Hydrocodone Combination Drugs Could Be Reclassified to Schedule II Category of Controlled Substances

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA. If approved, hydrocodone combination drugs, such as Vicodin, will be harder for physicians to prescribe.

The advisory committee met because the Drug Enforcement Administration (DEA) is requesting the FDA to approve the reclassification of hydrocodone combination products. The DEA wants to help curb the growing number of people across the country addicted to painkillers.

Click here to read an FDA briefing document given to the advisory committee.

It is now up to the FDA to decide whether or not to implement the advisory committee’s decision as to whether hydrocodone combination drugs will stay labeled as schedule III controlled substances or move to schedule II controlled substances. If medications containing hydrocodone are moved to schedule II, they will be in the same category as the widely abused oxycodone.

Hydrocodone Abuse is Serious.

Currently, hydrocodone products are the most widely prescribed drugs in the U.S., according to an article on MedPage Today. Records show that painkiller abuse kills more people in America than heroin and cocaine combined. The DEA argues that since these drugs are so frequently abused, they should be more tightly controlled.

To read the MedPage Today article, click here.

What You Need to Know as a Health Care Provider.

This change would have wide-spread consequences for health care professionals, especially doctors and pharmacists. Under the schedule II category of controlled substances, physician assistants (PAs) and nurse practitioners would no longer be legally allowed to prescribe hydrocodone combination drugs.

If the recommendation is accepted, it would be more difficult for patients to obtain refills on hydrocodone combination drugs. Refills without a new prescription, faxed prescriptions and prescriptions called in by telephone would all be banned. Only written prescriptions from a doctor would be allowed.

If the recommendation is adopted, much stricter scrutiny on the purchasing, prescribing, retailing and use of these medications can also be expected. Prosecutions and administrative actions can also be expected to follow.

The FDA is also debating the DEA’s request to limit prescriptions of hydrocodone combination pills to a 90-day supply instead of the current regulations which permit five refills within six months.

Arguments Heard Against the Reclassification.

According to an article in The New York Times, many opponents spoke against the recommendation. Advocates for nursing home patients argued that weak and elderly residents with chronic pain would have to make a difficult trip to see a doctor just to get a prescription refilled. Click here to read The New York Times article.

Some committee members questioned if there was another option to consider versus changing the scheduling. They questioned whether greater use of e-prescribing and Prescription Drug Monitoring Programs, as well as better education efforts for clinicians and patients would be better solutions for the drug abuse epidemic.

Now it remains to be seen how the FDA will interpret the advisory committee’s recommendation.

Florida’s Prescription Drug Abuse Epidemic.

Florida law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse in Florida.

We have written a number of blogs on the abuse of narcotics in Florida. See our blog on a fake prescription ring busted in Osceola County, and a Central Florida nurse accused of illegally obtaining prescriptions for painkillers, for example. Check our website for similar blogs.

Pharmacists, pharmacies, legal distributors and physicians are often too caught up in the frenzy to stem prescription drug abuse and to eliminate “pill mills.”

Call Experienced Health Law Attorneys for Your Legal Needs.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.
Sound Off.

As a health care professional, do you think hydrocodone products should be labeled as a schedule II controlled substance? What are the positive and negative effects of this decision? Please leave any thoughtful comment below.
Sources:

Fiore, Kristina. “FDA Panel Votes for Tighter Controls on Vicodin.” MedPage Today. (January 25, 2013). From: http://bit.ly/X8qlsu

Tavernise, Sabrina. “F.D.A. Likely to Add Limits on Painkillers.” The New York Times. (January 25, 2013). From: http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html?_r=0
About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Medical Negligence – An Accidental Overdose of Prescription Pain Pills Can Lead to Lawsuits

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

In February 2009, a 30-year-old male patient was prescribed, all together, 180 pills of Dilaudid and Xanax from a South Florida pain clinic. Sometime within the next 24 hours the patient died of what medical examiners ruled an overdose. According to the American Association for Justice, the patient’s family then sued the pain management clinic alleging the clinic’s physician prescribed a lethal overdose of the drugs and the defendant was liable for damages resulting from the patient’s murder. In the lawsuit, the jury awarded the plaintiff more than $5.33 million.

Physicians and Business Owners Liable for Medical Negligence.

According to an article in American Medical News, of the pharmaceutical-related overdoses in 2010, seventy-four percent (74%) were unintentional. As prescription drug overdoses rise across the country, we are seeing some physicians and business owners held liable for medical negligence.

For example, in May 2012, an Alabama jury ruled a widower to receive $500,000 after he sued his wife’s physician. His wife died of an accidental overdose after being prescribed a number of narcotic pain medications. In April 2012, a woman was awarded $1.9 million after she sued her family physician claiming he over prescribed her methadone, which led to brain damage after she stopped breathing, according to American Medical News.

Click here to read the entire article from American Medical News.

Protecting Your Business and License.

Health care professionals need to pay close attention to patients who request pain medication. Being proactive about prescription management can also deter lawsuits or help in doctors’ defense if they are sued. Physicians must make sure their records meet all requirements of state laws and regulations. In cases where a patient has been “doctor-shopping” in order to abuse pain pills, we see state disciplinary investigations initiated against each physician who prescribed that individual medication. In most cases, these physicians were unaware of the other prescribers. Disciplinary actions such as these can often be defended when the physician has taken the proper safeguards.

Click here to read legal tips for physicians to manage pain patients.

Drug Monitoring Programs are Here to Stay.

The growing epidemic has some states developing drug monitoring programs to track drug seekers.

In Florida, a bill that would require doctors to check with the state’s drug database before writing a prescription for addictive medications passed in a House panel on March 19, 2013. Recently, legislators in California, Pennsylvania and Kentucky are contemplating moves to tighten monitoring and prescribing of controlled substances. Click here to read a blog on the possible new actions in these states.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you think physicians and business owners should be held liable for medical negligence in cases of an accidental overdose? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Thirty-Two Indicted in Broward and Palm Beach Counties in Second Coordinated Pill Mill Takedown.” Department of Justice. (August 23, 2011). From: http://www.justice.gov/usao/fls/PressReleases/110823-04.html

Gallegos, Alicia. “Physician Liability: When an Overdose Brings a Lawsuit.” American Medical News. (March 4, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_Overdose%20Lawsuits.PDF

LaMendola, Bob. “Pain Clinic Boss Jeffrey George Pleads Guilty to Murder.” Sun Sentinel. (August 29, 2011). From: http://articles.sun-sentinel.com/2011-08-29/health/fl-hk-jeff-george-pleads-guilty-20110829_1_pain-clinic-cynthia-cadet-george-twins

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Number of Oxycodone-Related Deaths Down in Florida

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

It looks like Florida’s prescription drug legislation, the statewide prescription drug monitoring database and the prescription drug crackdowns by law enforcement may be working, according to the Florida Department of Law Enforcement (FDLE). The FDLE states in its semi-annual report, oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. A look at the national numbers shows that the number of people abusing prescription drugs is also down.

Florida and National Numbers.

In the first half of 2012, there were 759 oxycodone-related deaths in Florida, according to the Orlando Sentinel. That number is down from 1,058 during the same time period a year before. The Orlando Sentinel states that nationwide 7 million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. The Metropolitan Bureau of Investigation Director believes these numbers are down because young people are realizing these drugs are dangerous and can be deadly.

Click here to read the entire article from the Orlando Sentinel.

Florida Cracks Down on Prescription Drug Abuse.

Previously, Florida was known as a state where drug addicts and dealers could easily find a pill mill or go doctor shopping to get prescription drugs. In the past two years, Florida state leaders and law enforcement officials have stepped up regulations and made serious crackdowns on doctors, pharmacists and pharmacies.

In April 2013, a Lake Mary doctor was sentenced to 25 years in prison for trafficking prescription drugs. Click here to read that story. In December 2012, a fake prescription drug ring was busted in Osceola County. To read that story, click here. In June 2012, the Drug Enforcement Administration (DEA) and Florida law enforcement announced operation “Pill Street Blues” targeting doctors and clinic owners across Florida. Click here to read more.

Health Care Professional Must Stay Ahead of Patients with Chronic Pain.

Even though the number of people abusing prescription drugs is down, state regulatory boards, private certification boards and federal agencies are not going to ease up. Many physicians in practice today are eschewing multi-disciplinary approaches to treating chronic pain in favor of monotherapies with narcotic medications.

These physicians do this at their own peril. In our practice we see many physicians in trouble with state medical boards and law enforcement officials because of their prescribing practices. If you treat patients with chronic pain it is imperative that you stay ahead of them. Click here to read a blog on legal tips for health care professionals to manage pain patients.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you think the new legislation, the state prescription drug monitoring database and the crackdowns by law enforcement are making a difference in the war against prescription drugs? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.story

Pavuk, Amy. “Drug-Related Deaths Plunge in First Half of 2012.” Orlando Sentinel. (March 25, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-drug-deaths-down-20130325,0,6750345.story

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Drug Enforcement Agency (DEA) Blocks Shipping of Controlled Substances at Walgreens Distribution Center in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Suspension Order Only Stops the Distribution of Controlled Substances.

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Millions of Oxycodone Pills Purchased by Walgreens Stores.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article
.

Continued War on Prescription Drug Abuse.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

Oxycodone Numbers Published for Shock Value.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Where Do Legitimate Chronic-Pain Patients Turn?

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620. He does not own stock in Walgreens or any other pharmacy.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

CVS Possibly Under Investigation for Medicare Fraud

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Contacted By the Government About an Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers were not refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Cause for Investigation?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS  is actually promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Sanford, Fla., CVS Stores Make Headlines.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this story? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Orlando Pharmacist Accused of Filling Phony Prescriptions for Painkillers

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Sex, prescription drugs and money – sounds like the next big rock ‘n’ roll song, doesn’t it? According to a number of news sources, the owner of an Avalon Park-area pharmacist was allegedly knowingly filling phony prescriptions for painkillers. The pharmacist is also accused of exchanging sex for drugs with at least one woman, according to the Orlando Sentinel. This investigation was led by the Metropolitan Bureau of Investigation (MBI) and the Drug Enforcement Administration (DEA). Both agencies simultaneously raided the pharmacy on November 29, 2012.

Avalon Park is a community it the greater Orlando area.

DEA Agents Raided Pharmacy and Pharmacist’s Home.

According to WFTV, the owner of the pharmacy and two employees sat handcuffed outside the pharmacy as federal drug agents reportedly removed boxes of evidence from the pharmacy during the raid. Agents then moved onto the pharmacist’s nearby home.

It’s believed another person was producing fake prescriptions and asking others to get them filled at the Avalon pharmacy and others around town. The people who fill the prescriptions are nicknamed “smurfs.” They are usually hired by a drug ring. They return the pills from the prescriptions they get filled, back to the ring. Click here to read what Papa Smurf has to say about his name being used in such a manner.

According to WFTV, 230 fraudulent prescriptions were produced and 33 were filled at the Avalon-area pharmacy.

Click here to watch WFTV’s report on this raid.

Smurf Allegedly Received Drugs for Sex.

A woman, who worked as a smurf, allegedly told federal agents she had sex with the pharmacist. Afterward, the pharmacist gave her cash and oxycodone, according to the Orlando Sentinel. However, we want to make it clear that those who break the law and get caught often point the finger at innocent people, trying to divert blame from themselves.

To read the article from the Orlando Sentinel, click here.

Charges Being Faced.

The pharmacist faces up to 32 counts of trafficking in controlled substance and one count of conspiracy to traffic. Federal agents believe the pharmacist is part of a larger drug ring.

On the Florida Department of Health (DOH) website his license is still listed as clear/active. To see his license status, click here.

Remember, all who are name or discussed in our blog are innocent until proven guilty in a court of law.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Tell us your thoughts on this story. Are federal drug agents fighting a losing battle? Please leave any thoughtful comments below.

Sources:

Barrett, Steve. “Avalon Park Pharmacy Owner Accused of Filling Fake Oxycodone Prescriptions.” WFTV. (November 30, 2012). From: http://www.wftv.com/news/news/local/dea-agents-raid-avalon-park-pharmacy/nTJbw/

Pauk, Amy. “Pharmacist Accused of Over-Dispensing Painkillers, Exchanging Pills for Sex.” Orlando Sentinel. (November 29, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-avalon-park-pharmacy-20121129,0,6040870.story

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Drug Enforcement Administration Releases Details of Investigation into Two CVS Stores in Sanford, Florida

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In September 2012, the Drug Enforcement Administration (DEA) revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. Details into the investigation were made public on October 12, 2012, in a final order released by the DEA.

The order explains how the stores operated, whom they prescribed painkillers such as oxycodone to, and identified Central Florida’s top-prescribing doctors.

To read the final order from the DEA, click here.

I previously wrote about the two Sanford CVS stores losing their controlled substance licenses, click here to read that blog.

Testimonies from Employees Allegedly Explained Pharmacies’ Operating System.

The final order reveals testimonies from pharmacy personnel. In a press release from the DEA the pharmacist-in-charge at one of the Sanford stores told drug agents the stores would set a limit each morning on the number of oxycodone prescriptions they would fill based on the inventory. Once the limit was reached, the pharmacy would tell customers they were “out of stock,” even when they had inventory. The pharmacist told agents the reserved inventory was for their “real pain patients.”

Warning Signs.

Employees told drug agents that their customers would ask for oxycodone using street slang such as “the M’s” or “the blues.” Oxycodone was also allegedly dispensed frequently to customers who lived out of state, obtained prescriptions from South Florida doctors, and had the prescriptions filled in Seminole County.

Click here to read the press release from the DEA.

More Stings May Be Coming.

The Walgreens distribution center in Jupiter, Florida, is currently fighting its own war with the DEA. On October 17, 2012, the biggest pharmacy retailer in Florida filed a petition

asking a federal judge to lift an immediate suspension order (ISO) banning the center from shipping controlled substances to its stores in Florida and on the East Coast. To read more on that story, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the DEA’s decision? As a pharmacist how to do you regulate prescriptions for painkillers? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: DEA Blasts CVS for Ignoring ‘Red Flags’ at Sanford Stores.” Orlando Sentinel. (October 28, 2012). From: http://www.orlandosentinel.com/health/os-cvs-dea-oxycodone-ban-20121028,0,5395839.story

Drug Enforcement Administration. “Holiday CVS Final Order Reveals Gross Negligence By

Two CVS Pharmacies in Stanford, Florida.” DEA.gov. (October 15, 2012). Press Release From: http://www.justice.gov/dea/divisions/mia/2012/mia101512.shtml

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Locating a Healthcare Providers Service Organization (HPSO) Insurance Defense Attorney in Florida

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance.  In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.

Benefits of HPSO Insurance.

The professionals who are covered by HPSO Insurance have excellent insurance coverage.  HPSO Insurance provides professional liability coverage that protects in the event of a lawsuit or negligence claim.  But much more often the professional receives a notice of an investigation, a subpoena for a deposition in someone else’s case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality or Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action.

HPSO provides great coverage for these.  For example, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation of you at depositions.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your defense in a DOH or Agency for Health Care Administration (AHCA) notice of investigation or complaint.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your legal representation in defense of a complaint or investigation regarding breach of medical confidentiality.

If you are a pharmacist, own a pharmacy, are a massage therapist, own an assisted living facility (ALF), are a mental health counselor or a social worker, or you are one of the many other types of health care professionals who HPSO insures, it should be fairly easy to find experienced health lawyers to represent you, especially in Florida.

Our firm and our attorneys, including George F. Indest III, Michael L. Smith, Joanne Kenna, Carole C. Schriefer, Lance O. Leider, Christopher E. Brown and Danielle M. Murray, routinely represent licensed health care professionals, interns and students in all types of administrative investigations and hearings and in defending lawsuits and other actions that have been filed.  We also represent health facilities in license defense, survey complaints and administrative hearings.  We represent them throughout Florida, from Pensacola, to Jacksonville, to Key West.  We also occasionally represent them in other states, as well.  We accept HPSO Insurance assignments.

Free Legal Advice: Get Insurance Immediately.

It is very important for every health professional to carry insurance that covers any investigation, complaint or administrative hearing that might be filed or opened against your license.  You may think that you are covered for this by your employer, but you are not.  If your employer contradicts this, ask for a statement in writing that your employer will pay for your legal defense for any such matter arising during your employment.

What typically happens, especially in the case of a hospital employee, nursing home employee, pharmacy employee or corporate employee, is that the employer is the one who terminates the employee and then files a complaint with the DOH.  The DOH then opens an investigation against the health professional.  The employer is not going to pay your legal defense costs if the employer has reported you.

You may very well be out of work, out of money and face an investigation and complaint that could terminate your professional license and career.  You should not take this chance.  Insurance such as HPSO Insurance is inexpensive and reliable.  Buy it while you can afford it. After the actions have occurred, it is too late.

Find an Experience Health Law Attorney in the Event of an Investigation.

Also, you should immediately contact an experienced health law attorney if you are telephoned or visited by any investigator, or if you receive a letter advising you that an investigation has been opened regarding your care.  Call immediately for advice before you speak with an investigator or provide any documents or statements of any kind.

You cannot and should not seek “legal advice” on what to do from the investigator, from a DOH employee, from your professional board or from any attorney representing any of them.  They are not your friends.  They are on the side against you. You should definitely not take any advice from them.

Do Not Skimp on Insurance Coverage.

If you have good insurance, it will pay for your legal expenses from the very beginning, so use it.  However, beware of cheap insurance policies from professional associations that do not provide any coverage for disciplinary complaints and licensure investigations.  Always check to be sure this is covered.  Get it in writing.  With some companies you have to pay an extra premium to obtain this coverage.  With some insurers, they do not offer it, and you have to purchase a completely separate policy covering just this.  It is worth it!  Do it!

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

Our firm regularly represents pharmacists, massage therapists, mental health counselors, registered nurses, assisted living facilities, home health agencies, nurse practitioners, lab technicians, occupational therapists, physical therapists, social workers, physician assistants, psychologists and other health professionals in many different legal matters.

Services we provide include representation before your professional board, in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

We routinely represent physicians, dentists, nurse practitioners, and others in defending against malpractice claims, civil lawsuits, administrative complaints, peer review actions, DOH investigations, Medicare audits, Medicaid audits, and other matters. In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company.  If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Do you have professional liability insurance? Why or why not. Please leave any thoughtful comments below.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Professional Liability Insurance Benefits for Health Professionals

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I have been pleasantly surprised recently to discover that several professional liability insurance companies have raised their coverage amounts and added coverage in areas sorely needed by health professionals.  I’m referring to coverage for incidents not necessarily related to malpractice or professional liability.

I do note that Healthcare Providers Service Organization (HPSO) Insurance has increased its basic policy limits from a cap of $3,000,000 in the aggregate per year to $5,000,000 aggregate per year for counselors on professional liability coverage.

However, we have always maintained that the most important coverage for any licensed health professional is professional licensure legal defense coverage.  This is probably the most used type of coverage and the most beneficial for a health professional.

HPSO Insurance and Nurses Service Organization (NSO) Insurance, as well as several other insurers now provide up to $25,000 coverage.  If an employer whether it’s a hospital, nursing home, assisted living facility (ALF), home health agency (HHA), medical group or public health clinic or a patient complains about you to the state Department of Health (DOH) or state licensing authority, you could face investigation and hearings that would cost you tens of thousands of dollars to have properly defended by an experienced attorney.  If you don’t have the funds to pay for this, you could be forced to accept discipline on your license which could result in a number of unexpected additional adverse actions against you.

Although I would prefer to see this coverage increased to $50,000, and there are several companies that provide this much in coverage, $25,000 will go a long way toward defending you against meritless or unprovable complaints.

New HPSO Insurance and NSO Coverages.

Representation During a Deposition – A patient is injured at the facility where you work. You are not named in the lawsuit, but you receive a subpoena for testimony. Your coverage through HPSO Insurance will pay up to $10,000 per deposition with a $10,000 annual aggregate for you to be represented at the deposition by an attorney.

Information Privacy Coverage (added upon request) – People today are very conscious about their privacy. Most are aware of the protection they receive under the new Health Insurance Portability and Accountability Act (HIPAA) laws. This optional endorsement extends your coverage to pay for HIPAA fines and penalties arising from a HIPAA proceeding, subject to a $25,000 aggregate limit.

Sexual Misconduct – In the past, while your coverage through HPSO Insurance would pay to defend you against allegations of sexual misconduct related to your professional services, there was no coverage for a settlement. This new endorsement provides you with a $25,000 aggregate sublimit for covered sexual misconduct claims.

Reimbursement for Rendering First Aid – This benefit provides reimbursement up to $10,000 for expenses you incur while rendering first aid to a person other than yourself. For example, this could include supplies from your personal first aid kit that you used to help a victim of an automobile accident.

Accidental Injury to Others – If someone was hurt by something like a slip and fall at your residence or your workplace and required medical attention, they can receive reimbursement for their expenses up to $10,000 per incident with a $100,000 annual aggregate. It must be an accidental injury, not a medical incident.

Service to Animals (added for pharmacists, physical therapists (PTs), massage therapists and counselors) – In the course of providing professional services to an animal, if they are injured and the owner files suit, the new service to animals endorsement provides $25,000 aggregate coverage. (Added upon request for all others.)

Accidental Damage to Others’ Property – While you are providing care at a patient’s home what if you accidentally break something? No worries. Your policy pays for unintentional damage you cause to someone else’s property while at your personal residence or workplace. This coverage provides up to $10,000 per incident with a $10,000 aggregate.

Other Coverages Added to Professional Liability Insurance Policies.

In addition to the coverages I have discussed above, there have been some other coverages added to many professional liability insurance policies that could pay off for damages or injuries the individual health professional incurs, as well.

Workplace Violence Counseling – While your assault coverage pays for the medical expenses resulting from an attack, this new endorsement broadens your coverage to include $25,000 aggregate limits for the payment of any emotional counseling needed as a result of a covered incident.

Coverage If You are Assaulted – Violence in the workplace is a sad reality. Should you be the victim of a violent action at work or on your way to or from work, this coverage will pay up to $25,000 per incident with a $25,000 aggregate for medical expenses you incur or for damage to your personal belongings.

Reimbursement for Defendant Expenses – Regardless of its outcome, a malpractice suit will likely cost you money and could mean thousands of dollars out of your pocket. Your policy through HPSO Insurance will reimburse you up to $1,000 per day, up to $25,000 aggregate for lost wages, travel and other covered expenses.

Business Owner Coverage Extension (added upon request) – The ‘named insured’ on a policy for a healthcare firm is typically the business name. If the business owner volunteers or moonlights there is always the chance they could be named in a malpractice suit under their individual name. This new extension provides protection for the owner if sued under their personal name.

HPSO Insurance Also Provides Coverage For:

   Students (Health Professional Students)
   Counselors
   Interns (Health Professional Interns)
   Physician Extenders
   Physicians
   Fitness Professionals
   Integrated Health Practitioners
   Massage Therapists
   Nurse Practitioners
   Occupational Therapists
   Pharmacists
   Physical Therapists (PTs)
   Physician Assistants (PAs)
   Radiologist Assistants
   Radiology Practitioner Assistants
   Social Workers
Healthcare Businesses:

   Assisted Living Facilities (ALFs)
   Nurse Registries
   Home Health Agencies (HHAs)
   Pharmacies
   Physical Therapy Practices
   Occupational Therapy Practices
   Outpatient Therapy Clinics

There is no time like the present, when you have the funds and can afford it, to purchase professional liability insurance.  It is surprisingly inexpensive.  Every professional should carry it.  If you don’t buy it before you need it, when you do really need it, it will be too late.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

Our firm regularly represents physicians, dentists, nurse practitioners, pharmacists, massage therapists, mental health counselors, registered nurses (RNs), assisted living facilities (ALFs), home health agencies (HHAs), nurse practitioners, lab technicians, occupational therapists, physical therapists (PTs), social workers, physician assistants, psychologists and other health professionals in many different legal matters.

Services we provide include representation before your professional board in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company.  If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. 

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

CVS Has Allegedly Been Refilling Prescriptions and Submitting Insurance Claims Without Patients’ Permission

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Notified of Prescription Refill Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers weren’t refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Tempest in a Teapot?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS actually is promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Central Florida CVS Stores Get Controlled Substance Licenses Revoked by DEA.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this story? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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