legislature want to replace that 10-day process with a provision that requires the health care providers to "treat until transfer." This benign-sounding idea would mean that, in the vast majority of cases in which no transferee provider can be found, medically inappropriate treatment must be provided until death occurs, which may be months or even years later. A current example is the Tinslee Lewis case in Fort Worth, which has been in litigation for over two years. According to a motion filed by defendant Cook Children's Hospital,
a review of Tinslee’s case was initiated by third-party administrator Aetna’s Special Investigative Unit, which has requested all of Tinslee’s records. The Special Investigative Unit’s mandate under Medicaid regulations is to investigate “waste, abuse, and fraud,” the motion says.
“In Cook Children’s experience, such reviews are often precursors to efforts to deny payment or even claw back funds previously paid,” the motion said.
Monday, July 05, 2021
Happy Independence Day (almost)
For 32 years, NPR staff (news readers, correspondents, commentators) have read the Declaration of Independence during the Morning Edition show closest to the 4th of July. Pretty much in Frank's honor (and out of respect to John Adams), this year the date for the reading fell on Friday, the 2nd of July. For many years, the readers included Bob Edwards, Red Barber, and "Kim Williams of Missoula, Montana," whose distinctive voices and personalities were represented long after their departure from NPR (Bob) and the land of the living (Red and Kim).
This year was a little different, with a disclaimer that noted the hypocrisy of drafters and signers: "It famously declares 'that all men are created equal' even though women, enslaved people and Indigenous Americans were not held as equal at the time." So the Declaration remains an aspirational document for a country this is still reckoning with the long-term effects of its past.
It remains, for all its limitations, the founding document that added philosophy and history to the political message of the Lee Resolution. It provided an outline for large parts of the original Constitution and the Bill of Rights. And for all sorts of reasons it is well worth reading at least once a year to remind us not only of the founders who "mutually pledge[d] to each other [their] Lives, [their] Fortunes and [their] sacred Honor" but also of the work left to be done to achieve its goals.
Saturday, July 03, 2021
New Book: A political history of the Affordable Care Act
There is one scholar whose knowledge and understanding of the PPACA is second to none: Tim Jost. His book review of Jonathan Cohn's The Ten-Year War in the June 2021 issue of Health Affairs has sent me directly to the bookstore to buy my copy. Here are two key excerpts:
One of the main messages of The Ten Year War, Jonathan Cohn’s excellent history of the Affordable Care Act (ACA), appears in the final chapter: “The Affordable Care Act is a highly flawed, distressingly compromised, woefully incomplete attempt to establish a basic right that already exists in every other developed nation. It is also the most ambitious and significant piece of domestic legislation to pass in half a century—a big step in the direction of a more perfect union and a more humane one as well.”
Cohn has produced the most readable and comprehensive history of the ACA yet available—a must-read for anyone who wants to understand this history.
Looking forward to reading (and reviewing) this book!
Friday, July 02, 2021
SCOTUS grants review in 4 health law cases
- American Hospital Association v. Becerra, No. 20-1114, a challenge to a Department of Health and Human Services rule that cut Medicare reimbursement rates for prescription drugs for hospitals that participate in a program for underserved communities. The U.S. Court of Appeals for the District of Columbia Circuit ruled that the reimbursement cut was a reasonable interpretation of the Medicare statute; the justices on Friday agreed to weigh in on whether that deference is appropriate in this case. The court also asked both sides to discuss whether the challenge is barred by a provision of federal law that limits judicial review of certain Medicare-related calculations.
- Gallardo v. Marstiller, No. 20-1263, in which the court will decide whether a state Medicaid program can get reimbursed for past medical expenses that it has paid by taking money from a settlement or jury award that is intended to compensate for future expenses.
- Becerra v. Empire Health Foundation, No. 20-1312, a dispute over how to calculate additional payments under the federal Medicare program for hospitals with a large number of low-income patients.
- CVS Pharmacy v. Doe, No. 20-1374, in which the court will consider whether the Rehabilitation Act, which bars discrimination on the basis of disability by any program or activity receiving federal funding, and the Affordable Care Act allow plaintiffs to bring claims alleging that a policy or practice disproportionately affects people with disabilities.
Thursday, July 01, 2021
CMS Proposes Final Interim Rule to Implement the No Surprises Act
Grand Jury Declines to Indict Houston Doctor Accused of Stealing COVID Vaccine
- The doses were about to be destroyed due to nonuse and aging.
- It was his duty as a physician -- and one employed by the Harris County health department -- to maximize health and protect life.
- Allowing the doses to be destroyed would have been a violation of his professional duties and sacred oath.
Tuesday, June 29, 2021
Hospitals Now Employ 50% of all U.S. Physicians
Once upon a time, it was a virtually universal no-no for a corporation or other lay entity or person to own, or even have an ownership interest in, a physician's practice. There were various rationales for the so-called "corporate practice prohibition," including:
- only natural persons could meet the requirements for medical licensure,which ruled out corporations, trusts, partnerships, etc.
- a corporate or other lay owner created at least the potential for dual loyalties, putting doctors in the impossible position of choosing between his or her patient and corporate overlords; and
- allowing non-physicians to get in on a medical practice's action represented an unseemly commercialization of medical practice.
Thursday, June 17, 2021
SCOTUS Rejects Red States' Challenge to ACA
In a 7-2 decision (majority opinion by Justice Breyer, dissent by Justice Alito), the Supreme Court today tossed out the suit filed by Texas plus other states and two individuals, not on the merits but for lack of standing.
Basic standing analysis requires a direct harm to the plaintiff that is [1] traceable to an unlawful action or provision of law and is [2] redressable if a court were to give the plaintiff the relief it seeks. The majority opinion concluded that -- even if it agreed that the individual mandate lost its constitutional moorings when in 2017 Congress zeroed out the tax for noncompliance -- the only burdens (i.e., "harms") the plaintiffs could point to were the costs of complying with the presumptively lawful parts of the ACA that remained on the books. It is hard to see how future plaintiffs would be able to overcome the standing hurdle created by this opinion.
As the dissent points out,
Today’s decision is the third installment in our epic Affordable Care Act trilogy, and it follows the same pattern as installments one and two. In all three episodes, with the Affordable Care Act facing a serious threat, the Court has pulled off an improbable rescue.
None of this is to say that challenges to the ACA on other grounds can't or won't be brought, but opponents are running out of constitutional theories. Indeed, the Court has already granted cert. in two ACA cases for the 2021 Term (Nos. 20-429 and 20-539), and there are 6 more ACA cases listed for the Court's next conference. See Nos. 20-219, 20-1162, 20-1200, 20-1374, 20-1432, and 20-1536. All 8 cases are statutory-interpretation cases and none challenge the constitutionality of the ACA or any part of it.
Wednesday, June 16, 2021
Surprise billing: It's still a thing
From the Kaiser Family Foundation's news service:
In Alleged Health Care ‘Money Grab,’ Nation’s Largest Hospital Chain Cashes In on Trauma Centers
After falling from a ladder and cutting his arm, Ed Knight said, he found himself at Richmond, Virginia’s Chippenham Hospital surrounded by nearly a dozen doctors, nurses and technicians — its crack “trauma team” charged with saving the most badly hurt victims of accidents and assaults. But Knight’s wound, while requiring about 30 stitches, wasn’t life-threatening. Hospital records called it “mild.” Nevertheless, Chippenham, owned by for-profit chain HCA Healthcare, included a $17,000 trauma team “activation” fee on Knight’s bill, which totaled $52,238 and included three CT scans billed at $14,000. His care should have cost closer to $3,500 total, according to a claims consultant which analyzed the charges for KHN. (KHN, Richmond Times-Dispatch)
The federal No Surprises Act (signed Dec. 27, 2020) was supposed to curb billing abuses. The KHN link has an exhaustive analysis of the problem, but it doesn't say whether Mr. Knight's trip to the ER was before or after the effective date of the new law. (And the Richmond Times-Dispatch link didn't work for me; I've included it here in case it works for you.)
Monday, June 14, 2021
Public Health: The Neglected Infrastructure Crisis
Dr. Anne Schuchat's June 10th NY Times op-ed is a must-read for any and all who want to understand the importance of investment in public health resources as part of our renewed interest in rebuilding the nation's infrastructure. Published upon the eve of her retirement as second-in-command at the CDC after 33 years of public service. It's a great essay that celebrates public service as a career path. It's also a scary-as-hell depiction of the sorry state of public health in this country. Here's an example:
The Covid-19 pandemic is not the first time the U.S. public health system has had to surge well beyond its capacity, but with the worst pandemic in a century and, initially, a heavily partisan political context, the virus collided with a system suffering from decades of underinvestment. A recent report from the National Academy of Medicine revealed that state and local public health departments have lost an estimated 66,000 jobs since around 2008. [emphasis added]
We cannot count on a once-in-a-century cycle of pandemics. There is every reason to believe that all countries -- the more economically developed chief among them -- are susceptible to increasingly frequent outbreaks.
It's time to wake up and get prepared for when not if.
Wednesday, May 26, 2021
SCOTUS still has to decide a big ACA case
I have a hard time believing the Court will affirm the Fifth Circuit and the District Court and toss out the entire ACA on the specious ground that Congress wouldn't want the ACA to survive without the individual mandate. The premise -- that there is no longer an individual mandate -- flies in the face of the fact that the ACA still contains the individual mandate. The penalty for not purchasing health-insurance coverage was reduced to $0 in the 2017 tax reform law, which renders the mandate a somewhat toothless requirement, But even before 2017, the IRS's collection tools under the ACA were quite limited, which rendered the individual mandate one of the most under-enforced requirements in the United States Code.
Even if the Court agrees that the individual mandate is no more, however, the idea that the Court would go along with tossing out the entire ACA is mind-boggling. That would mean:
- no more prohibition against pre-existing condition exclusions
- no more prohibition against arbitrary and discriminatory rescissions
- no more family coverage for children up to age 26
- the reintroduction of annual and lifetime caps on coverage
- no more Medicaid expansion funds (raising a serious question about the status of funds for the 39 states that have expanded eligibility based on a promise of a generous (read: massive) federal subsidy)
- the elimination of federal insurance exchanges and possibly state exchanges, too
- the elimination of premium tax credits for low-income households
- the elimination of subsidies for out-of-pocket expenditures
- the elimination of what amounts to a cap on the amount insurers can spend on items other than health-care claims (accompanied by a premium rebate when non-health-care expenditures exceed the permitted amount)
- and on and on and on.
Tuesday, May 25, 2021
COVID-19 at the Intersection of Criminal Justice Reform and Public Health
As jails and prisons remain leading sites of COVID-19 outbreaks, mass incarceration poses ongoing health risks for communities. We investigate whether short-term jailing of individuals prior to release may drive COVID-19 spread. We find that cycling individuals through Cook County Jail in March 2020 alone can account for 13% of all COVID-19 cases and 21% of racial COVID-19 disparities in Chicago as of early August. We conclude that detention for alleged offenses that can be safely managed without incarceration is likely harming public safety and driving racial health disparities. These findings reinforce consensus among public health experts that large-scale decarceration should be implemented to protect incarcerated people, mitigate disease spread and racial disparities, and improve biosecurity and pandemic preparedness.
The full article is well worth a close read.
Monday, May 24, 2021
Texas Blows it Again on Medicaid Expansion
Health Affairs has posted a nice summary of the Biden Administration's attempt to entice the hold-out states to expand Medicaid pursuant to the ACA (though it unfortunately has absolutely no relevance to Texas -- read on):
In the newest addition to our “Eye On Health Reform” series, Katie Keith covers the American Rescue Plan Act, which was signed into law by President Joe Biden in March.
Keith explains that the legislation temporarily expands the Affordable Care Act’s premium tax credits and increases federal financial incentives for holdout states to expand their Medicaid programs. Keith also explores enrollment trends in states that use HealthCare.gov, current ACA litigation, and ACA guidance from the Biden administration.
I wrote about an earlier plan to pay hold-outs on Feb. 16, back when the prospects for expansion in Texas seemed, if not bright, at least alive. By my count there were five House bills, two Senate bills, four House Joint Resolutions, and three Senate Joint Resolutions that would have authorized (or required) Texas to take advantage of the federal dollars that would become available if Texas were to expand Medicaid eligibility to 138% of the federal poverty limit. Would it be cynical of me -- or simply realistic -- to report that every single one of these proposals died in committee? Every one! What is there to say other than it really sucks to be poor and live in Texas, where the legislature seems determined to keep a minimum level of health care out of reach for five million of its citizens.
For the record, here are the links to the bills and JRs, along with the names of co-sponsors:
HJR 9, 23, 24, 86
SJR 11, 14, 15
HB 143, 398, 513, 1730, 4406
SB 38, 119
Tuesday, May 11, 2021
"What Has President Biden Done in Health Care Coverage in His First 100 Days?"
Tuesday, March 23, 2021
AstraZeneca in Major Dispute with U.S. Regulators
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
It is almost (but not quite) inconceivable that AstraZeneca made an innocent error. The DSMB is accusing the firm of essentially "cherry-picking" the data “most favorable for the study as opposed to the most recent and most complete.” (NY Times, 3/23) The DSMB's letter to the NIH and AstraZeneca stated that the efficacy rate of the firm's COVID-19 vaccine might be between 69% and 74%, rather than the 79% rate touted by AstraZeneca itself. Did AstraZeneca really think they could slip one past the regulators? And at what cost to its reputation? Not to mention at what cost to the worldwide public-health crisis, where mistrust of science and vaccine-skepticism don't need any more encouragement and support.
From the Times article: “'Decisions like this are what erode public trust in the scientific process,' the board wrote."
Monday, March 22, 2021
Medicaid Expansion in Texas: The Time is Now
The Legislature is back in session. A bill has been introduced to authorize Texas to accept the federal government's offer to pay for 90% of the cost of expanding Medicaid eligibility to include all Texans under the age of 65 (when Medicare kicks in) and whose income does not exceed 138% of the federal poverty level: HB 1730, introduced by Republican Representative Lyle Larson. Sen. Johnson's own companion bills are SB 118 and SB 119.
The case for expansion is made in a most compelling and entertaining video (10.5 minutes) by Senator Nathan Johnson (D-Dist. 16 (which covers a big chunk of Dallas)). Please watch it. Share it with your family. Send it to your friends. Get involved. We have already waited too long, left billions of federal dollars on the table, and worst of all, we've ignored the health care needs of 1 million Texans who would benefit from expansion. Let's make this happen this year.
And thanks to DFW Hospital Council CEO Stephen Love for passing the video on to me.