CMS angers hospitals with plans for site-neutral rates in outpatient payment rule

http://www.modernhealthcare.com/article/20160706/NEWS/160709964

The CMS has responded to calls to eliminate patient satisfaction on pain management from Medicare’s value-based purchasing program. The agency angered hospitals, however, with plans to stop paying their off-campus facilities the same as hospital-based outpatient departments.

Both policies are included in the proposed rule for the 2017 Hospital Outpatient Prospective Payment System issued Wednesday.

The CMS’ actuary has estimated that so-called site-neutral payments for ambulatory care, which Congress called for a 2015 spending bill, would save Medicare about $500 million in 2017. The American Hospital Association quickly issued a harshly worded statement criticizing the CMS for declining to include support for hospital outpatient departments.

The AHA was among several prominent healthcare associations that had called on the Obama administration to stop incorporating patients’ responses to pain-management questions in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) in the value-based purchasing program. HCAHPS results are a significant factor in how hospitals fare under value-based purchasing, and providers have complained the program gives them a financial incentive to over-prescribe painkillers to keep patients happy.

The survey asks patients if they needed medicine for pain, how often their pain was well controlled and—of most concern to the healthcare industry—if the hospital staff did everything they could to help with the pain.

“Some stakeholders believe that the linkage of the pain management dimension questions to the Hospital VBP program payment incentives creates pressure on hospital staff to prescribe more opioids,” the CMS said in the proposed rule. The agency said removing the questions from the survey would “mitigate even the perception that there is financial pressure to overprescribe opioids.”

However, the CMS also said in a news release that it still believes pain control is “an appropriate part of routine patient care that hospitals should manage.” The agency is currently developing and field-testing new questions to add to the program.

The CMS is proposing to increase the rate for hospital outpatient services by 1.6%, or $671 million, and ambulatory surgical centers by 1.2%, or $39 million, in 2017 compared with 2016.

In response to the rule’s provisions on site-neutral payments for outpatient services, AHA Vice president Tom Nickels said in a statement that the lack of support for outpatient care provided by hospitals “does not reflect the reality of how hospitals strive to serve the needs of their communities.”

Nickels also called it “unreasonable and troubling” that the CMS does not plan to continue paying hospitals their current rates if they relocate or rebuild outpatient facilities. “Taken together, it appears that CMS is aiming to freeze the progress of hospital-based health care in its tracks,” Nickels said.

The draft rule does include exceptions for dedicated off-campus emergency departments. The CMS notes in its news release that the higher payments received by hospital-owned facilities are a long-standing concern among the Medicare Payment Advisory Commission, HHS’ Office of Inspector General and lawmakers. Many policy experts believe hospitals are acquiring physician offices at a rapid clip because of the higher rates.

America’s Essential Hospitals, a trade group that represents safety net providers, said the CMS “appeared to ignore Congress’ intent” to use a different payment system for new hospital-owned outpatient facilities. “Hospital systems that otherwise would seek to enhance access by establishing new clinics in underserved areas will not do so, as this damaging payment policy makes new outpatient centers economically unsustainable,” the organization said in a statement.

The 764-page proposal also includes changes to the Medicare incentive program for hospitals’ use of electronic health records, including allowing hospitals to use any 90-day period in 2016 to attest that they’ve met the requirements.

Filed under: General Problems | Leave a Comment »

Long-acting opioid therapy linked to increased mortality risk

http://www.clinicaladvisor.com/pain-information-center/increased-mortality-risk-with-long-acting-opioid-therapy/article/507694/

Prescription of long-acting opioid medications for chronic, noncancer pain is associated with an increased risk of all-cause mortality when compared to alternative medications, according to research published in JAMA.

Wayne A. Ray, PhD, Vanderbilt University School of Medicine, Nashville, and colleagues conducted a retrospective cohort study of Tennessee Medicaid patients with chronic, noncancer pain between 1999 and 2012. Patients had received either long-acting opioid therapy or comparable therapy with either an analgesic anticonvulsant or low-dose cyclic antidepressant. Patients had not received palliative or end-of-life care.

The researchers found 22,912 new episodes of prescribed therapy for both long-acting opioids and control medications; 185 deaths were recorded in the long-acting opioid group, compared to 87 deaths recorded in the control group. Data analysis showed that patients who were prescribed long-acting opioid therapy had a 1.6 times greater risk of all-cause mortality and a 1.9 times greater risk of out-of-hospital death.

“More than two-thirds of the excess deaths were due to causes other than unintentional overdose; of these, more than one-half were cardiovascular deaths,” noted Dr Ray. “These findings should be considered when evaluating harms and benefits of treatment.”

Filed under: General Problems | 9 Comments »

McDonald’s Management Responds to Lawsuit

http://www.nwahomepage.com/news/mcdonalds-management-responds-to-lawsuit

A company that manages a Bentonville McDonald’s responded on Wednesday to accusations it fired an employee for being HIV positive.

According to a lawsuit filled by the U.S. Equal Employement Opportunity Commision, the restaurant violated federal law by firing the employee for having HIV, and it also violated the Americans with Disabilities Act by maintaining a policy of requiring all employees to report the use of prescription medication.

Filed under: General Problems | Leave a Comment »

We are all aware of the push to try and get Naloxone (Narcan) into as many pockets as possible. And who has the most a need for Naloxone… substance abusers… and as of 1917 our court system decided that the mental health disease of addictive personality disorder is going forward a CRIME.

So what happens if the DEA gets a hold of wholesaler records of what pharmacies are purchasing above average units of Naloxone and/or gets insurance records of what pharmacies and/or which prescribers has been writing or selling Naloxone.

Could that information be used to suggest that the prescriber or pharmacies is prescribing and/or selling Naloxone to people that the Pharmacist and/or prescriber had concerns that the pt was “abusing” their opiates.

So the DEA could come to the conclusion that the Pharmacist or Doctor is writing/filling Rxs for pts that don’t have a legit medical need.. and thus breaking the law.

Given previous actions of the DEA .. all they need is the OPINION that one or two pts are not legit for them to raid a doc’s practice and/or pharmacy.

All that talk about “doing good” and helping save lives of those suffering from addiction… could it be just “bait on a hook ” ?

We probably won’t see any action out of the DEA on this issue until all the states has put regulations in place for Naloxone to be OTC… which may be another year or two.

Filed under: General Problems | Leave a Comment »

Overcoming Obstacles to Medication Error Reporting

http://www.pharmacytimes.com/contributor/alan-polnariev-pharmd-ms-cgp/2016/07/overcoming-obstacles-to-medication-error-reporting

Filed under: General Problems | Leave a Comment »

Two reports offer different numbers for drug deaths in Pennsylvania

http://www.readingeagle.com/news/article/two-reports-offer-different-numbers-for-drug-deaths-in-pennsylvania&template=mobileart

Glaring differences between two high-profile reports on how many people died from drug overdoses in Pennsylvania in 2014 have called into question the reliability of numbers given to the public on the toll of the heroin and opioid drug crisis.

The reports were produced by the Pennsylvania State Coroners Association and the federal Drug Enforcement Administration. The coroners association report lists 2014 drug death totals for Lehigh, Chester and Lebanon counties as 85, 82 and 15, while the federal report lists the totals as 66, 36 and 11, respectively.

The reports show large discrepancies involving many other counties, as well. Both got media coverage across the state.”I think it’s important to get the numbers right,” said Frances Cortez Funk, director of health promotion and alcohol and other drug services at Kutztown University. “The numbers are important because every number represents a life.”

Berks County Coroner Denny Hess said drug death numbers generated by coroners have changed as they pass through the state Department of Drug and Alcohol Programs, which has served as a resource for the DEA.

He said he had no indication the changes were intentional, but they made the information inaccurate.”Ours are real numbers,” he said. “Nobody is looking at the state and saying, ‘Why are they changing those numbers?’ “Hess’ office sends reports on drug deaths to DDAP and the state coroners association. The association’s legislative liaison, Susan Shanaman, said she has found inaccuracies in a DDAP spreadsheet on statewide drug deaths.”I have found discrepancies in the numbers, where I know the data has been sent to both DDAP and myself. I don’t have an explanation for why DDAP’s numbers are fewer,” Shanaman said.DDAP spokesman Jason Snyder said any assertion the department gave out information significantly different from what it had collected was “unequivocally false.”He said human error may have produced a few mistakes in a spreadsheet, but it would not explain the “sweeping discrepancies” between the two reports.”What comes in to DDAP goes out, just as it came in,” Snyder said.He stressed the importance of accurate data.”There is no question about that. We do need to come up with a way where we are sure what we are looking at is accurate,” Snyder said. “This is something on a lot of people’s radar screens.”But he said questions about the accuracy of two reports should be put to the organizations that produced them.On Wednesday afternoon, the author of the DEA report, Laura Hendrick, said in a telephone interview that DEA’s source material for its 2014 report included a spreadsheet from DDAP. She said it was understood that the spreadsheet was “not complete” because it did not include information from some counties.DEA will issue revisions to some of its 2014 numbers when it issues the 2015 report, Hendrick said. All of the revisions will be increases in county totals.State Rep. Gen Yaw, a Lycoming County Republican who has gone around the state for hearings about the heroin crisis, said he heard of differences between the reports and then learned that the DEA had changed its 2014 numbers.He said he believed the 2014 coroners association report was the more accurate of the two.But Shanaman, who compiled the association report, acknowledged it had at least one inaccuracy.The single largest county discrepancy involved Bucks, for which the coroners’ association reported 205 deaths and the DEA 113 deaths. In that case, Shanaman said her Bucks drug death tally included many fatalities where drugs were present but did not actually cause the death.”Bucks is the only one I did that on,” she said.Coroners are not required by law to report drug deaths. Some coroners – especially those in counties with very few deaths – worry that sharing data on them might lead to identities becoming known, against families’ wishes.Hendrick, who is the highest ranking intelligence officer in DEA’s Philadelphia Field Division, said the original sources for all the data in both reports are county coroners.In some cases, the DEA has issued subpoenas to obtain information from coroners, she said. The lack of mandatory reporting has hampered efforts to get good data.”We have struggled for years to get this information,” she said.At the same time, she said, the type of training and experience of each coroner may affect how they classify deaths. And they have latitude in deciding which deaths to report.”There is a lot of leeway,” she said.Yaw has floated a concept for strengthening the drug death reporting system with other lawmakers.He said, “We need accurate reporting.”Chuck Kiessling, Lycoming County coroner and president of the association, said it was vital to have accurate information. The number of deaths, he said, gives the public a “gauge” to measure the drug crisis.Shanaman said she believed coroners should remain the primary conduits for information.She described them as “the guys and gals who are there and who are seeing the bodies and seeing the deaths up close and personal.”

Filed under: General Problems | 2 Comments »

What part of our corrupt Washington DC system are we have trouble understanding ?

When does “extremely careless ” crosses the line into intentional deceitful behavior ?

Filed under: General Problems | 4 Comments »

DEA takes Utah to federal court for access to prescription drug database

http://fox13now.com/2016/07/06/dea-takes-utah-to-federal-court-for-access-to-prescription-drug-database/

The question that has to be asked is why isn’t the OFFICE OF CIVIL RIGHTS… which is part of the Dept of Education.. not defending HIPAA when the DEA is out to violate PHI (Personal Health Information) of Utah’s Prescription Monitoring Program ? Could it be.. as some has suggested that the whole Washington DC system is CORRUPT ?

SALT LAKE CITY — The Drug Enforcement Administration is asking a federal judge to enforce subpoenas served on Utah’s Department of Commerce seeking access to the state’s prescription drug database.

In court papers obtained by FOX 13, it appears the state of Utah is resisting the DEA’s attempts.

The DEA revealed in a declaration it is investigating a “licensed medical professional” in the Salt Lake City area. The court filings do not reveal who is under investigation, but the federal agency claims that person has been prescribing a lot of pills to people who turn around and sell them. The DEA claims those people are members of a “criminal organization” with overseas ties.

As part of its investigation into that physician, the DEA served administrative subpoenas on Utah’s Department of Commerce and the Utah Division of Professional Licensing for access to the controlled substance database. The state of Utah has apparently refused to grant federal agents access.

Utah Department of Commerce Executive Director Francine Giani declined to comment to FOX 13 on the subpoenas, referring the matter to the Utah Attorney General’s Office. It also declined to comment, but is expected to reply in court filings by next month.

Access to the controlled substance database recently required a warrant after state lawmakers changed the rules. It followed an incident where Unified Fire Authority firefighters found their records accessed by police looking into missing medications.

Greg Skordas, a criminal defense attorney who represented an accused firefighter in that case, said the problem with the DEA request is it involves more than the specific doctor — it would drag in patients, too.

“Administrative subpoenas are issued based on a very low standard. They’re really just investigative,” he said. “Whereas a warrant requires a higher level of what we call probable cause. You have to go to a judge and say, ‘I have probable cause to believe the information is where I’m looking,’ where an investigative subpoena you go to a judge and say, ‘I’m curious.'”

Skordas said the DEA has tried this same tactic in other states, and said the battle between subpoena and warrant may go beyond federal court in Salt Lake City to appellate level courts to weigh in.

“It’s all going to come to a head probably with the United States Supreme Court or with the circuit courts,” he said.

Filed under: General Problems | 5 Comments »

17 Heroin Overdoses, 1 Death: Could Happen Anywhere Says DEA Agent

detroit.cbslocal.com/2016/07/06/17-heroin-overdoes-1-death-could-happen-anywhere-says-dea-agent/

THREE TIMES  the Heroin user in abt 10 yrs and FIVE TIMES the Heroin related deaths in abt 15 yrs.  Wonder why that is.. the DEA is not doing their job of preventing drugs from crossing the boarder ? Heroin is now the least expensive opiates ? All too many chronic pain pts have been denied their needed pain medication by prescriber and has turned to “the street” in an effort to help address their unrelenting pain. Remember the chemical name of Heroin is ACETYLMORPHINE… which metabolizes into MORPHINE in the body… it is about 2-3 times mg/mg stronger than Morphine. Still FRACTION OF  PEOPLE die every year from opiate overdoses than die from the use/abuse of the drug drugs ALCOHOL & NICOTINE !

The city of Akron, Ohio, is reeling with a rash of heroin overdoses within a 24-hour span.

Special Agent Rich Issacson with the DEA’s Detroit field division isn’t surprised.

“It’s a huge problem in Akron, Ohio but it’s also a huge problem across the United States,” said Issacson. “There is not a community in southeast Michigan that hasn’t been hit hard by the opiate abuse problems, that’s including pain killers, like hydrcodone and oxycodone products as well as heroin.”

Issacson says word of the deaths probably won’t scare a lot of people into rehab.

“On occasion when there’s talk of heroin overdose deaths – or a series of heroin overdose deaths; sometimes as counter-intuitive as it sounds – that actually sounds attractive to a heroin addict because they know that if that heroin caused the death of another user, that must have been pretty strong heroin,” Issacson said.

Police in Ohio say the calls began around 1 p.m. and continued through the afternoon and evening and three of the victims include a mother and her two daughters.

The Summit County Medical Examiner’s Office says a 44-year-old man died of a suspected overdose and an autopsy is set for Wednesday.

Edwards says 55 people have died from heroin overdoses in the city this year.

Heroin use has reached the highest level in 20 years in the United States, according to a recent global drug report that calls the trend “alarming.”

The UN Office on Drugs and Crime released its World Drug Report last month, which said heroin is the deadliest drug worldwide, and said its increasing use in the U.S. is of particular concern.

There were about one million heroin users in the U.S. as of 2014, almost three times the number in 2003. Deaths related to heroin use have increased five-fold since 2000.

There are an estimated one million heroin users in the U.S. as of 2014 … three times the number of a decade before.

Filed under: General Problems | 3 Comments »

https://www.washingtonpost.com/national/health-science/pfizer-agrees-to-truth-in-opioid-marketing/2016/07/05/784223cc-42c6-11e6-88d0-6adee48be8bc_story.html

This is just a slippery slope for everyone.. the judicial system has gotten Pfizer to admit that they are against off-label use… which it is estimated that 1:5 outpatient Rxs are written for off-label.  Yet one of Pfizer’s products  (methylprednisolone)  is routinely use in off-label Epidural Spinal Injections. What happens if insurance companies start refusing to pay for any Rxs that are prescribed off-label ?

The reason that there is no studies on the long term use of opiates is that opiates were commercially available before the FDA and all their need for clinical trials and they were “grandfathered” as a FDA approved medication. Since no manufacturer would be granted a patent – and high price – on a opiate… no one was going to invest the money to prove the long term use/benefit. anecdotal evidence based on pt feedback, does not meet the FDA’s criteria for double blind studies.  Thus there is no “studies” that prove that opiates are beneficial for the long term treatment of pain.

http://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

https://www.pennlawreview.com/debates/index.php?id=50

Off-label promotion�pharmaceutical manufacturers� marketing of FDA-approved drugs for unapproved uses�is considered a First Amendment right by some, a threat to the safety and effectiveness of pharmaceutical drugs by others.

Pfizer, the world’s second- ­largest drug company, has agreed to a written code of conduct for the marketing of opioids that some officials hope will set a standard for manufacturers of narcotics and help curb the use of the addictive painkillers.

Though Pfizer does not sell many opioids compared with other industry leaders, its action sets it apart from companies that have been accused of fueling an epidemic of opioid misuse through aggressive marketing of their products.

Pfizer has agreed to disclose in its promotional material that narcotic painkillers carry serious risk of addiction — even when used properly — and promised not to promote opioids for unapproved, “off-label” uses such as long-term back pain. The company also will acknowledge there is no good research on opioids’ effectiveness beyond 12 weeks.

The terms of the agreement were reached with the city of Chicago, which two years ago sued five other opioid manufacturers over alleged misleading marketing of opioids. An announcement of the agreement is expected Wednesday. Pfizer has also been aiding the city’s investigation and lawsuit.

Stephen R. Patton, Chicago’s corporation counsel, called Pfizer “a company that has agreed to embrace what we think are the common-sense proscriptions that we are seeking as part of our lawsuit. We hope that this trailblazing agreement . . . will set the bar for others in this industry.”

But Adriane Fugh-Berman, an associate professor of pharmacology and physiology at Georgetown University School of Medicine, and director of Pharmed Out, which advocates rational prescribing practices, said she saw limited value in the agreement.

“Maybe it’s a first step, but I think counting on pharmaceutical companies to get us out of this opioid mess is not likely to be successful,” she said.

Aggressive, sometimes fraudulent marketing of OxyContin by Purdue Pharma, one of the targets of Chicago’s lawsuit, is widely blamed for the rapid growth of painkiller use across the United States. Around the turn of the century, the company mounted an aggressive campaign, initially claiming that the long-acting formulation reduced the risk of abuse and addiction.

The company swarmed primary care physicians, who had little expertise in pain management, in their offices and at ­company-sponsored conferences, at a time when the medical profession was concerned that it was not treating pain aggressively enough. Subsequent research has shown that the effort helped achieve stunning growth in the use of the painkiller, which was developed for severe pain after surgery and end-of-life care.

In 2007, Purdue pleaded guilty to criminal charges of misleading physicians, regulators and the public about the drug’s addictive qualities.

In its lawsuit, Chicago contends that in 2009, about 1,100 emergency room visits were the result of opioid misuse or overdose. The city also said it paid out $12.3 million in insurance claims for painkiller prescriptions between 2008 and 2015.

This year, the federal government has redoubled its efforts to address the crisis. The CDC released new guidelines that call on doctors to sharply curtail the use of narcotic painkillers. The Food and Drug Administration required that its strongest warning on immediate-release opioids include information about misuse, abuse, addiction, overdose, death and risk of neonatal withdrawal syndrome. The House and Senate each have approved bills that address the drug crisis.

Other cities and states, including Santa Clara and Orange counties in California and the state of West Virginia, have also sued pharmaceutical manufacturers and distributors for stoking the opiate epidemic.

New York City-based Pfizer actively promotes only one opioid painkiller, Embeda, which it acquired when it bought King Pharmaceuticals in 2011. A spokeswoman said she had no separate total for its sales, but a first- ­quarter report for 2016 shows that it is part of an “other” category of drugs that brought in $171 million worldwide.

Purdue’s blockbuster OxyContin, by contrast, produced $3.1 billion in revenue in 2010. So many opioids are sold, however, that the drug has never made up a large share of the opioid analgesic market. Last year it accounted for just 2 percent of the market, according to the company.

Pharmaceutical and biotechnology companies adhere to voluntary standards last updated in 2009 by their trade association, the Pharmaceutical Research and Manufacturers of America.

Filed under: General Problems | Leave a Comment »