Executive order hopes to improve flu vaccine effectiveness, but funding is unclear.

This article was first published on Friday, September 20, 2019 in MedPage Today.

By Molly Walker, Associate Editor, MedPage Today.

President Donald Trump fired the first shot of the 2019-2020 flu season, with an executive order Thursday aiming to improve processes for manufacturing influenza vaccines, including greater effort toward a "universal" flu vaccine.

The order calls for reduced reliance on current egg-based flu vaccines, and an approach that hopes to modernize the process -- from expanding capacity for alternative flu vaccines, such as newer cell-based vaccine technology, to the development of newer, more broadly protective vaccine candidates that don't have to be reformulated every year.

However, the order did not indicate how this aggressive program would be funded, noting that its implementation would be "subject to the availability of appropriations."

Andrew Pavia, MD, co-chair of the Infectious Diseases Society of America (IDSA) Treatment Guidelines Panel, and chief of pediatric infectious diseases at the University of Utah, characterized the executive order as "an important and clear commitment to goals" for the prevention of influenza in the U.S.

"We are at a point where we can move to 'Generation 2' vaccines, such as cell-based and recombinant vaccines, but they are not being produced in large amounts or being preferred," Pavia told MedPage Today.

Indeed, a senior administration official in a "background" press call stated that there is a "lack of appropriate innovation incentives" for such vaccines "due in part to a misalignment between social and private returns."

Or, as Pavia noted, the government needs to "figure out what the incentives are for us to move away from egg-based vaccines."

He added that the government also "could act as a pull mechanism": because the government has so much vaccine purchasing power, with programs such as Vaccines for Children and Medicare Part D, that could help "move the commercial market at the same time."

In fact, the executive order included instructions to various agencies, including the Veterans Affairs system and the Department of Defense, to take steps toward buying flu vaccines produced with "faster, more scalable, and innovative technologies."

During the press call, an official cited a Council of Economic Advisors analysis estimating that treating influenza currently costs some $50 billion, a number that could reach $1.8 to $3.8 trillion in direct costs, lives lost and lost productivity in the event of an influenza pandemic.

"Moving to faster vaccine manufacturing technologies that would make a vaccine available near the outset of a pandemic would save over $730 billion, over an average pandemic," said the official, who spoke on condition of anonymity. "And if that new technology also includes vaccine effectiveness by 30% over the effectiveness seen in the most recent pandemic in 2009, it would save $953 billion, or roughly half the cost of an average pandemic."

The executive order creates a National Influenza Vaccine Task Force co-chaired by the secretaries of Defense and Health and Human Services. It will include input from public health agencies such as the NIH, CDC, FDA, Biomedical Research Development Authority, as well as the Veterans Affairs and Homeland Security departments.

The Task Force will have 120 days to develop a 5-year plan, with annual reports and updates.

Pavia said the new approach could speed seasonal vaccine selection ("so we don't have to decide in March what we have to use in September") and expand the CDC Vaccine Effectiveness Network. Ultimately, data collected this way could result in the CDC's Advisory Committee for Immunization Practices (ACIP) being able to recommend different vaccines for specific populations, such as older adults and children, Pavia noted.

He added that input from medical experts, such as IDSA, as well as industry would be important, especially for goals such as re-prioritizing the research agenda and developing incentives.

But ultimately, none of this will happen without appropriate funding, and according to a senior administration official, this will be "dependent on the evaluation of what is the current status of our seasonal and pandemic influenza abilities." But the executive order requires an estimate of the cost to improve vaccine production and redirect funds into more modern vaccine research and development.

This would include the longed for universal flu vaccine, but Pavia said that is still years away, even though it's "receiving a lot of attention and money."

"What this [executive order] does is very useful, spells out the steps that can be taken and makes it a national priority," Pavia noted. "But to make it happen, it's going to require money. That's the next step we need to hear about."

Four antibiotic classes linked with heightened infection risk.

This article was first published on Tuesday, September 16, 2019 in MedPage Today.

By Molly Walker, Associate Editor, MedPage Today September 16, 2019

Use of high-risk antibiotics in hospitals, such as cephalosporins, fluoroquinolones, carbapenems, and lincosamides, was linked with a greater risk of Clostridioides difficile in hospitals, researchers found.

After adjusting for confounders, for each 100-day increase in high-risk antibiotic use per 1,000 days present, risk of hospital-associated C. difficile infection rose 12% (RR 1.12, 95% CI 1.04-1.21), reported L. Clifford McDonald, MD, of the CDC, and colleagues, writing in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.

"This highlights the importance of ongoing monitoring of antibiotic use in hospitals for patient safety as it relates to the effect of antibiotics on C. difficile infections," McDonald said in a statement.

The authors noted that antibiotic overuse is now being looked at as a major driver of C. difficile infections, especially prior research finding that around half of inpatients were prescribed an antibiotic and potentially 30% of those antibiotics were unnecessary, they said.

"In addition to the direct effects of antibiotics on [C. difficile infection] risk, antibiotics mediate carriage of C. difficile spores by asymptomatic carriers ... and are sources of transmission that may further increase the [C. difficile infection] burden in acute-care settings," the authors wrote.

Researchers examined data from 171 hospitals in 2016-2017 through the BD Institute Research Database. They defined 4 antibiotic classes as high risk based on prior research and guidelines that looked at specific antibiotics to treat C. difficile infection, they said: second-, third-, and fourth-generation cephalosporins, as well as fluoroquinolones, carbapenems, and lincosamides. The authors noted piperacillin/tazobactam was also evaluated, as some studies considered it "medium risk" for C. difficile infection.

Of the 171 study sites, the majority were non-teaching hospitals (61%), and about half were located in the southern U.S. Cephalosporins comprised about half of the most frequently used antibiotics, followed by fluoroquinolones (31.6%). There was a significant correlation between use of high-risk antibiotics and C. difficile infection, with higher correlation between the two observed in teaching versus non-teaching hospitals.

The authors found that the overall pooled hospital-associated C. difficile infection rate was 35 per 10,000 admissions, with a median of 33 per 10,000 across 171 hospitals. Not surprisingly, factors associated with higher rates of hospital-associated C. difficile infection included increased high-risk antibiotic use, larger proportions of patients older than age 65, longer average length of stay, and higher proton pump inhibitor use.

Limitations to the data include that the study is not representative of all U.S. hospitals and as an ecologic study, it does not depict causal relationships.

McDonald said in a statement that in the future, it will be important to look at the effect of antibiotic use on C. difficile infection and antibiotic resistance together versus separately.

"A facility can use the National Healthcare Safety Network Antibiotic Use and Resistance Module and interpret results using the standardized antibiotic administration ratio (SAAR) to have a better understanding of how antibiotics are being used and identify areas for improvement," he said.

Funding for this study was provided to the BD Insights Research Team of Becton, Dickinson and Co. by Nabriva Therapeutics.

Tabak and three co-authors are full-time employees of Becton, Dickinson and Co., whose life science business segment develops, manufactures, and sells diagnostics for infectious diseases, including CDI.

Two co-authors disclosed either past or current employment at Nabriva.

McDonald disclosed no conflicts of interest.

Five surrender licenses after claims of grossly negligent overprescribing; more to come.

This article was first published on Wednesday, September 3, 2019 in MedPage Today.

By Cheryl Clark, Contributing Writer, MedPage Today.

The so-called Death Certificate Project initiated by the Medical Board of California that began in 2015 has now resulted in formal accusals of wrongdoing filed against 64 physicians related to their drug prescribing, primarily involving opioids, newly updated records show.

Five of the 64 have surrendered their licenses; six others were put on probation, and eight received public reprimands.

These are out of a total of 469 physicians investigated for excessive prescribing because of patients' overdose deaths in 2012 or 2013.

Two of the 64 accusations were withdrawn, according to statistics released by the board last week.

The remaining 43 physicans of the 64 accused still await final decisions; half of these have been hanging more than 7 months and five for nearly a year.

Beyond the 64 doctors against whom an accusation had been filed, another 11 of the 469 are still under investigation. It remains to be seen whether a round orange gavel signifying a disciplinary action will mark any of their profile pages.

The agency's investigators continue to prowl the state Department of Justice's prescription drug database to identify doctors who prescribed opioids to a patient who, according to a death certificate, fatally overdosed in 2012 or 2013, even as long as three years after that doctor wrote that script, and not necessarily from the same drug the doctor prescribed.

Separate investigations were conducted of 72 nurse practitioners, physician assistants, and osteopathic physicians -- who are governed by different state boards -- but the results of those were not immediately available.

In the next leg of the investigation, the medical board, which licenses some 140,000 physicians, will scrutinize practices of doctors whose patients fatally overdosed in 2016 and 2017, when presumably far more conservative opioid prescribing had replaced more liberal practices and as the extent of addiction potential and lethality of these drugs was better understood.

'Witch-hunt'
 

The project is intended to stop overdoses and save lives. But it has been harshly lambasted by some doctors as a "witch hunt." It also has disrupted practices by many physicians who -- prior to 2014 -- were abiding by the now outdated mantra that patients' pain complaints should be aggressively treated with whatever it takes.

Many representatives of organized physician groups said the project is now hurting patients in pain trying to get relief. Pain specialists' waiting lists have backed up and increasing numbers of primary care providers refuse to prescribe opioids in fear that years later, a patient death -- even by suicide -- may put their licenses under public scrutiny as well.

But Kimberly Kirchmeyer, the medical board's executive director, defended the project. In an e-mailed statement, she said it "is helping the board meet its mission of consumer protection in a proactive way." She added that her agency "will continue to find ways to improve this process."

In remarks to the board during its January meeting, Kirchmeyer gave more detail. She said expert reviewers looked for high-dose opioid prescribing patterns that included morphine equivalencies greater than 90 mg, opioids in combination with sedating drugs like benzodiazepines, Soma, sleeping pills, and other unsafe combinations of medications. Additionally, the reviewers zeroed in on doctors who prescribed dangerous drugs frequently, "and other red flags."

A welcome change?
 

Perhaps not surprisingly, consumer advocates have applauded the Death Certificate Project for calling out doctors with reckless prescribing habits.

Carmen Balber, executive director of Consumer Watchdog, spoke from "the injured patient's perspective," saying, "Doctors in this state are accustomed to weak or non-existent regulatory oversight. For patient safety, it's about time that the medical board started acting to proactively investigate the opioid crisis."

In many accusations she's read, dangerous prescribing practices are obvious. "Patients are not getting medical exams. Doctors are not confirming the injuries the patients came forward with. Doctors are prescribing wildly excessive doses of medications. Even to a lay person it seems blatantly obvious that action should have been taken," Balber said.

Patient safety activist Eric Andrist of Los Angeles, who started the newer Patient Safety League which posts stories about medical harm and patient experiences, travels around the state to every medical board meeting to complain that the agency is too soft, allowing hundreds of dangerous doctors to get off with no more than a slap on the wrist. He said he's pleasantly surprised the board tackled the opioid issue in the first place.

"They've always said that they don't and won't look for cases themselves ... and only act on complaints brought to them," he said. Without this initiative, these doctors would never have been punished or called out. He also praised the yield of 19 accusations resulting in disciplinary action to date -- even with 43 more to go -- because by his count the agency's average is much lower.

Five licenses surrendered
 

Among the most egregious cases, those that prompted five physicians to surrender their licenses, departure from the standard of care was especially well documented.

In the longest accusation, a 63-page petition to revoke the license of Frank D. Gilman, MD, of San Diego, the board listed hundreds of prescriptions written for four patients. He prescribed 370 prescriptions for one of them, and of those more than 200 were for oxycodone. Two of his patients died from overdoses. Gilman was accused of gross negligence, repeated negligent acts, incompetence, repeated acts of clearly excessive prescribing, and failure to maintain adequate and accurate medical records.

John Winthrop Pierce, MD, of San Francisco, surrendered his license after one of his patients died of an overdose of hydrocodone. The board's 28-page accusation said that he had prescribed a long-acting combination of fentanyl and morphine for another patient who had exhibited suicide ideation, and overall prescribing behavior that constituted gross negligence and repeated negligent acts.

Robert M. Littman, MD, of San Diego, also surrendered his license after the board's accusation said that his treatment of a patient, who was found dead at her home from "carisoprodol, lorazepam, oxycodone, zolpidem and trazodone toxicity" with traces of amphetamines and clonazepam, constituted "gross negligence." The patient had received prescriptions from multiple doctors, and "doctor shopped," but Littman had failed to conduct toxicology screenings and had not checked the prescription database to see what other prescriptions she had been getting.

Philipp Leo Bannwart, MD, of Zermatt, Switzerland, surrendered his license after the board found fault with his treatment of a patient in Concord, near San Francisco. She died of "acute methadone intoxication." The board accusation says that Bannwart wrote combination prescriptions for her, including methadone, Percocet, Norco, and promethazine-codeine syrup, constituting what the board called "gross negligence, repeated negligent acts/incompetence/improper prescribing without an appropriate prior examination and medical indication."

Daniel George Clark, MD, of Auburn, surrendered his license after the agency found that a patient died after Clark increased dosages of fentanyl, which it labeled "gross negligence."

Probation and public reprimand Northwell
 

Six accused physicians were placed on probation for periods of 3-7 years: Ashmead Ali, MD, of California City; Jay Milton Beams, MD, of Susanville; Harold Budhram, MD, of Shasta Lake; William Lee Matzner, MD, of Simi Valley; Michelle Anne Orengo-McFarlane, MD, of Martinez; and Ilona Sylvester, MD, of Thousand Oaks.

Another eight physicians were formally reprimanded and ordered to take courses on prescribing practices and, in most cases, medical record-keeping: Alyn Gary Anderson, MD, of Huntington Beach; Michael S. Basch, MD, of Temecula; Jose Rosendo Cesena, MD, of El Cajon; Vorakiat Charuvastra, MD, of Los Angeles; Moshe Miller Lewis, MD, of San Francisco; Diana Maria Prince, MD, of Rohnert Park; Charles Yang, MD, of Huntington Beach; and Tahir Yaqub, MD, of Atwater.

Still-pending accusations against the remaining 43 physicians can be read here.

The California Medical Association did not respond to a request for comment about the current status of the Death Certificate Project. But in an interview late last year, David Aizuss, MD, CMA president and an ophthalmologist from Encino, criticized the board for going after doctors because of how they prescribed controlled substances before 2014. "I don't think it's appropriate to apply our current clinical guidelines to what was going on six or seven years ago," he said then.

Asked why the investigations take so long, medical board spokesman Carlos Villatoro replied that for the latest fiscal year ending June 30, 2018, it took an average of 322 days after an accusation was filed for the case to conclude without compromising due process. He added that the process involves the Attorney General's office and the office of administrative hearings, both of which are outside the board's control, he said.

Proposed rule now slated for a December release, according to Unified Agenda.

This article was first published on Tuesday, August 28, 2019 in MedPage Today.

By Joyce Frieden, News Editor, MedPage Today

WASHINGTON -- "Standards for healthcare attachments." Those four words, contained in this year's Unified Agenda from the Office of Management and Budget, belie a long and unfinished struggle to get the federal government to help with one of physicians' biggest hassles: getting prior authorization from insurers for certain tests and procedures.

Electronic attachments -- test results, x-rays, or anything else that could be sent electronically as part of a prior authorization request -- have long been a hassle for providers because there is no standard format for including them with a prior authorization. Lack of a standard for electronic attachments was one of six barriers to improving the prior authorization process listed in a recent report from the Committee on Operating Rules for Information Exchange (CORE), a division of the Council for Affordable Quality Healthcare (CAQH). The six barriers cited by CAQH CORE included:

• The need for consistency in data content
   
• Lack of federally mandated standards for attachments and clinical documentation
   
• Lack of integration between clinical and administrative systems
   
• Limited availability of vendor products that readily support the standard transaction
   
• State requirements for manual intervention
   
• Lack of provider awareness

Voluntary Use a Success
 

The push to standardize handling of attachments began with the Health Insurance Portability and Accountability Act (HIPAA) back in 1996, according to Robert Tennant, director of health information technology policy at the Medical Group Management Association (MGMA).

HIPAA included a directive for the federal government to develop standards for electronic attachments, but that provision didn't seem to be getting any results, so when the Affordable Care Act (ACA) was passed in 2010, it too included a provision requiring the federal government to issue a final rule on standardizing electronic attachments. The ACA provision, which was included in Section 1104 of the law, even had a deadline: Jan. 1, 2014. But that day has long since passed without any action.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS) "has called for reduction in the provider burden, for putting 'Patients Over Paperwork,' and for cutting red tape," Tennant said in a phone interview. "Here's a low-hanging piece of fruit that the administration could very easily get out in regulation."

Even now, some payers and providers are voluntarily using a standard known as 275 -- which is used by Medicare -- to exchange electronic attachments, "and it's working great," he said. "They both report savings and tremendous advantages. So it's not like it hasn't been tried. We just need a mandate so vendors will support it and all payers be required to offer it. Without a mandate, we can't move forward as an industry."

"About a year and a half ago, a group of us went to CMS to make the case for the 275," said Tennant. "Here's a rare example in which industry came together -- large health plans, EPIC, Cerner, MGMA, the American Hospital Association, and the clearinghouses. We all went to CMS, because they didn't see the industry was solidly behind this. We said, 'We are.' We went in and made the case for why we need this standard. CMS put it on its regulatory agenda, and [the rule] was supposed to come out [last] August, but it never did."

Why the Delay?
 

For now, the electronic attachment standard is listed in the Unified Agenda as a proposed rule targeted for release in December. But why has it been delayed for so long despite two mandates -- over 23 years -- for its release? That gets into the area of speculation, said Tennant, who has a few ideas of the reasons why. "It's a combination of a couple of things; one is that Medicare, as a health plan, doesn't require very much prior authorization," he said. "It would be an expensive upgrade to the CMS computer system ... to support this. Also, there's a new [interoperability] standard called FHIR [Fast Healthcare Interoperability Resources], and there's a prior authorization use case for FHIR."

"Some of us are thinking that the agency is delaying the 275 [assuming] that the FHIR standard will solve the problem down the road, and I think that's still a long way away and we could reap benefits in the here and now with 275 transaction standard," Tennant said. "Not to discount the opportunities FHIR presents, but there is no reason the two couldn't co-exist for some period of time."

However, other efforts are proceeding on several fronts. In May, CORE finalized rules addressing the consistency of data exchanged between plans and providers, explained April Todd, senior vice president at CORE. "Oftentimes on prior authorization, the provider sends in a request to the health plan saying, 'I'm requesting this particular service for this particular patient,' and the health plan immediately sends back a response that 'This is pended.' The provider doesn't know why it"s pended, and doesn't know what to do next, and it leads to a lot of manual work," such as calling the health plan or sending the plan unsolicited information, she said.

"These rules provide consistency about what data goes back to the provider to help them figure out what to do next," Todd explained. "So a plan would send back particular codes that tell the provider, 'This is pended because we need a lab result' or 'This is pended because we need you to do a certain test first,' so it will provide the information needed for the provider to move the claim along."

CORE is in the process of developing a certification test allowing plans, vendors, and others to test their system to make sure they're compliant with the new rules. "We anticipate we'll have early-adopter organizations that will come in later in the year to start testing their system," she said.

CMS Launches Compliance Review
 

In addition, a month before the CORE rules came out, the CMS launched its compliance review program to "ensure compliance among covered entities with HIPAA Administrative Simplification rules for electronic health care transactions," the agency said on its website. This includes the "278" rule for standardizing prior authorization transactions. After pilot-testing the program, CMS randomly picked nine health plans and claims to clearinghouses for review, to make sure they were compliant with standards for transaction formats, code sets, and unique patient identifiers.

"Covered entities found to be noncompliant will be given the opportunity to take actions to correct issues and achieve compliance," the agency said in a bulletin on the new program. "Covered entities who do not achieve compliance may be subjected to escalated enforcement actions."

CORE also has been trying to educate providers about their rights under current regulations through webinars as well as provider surveys and site visits, Todd said. "We very frequently will hear from a provider that they didn't understand that if they asked the health plan to use the 278 transaction standard to conduct prior authorization, the health plan needs to do that. They weren't aware that there is a standardized transaction to use for prior authorizations and that they could file a complaint with the Department of Health and Human Services when a plan refuses [to use the standard]."

Until CMS releases the electronic attachment standard, prior authorization remains "one task the physician and their staff do that almost inevitably leads to expletives, mainly because it directly impacts patient care," said Tennant. "It slows it down, it goes against the judgment of the physician ... and adds to the frustration level of the entire staff within the office."