Opioid prescribing drops largest amount in 25 years

https://www.washingtonexaminer.com/policy/healthcare/opioid-prescribing-drops-largest-amount-in-25-years

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Trial for doctor linked to Glen Cove overdose begins

Opening statements, undercover video in Day 1 of Belfiore opioid trial

http://liherald.com/stories/feds-merrick-doctor-a-dealer-not-a-healer,102325

The Merrick physician facing federal charges of illegally prescribing opioids, and causing the overdose deaths of two South Shore men, began on Wednesday, with prosecutors calling Dr. Michael Belfiore “a dealer, not a healer,” and Belfiore’s defense attorney insisting that the doctor is being unfairly prosecuted.

Belfiore was also implicated in the 2009 death of Mario Marra, of Glen Cove. Medical records in the case were subpoenaed, although charges were not filed.

Medical records indicate that Belfiore prescribed Marra fentanyl on March 7, 2009. He died on March 15, according to the coroner’s report.

Belfiore, in an interview last summer, admitted Marra was a patient, but disputed much of Claudia’s account, adding that if Marra was “responsible with the medication, and took it as directed, he’d still be here.”

Belfiore’s trial, at the U.S. District courthouse in Central Islip, is expected to last five weeks, according to his attorney, Tom Liotti, of Garden City.

After a jury was selected, Assistant U.S. Attorney Bradley King made his opening argument, describing the circumstances in which John Ubaghs, of Baldwin, and Edward Martin, of East Rockaway, were found dead — both allegedly with bottles of oxycodone prescribed to them by Belfiore.

King also introduced the government’s first witness against Belfiore: Detective James Marinucci, of the Nassau County Police Department’s vice squad. Marinucci — undercover as James Burke, a factory worker with back pain — saw Belfiore as a patient six times in 2013, obtaining six prescriptions for oxycodone. He paid in cash each time.

In a lengthy video — taken by a hidden camera Marinucci wore on a necklace — shown to jurors, the undercover detective was seen and heard during an initial appointment with Belfiore in March 2013.

During the visit, Marinucci complained of back pain, and told Belfiore that his ex-girlfriend used to share her “Oxy 30s” with him — Marinucci testified that he used this “street” phrase for the medication deliberately with Belfiore.

Belfiore agreed to write Marinucci multiple prescriptions, including for oxycodone, anti-inflammatories and Trazodone, for sleep, but did warn the undercover detective — using colorful language — about the dangers of sharing controlled substances with others.

“I’m not gonna share a jail cell with you,” Belfiore joked at one point, later stressing, “You don’t understand the stigma that’s attached to these medications now.”

Liotti was expected to cross-examine Marinucci on Thursday.

Liotti, has maintained that opioid manufacturers are the culprits in Ubaghs’s and Martin’s deaths — and in the country’s larger opioid crisis.

The defense attorney reiterated the point during his opening arguments, also calling the grand jury process that led to Belfiore’s indictment, in which he was not allowed to be present, a “one-sided proceeding.”

“We offered our own expert testimony — the government wouldn’t allow it,” Liotti said, also warning jurors that he believed the government would try to connect Belfiore’s case to the hundreds of thousands of opioid deaths nationwide.

He also challenged prosecutors to define the number of pills Belfiore could have prescribed that would have met their definition of “with a legitimate medical purpose.”

“There can be no guess-work or speculation here,” he added.

Belfiore also, Liotti said, had been honest with law enforcement throughout the yearslong case, “perhaps to a fault,” and made reference to both Arthur Miller’s “The Crucible,” and the film “12 Angry Men,” as he tried to paint Belfiore as the government’s scapegoat.

“His career and his life are on the line,” Liotti said.

Look for more coverage of Belfiore’s trial in next week’s edition, and online.

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http://wvah.com/news/local/charleston-family-says-local-pharmacy-gave-out-the-wrong-dose-of-hepatitis-a-vaccine

http://wvah.com/news/local/more-than-1200-alpha-kappa-alpha-sorority-members-visit-charleston

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Nursing home ranks at bottom

https://www.t-g.com/story/2506038.html

In a September 2016 court filing, federal prosecutors said Glen Oaks Health and Rehabilitation of Shelbyville was providing “grossly substandard, and/or worthless nursing home services to Medicare and TennCare” patients.

Nearly two years later Glen Oaks is still in need of improvements.

In recently released reports rating 28 nursing homes within a 50-mile radius of Shelbyville that are ranked by the Center for Medicare and Medicaid Services, Glen Oaks Health and Rehabilitation of Shelbyville got the lowest possible ranking.

One star

Based on the survey conducted late last year, Glen Oaks was ranked with one out of five stars, a “Much Below Average” rating.

Of the 517 nursing homes that accept Medicare payments within 200 miles of Shelbyville, 13.5 percent (70) were ranked with just one star.

The most recent health inspections of area nursing homes were conducted in late November and December 2017 and the results were posted recently on the Medicare website (Nursing Home Compare).

Of the 28 nursing homes that accept payment from the Medicare/Medicaid program within 50 miles of Shelbyville four were rated with just one star.

(One of those, Manchester Healthcare Center, is owned by the same company that owns Glen Oaks.)

Six in the area were rated with two stars, “below average,” (including The Waters of Shelbyville).

Five were rated with three stars (average).

Seven area nursing homes were rated with four stars (above average) including two in Lewisburg — NHC Healthcare and NHC Healthcare Oakwood. Lynchburg Nursing Center was also rated “above average.”

Six were rated with five stars (Much Above Average) including two in Tullahoma — NHC Healthcare Tullahoma and Life Care Center of Tullahoma.

About the ratings

The rating system, developed by the Center for Medicare and Medicaid Services (CMS), ranks nursing homes in three broad categories — health inspections, staffing and “quality measures.”

Glen Oaks was rated “below average” in health inspections and “much below average” in staffing (not enough personnel). The facility was rated as average in “quality measures.”

Quality measures

Glen Oaks was rated as “Average” — three stars — in this category.

CMS determines “Quality of resident care” using 16 measures. Each of the measures is expressed in a percentage of the number of patients and is compared with rates in Tennessee and nationwide. The measures include short-term residents and long stay residents.

One common problem associated with poor care or neglect of patients is pressure ulcers, commonly called bed sores. At Glen Oaks the percentage of short term patients with bed sores that were new or worsened was four times worse than the state average — 2.5 percent as compared with the Tennessee average of 0.6 percent and the national average of 0.9 percent.

The rate of bed sores in long stay residents at Glen Oaks was much closer to the state and national averages: 6.2 percent at Glen Oaks, 5.3 percent statewide and 5.6 percent nationally.

Glen Oaks also fell short in the high percentage of long-stay residents whose ability to move independently got worse. Glen Oaks: 34.3 percent got worse; Tennessee: 21.4 percent got worse; and nationally 18.2 percent got worse.

Glen Oaks did do better in some quality measure areas including the number of patients who got flu shots, a low percentage of patients who lost too much weight, low percentage of patients who suffered major injury from falls and low percentage of long term patients who had symptoms of depression.

Staffing

It was in “Staffing” that Glen Oaks did most poorly with only one star — “much below average.”

CMS says of this category: “Higher staffing levels in a nursing home may mean higher quality of care for residents. This section provides information about the different types of nursing home staff and the average amount of time per resident that they spend providing care.”

At Glen Oaks the total amount of time a Registered Nurse is available per resident, per day is 26 minutes, half that of the national average. Tennessee’s average is 46 minutes a day and the national average is 50 minutes. The availability of physical therapy staff at Glen Oaks was also lacking: 3 minutes as compared with the state and national averages of 6 minutes.

Health Inspections

Glen Oaks was ranked “below average” (two stars) in this category.

Glen Oaks was cited for eight violations, as compared with the Tennessee average of four and the national average of 5.8.

In the most recent available “statement of deficiencies and plan of correction” from a July 2017 inspection.

According to the report:

* Glen Oaks failed to immediately report allegations that a resident had been abused. The incident was not reported until seven days later. CMS requires that such allegations be reported within 24 hours.

*Glen Oaks failed to adopt an abuse policy that met CMS requirements.

*Glen Oaks failed to provide care that protects its residents’ dignity.

*Glen Oaks failed to provide proper housekeeping services. This finding was the result of a wheel chair coated with a “heavy accumulation of dried debris”. Wheel chairs are supposed to be cleaned daily.

*Glen Oaks staff failed to properly secure medications, and failed to keep the rate of medication errors (wrong drug, wrong dose, wrong time) to less than 5 percent.

One example of this, was that a prescription medication that was supposed to have been stopped on June 9 was still being given to the patient on July 11.

*Glen Oaks staff failed to properly secure prescription medications. A prescription medication with no pharmacy label or any label indicating patient information was found unopened on a resident’s bedside table.

• Glen Oaks failed to follow infection control practices in dispensing medications to eight patients. The facility’s workers failed to “wash/sanitize hands between residents for two residents, failed “to prepare medications in a safe manner for two residents,” failed “to dispose of unused medications appropriately for one resident,” and failed to “protect respiratory equipment from contamination for seven residents.”

In summary

In a summary of all health inspection deficiencies in recent years, Glen Oaks was cited eight times in the period from March 2017 to March 2018; three times from March 2016 to March 2018 and six times from March 2015 to March 2016.

Fire safety inspection

In July 2017, fire inspectors identified six “smoke deficiencies,” reporting that Glen Oaks did not:

• have walls in “special areas” constructed so that they can resist fire for one hour or more or have an approved fire extinguishing system,

• have a fire alarm that can be heard throughout the facility,

• Inspect, test, and maintain automatic sprinkler systems,

• Properly select, install, inspect or maintain portable fire extinguishers, and

• Ensure smoke barriers are constructed to provide one hour fire resistance.

Glen Oaks corrected all the fire safety issues 44 days after the inspection.

Not first problem for owners

Glen Oaks has been owned by Vanguard Healthcare LLC since July 2007. The company has been in litigation with the federal government since 2016 accused of filing false claims. (See related story.)

• Vanguard healthcare CEO William “Bill” Orand did not return phone calls seeking comment. Glen Oaks administrator Cassandra Callahan also did not return phone calls seeking comment.

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West Virginians weigh opioid response as they look at GOP Senate candidates

http://www.foxnews.com/politics/2018/04/20/west-virginians-weigh-opioid-response-as-look-at-gop-senate-candidates.html

CHARLESTON, W. Va. –  Republican candidates running in the Mountain State’s Senate primary have spent time in court, in Congress and in a correctional facility.

Each has different ideas about how to fix the opioid epidemic, and voters are carefully weighing those ideas, less than three weeks until the election that will decide who gets to challenge Sen. Joe Manchin, a Democrat.

West Virginia Attorney General Patrick Morrisey is taking credit for a court victory that inspired a freshly proposed Drug Enforcement Administration (DEA)  rule that could cut down on opioid production.

“We’ve been tackling the problem about as aggressively as any office can,” Morrisey said. “Part of the reason why we sued the DEA is that we found out the national drug quota system had utterly failed our citizens, they were rubber-stamping ever increasing amounts of pills flooding into our state and across the country.”

West Virginia has the highest rate of drug overdose deaths in the country, and those fatalities are driven by opioids, according statistics kept by the Centers for Disease Control and Prevention.

Congressman Evan Jenkins (R-W.Va.) is the only candidate in the GOP primary field now serving in D.C., and since Congress cuts checks meant for opioid education and treatment, he believes he’s best positioned to continue the fight as senator.

“We’re walking the walk,” Jenkins said. “I have served on the appropriations committee, the $6 billion working with the white house that we’ve just approved is a significant, positive step in the right direction.”

Jenkins also helped establish Lily’s Place in Huntington, a neonatal abstinence syndrome center that was visited by First Lady Melania Trump last year.

President Trump won West Virginia by 42 points in 2016, and an outsider candidate with a business background is now pitching himself as the best to address the state’s opioid crisis – with a broad pitch that sounds a lot like the one candidate Trump brought to coal country.

“The wall is very important,” Don Blankenship said. “Ending the sanctuary cities is important, drug testing public officials – particularly teachers and judges and prosecutors, is important, and basically getting after the doctors and keeping better measurement of who is prescribing the drugs and who is distributing them.”

Blankenship recently served a one-year prison term following a conviction to skirt mine safety regulations, tied to his role as the former chief executive of Massey Energy, when the Upper Big Branch mine disaster occurred and killed 29 people.

The former coal baron is now trying to get his conviction, which he insists is not a liability, overturned.

And with regard to the opioid epidemic, Blankenship believes he’s the only one running whose hands are clean from the crisis.

“I think both of them are greatly responsible for the epidemic,” Blankenship said about his opponents Jenkins and Morrisey, “because they haven’t done enough.”

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http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/will-pbms-be-next-target-opioid-lawsuits

Although suing physicians and pharmacists over the opioid crisis is nothing new, up until now pharmacy benefit managers (PBMs) have been off the radar screen. But in February, a south Texas county included the three largest PBMs—CVS, Express Scripts, and OptumRx as well as some smaller ones operating in Texas—in a nationwide lawsuit focusing on the opioid epidemic because of their role in allowing access to prescription opioids.

PBMs set the rules that determine drug availability and how much patients have to pay out of pocket to get them. So why haven’t they been targeted until now?

Nelson

Harry Nelson, managing partner, Nelson Hardiman, LLP, a healthcare law firm, says physicians have been targeted based on their role as prescribers and as frontline decision makers with the capability to avoid opioid overprescribing, dependency, and resulting harm. Similarly, pharmacists have been sued because of their roles as dispensers and their capacity to serve as the last safeguard before patients end up at risk from overprescribing.

“While PBMs play a critical role in drug’s pricing and availability, they are not expected to question physician’s therapeutic choices,” Nelson says. “They don’t have the same professional obligations that pharmacists do to avoid suboptimal dispensing choices. As unlicensed entities, they don’t hold individual licenses, as physicians and pharmacists do, so they are not held to the same standard. Their roles and responsibilities are less well-defined, so there is less basis to hold them responsible.”

Metzler

Nonetheless, PBMs actually have a lot of power, says Christopher J. Metzler, PhD, JD, CEO, Gordium Healthcare, a multidisciplinary behavioral healthcare organization. They are the middlemen who operate between the doctor, patient, and pharmacy. They provide insurance contracts with pharmacies and can deny a claim’s payment. They have the most to gain from a prescription’s cost.

Given the number of governmental entities now bringing lawsuits, and the limited number of manufacturer and distributor targets, Lawrence Ingram, a partner in the law firm Freeborn & Peters’ Litigation Practice Group, and a member of its Insurance and Reinsurance Industry Team, foresees every entity in the distribution chain eventually getting caught up in this type of litigation. 

Ingram

Similar lawsuits likely

In the Texas case, The Webb County lawsuit alleged that PBMs drove the opioid epidemic as a result of increasing profits from the drugs.

Nelson says since it doesn’t cost much to name a PBM as an additional party in litigation, he expects PBMs to increasingly be named in opioid-related lawsuits. “While it takes some creativity to do something new (like looking at PBMs) as a responsible party, my hunch is that other lawyers are likely to learn from this and will be interested in a potential additional source of settlement funds,” he says.

Metzler also expects more PBMs to be sued. “Lawyers who present a well-written and brutal set of discovery questions, review the prescription paper trail, and talk to pharmacies and patients will find a treasure trove of evidence to present to a jury,” he says.

So on what grounds could PBMs be sued? Nelson says PBMs may not hold licenses that impose obligations, but their contractual commitments as intermediaries between health plans and pharmacies provide a potential argument that they also owe responsibility to patients, who are arguably third-party beneficiaries of those contracts. In other words, health plans are contracting with PBMs for the benefit of patients, so PBMs have the responsibility to protect patients from harm. There may also be an argument that PBMs are in a better position than individual pharmacies because of their data access to red flag problematic prescribing practices.

Ingram says allegations would likely be that the PBMs somehow allowed a greater amount of these drug products to be permitted in communities than could be supported by legitimate medical needs.

Likely outcomes

As a novel legal theory, lawyers will have to explain in detail to the courts what PBMs are and how they operate. “Unless lawyers are able to do so and prove causation, this will be a very difficult road to travel,” Metzler says. “As in most novel legal theories, this is a test, the outcome of which is uncertain. It is up to lawyers to educate, persuade, and prove causation.”

In the future, Nelson says PBMs may put additional safeguards in place to scrutinize troubling practices that surface through data, such as potential indicia of excessive prescribing. For patients, getting access to opioids is likely to get even tougher, with another hurdle in the form of PBMs. This may also make opioids more expensive, as PBMs begin to factor in the additional costs and risks associated with opioid prescribing.

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http://www.breitbart.com/big-government/2018/04/18/politicians-get-opioid-crisis-wrong-patients-suffer-street-drugs-kill/

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http://www.dispatch.com/news/20180419/iowa-lawmakerpharmacist-literally-calls-bs-on-cvs-rationale-for-high-drug-prices

Pharmacy giant CVS has for months ignored questions in Ohio about a controversial pricing practice, but an Iowa legislative committee on Wednesday got the executive in charge to describe it.

He came after a lawmaker threatened a subpoena.

Rich Ponesse, senior director of trade finance for CVS Caremark, appeared before the Iowa House Government Oversight Committee to explain the difference between what his company pays retail pharmacies and what it charges health plans, a practice known as “spread pricing.”

Most people know CVS as a retail pharmacy, but its CVS Caremark subsidiary manages pharmacy benefits for health plans, including those that contract with Medicare, Medicaid and private employers. CVS Caremark and two other “pharmacy benefit managers” dominate a business in the United States that is worth more than $300 billion a year.

In Ohio, a group of lawmakers and the Department of Medicaid have asked for — and received — confidential data to determine whether the state is getting gouged through spread pricing. Medicaid officials said Thursday they are beginning a promised review.

“We are just starting to go through a very manual process to analyze that information,” Medicaid Director Barbara Sears said. The analysis should be completed by June, she said.

CVS Caremark has not answered questions from The Dispatch about the spread pricing. But Ponesse told the Iowa legislative committee that his company uses it and that it’s fair to customers.

“As far as spread pricing is concerned, we are very transparent with our clients,” Ponesse said, according to a video of the hearing that state Rep. John Forbes, D-Urbandale, posted on Facebook. “They have multiple options. One is a pass-through option and the other is spread pricing.”

Ponesse said some managed-care companies opt for spread pricing because the risk of pharmacy costs suddenly jumping is mitigated by using that option, Ponesse said.

However, the spread pricing option appeared pretty risky for one Iowa county. Ottumwa pharmacist Mark Frahm told the committee that he determined that CVS Caremark in January reimbursed him $1,000 for drugs he supplied to inmates at the Wapellow County Jail, and then billed the county $5,000 for the same drugs. Worse, Frahm said, the drugs cost him $1,500, so he lost $500 on the deal.

He, Forbes and county officials checked 160 claims from the jail and determined that on average, CVS Caremark was paid $26 more for a filling a prescription than it paid a pharmacy.

The spread on some drug prices was extreme. One cost the county $123.91, but CVS Caremark only paid the pharmacy $2.69. Another cost the county $162, but the pharmacy only got $16.

Ponesse, the CVS executive, said his company’s pricing is “not an exact science,” but overall it treats retail pharmacies fairly.

Ponesse said his company regularly adjusts reimbursements for pharmacists who use a CVS portal to complain that reimbursements were forcing them to lose money. Forbes, who also is a pharmacist, was incensed.

“You never adjust. Bullshit,” he said. “I’ve been in this business for 38 years. You can’t fool me.”

Forbes said CVS Caremark’s reimbursement-appeals system is rigged. When Iowa pharmacists intentionally put made-up drugs in the portal, they got the same canned brushoff as when they complained about reimbursements for real drugs, he said.

“They’re just not even reviewing them,” Forbes said. “That’s what I think.”

Ponesse denied the accusation, promising the panel data on adjustments CVS Caremark has made.

In a phone interview Thursday, Forbes said, “Normally I don’t get upset too much,” but Ponesse’s praise of CVS’s mail-order business and his assertions of fair reimbursements were too much for him.

So how did he get the guy who sets pharmacy reimbursements to the hearing?

“I said I want somebody who’s not going to get in here and say, ‘I need to check that,’ or, ‘I’ll have to get back to you.’ I want somebody who knows,” Forbes said. “I also said that if we have to use subpoena power, we will.”

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https://www.advisory.com/daily-briefing/2018/04/18/dea-opioids

The Drug Enforcement Administration (DEA) increased production quotas for certain drugmakers to help alleviate a shortage of injectable opioids that has plagued providers since the summer—but industry experts say relief is still several months away. 

Background

The shortage, which industry experts largely attribute to manufacturing issues at Pfizer, comes amid a federal push to reduce the use of prescription opioids. As part of that effort, DEA last year sought a 25% reduction in production of all opioids and a 20% additional reduction this year. DEA on Tuesday proposed a rule that would require the DEA administrator to consider a broader set of criteria when setting production quotas for drugmakers, including the extent to which the drugs, particularly prescription opioids, are being misused and contributing to overdose.  

The opioids in short supply are not prescription pills but rather packaged vials, patches, and syringes that are distributed to hospitals and other medical providers. The medications are intended to treat pain in patients who are undergoing major surgery or are experiencing severe pain due to trauma or cancer. The specific medications include injectable morphine, Dilaudid, and fentanyl.

Pfizer spokesperson Steve Danehy said the shortage of clinical injectable opioids began in June 2017 when the company scaled down production of the drugs while upgrading a plant in Kansas. Pfizer, which holds at least 60% of the injectable opioids market, also said it is experiencing “technical and process issue[s]” with an unnamed third-party supplier, and is not currently distributing prefilled syringes “to ensure patient safety.”

Although Pfizer has resumed some of its production, the company doesn’t expect to be back to full production until the second quarter of next year, according to Modern Healthcare. In March, Danehy said the company was “exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers.”

Stakeholders call for quota boost

To help mitigate the shortage, the American Hospital Association and other industry stakeholders have asked DEA to ease quotas on opioid production for liquid opioids. Under current regulations, if a major drugmaker, such as Pfizer, hits a roadblock in production, smaller manufactures have to petition DEA to boost their own levels of production.

In the meantime, hospitals and health systems around the country have had to adopt multiple coping strategies, including inventory tracking and the use of opioid alternatives when feasible.

After delay, DEA raises quotas

According to Modern Healthcare, DEA received requests for additional raw ingredients on Jan. 1. However, the agency waited until mid-February and mid-March to grant partial approvals for Fresenius Kabi and West-Ward Pharmaceuticals—as well as a smaller, unidentified drugmaker—to manufacture the ingredients.

Modern Healthcare reports that while the agency can typically meet extra quota requests within four weeks, DEA in this case had to dispatch inspectors to facilities to reconcile drugmakers’ inventory checks with their year-end reports to ensure there wasn’t any drug diversion. According to DEA, the goal of such reviews is to make sure that manufacturers are not stockpiling raw ingredients that could be used to mitigate the shortage.

However, industry experts said the risk of drug diversion is minimal among manufacturing and inpatient settings—it’s a greater risk among retail pharmacies. “The potential for diversion in the institutional setting versus the retail setting is infinitesimally small,” William Larkin, EVP and chief pharmacy officer for Acurity said.

Comments

Providers and other stakeholders praised DEA for increasing the quotas, but they expressed concern about the delay—and noted that relief likely remains several months away, Modern Healthcare reports.

For instance, Scott Knoer, chief pharmacy officer at Cleveland Clinic, said there’s typically an eight- to 12-week quarantine between when the opioids are manufactured and when they receive quality control approval necessary to ship the product—and then the products need a few more weeks to get through the wholesale distribution supply chain. “Bottom line, this is good news, but it will likely be summer before we have some relief and longer for full relief,” Knoer said.

Similarly, Todd Ebert, CEO of the Healthcare Supply Chain Association (HSCA), said that HSCA was “encouraged” by the DEA’s decision, but hopes that, in the future, “DEA will develop processes and procedures to recognize and respond to these market issues much more quickly … as three months seems to be too long.”

Meanwhile, Daniel Motto, EVP of commercial and business development for West-Ward, said the company is “doing [its] best to meet the significant need that this shortage has presented for these important injectable medicines,” but added that the company does “have limitations based upon the quota granted by the DEA.” Motto said the company has asked for additional active pharmaceutical ingredients (Kacik, Modern Healthcare, 4/14; Wilber, Wall Street Journal, 4/17).

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