When they say that it’s NOT a fishing expeditions… it probably is !

fishing

Law enforcement access to CT drug monitoring data raises privacy concern

http://ctmirror.org/2015/08/13/law-enforcement-access-to-drug-monitoring-program-raises-privacy-concerns/

Washington — Connecticut’s Prescription Monitoring Program aims to stop the misuse of opioids and other dangerous drugs and save lives. But some are concerned these programs have given law enforcement officers access to private information about prescription drugs in your medicine cabinet.

Like many states, Connecticut has placed strict limits on the access law enforcement officers have to the database created by the monitoring program. Connecticut is also one of several states to give the federal Drug Enforcement Administration (DEA) access to the information.

DEA spokeswoman Barbara Carreno said her agency can only tap the program’s database “with a bona fide complaint investigation — no fishing expeditions.”

That means DEA agents and other law enforcement officers can only tap the database if they show evidence of an ongoing investigation and must limit searches to people linked to that investigation. But they need no warrant.

“The (prescription monitoring program) is one of many tools we use, but it is an effective one that saves time and resources,” Carreno said.

To Dan Barrett, legal director of the Connecticut American Civil Liberties Union, the establishment of drug monitoring programs like the one in Connecticut aimed at helping doctors treat their patients, has had an unintended consequence; they have become another weapon in the war on drugs.

“It was built for one purpose and used for another,” Barrett said. “It should not be a system where the computer is telling the police there is something going on with a patient.”

Several states, including Vermont, bar all law enforcement agencies from access to information collected in their drug monitoring programs.

Purpose of the database

Connecticut’s Prescription Monitoring Program, run by the state Department of Consumer Protection, was established in 2008 to give doctors a complete picture of a patient’s controlled substance use, including prescriptions by other providers, so that the physician can properly manage the patient’s treatment.

The latest change in the program will be implemented on Oct. 1, when Connecticut doctors will be required to check the database if prescribing more than a 72-hour supply of a drug listed on Schedule II through Schedule V of the federal controlled substance law. Those drugs include stimulants like amphetamines, anabolic steroids, opioids and other narcotics.

The monitoring program also tries to stop addicted patients from “doctor shopping” to obtain the drugs they want and to help doctors identify patients who need help for their drug abuse and addiction.

Prescription drug monitoring programs, now in nearly every state, also aim to shut down “pill mills” — medical practitioners who overprescribe — and ferret out “drug diversion,” the practice of transferring a legally prescribed drug to another person for illicit use.

Every week, at a minimum, Connecticut-licensed pharmacies are required to enter information about prescriptions they have filled for those Schedule II through Schedule V drugs into the database of the web-based system to provide patient information to doctors and pharmacists.

As far as law enforcement, John Gadea, Jr., director of the consumer protection department’s drug control division, said the state limits access to the database to officers involved in ongoing criminal investigations, mostly those in police narcotics and detective units.

To be granted access to the drug monitoring program information, these police officers must be recommended or authorized in writing by superiors and receive special training, Gadea said.

All requests for access by police must include an open, active case number. Those authorized to tap the system gain access through their computers with a special password.

Gadea said police should use the database to help speed up an investigation, but the legal record is still the prescription presented to a pharmacist.

“The (database) should never be used as probable cause for an arrest warrant,” he said.

But, Jay Ruane, president-elect of the Connecticut Criminal Defense Lawyers Association, said information culled by police from the database often leads to an arrest.

“It’s step one in a multi-step process,” Ruane said, one that is often followed by a search warrant for an individual’s home.

“The intention of the prescription drug monitoring program was good, but now it’s just a tool of law enforcement,” he said. “We often pass legislation without considering the consequences.”

But the pressure to stop prescription drug abuse is great.

Connecticut has been swept up in the nationwide increase in opioid addiction, which has led to a resurgence in the popularity of heroin.

The Connecticut Hospital Association says there were nearly 1,900 visits to emergency rooms in Connecticut last year related to opioid overdose, a 50 percent increase over 2011.

The association says nearly 500 people died from drug overdoses in Connecticut in 2013, about half from heroin overdoses and the rest from oxycodone, morphine and other prescription drugs.

In the dark

Tom Clark, clearinghouse manager at the Prescription Monitoring Program Center of Excellence at Brandeis University, said there’s a tradeoff between privacy and public health when it comes to drug monitoring programs.

“We’d be completely in the dark about prescription drug abuse without these programs,” he said.

Clark said most states have strict limits on law enforcement access to monitoring information.

“There are certain concerns about law enforcement access, but on the other hand, the information is extremely valuable in expediting investigations,” he said.

Clark cites a Brandeis study that showed the prescription drug monitoring program in Kentucky resulted in quicker identification of drug diversion cases that warranted investigation and gave law enforcement officials important new sources of evidence.

“This permitted work on many more cases than was possible prior to the PMP, and achieved a high rate of conviction,” the Brandeis report said.

Meanwhile, the ACLU has successfully sued the DEA over its access to information in Oregon’s drug monitoring program. The organization represented two transgender men taking prescription testosterone, a person taking anti-anxiety medication for post-traumatic stress disorders, and a person taking narcotic painkillers to help treat recurring kidney stones.

The ACLU said its clients consider their prescription information to be extremely sensitive, and were concerned that their privacy would be violated by the DEA’s access to their medical records.

A federal District Court judge agreed, ruling last year that patients have a reasonable expectation of privacy in their drug prescription records, and that law enforcement must obtain a warrant in order to search such information.

The DEA has appealed the decision to the U.S. Court of Appeals for the 9th Circuit.

Do we need to ask this question ?

Do we need a BIGGER GOVERNMENT to enforce all our laws or FEWER LAWS so that they can be enforced by the existing – or smaller government ?

Dear Steve,

Fill out this survey to tell us what kind of legal cannabis market you want!   Thanks again for taking the survey and passing it around.

There is a Chinese proverb about living in interesting times, we certainly do know these are interesting times.

You may already know that several groups have developed citizens’ initiatives. That is, they have filed petition language with the Secretary of Elections and have begun the daunting process of collecting nearly one million petitions from registered voters in Florida.

If you followed our Twitter or Florida Decides posts, you know several members of the FLCAN staff recently traveled to Colorado to experience the adult market. Colorado is very different from Florida. The state removed criminal penalties for cannabis possession in 1978 – no one went to jail for cannabis before legalization! The officials we met told us they spend every penny of the tax revenue to regulate the market.

For several months, attorneys have poured over previous amendments, Supreme Court decisions and other state initiatives. We’ve come to believe – when it comes to the Constitution – less is more.

Now, we want to know what you think. Here is a questionnaire to help us understand what type of cannabis market you expect to get. Don’t keep this questionnaire to yourself. Spread it around. More information is better as we decide exactly how to use Florida CAN resources to create the quickest path to a regulated market.

Watch for our next newsletter where you will find a Florida initiative round-up.

Thanks again for taking the survey and passing it around.

Yours until victory,

Jodi James

Bondi will stand up to some Federal Agencies.. others just gets in lock-step ?

pambondi

Bondi, 16 other AG’s sue EPA over rejection of air quality plans

http://protectingyourpocket.blog.palmbeachpost.com/2015/08/11/bondi-16-other-ags-sue-epa-over-rejection-of-air-qualilty-plans/

Florida Attorney General Pam Bondi is leading 16 other attorneys general in a legal action against the U.S. Environmental Protection Agency for illegally invalidating the individual air quality protection plans in those states.

In June, the EPA issued a final rule requiring 35 states, including Florida, to revise their individual State Implementation Plans governing carbon emissions during power plant Startup, Shutdown or Malfunction.

“We will not step aside while the EPA, through heavy-handed federal overreach, threatens to upend a system that the EPA has approved multiple times and has provided a consistent, reliable framework to safely provide electricity to millions of Floridians across the state; furthermore, the agency’s action could result in higher utility bills for Florida consumers,” Bondi said.

To view the petition click here.

The Clean Air Act establishes a cooperative-federalism approach to regulating the nation’s air quality and dictates that EPA has the primary responsibility to identify air pollutants that pose a threat to public health and to set national air quality standards; however, the Act gives states the primary responsibility to determine how to achieve those standards.

For decades, states have ensured compliance with the standards set for power plant startup, shutdown or malfunction through their individual State Implementation Plans. The adoption and adherence to Florida’s plan has helped to tremendously and measurably improve the state’s air quality.

The EPA’s final rule illegally requiring the states to change their previously approved plans, came after the agency agreed to settle a lawsuit. The EPA’s imprudent rush to settle the matter has led the agency to adopt an illegal final rule that is in conflict with the Clean Air Act and imposes on Florida’s right to determine the most effective strategy for achieving air quality standards, Bondi said.

Today,  Bondi filed the petition for review in the United States Court of Appeals for the District of Columbia Circuit asking the Court to review the EPA’s final rule. Besides the clear violation of state’s rights enumerated in the Clean Air Act, the final rule also stands to stall or reverse progress the plaintiffs have made in improving the quality of the air in their state.

The computer tells me .. NOT TO FILL IT ?

How in the hell did APPRISS,INC get permission to access the various PMP – PRIVATE HEALTH INFORMATION – without the pt’s permission ? They  have to have access to be able to assign some arbitrary numeral figure as to the appropriateness of a pt’s pain therapy.. ??? 

Appriss Inc., a leading technology provider for risk assessment and analytics in public safety and healthcare, announced that The Kroger Co. has introduced NARxCHECK™ into over 200 stores in Ohio, West Virginia, and Arizona in an effort to improve patient safety and combat prescription drug abuse.

NARxCHECK™ (http://www.appriss.com/narxcheck.html), is an analytics engine that provides real-time clinical decision support to physicians and pharmacists when making prescribing and dispensing decisions around controlled substances. The program provides three key components for prescribers and dispensers: a patient score, an interactive graph depicting the usage pattern of drugs, and detailed analytics about controlled substance prescriptions filled by the patient. The NARxCHECK™ algorithm assesses a patient’s controlled substance history from state prescription monitoring programs, computes a score and highlights potential issues with overuse or abuse of narcotics, sedatives and stimulants.

The NARxCHECK™ system assigns a numerical score that is derived by analyzing the patient’s prescription patterns.

Lower scores improve doctors’ and pharmacists’ confidence that the patient may not have any controlled substance usage concerns. More elevated scores cue the doctors and pharmacists to carefully consider the patient’s controlled substance usage.

“We are thrilled to be working with Kroger in their Ohio, West Virginia and Arizona pharmacies and look forward to expanding into additional stores,” said Krishnan Sastry, Executive Vice President at Appriss, Inc. “We look forward to helping thousands of pharmacists in The Kroger Company to leverage our analytics to effectively and efficiently identify potential over-prescribing issues with opioids and improve patient safety.”

“Our Kroger pharmacists can now easily identify patients for whom controlled substance usage is unusually high and address overuse or abuse concerns without the need to log into different websites for historical data,” said Mike Menkhaus, a manager on the pharmacy system development team at Kroger. “The NARxCHECK™ scoring system and immediate access to prescription monitoring program data right within the pharmacist workflow put the best tools available in the hands of our pharmacists to ensure the safety of our patients and to comply with state regulations.”

About Appriss

Appriss provides data-driven solutions to fulfill our mission of keeping communities safe and informed. Partnering with public safety, healthcare, and leading private and public companies, Appriss delivers solutions that prevent fraud, mitigate risk, fight crime, ensure compliance, increase public safety and save lives. Appriss’ solutions are always backed by excellent customer support with technical agents in the US that are available to help 24x7x365.

For more information, visit www.appriss.com (http://www.appriss.com).

Drug Enforcement Administration obtaining and review medical records, without a warrant ?

deathief

DEA medical record case could impact use of telemedicine to prescribe meds

http://www.fiercehealthit.com/story/dea-medical-record-case-could-impact-use-telemedicine-prescribe-meds/2015-08-12

A case pending in the Fifth Circuit Court of Appeals may have an impact on providers who use telemedicine to prescribe controlled substances.

The case, United States v. Zadeh, centers on whether the Drug Enforcement Administration can obtain and review medical records, without a warrant, through administrative subpoenas to find out if a provider violated prescribing laws for controlled substances, according to an article at Health Care Law Today.

In the case, the DEA is looking to obtain medical records for the patients of Texan physician Joseph Zadeh, write Nathaniel Lacktman and Blake Taelman, of Foley & Lardner LLP.

Zadeh appealed a ruling by the Texas District Court that said the DEA could obtain the records without a warrant. The physician said the ruling will impact patients’ willingness to share information with their provider, which also could hinder information exchange.

Patients are becoming more willing to share their health information, but only for good reasons such as care improvement and research, according to a study in the Annals of Internal Medicine.

“If the Fifth Circuit rules in favor of the DEA, the DEA might issue similar administrative subpoenas with greater frequency,” Lacktman and Taelman write, adding that telemedicine prescribers should keep their eyes on the case.

Telemedicine has seen its share of troubles in the industry.

A recent report by the Center for Connected Health Policy found that while 48 states and the District of Columbia all have definitions of telehealth or telemedicine written into law or their Medicaid program, differences in those definitions are creating “confusing environments” for end users.

In addition, patients are wary of the technology, and many would be less likely to use telemedicine services compared to an in-person visit with a physician, a study by TechnologyAdvice Research found.

To learn more:
– here’s the article

Regulation violations, med errors… pts harmed ?

State boosts pharmacy checks, uncovers more reg violations

http://www.bostonherald.com/news_opinion/local_coverage/2015/08/state_boosts_pharmacy_checks_uncovers_more_reg_violations

State regulators stepped up pharmacy inspections and found more violations in the year that followed a nationwide meningitis outbreak stemming from tainted drugs, according to a new state report.

Regulators have inspected more than 900 pharmacies since February 2014, according to the recent report by the Board of Registration in Pharmacy.

But a large portion of the inspections were done at retail chain and independent community pharmacies, not compounding pharmacies like the one responsible for the outbreak, according to the report which details complaints, investigations and disciplinary actions taken by the board between Dec. 1, 2013, to Dec. 1, 2014.

The pharmacy regulators reported:

•  Inspectors doubled the number of retail pharmacy checks last year, which 
officials reported was due in part to contracting of additional investigators in late 2013.

•   The number of pharmacy investigations pending, closed or done in conjunction with outside agencies jumped from 482 in 2013 to 616 last year.

• Cases resulting in disciplinary action increased by 45 percent — rising from 51 to 74 cases over the one-year period.

Complaints that were investigated included:

• Failure to fill prescriptions properly.

•  Drug violations such as improper use or distribution by pharmacists.

• Confidentiality violations.

• Failure to report drug reactions or improper dosages.

The report, posted on the agency’s website last month and filed with the House Clerk last week, highlighted changes the state pharmacy board made in the wake of the 2012 meningitis outbreak, including updated guidelines for investigations and handling evidence and a new weekly critical incident report.

A Herald review in April found the state was inspecting most compounding pharmacies only about once a year and several hadn’t been inspected in more than 12 months — despite calls for more random spot checks after the meningitis scare.

The Herald also found DPH regulations don’t require all compounders to use the most rigorous tests for contamination risks of bacteria and fungus.

Fungal-tainted steroid injections mixed at the now-closed New England Compounding Center in Framingham were responsible for a meningitis outbreak that killed 64 and sickened 751 nationwide.

In Massachusetts, only “high-risk” compounders mixing non-sterile ingredients are required to conduct the maximum level of testing, despite the fact that the majority of compounding pharmacies in the state are classified as low- or 
medium-risk facilities.

An agency spokesman had no immediate comment on the report or whether the board is considering tightening regulations or increasing inspections of compounders.

When you dig down “into the weeds”.. amazing what you can find ?

A CVS Pharmacist Stood in the Way of My Abortion — And the Law Says That’s OK

http://www.cosmopolitan.com/politics/news/a44409/cvs-pharmacist-stood-in-the-way-of-my-abortion/

You can read this whole long article about CVS Pharmacist denial of care..  What struck me as odd/funny/ironic.. is from the paragraph below.. abt 50% of the population is female 115 million and maybe 50% are of child bearing age – 57 million… abt 50 % of the number of chronic pain pts in this country and the ACLU has a Reproductive Freedom Project. I checked the ACLU website and there has been only one action since 2009 involving chronic pain and that was when Indiana tried to mandate urine testing..  Is it just me… a 116 million chronic pain pts.. a protected class under the ADA … but to have a whole frigging group/dept to deal with half as many women over reproductive rights… and the last time I looked … most women of reproductive age.. are not a protected class..  Maybe the ACLU also has a fear of the DEA… they seem willingly to deal with the major pharmacy chains over female reproductive issues..

Brigitte Amiri, a senior staff attorney from the ACLU’s Reproductive Freedom Project, works directly with major chain drugstores to come up with corporate policies relating to women’s reproductive rights. Amiri’s goal is to make sure prescriptions for birth control, emergency contraception, drugs used for miscarriage management, et al. are handled as efficiently as other prescriptions without imposing any burden on the customer. When I spoke with her, she was cautiously optimistic about these stores’ willingness to ensure that their customers are provided with timely and seamless care, saying, “The good news is, when we’ve gone to the headquarters of Walmart, Target, Walgreens, or CVS and said, ‘This has been a problem for your consumers,’ they’ve taken it very seriously.” When confronted, these chain stores have been quick to recognize problems, express desire to fix them, and even launch investigations or submit formal written apologies to consumers who have been denied prescriptions (or over-the-counter contraception, like Plan B.)

Book smarts vs age/experience/wisdom ?

<

An old geezer became very bored in retirement and decided to open a medical clinic.
His sign read: “Dr.Geezer’s clinic. Get your treatment for $500, if not cured,  get back $1,000.” 
Doctor “Young,” who was positive that this old geezer didn’t know beans about medicine,
thought this would be a great opportunity to get $1,000. So he went to Dr.Geezer’s clinic.

 Dr. Young: “Dr.Geezer, I have lost all taste in my mouth. Can you please help me ??”  

Dr. Geezer: “Nurse, please bring medicine from box 22 and put 3 drops in Dr. Young’s mouth.”  

Dr. Young: Aaagh !! — “This is Gasoline!”  

Dr. Geezer: “Congratulations! You’ve got your taste back.That will be $500.”  

Dr. Young gets annoyed and goes back after a couple of days figuring to recover his money. 

Dr. Young: “I have lost my memory, I cannot remember anything.” 

Dr. Geezer: “Nurse, please bring medicine from box 22 and put 3 drops in the patient’s mouth.” 

Dr. Young:  “Oh, no you don’t,  — that is Gasoline!” Dr. Geezer: “Congratulations! You’ve got your memory back.  That will be $500.”

Dr. Young (after having lost $1000) leaves angrily and comes back after several more days.   Dr. Young: “My eyesight has become weak —  I can hardly see anything !!!!

Dr. Geezer: “Well, I don’t have any medicine for that so, ” Here’s your$1000 back.” (giving him a $10 bill)

Dr. Young: “But this is only $10!
Dr. Geezer: “Congratulations! You got your vision back!  That will be $500.”
Moral of story  —  Just because you’re “Young” doesn’t mean that you can outsmart an “old Geezer”

Is it time for Senator Schumer to retire ?

Sen. Schumer demands funds restored for war on drugs

http://longisland.news12.com/news/sen-charles-schumer-demands-money-be-restored-to-dea-atf-and-u-s-marshals-to-combat-war-against-d-1.10729074

Schumer is demanding $154 million be restored to the budgets of the DEA, ATF, and U.S. Marshals. (1:18 PM)

 WOODBURY – Sen. Charles Schumer was on Long Island today demanding funds be restored for the war against drugs.

Schumer is demanding $154 million be restored to the budgets of the DEA, ATF, and U.S. Marshals.

“If we ease up on them now, especially knowing that El Chapo is still on the loose, it could spell real trouble for Long Island, and for all of New York,” he said. “So, I am urging my colleagues in Congress to restore these critical cuts, and undo a wrong-headed DEA special agent hiring freeze that will impact Long Island.”

READ MORE: Long Island Politics

Suffolk County District Attorney Tom Spota also asked for federal support to stop the flow of heroin and meth to Long Island.

Stay with News 12 for more on this story.

When you are in charge of paying the bills.. can you dictate what care is provided ?

toobigbritchcvs

CVS isn’t stopping with PCSK9 discount demands. It wants concessions from ACC/AHA, too

http://www.fiercepharma.com/story/cvs-isnt-stopping-pcsk9-discount-demands-it-wants-concessions-accaha-too/2015-08-11

CVS Health ($CVS) has no intention of shelling out more than it has to on the new PCSK9 drugs. It’s been saying so for more than a year–and now, it has taken a double-barreled shot at the next-gen cholesterol fighters.

Following up on a gloomy Journal of the American Medical Association (JAMA) report last year, CVS execs have published a new manifesto, calling on the American College of Cardiology and the American Heart Association to revamp their cholesterol-treatment guidelines. The 2013 treatment advice tossed out numerical targets for “bad” LDL cholesterol, in favor of a more qualitative assessment of heart risks.

CVS wants them to change right back. And it fully admits its selfish reasons: Without the numerical targets, doctors would have more leeway to prescribe pricey new PCSK9s rather than the vastly cheaper, largely generic statins that have been standard treatments for decades now.

And that, of course, could frustrate CVS’ attempts to control access to the new class. “As we work to encourage cost-effective use of these new cholesterol-lowering medications … guidelines that incorporate specific LDL targets would be important to help determine where PCSK9 inhibitors best fit,” CVS Chief Medical Officer Troyen Brennan said in a statement, adding that CVS wants guidelines that offer “clear guidance” for doctors and “enable effective utilization management programs to help control healthcare costs.”

In the meantime, CVS is holding off on covering Sanofi ($SNY) and Regeneron’s ($REGN) first-in-class med Praluent, approved last month, Brennan told Reuters. Amgen’s ($AMGN) direct rival, Repatha, is up for FDA approval later this month, and CVS wants to wait and see the language on Repatha’s official label, which will define the size of the population recommended for therapy. It’s no doubt waiting to see how Amgen’s prices Repatha, too; Sanofi and Regeneron put a $14,600 tag on their med, somewhat higher than most analysts had expected. That price applies to both doses of Praluent, despite previous predictions that the companies would use a lower price on the lower dose to gain favor with payers.

CVS and its fellow pharmacy benefits manager Express Scripts ($ESRX), as well as other payers, fought a similar fight with Gilead Sciences ($GILD) and AbbVie ($ABBV) over their hepatitis C medication costs. Stuck with Gilead’s $1,000-per-pill drug Sovaldi till AbbVie’s Viekira Pak was approved, payers tried to keep a lid on spending by restricting coverage only for the sickest patients. After AbbVie’s rival hit the scene, there was a quick scramble for exclusive formulary placement in return for big discounts.

CVS and Express Scripts have been promising a similar scrap with the PCSK9 drugs, given that their benefits are similar and their prices high. Last month, Express Scripts President Tim Wentworth said the new meds are poised to “wreak havoc” on drug spending, and promised that patients would face a high bar for coverage approval–not to mention pit Sanofi/Regeneron against Amgen for big discounts.

CVS has put a price tag on that havoc: $150 billion over 10 years, according to a JAMA article published last year. That apocalyptic figure depended on a broad definition of eligibility–one that likely won’t come close to real-world use. But as a rhetorical device, it struck the note CVS wanted. And the events of the past two days demonstrate–for the drug companies and, importantly, for CVS clients–that the PBM is almost hysterical in its seriousness about controlling PCSK9 spending.

Two questions now: Whether the ACC and AHA would bow to payer pressure and change its guidelines on cholesterol management. The guidelines have drawn fire elsewhere for lack of specificity, so the groups would have a way to save face, but then again, they might just balk at the very idea. Doctors don’t like to be pushed around, and CVS could be over-reaching here.

Also, just how far are Sanofi/Regeneron and Amgen willing to go to win payer coverage for the new meds? The drugmakers do have leverage of their own; doctors are excited about the new drugs, and patients will want them. They could try to paint the PBMs as bad guys more worried about their own bottom lines than about patient care.