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Friday, September 7, 2018

Unintended consequences of free medical school


I’m probably in the minority on this, but I’m not a fan of the NYU School of Medicine free tuition program. Now I’m all for debt relief for medical students who start their careers with a mortgage. I was one of them. After 13 years, I’m still one of them! I’m also for any initiative that drives more medical students to career paths like primary care, where massive debt makes higher paying subspecialties more desirable. As a practicing primary care internist, and a former academic physician that worked with medical students, this is a cause I’m passionate about. But while NYU continues to be lauded from all directions for this incredible investment and commitment, I suspect the program will not achieve its purported goals.
Let’s start off by respecting the fact that NYU is one of the best medical schools in the country. As a former residency program director at an excellent academic institution, we were always thrilled to recruit students from NYU. NYU med themselves recruit the best and brightest undergraduate students across the country. But the current reality of medical education is this. Whether it’s medical school or in residency, the best students often pursue the highest paying and most competitive fields. There are many reasons for this and education debt is certainly one of them.
With the tuition relief NYU is offering, the medical school will suddenly become even more competitive. I suspect their upcoming classes will be an even less academically diverse sampling of ultra-driven students trying to climb Mount Everest. The assumption that these extremely bright hard-working students will suddenly give up on competitive subspecialty fields (that earn a lot more by the way) is basically the antithesis of their academic and personality traits that probably got them there in the first place. It seems like the school is hoping that being debt free will suddenly cause a rush of altruism that will bring students to fields like medical research, pediatrics, and family medicine. But let’s remember, it is altruism that partly got them into medicine and accepted into medical school in the first place. After talking to students and residents for ten years, I’ve learned that once they are in, many feel that selflessness and commitment to the well-being of others can also be achieved through higher-paying specialty fields like dermatology, emergency medicine, plastic surgery, and cardiology. And I agree with them.
I hope I’m wrong about this. Our broken health care system needs more medical students to choose careers in research and primary care. But a free ride at an elite medical school is not the answer. Like tax cuts to wealthy corporations that often do stock buybacks while augmenting the bottom lines of investors, most of these great students at NYU Med will take the tuition relief and probably just run with it to well-deserved and lucrative career options. And instead of being indebted to banks, perhaps they will feel indebted to their alma mater and become generous donors. That’s a good way to help keep a program going that although looks good on press releases, may not actually make a huge difference.

Gwyneth Paltrow’s Goop to settle on unscientific health claims


Gwyneth Paltrow’s lifestyle company, Goop, has agreed to pay a settlement after it was accused of making unscientific claims regarding three of its products.
According to Goop, its $66 Jade Egg can help balance hormones, regulate menstrual cycles, and increase bladder control when inserted vaginally. However, 10 prosecutors from the California Food, Drug and Medical Device Task Force said in their lawsuit that Goop’s claims “were not supported by competent and reliable science.”
Goop agreed to pay the $145,000 settlement but told SFGate in a statement, “While Goop believes there is an honest disagreement about these claims, the company wanted to settle this matter quickly and amicably.”
Santa Clara District Attorney Jeff Rosen said in a press release, “We will vigilantly protect consumers against companies that promise health benefits without the support of good science…or any science.”

The other two products called into question were Goop’s $55 Rose Quartz Egg and its $22 Inner Judge Flower Essence Blend. Customers who purchased the products between Jan. 12, 2017 and Aug. 31, 2017 will be refunded.
The ruling also stops Goop from making “any claims regarding the efficacy or effects of any of its products without possessing competent and reliable scientific evidence that substantiates the claims.”
Last year, Paltrow’s wellness company was awarded the “Rusty Razor” award for being the “best” at promoting “pseudoscientific nonsense.” The company has long been been criticized for promoting “health benefits” without scientific proof.

The 9 Calif. Docs Accused of Overprescribing Opioids


Last week, MedPage Today reported on the California state medical board’s investigations of physicians, nurse practitioners, and physician assistants who prescribed opioids for individuals who later overdosed. Here we take a closer look at the nine physicians who, so far, have been formally accused of wrongdoing.
If one had to identify a physician to symbolize its “Death Certificate Project,” an aggressive effort by the Medical Board of California to nab doctors who overprescribe opioids, a likely candidate would be Harold S. Budhram, MD, of Shasta Lake. (All cities named in this article are in California.)
Triggered by deaths of two of his patients attributed to opioid overdoses, the board investigated his practice and, in April, filed a 39-page complaint listing 16 separate accusations.
Those two deaths were summarized as follows: “Patient A, a 22-year-old male, died of an apparent accidental morphine overdose, complicated by a known seizure disorder, which developed after the patient was taking opioids,” and “Patient B, a 52-year-old female, died of an apparent methadone overdose, which were prescribed by respondent.”
A third referenced death, a suicide, was said to occur after Budhram prescribed “a cocktail of Norco, methadone, Seroquel, Trazodone, and two different benzodiazepines” which “increased her risk of death or severe injury even without her ultimate suicide.”
Other phrases scattered through the complaint include “did not choose the lowest doses,” “never attempted to wean the patient off the medications,” “failed to conduct an assessment of the patient’s addiction risk,” and “continued prescribing opioid pain medication despite this red flag.” Budhram’s care of one patient was “grossly negligent,” according to the document.
Adding insult to injury, the complaint also dinged Budhram for “poor penmanship.”
The complaints against Budhram and eight other physicians are the result of the medical board’s review of death certificates of patients who lethally overdosed in 2012 and 2013. The board matched those names in the state’s prescription drug database to identify providers who prescribed opioids to those patients within 3 years of their death. Nearly 450 allopathic physicians, 12 osteopaths, and 60 nurse practitioners and physician assistants were targeted by expert reviewers for investigation and possible action. About half of the cases have been closed without further action; but in addition to the nine who have been formally accused of wrongdoing, dozens of others still face potential sanction.
The California effort is said to be the only one like it in the country with such a broad, 3-year lookback. (A project in North Carolina has tighter restrictions on what it can review. For example, it limits scrutiny to those doctors with two or more patient deaths in 1 year and who prescribed opioids within 60 days of that patient’s death while the California program goes back 3 years.)
‘Incredibly high’ doses
Many of the accusations repeat these phrases: “gross negligence,” “furnishing dangerous drugs without examination,” “unprofessional conduct,” and “inadequate record keeping.” Several physicians were said to have failed to check the state’s prescription database, CURES (the California Controlled Substance Utilization Review and Evaluation System), which could have told them their patient had received opioids from other prescribers.
Bradley Howard Chesler, MD, of Escondido faces nine causes of discipline. “Patient E,” the accusation said, “was found dead in his home as a result of the combined effects of multiple substances including alcohol, methadone, hydrocodone, alprazolam, and bupropion.” And for “Patient A,” Chesler was said to have written 56 prescriptions for opioids and other medications, including products containing “an average of 5000 mg. of acetaminophen per day.” (The FDA-approved label for products containing acetaminophen says daily doses should not exceed 4,000 mg, even under a professional’s supervision.)
David James Smith, MD, of San Diego faces six causes of discipline in an accusation that references two patient opioid deaths. For one, Smith “prescribed patient B escalating doses of opioids in combination with other controlled drugs, including, but not limited to benzodiazepines, antidepressants, muscle relaxants, and testosterone.
“In fact, [Smith] prescribed excessive amounts of opioids including, but not limited to, on or about Oct. 1, 2013, issuing a prescription for Roxicodone (30mg) (#140) amounting to approximately ten (10) tablets daily. Significantly, this prescription alone equaled an incredibly high four hundred fifty (450) MME” (morphine milligram equivalents).
The board’s accusation against Tahir Yaqub, MD, of Atwater details two long lists of drugs he prescribed to a patient in 2011 and 2012, including methadone, zolpidem, diazepam, alprazolam, temazepam, hydrocodone bitartrate, and clonazepam. Though Yaqub noted his patient was non-compliant, he provided refills. The medical board’s formal complaint said “documentation of the assessment and plan at each visit was cursory at best.”
Methadone and other opiates don’t mix
At this writing, the most recent accusation stemming from the project was filed Aug. 24 against Emanuel Vincent Dozier, MD, alleging four causes of discipline. The Bakersfield doctor is said to have committed an “extreme departure from the standard of care” and prescribed “Patient A” carisoprodol, alprazolam, and methadone (at her previously established dosage). Patient A died on April 25, 2012 of methadone toxicity (overdose). The accusation adds that when a patient is taking methadone, no other opiates should be prescribed.
Asked for comment, Dozier said he was unaware of the project but said the accusation references care he provided as far back as 2011. He said he’s meeting with his attorney to decide how to respond.
The accusation against David Betat, MD, of Lakeport, references his care of three patients including three who died: one listing polypharmacy as the probable cause of death, the second from cardiorespiratory arrest after possibly being overmedicated, and a third from metastatic cancer, for which tests were not ordered to diagnose. He is accused of “prescribing excessively and/or inappropriately” to five patients.
Jay Milton Beams, MD, of Susanville, faces 10 causes of discipline, many related to his “extreme departure from the standard of care” involving several patients, one of whom died in 2013 of an oxycodone overdose one day after he prescribed 240 pills of that drug, which he had prescribed to her since 2010 monthly or every other month. He also prescribed many other controlled substances during this period.
Moshe Miller Lewis, MD, of Susanville has had a determination of his case following accusations against him stemming from the Death Certificate Project. He was issued a public reprimand and ordered to enroll in courses on record keeping and prescribing. He was alleged to have repeated documentation for multiple patient visits in chart notes, not discussing a patient’s addiction risk before prescribing fentanyl, oxycodone, and Norco (acetaminophen-oxycodone), and not documenting discussions about non-opioid alternatives.
Raymond Paul Freitas, MD, of Santa Rosa, faces two causes for discipline in his alleged care of a patient at heightened risk of suicide, for whom he prescribed diazepam for anxiety and did not consider options for treating the patient’s headache besides butalbital and codeine, “medications with a known side effect of causing headaches.”
Requests for comment were placed to all physicians but Dozier was the only one to respond as of publication.
The board’s executive director, Kimberly Kirchmeyer, said the board intends to proceed with reviews of death certificates in subsequent years. Additional staff have been assigned to the project. A board spokesman said all nine accusations involve patients who died of opioids, although not all the documents made public to date reference a patient death.
She noted that for most of the cases so far, a hearing has not yet been held so the physician has not been found guilty.

Sharp Drop in Portable Oxygen Access Blamed on Provider Pay Changes


A coalition of pulmonary health groups called on the Centers for Medicare & Medicaid Services (CMS) to change its supplemental oxygen reimbursement policy to remove liquid oxygen from competitive bidding requirements.
The American Lung Association (ALA), the American Thoracic Society, the COPD Foundation, and 17 other groups said that competitive bidding has dramatically reduced access to portable liquid oxygen among oxygen-dependent patients with the most severe lung diseases, leaving thousands of patients home-bound and tethered to home-based high liter flow oxygen systems.
On Thursday, the groups sent a letter to CMS commending the agency for recognizing the scope of the problem, while recommending specific changes to improve access to portable oxygen for those who need it most.
“Over the last 10 to 12 years the changes in reimbursements to (oxygen) suppliers, most notably competitive bidding, have represented something of a perfect storm resulting in the most dependent patients not getting the types of oxygen they need to meet their clinical needs and their quality-of-life needs,” ALA spokesperson Erika Sward told MedPage Today.
Liquid oxygen is required for people who need high liter flows of oxygen (>6 liters/min), and is most often prescribed to patients with advanced chronic obstructive pulmonary disease, pulmonary fibrosis, or other advanced lung diseases.
Home-based high-flow systems typically require bulky ancillary humidification systems. Without access to portable liquid oxygen, patients who require high-flow oxygen are mostly home-bound.
Sward noted that by reducing compensation to suppliers, competitive bidding has been largely responsible for a 10-fold reduction in the number of Medicare recipients receiving portable liquid oxygen.
According to Medicare records, just 8,141 Medicare recipients with advanced lung diseases received portable liquid oxygen in 2016, compared with 80,571 in 2004.
In the letter sent to CMS, the 20 lung health groups noted that there has been no change in respiratory disease patterns that would explain the sharp decrease in utilization of liquid oxygen systems.
“No differences or advancements in treatment of respiratory disease can explain the decrease; nor has there been a new ‘disruptive’ innovation or technology that has pushed liquid oxygen systems aside for a more novel technology,” the letter stated.
Karen L. Erickson of the Alpha-1 Foundation, who is a double-lung transplant recipient, has seen first hand the hardships patients with high-flow oxygen needs have faced due to lack of access to portable liquid oxygen: “We heard from someone who had been getting portable systems, and all of a sudden one day the provider dropped off a five-foot tank with a 50-foot hose,” she told MedPage Today. “[The patient] was suddenly tethered to an oxygen supply and couldn’t do much of anything. She could reach the bathroom, but not the laundry.”
Late last month, the U.S. Government Accountability Office released a report examining CMS competitive bidding programs, including supplemental oxygen. The report identified a 10% decline in supplemental oxygen suppliers in the U.S. between 2015 and 2016 alone.
Sward said while provider reimbursement is largely responsible for reduced access to portable liquid oxygen, the problem has been exacerbated by lack of enforcement of requirements that suppliers provide the oxygen when physicians order it.
The health groups addressed this in their letter to CMS: “We believe there is a huge disconnect between statutory requirements, contractual requirements, and the actual delivery of supplemental oxygen therapy in general, and more specifically as it relates to liquid oxygen,” the groups wrote. “Competitive bidding contracts stipulate that suppliers MUST provide liquid when ordered by a physician and is clinically justified by that physician.”

China drug safety body finds no problems in inspections of vaccine makers


China’s drug safety body has found no problems in its inspection of 45 vaccine makers and will step up supervision of vaccine quality, it said on Friday, following a scandal that put children at risk.
The inspections were done between July 23 and Aug 9, the State Administration for Market Regulation said in a statement.
The statement comes after a public outcry over the discovery that Changsheng Bio-technology Co Ltd falsified data for a rabies vaccine and made an ineffective vaccine for babies. Beijing has promised to punish all those responsible and prevent a recurrence.

iKang Healthcare announces buyer’s re-evaluation of merger, requests extension


iKang Healthcare Group announced that IK Healthcare Investment Limited and IK Healthcare Merger Limited have informed the Special Committee of the Board of Directors of the Company that Parent and Merger Sub are re-evaluating the commercial viability of the merger contemplated under the Agreement and Plan of Merger, dated as of March 26, 2018, entered into by and among Parent, Merger Sub and the Compan and have requested an extension of the termination date under the Merger Agreement from September 26, 2018 to October 31, 2018. Parent and Merger Sub made a public announcement regarding their current intentions with respect to the Merger and their request for an extension of the termination date under the Merger Agreement. The Special Committee and the Board of Directors of the Company are currently evaluating the request to extend the termination date by Parent and Merger Sub. Due to the absence of any certainty as to whether the Buyer Group will proceed to consummate the Merger, the Special Committee and the Board are currently evaluating the potential risks to the Company if the Merger process is further delayed in light of, among other factors, the upcoming maturity in December 2018 of certain convertible loan agreements entered into by iKang Healthcare Technology Group Co. Ltd., one of our affiliated PRC entities, with an aggregate outstanding principal amount of RMB850 million (equivalent to approximately $124.23 million). The Company currently does not have sufficient cash to repay the Convertible Loans. If the Merger is not consummated or the process is further delayed, the Company may not have adequate time or otherwise be able to obtain sufficient financing to repay and/or refinance the Convertible Loans in amounts or on terms acceptable to the Company, if at all. Accordingly, the Special Committee and the Board have instructed management of the Company to explore potential financing alternatives for the Company in the event that the Merger is not consummated.
https://thefly.com/landingPageNews.php?id=2787585

Hospital groups renew 340B drug discount fight with HHS lawsuit


Several hospital groups, including the American Hospital Association, refiled their lawsuit against the Department of Health and Human Services over cuts to the 340B drug discount program.
The American Hospital Association, America’s Essential Hospitals, the Association of American Medical Colleges, Eastern Maine Healthcare Systems, Henry Ford Health System and Fletcher Hospital originally sued HHS in November after the Centers for Medicare & Medicaid Services issued a final rule that would slash payments to hospitals that participate in the 340B program.
The suit came after CMS changed the program’s payment rate from up to 6% more than the average price of drugs to 22.5% less than the average price, which cuts $1.6 billion in 340B payments. There was an immediate outcry to the policy from hospitals and providers enrolled in the program.
A federal judge dismissed the AHA’s lawsuit at the beginning of January, but the groups filed an appeal (PDF) shortly thereafter. In July, an appeals court delayed a ruling on the merits of the case because no claims had been filed when the case was originally brought to prevent the rule from going to effect.
Since the hospital group has filed claims that have progressed through the appeals process to address the court’s procedural concern, American Hospital Association officials said, they have refiled the suit asking for expedited relief (PDF).

The drug discount program once enjoyed bipartisan support and has been expanded three times by Congress. But drug companies say it’s grown too large and contributes to the rising cost of medication. Leaders of major health systems in both urban and rural settings have raised concerns over the serious risks they face if those savings sustain significant cuts.