Acadia faces US federal probe into Nuplazid marketing

Acadia Pharmaceuticals may have thought it got out of trouble last year after an FDA safety investigation into its flagship Parkinson’s drug Nuplazid revealed no new risks – but documents have emerged showing the US Department of Justice has launched a separate probe into its marketing.

Nuplazid (pimavenserin) was first approved in April 2016 for psychosis associated with Parkinson’s disease, and although it was the first drug approved to treat the condition, marketing it has hardly been easy for Acadia.

The latest drama at the San Diego-based biotech comes after CNN uncovered documents, alerting shareholders to an investigation by the US Department of Justice into the sales and marketing of Nuplazid.

The filings with the Securities and Exchange Commission financial regulator began in November when Acadia disclosed it had received a civil investigative demand, requesting documents and information under the False Claims Act.

The Federal government uses this legislation to recoup fraudulent gains and the company provided no further information, other than that the investigation began in September.

However, CNN noted that the experts it interviewed suggested the DoJ must have “strong evidence of wrongdoing”.

The company’s annual report stated: “In September 2018 the company received a civil investigative demand (“CID”) from the Department of Justice (“DOJ”) requesting certain documents and information related to the company’s sales and marketing of Nuplazid.

“The company is cooperating with the DOJ’s request. Responding to the CID will require considerable resources and no assurance can be given as to the timing or outcome of the DOJ’s investigation.”

The FDA issued a statement in September reaffirming that there were no new safety issues with Nuplazid other than those outlined in a “black box” warning highlighting increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis.

The regulator issued the statement after re-examining evidence in the light of press reports raising concerns about the drug’s safety, which have caused its share price to fluctuate wildly.

https://pharmaphorum.com/news/acadia-faces-us-federal-probe-into-nuplazid-marketing/

AMA: prior authorizations increasing, interfering with care continuity

• The number of prior authorization requirements has increased in the past five years and 85% of physicians say the practice interferes with continuity of care, according to a new survey from the American Medical Association.
• Findings from the survey of 1,000 physicians released Tuesday found that more than two-thirds said it’s difficult for them to determine whether a prescription or service needs prior authorization. Fewer than 10% said they contract with a health plan that allows programs that can exempt providers from the requirement.
• Most prior authorizations are obtained by phone or fax, according to the report. Just over 20% of physicians said their EHRs allowed for electronic approvals, which can be more efficient.

AMA and groups like the American Academy of Family Physicians have argued that payers need to improve the prior authorization process. In a statement released with the survey findings, AMA charged insurance companies with a “year of foot-dragging and opposition” to prior authorization reforms.

A group of Michigan healthcare organizations came together and created Health Can’t Wait to protest prior authorizations. Critics of the practice allege that requiring payers to approve certain services leads to delayed and disrupted care.

However, payers view prior authorizations as a vital cost control that limits unnecessary care. Prior authorizations also have their supporters in Washington. A Government Accountability Office report released in 2017 found that prior authorization in Medicare saved as much as $1.9 billion through March 2017. The Trump administration’s proposed budget also includes expanded prior authorization measures for Medicare.

Anders Gilberg@AndersGilberg

The #TrumpBudget includes 5+ new proposals to expand #PriorAuthorization in Medicare. #PriorAuth negatively impacts patient care and increases administrative costs. Who should decide what’s best for patients: your doctor or the govt? #LetDocsDecide #MGMAAdvocacy#FixPriorAuth

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4:31 PM – Mar 11, 2019

However, providers complain that the process is burdensome and affects patient care. The American Academy of Family Physicians has called the practice family physicians’ “number one administrative burden.”

Though manual prior authorizations are considered cumbersome, electronic prior authorizations have shown to speed the process and save money. Automating prior authorizations reduces wait time for providers and patients and can lead to cost savings. The Council for Affordable Quality Healthcare estimated that electronic methods can save $6.84 per transaction.

Payers understand there is a problem with manual prior authorizations. America’s Health Insurance Plans and the Blue Cross Blue Shield Association came together with the AMA, American Hospital Association, American Pharmacists Association and Medical Group Management Association. The groups released a “Consensus Statement on Improving the Prior Authorization Process” last year.

The groups agreed that reforms are needed. However, the latest AMA survey found that providers haven’t seen an improvement yet. The findings echo a February AMA report that more than a quarter of physicians said prior authorizations lead to “serious or life-threatening events.”

In a statement Tuesday, AMA President Barbara McAneny said prior authorizations can work against people seeking treatment for opioid use disorder and that can be deadly. “The AMA urges all health insurers to join with the medical community to enact vital legislation that is an important step in reversing the opioid epidemic,” she said.

https://www.healthcaredive.com/news/ama-says-prior-authorizations-increasing-interfering-with-care-continuity/550342/

Blood test to diagnose heart attacks is flawed, warn researchers

The blood test used to diagnose a heart attack (acute myocardial infarction) in patients admitted to hospital can be misleading, warn researchers in a study published by The BMJtoday.

Of 20,000 consecutive patients undergoing blood tests at University Hospital Southampton, one in 20 had levels of troponin (a protein released into the bloodstream during a heart attack) greater than the manufacturer’s recommended upper limit. But in most of these patients were being seen for other conditions and so there were no clinical signs or symptoms of a heart attack.

Troponin levels also differed according to several factors such as age, sex and whether inpatient or outpatient.

The researchers, led by cardiologist Professor Nick Curzen, say these results highlight the need for medical staff to interpret troponin levels carefully in order to avoid misdiagnosis of a heart attack and inappropriate treatment.

Current guidelines recommend troponin tests to help exclude or diagnose a heart attack. Manufacturers of troponin tests provide a recommended level (known as the 99th centile) based on values from a few hundred healthy individuals.

This recommended level is used as the upper limit of normal (ULN). In other words, if the value of troponin is above the 99th percentile, that is considered to be abnormal, and would indicate a heart attack in appropriate clinical circumstances.

But little is known about the true distribution of the troponin level across a whole hospital population that includes inpatients, outpatients, patients undergoing surgery, in intensive care etc.

So researchers measured levels of high sensitivity cardiac troponin I (hs-cTnI) in 20,000 inpatients and outpatients undergoing blood tests for any reason at University Hospital Southampton between 29 June and 24 August 2017.

The average age of participants was 61 and 53% (10,580) were women.

The researchers found that the 99th centile of troponin for the whole study population was 296 ng/L compared with the manufacturer’s recommended level of 40 ng/L.

One in 20 (1,080; 5.4%) of all 20,000 patients had a troponin level greater than 40 ng/L, but in most of these patients there was no clinical suspicion of a heart attack.

Overall, 39% of all patients from the critical care units, 14% of all medical inpatients, and 6% of all patients from the emergency department had a troponin concentration greater than the recommended ULN.

This is an observational study, and as such, can’t establish cause, and the researchers point to some limitations, such as relying on patient records for details about management and diagnoses, and being unable to examine clinical outcomes.

Nevertheless, they say this study shows that “the 99th centile of high sensitivity troponin I concentration of the population in our hospital was substantially higher than the manufacturer’s recommended ULN used in clinical practice based on the 99th centile for a healthy population.”

These data “highlight the need for clinical staff to interpret hs-cTnI concentrations carefully, particularly when applying the recommended ULN to diagnose acute myocardial infarction, in order to avoid misdiagnosis in the absence of an appropriate clinical presentation,” they conclude.

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First randomised trial tests criteria used to diagnose heart attack

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More information: True 99th centile of high sensitivity cardiac troponin for hospital patients: prospective, observational cohort study, BMJ (2019).www.bmj.com/content/364/bmj.l729

https://medicalxpress.com/news/2019-03-blood-heart-flawed.html

AI Takes Aim at Lung Cancer Screening

The term artificial intelligence (AI) might bring to mind robots or self-driving cars. But one group of researchers is using a type of AI to improve lung cancer screening.

Screening is important for early diagnosis and improved survival odds, but the current lung cancer screening method has a 96 percent false positive rate.

But in the new study, investigators were able to reduce false findings of lung cancer without missing any actual cases.

A low-dose CT scan is the standard diagnostic test for people at high risk of lung cancer. In the United States, about one-quarter of these scans reveal shadows indicating nodules in the lung. Despite that positive result, fewer than 4 percent of those patients actually have cancer.

“A positive test creates anxiety, increases health care costs, and the follow-up tests are not risk-free,” said study co-author Panayiotis Benos. He’s vice chairman of computational and systems biology at the University of Pittsburgh.

“For the 96 percent of people who have benign nodules, these procedures are unnecessary. So, we try to mine the data to tell which are benign and which are malignant,” Benos explained in a university news release.

Benos and his colleagues entered CT scan data from 218 high-risk patients into a machine learning algorithm — a form of artificial intelligence — to create a model that calculates the probability of cancer.

The researchers then compared the model’s results against the patients’ actual diagnoses. The model would have spared 30 percent of patients with benign nodules from further, unnecessary tests, without missing a single case of cancer, the team reported.

According to the study authors, they were able to rule out cancer in about one-third of the patients. This means these people wouldn’t need biopsies, PET scans or short-interval CT scans. They could just make an appointment to come back in a year.

This is the first time artificial intelligence has been used in this way, the researchers said.

The study was published March 12 in the journal Thorax.

According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women. This year, in the United States, the society estimates that there will be about 228,000 new cases of lung cancer and about 143,000 lung cancer deaths.

More information

The U.S. Centers for Disease Control and Prevention has more on lung cancer.

SOURCE: University of Pittsburgh, news release, March 12, 2019

https://consumer.healthday.com/cancer-information-5/lung-cancer-news-100/ai-takes-aim-at-lung-cancer-screening-743711.html

Cellectis initiated at William Blair

Cellectis initiated with an Outperform at William Blair. William Blair analyst Raju Prasad started Cellectis with an Outperform rating.
https://thefly.com/landingPageNews.php?id=2878883

Hospitals could sustain 10% cut under Medicare public option proposals: report

If the U.S. were to pursue a Medicare public option proposal, it could “decimate” insurance coverage as it looks today and result in a nearly 10% cut to U.S. hospitals, leaders from two top hospital organizations said in a call with reporters on Tuesday.

More than 36 million people would likely leave private coverage if a new government-run public option were to be rolled out, according to a report released by the American Hospital Association and the Federation of American Hospitals.

The study specifically looked at the potential effects of the Medicare-X Choice Act, a bill introduced in 2017 which would be less expansive than Medicare-for-All proposals introduced by some Democrats last month. The big problem: “Under Medicare X-Choice, the public plan would reimburse providers using Medicare rates, which are significantly less than commercial rates and, for hospitals, fall below the cost of providing care,” the report said.

“This ill-conceived program would undermine access to care and threaten the ability of providers and clinicians to meet the needs of their patients,” said FAH President and CEO Chip Kahn in a statement. “Moreover, this study highlights the disruption proposals like this would have on the private coverage Americans are satisfied with today.”

The report was prepared by KNG Health Consulting on behalf of the AHA and FAH.

The study found that the proposal could harm the employer-sponsored health insurance market while only resulting in a modest drop in the overall number of uninsured.

“It is not practical to disrupt coverage provided through employer-sponsored plans that already cover more than 150 million Americans,” said Tom Nickels, AHA executive vice president.

The study estimated:

• Medicare-X Choice would result in a reduction of 5.5 million uninsured patients. In comparison, they said, a fully implemented ACA would result in a reduction of 9.1 million in the number of uninsured.
• By 2024, approximately 174 million individuals will be insured through either an employer or the nongroup market and 29 million would be uninsured. Without any changes in policy, the number of individuals and nongroup would grow by 2.4 million and the uninsured would grow by 2.2 million. Under Medicare-X Choice, they estimate that public plan participation would be 40.7 million in 2024 and 42.3 million in 2033.
• Total healthcare spending is expected to hit $1.3 trillion in 2024 among those with employer-sponsored coverage, nongroup coverage, or among those individuals who are uninsured, with projected growth to hit $1.9 trillion by 2033. Under Medicare-X Choice, spending would fall by $1.2 trillion over the same 10-year period.
• Hospital-based services represent just under half of healthcare spending but would account for 67% of the projected reduction in total healthcare spending. Under Medicare-X Choice, payments to hospitals would be reduced by 10%, or $774 billion, between 2024 and 2033.

https://www.fiercehealthcare.com/hospitals-health-systems/aha-fah-study

UnitedHealth to expand use of point-of-sale drug discounts

UnitedHealth Group is expanding its point-of-sale discounts for drugs, the insurer announced Tuesday.

Beginning in 2020, all new employer plans with UnitedHealth and its pharmacy benefit manager subsidiary Optum will be required to offer all drug discounts directly to members at the pharmacy counter, the insurer said.

Deals in place with current employer clients, including those set to begin Jan. 1, will be grandfathered, UnitedHealth said. The insurer first announced it would expand its use of point-of-sale discounts a year ago, and said in the announcement that it will reach 9 million members with these benefits in 2019.

“Patients are seeing concrete benefits from UnitedHealthcare’s groundbreaking point-of-sale discount program, which is just one element in our commitment to help deliver better health, lower costs and a better experience,” Daniel Schumacher, president and chief operating officer of UnitedHealthcare, said in a statement.

Employers who already contract with UnitedHealth and Optum can take advantage of this new plan design when they renew their deals, UnitedHealth said.

Already this year, the point-of-sale discounts have saved UnitedHealth plan members an average of $130 per prescription, the insurer said. In addition, for people enrolled in plans without deductibles or high out-of-pocket costs, these discounts have improved medication adherence between 4% and 16%.

Under pressure amid the ongoing debate over rising drug costs, insurers and PBMs have begun to turn to point-of-sale discounts instead of the traditional pricing rebates. Doing so addresses a major criticism from policymakers and drug companies: that PBMs and payers pocket many of the discounts on medications instead of passing them on to consumers.

The Trump administration has taken steps to sunset the existing rebate system entirely. It issued a proposed rule in late January that would end legal protections for rebate negotiations and instead extend them to point-of-sale discounts in federal programs.

  

Congress is poised to weigh in as well, with a new Senate bill aiming to end the legal protections for rebates in the commercial sector as well. The Department of Health and Human Services expects its rule, if finalized to have ripple effects in the private market even if Congress doesn’t act.

In the announcement, UnitedHealth said that point-of-sale rebates were an option in all of its employer plans before, but it believes the latest expansion will grow the program’s reach across its commercial insurance business, including to self-funded plans.

“Together with employer partners and OptumRx, UnitedHealthcare has taken innovative action, bringing real value to consumers while mitigating the impact of persistent drug inflation brought on by drug manufacturers affecting consumers’ ability to afford medications and comply with their physicians’ treatment plans,” Schumacher said.

https://www.fiercehealthcare.com/payer/unitedhealth-to-further-expand-use-point-sale-drug-discounts