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Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice or has to suffer the consequences of having no legal representation.

Administrative Proceedings Can be Complex.

In some cases, individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters, can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Legal Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases, it may even be possible to obtain a change in the forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing. Click here to read our blog on this matter and learn more.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy and tagged Administrative Law Judge, administrative procedure act, administrative proceeding, ALJ, Board of Pharmacy, Board of Pharmacy hearing, defense attorney, defense lawyer, Department of Health, deposition coverage, disciplinary charges, disciplinary complaint, FAC, final hearing, Florida Administrative Code, formal hearing, health law firm, health professional, hearing representation, Informal hearing, last-minute deposition coverage, legal representation, legal representation for pharmacist, legal representation for pharmacy, local deposition coverage, negligence lawsuit, noticed of a deposition, pharmacist, pharmacy, professional liability insurance, rights for an appeal, Rules of Civil Procedure, Rules of Evidence, short notice of representation of pharmacy, short notice representation of pharmacist, subpoena, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Ready or Not, It’s Irregular Behavior Season Once Again…

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

Every year, our firm receives calls from panicked medical students and residents about a recent letter they have received, alleging irregular behavior on standardized medical examinations.

This letter may come from the National Board of Medical Examiners (NBME), the United States Medical Licensing Examination (USMLE), or the Educational Commission for Foreign Medical Graduates (ECFMG). No matter the organization, if you receive a letter alleging irregular behavior, it will typically say the following:

A bulletin or policy related to the exam stating that Irregular Behavior is not permitted.

The facts alleging irregular behavior in this case.

You have an opportunity to respond to the allegations, in person, with counsel.

Often there is a very short window of time to respond to such allegations. While this is important because it is urgent that you get your results test results, it also gives a limited time to prepare to defend yourself.

What is Irregular Behavior?

Although irregular behavior is not the same thing as cheating, it is often thought of as the same by medical school officials and residency program directors. A notice of irregular behavior may hold up and delay your entry into a residency program, your graduation from medical school, and your job opportunities. Your examination scores will be held up while the matter is reviewed by a USMLE Committee on irregular behavior or until a hearing can be held.

What Should You Do?

Once you receive an irregular behavior letter, begin to compile documents to defend yourself. Write out your version of events in order to recall what happened. Collect character reference letters from professors and administrators that attest to your integrity.

Place the personal appearance date listed in your letter on your calendar. It is of upmost importance that you attend in person, preferably with representation. Hearings are usually held in Philadelphia, Pennsylvania, so plan accordingly.

Why Hiring an Attorney Matters.

An attorney can provide the following services to someone accused of irregular behavior:
Review documents, videos, photographs, and all other information that pertains to your case.

Recommend other documents that you should obtain in your defense.

Prepare you for a personal appearance before the respective board or committee making the allegations, and will also make a personal appearance with you at hearing.

Prepare you to answer questions under pressure and on the day of your hearing.

The takeaway message is that retaining an attorney to represent you against irregular behavior allegations could be the difference between a clear record and a mark that will follow you for the rest of your career. Don’t risk jeopardizing your future as a healthcare practitioner. Consult with an attorney as soon as you receive notice of allegations against you regarding irregular behavior.

Consequences of an Irregular Behavior Finding.

If a finding of irregular behavior is made against you, then this usually means that your best score is voided, and you must retake it. The USMLE Committee may require you to wait a year or more to retake the examination. This can prevent you from obtaining or entering a residency program or it may delay you from graduating. Furthermore, the notation that you were found to have committed irregular behavior will be placed on your Step exam transcript. This will be reported out when your test scores are reported.

As indicated above, many medical decision makers view this as similar to cheating. It may disqualify you for many jobs or residency programs that you would otherwise be considered for. If you are accused of irregular behavior, immediately consult with an attorney who has actual experience in dealing with this matter. You can find more information about irregular behavior by clicking here to watch our informational video blog. Click here to read one of my prior blogs on USMLE.

Contact Experienced Health Law Attorneys For Irregular Behavior or USMLE Issues Today.

The attorneys of The Health Law Firm provide legal representation to medical students, residents, interns and fellows in academic disputes, graduate medical education (GME) hearings, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.
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.

Keywords: National Board of Medical Examiners (NBME), medical students, medical resident, irregular behavior, United States Medical Licensing Examination (USMLE), Examination Committee for Foreign Medical Graduates (ECFMG), cheating, USMLE preparation course , USMLE hearings, USMLE appeals, defense attorney, defense lawyer, legal representation, medical student lawyer, medical student attorney, medical resident lawyer, medical resident attorney, medical intern lawyer, medical intern attorney, accused of irregular behavior, The Health Law Firm reviews

“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 © 2018 The Health Law Firm. All rights reserved.

E&M Services Now Under Review by the Recovery Audit Contractors (RACs)

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

In September 2012, the Centers for Medicare and Medicaid Services (CMS) made the decision to allow Recovery Audit Contractors (RACs) to begin reviewing the billing codes for office visits for healthcare providers. Those at issue are the codes referred to as evaluation and management (E&M) codes. These claims had previously been off-limits to RACS.

Connolly, Inc., the contractor for RAC audit services for 15 states and two U.S. territories, will sort through claims filed by doctors and hospitals from as far back as October 1, 2007. According to an article in American Medical News, the plan is to conduct limited reviews in those states and territories using statistical sampling to project how many physician claims that used the high-level, established patient evaluation and management code 99215 were paid correctly.

To read the entire article from American Medical News, click here.

American Medical Association (AMA) Says E&M Codes Are Too Complicated for RACs to Audit.

The American Medical Association (AMA) disagrees with the decision to allow RACs to review E&M codes. In a letter to CMS, the AMA requests the Medicare agency reconsider its decision. The AMA believes E&M services are complex and based on several components.

In the letter the executive vice president of the AMA stated, “Based on our historical experience with the RACs, and in light of the fact that the RACs are not required to have same-specialty physicians review RAC determinations, we have no confidence that the RACs will be up to the task of understanding these variables or their clinical relevance.”

Click here to read the entire letter from the AMA to CMS.

An Increased Use of Higher-Level E&M Codes by Physicians and Hospitals Led to Audit Approval.

The use of office visit codes by doctors and hospitals has been a topic of discussion lately. According to American Medical News, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG) reported almost 442,000 physicians billed E&M services in 2010. Of those physicians, 1,669 were found to be consistently billing higher-level E&M codes, such as the 99215 code that Connolly will review.

A recent article in New York Times discusses the reason for the increase in billing could be the switch to electronic health records. The article states some of the programs will automatically generate detailed patient histories, or allow doctors to cut and paste the same examination findings for multiple patients, a practice called cloning. Cloning can make it appear the physician conducted a more extensive exam, than perhaps he or she actually did.

Click here to read the entire article from The New York Times.

15 States and Two U.S. Territories Face RAC Audits of E&M Services?

Physicians and other healthcare professionals in 15 states, including Florida, and two U.S. territories may face these audits. RACs within these states will be permitted to extrapolate their findings based on a statistical sample of claims.

The states and territories in Connolly’s jurisdiction are: Alabama, Arkansas, Colorado, Florida, Georgia, Louisiana, Mississippi, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia, Puerto Rico and the U.S. Virgin Islands.

What To Do If You Receive a Notification of a Medicare Audit.

When a physician, medical group or other healthcare provider receives a notice of an audit and site visit from Medicare, the Medicare Administrative Carrier (MAC) or the Zone Program Integrity Contractor (ZPIC), things happen fast with little opportunity to prepare. To help, read our checklist of what to do when notified of a Medicare or ZPIC audit. Click here for part one and click here for part two.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

As a healthcare provider, how to do feel about these audits? Please submit any thoughtful comments below.

Sources:

Abelson, Reed, Creswell, Julie and Palmer, Griff. “Medicare Bills Rise as Records Turn Electronic.” The New York Times. (September 21, 2012). From: http://www.nytimes.com/2012/09/22/business/medicare-billing-rises-at-hospitals-with-electronic-records.html?pagewanted=all

Fiegl, Charles. “Medicare Auditor Targets E&M Services for Review.” American Medical News. (October 1, 2012). From: http://www.ama-assn.org/amednews/2012/10/01/gvl11001.htm

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.

Fake Pharmacist Sentenced to Prison for Working in Central Florida Pharmacies

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

On November 2, 2012, a former Altamonte Springs resident was sentenced to three and a half years in federal prison for fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ).

Click here to read the press release from the DOJ.

I previously blogged about this story when the fake pharmacist pleaded guilty. Click here to read that blog.

Phony Pharmacist Worked at Central Florida Pharmacies Including CVS and Walgreens.

According to an article in the Orlando Sentinel, the man worked at pharmacies throughout Central Florida, including a CVS and a Walgreens. While working at one of the pharmacies, he allegedly gave a customer the incorrect medication, causing that person to suffer a stroke.

Man Will Spend Time in Prison and Must Change His Name.

Allegedly, the man fraudulently obtained a pharmacy license in September of 2000

from the Florida Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist in Arizona. In 2004 the man actually changed his legal name by fraud to the name of the licensed pharmacist.

Along with his prison sentence, the fake pharmacist was ordered to change his name back to his legal name.

Fun with Alliteration.

Pardon my alliteration, but I just love all of those “F” sounds like I used in the title for this blog. For comparison, see my blog on Franck’s Pharmacy fungus case.

Look for More Stories on Phony and Fraudulent Health Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health professionals, some old, some new.

To see a recent blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

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?

What do you think of all the fake health provider stories? Please leave any thoughtful comments below.

Sources:

FBI.gov. “Pharmacist Impersonator Sentenced to Prison and Ordered to Change His Name.” FBI, Tampa Division. (November 1, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-sentenced-to-prison-and-ordered-to-change-his-name

Pavuk, Amy. “Fake Pharmacist Sentenced to Federal Prison.” Orlando Sentinel. (November 1, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-fake-pharmacist-prison-20121101,0,4565731.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.

What Health Providers Need to Know About Telemedicine

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

For years providing health care to patients has been at a location that is convenient to the health provider. With emerging trends in telemedicine and upcoming healthcare reforms, recently enacted, patients may begin to enjoy the convenience of medical evaluation and follow-up by video, telephone and computer. The biggest bar to this to date has been the refusal of Medicare, Medicaid and insurers to pay for this, along with restrictive state board of medicine regulations prohibiting it. For example, a big thorn in the side of physicians treating pain management patients has been regulatory prohibitions by the Florida Board of Medicine.

According to a Star Tribune article, 30 million Americans are expected to gain access to insurance through the Health Care Reform Act in 2014. Telemedicine is one effective and low-cost solution to treat easy-to-diagnose medical conditions. It is also expected to assist in relieving the looming shortage of physicians.

Telemedicine uses technologies, such as the internet, streaming media, telephones and video conferences to meet the needs of patients. When deciding whether to establish a telemedicine program it is important to look at the state licensure requirements, as requirements are different in each state.

Click here for a breakdown of telemedicine legislation by state.

What You Need to Know About Telemedicine in the Sunshine State.

According to rule 64B15-14.008, Florida Administrative Code, prescribing medication based solely on an electronic medical questionnaire constitutes unprofessional conduct and it groups for disciplinary action. At least in Florida, the medical authorities have required that physicians must see the patient in person in a face-to-face encounter before prescribing medication. Physicians may not provide treatment recommendations unless a document patient evaluation has occurred, sufficient dialogue between the physician and patient regarding treatment options and the risks and benefits of treatment have occurred, and medical records are properly maintained.

Click here to learn more on the standards for telemedicine practices in Florida.

Federal laws and regulations may bring a change in the state requirements.

Online House Call.

Virtuwell is an online medical clinic offered in Minneapolis, Minnesota. Patients log onto the Virtuwell website and answer a number of questions. Using the patient’s answers, a nurse practitioner will diagnose the ailment, give treatment advice and, if necessary, send a prescription to a pharmacy. This service costs around $40 per diagnosis. The Virtuwell website launched in 2010. In just two years, more than 40,000 patients have logged on to receive medical advice. This form of telemedicine may be the future of health care.

To read more on Virtuwell from the Star Tribune, click here.

It is important to note that Minnesota allows physicians to offer this service if they are registered to practice telemedicine or are registered to practice across state lines.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.
At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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 telemedicine? Do you think it is the future of doctor’s office visits? In your opinion what are the benefits and what are the difficulties of telemedicine? Please leave any thoughtful comments below.

Sources:

Crosby, Jackie. “The New House Call is Online.” Star Tribune. (November 24, 2012). From: http://www.startribune.com/business/180632701.html

Gardner, Elizabeth. “Is Your Doctor Out of the Office? Try an E-Visit.” U.S. News. (September 4, 2012). From: http://health.usnews.com/health-news/articles/2012/09/04/is-your-doctor-out-of-the-office-try-an-e-visit

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.

Health Care Professionals Take Note of the New HIPAA Rules

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

With the popularity of electronic health records (EHRs), social media and everything in between, the U.S. Department of Health and Human Services (HHS) has released stronger rules and protections governing patient privacy. On January 17, 2013, the HHS announced the omnibus rule to strengthen the privacy and security protection established under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

Click here to read the entire 563-page rule.

Now, I can’t say that I’ve read the entire document yet, but I can tell you about the major parts of the omnibus rule, and what it means to you.

It is Your Responsibility to Keep Patient Information Safe.

HHS is expanding the government’s jurisdiction over healthcare providers, health plans and other entities that process health insurance claims to include their contractors and subcontractors with whom providers share protected health information. As the industry embraces new care delivery models, including accountable care organizations (ACOs) and integrated delivery systems, data is exchanged between physicians, hospitals and additional providers to improve care and reduce costs. This all has to be done while keeping patient data safe. According to the HHS, some of the largest breaches involve business associates and not the covered entities themselves.

The government is committed to doing more HIPAA compliance audits and collecting more fines.  The fines the government collects will help to fund the audit process. Because of this rule, we will see audits of business associates and their subcontractors, not just covered entities.

Under the new rule, penalties have been increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation.

The “Wall of Shame” is a Public Display of Breaches.

The changes also improve the Health Information Technology for Economic and Clinical Health (HITECH) breach notification requirements by making it clear when breaches must be reported to the Office for Civil Rights (OCR), according to the HHS.

Once reported to the OCR, the breaches are then placed on what is commonly known in the healthcare industry as the “Wall of Shame.” It’s a comprehensive list of privacy breaches each affecting more than 500 people. We’re currently working on a “Wall of Shame” blog, so more on that later.

Patient Demographics and Marketing.

One part of the final rule also sets new regulations for how patient information can be used for marketing and fundraising. It ensures that such information cannot be sold without a patient’s permission. According to an article in Fierce Healthcare, this provision is a huge win for patient advocates and privacy groups who blast hospitals for mining patient data to target affluent or privately insured patients. Hospitals using health and demographic data from patients’ records to target advertising could be in hot water.

Click here to read the entire Fierce Healthcare article.

If Your are Unsure, Get a HIPAA Risk Assessment.

Since the HIPAA laws have changed, you need to edit your privacy forms and procedures. Many health providers simply don’t have the time to re-review their policies and revise documents. A HIPAA risk assessment is a thorough review and analysis of areas where you may have risk of violating the HIPAA laws.  Federal regulations require that covered entities have this assessment done. A HIPAA risk assessment can significantly reduce, if not entirely eliminate, your exposure to regulatory and litigation sanctions.

When the OCR auditor comes to visit your office to check for HIPAA compliance, they will ask for your risk assessment. Do you have one? Does your staff know who your HIPAA compliance officer is? Call an experienced health law attorney to complete a risk assessment of your practice today. To learn more on HIPAA risk assessments, click here to read a blog we wrote.

Take a Closer Look at Your Privacy Practices.

Healthcare providers, now is the time to revise your Notice of Privacy. The final rule will be effective on March 26, 2013. Covered entities and their business associates will have until September 21, 2013, to comply.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Sound Off.

What do you think about the new HIPAA rules? Do you think these updates were necessary? Do you think it will be difficult for health professionals to comply? Please leave any thoughtful comments below.

Sources:

HHS Press Office. “New Rule Protects Patient Privacy, Secures Health Information.” U.S. Department of Health and Human Services. (January 17, 2013). From: http://www.hhs.gov/news/press/2013pres/01/20130117b.html

Struck, Kathleen. “HIPAA Rules Fortify Patient Privacy.” MedPage Today. (January 21, 2013). From: http://www.medpagetoday.com/PracticeManagement/InformationTechnology/36940

Conn, Joseph. “New Rule: Hospital, Physician Partners Face Penalties for Privacy Leaks.” Modern Healthcare. (January 17, 2013). From: http://www.modernhealthcare.com/article/20130117/NEWS/301179957/new-rule-hospital-physician-partners-face-penalties-for-privacy&utm_source=home&utm_medium=web&utm_campaign=most-popular-box

Caramenico, Alicia. “New HIPAA Rule a Delicate Balance Between Privacy, Sharing.” Fierce Healthcare. (January 18, 2013). From: http://www.fiercehealthcare.com/story/new-hipaa-rule-delicate-balance-between-privacy-sharing/2013-01-18

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.

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.

“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.

Two More Compounding Pharmacies Recall Drugs

CCS Blog LabelBy Carole C. Schriefer, R.N., 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

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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 harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: 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.

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 Students and Residents Must Fight Allegations of “Irregular Behavior” on the USMLE Step Exams

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

I am constantly taking calls from medical students and residents (or future residents) relating to allegations brought against them of “irregular behavior” in connection with the United States Medical Licensing Examination (USMLE) exams. Although the term “irregular behavior” is equated by many with the word “cheating,” it is actually defined by the USMLE to mean:

Irregular behavior includes any action by applicants, examinees, potential applicants, or others when solicited by an applicant and/or examinee that subverts or attempts to subvert the examination process.

The notice that a person has been accused of irregular behavior may come in a letter from the USMLE, National Board of Medical Examiners (NBME), or Examination Committee for Foreign Medical Graduates (ECFMG). In serious cases, one might be approached by a private investigator or law enforcement authority, for example in the case of an alleged theft of an examination or illegal use of examination questions.

Regardless, any notice that you are suspected or accused of irregular behavior should be treated as an extremely serious matter that can suspend your medical education or residency and place your medical career on hold. You should immediately contact an attorney familiar with health and medical law and, especially, one familiar with USMLE, NBME and ECFMG proceedings.

Examples of What Not To Do.

A few examples of irregular behavior we have consulted on include:

1.  A student soliciting information about the contents of a USMLE step examination in an online blog.

2.  Individuals blogging online regarding a certain step exam preparation course they took when the course instructor allegedly used actual examination questions to teach it.

3.  An individual allegedly using an iPhone during a step examination.

4.  Someone setting a fire in a bathroom in the testing center where the examination was given.

5.  An individual who allegedly had written notes on his arm to use during the exam.

6.  Someone who wrote down notes about the exam on a piece of tissue paper after the exam was over.

No matter how trivial the matter may initially seem, it can have devastating effects. The reporting of your test results will be held up until the matter is completely resolved, thereby delaying entry into or continuation of a residency program or, in some cases, medical school graduation. Choice residencies can be lost and a promising medical career can be placed on hold.

If irregular behavior is confirmed, test scores will be voided, your transcript of USMLE tests will be annotated with the fact that you were found to have committed irregular behavior and you may not be allowed to retake the exams for a period of time. This can really screw up your life.

Ask for a Hearing and Be Prepared.

If you are accused of irregular behavior, you will be given the right to have a hearing before a committee of the USMLE which will hear evidence on the matter. Ask for the hearing! Do not waive it.

You will have the right to submit documents on your own behalf. Do this. Use any favorable document that supports your side of the story, shows your good character, shows your academic and clinical performance and mitigates from the seriousness of the alleged conduct.

Attend the hearing in person and with your attorney. You have this right. Do not expect to win a hearing if you do not attend it yourself to answer any questions the committee may have. These committee hearings are all held at MBE headquarters in Philadelphia, Pennsylvania, so it may be a challenge to attend. But you must do so; this may be the most important hearing of your life.

Retain expert witnesses to support you if appropriate. In matters where a statistical extrapolation is used against you, a statistics expert can be a valuable asset.

Many times the facts of the situation turn out to be far different from what the USMLE secretarial has initially reported. But you must avail yourself to the procedures and opportunity to prove this.

Don’t delay. At your first notice, contact an experienced attorney to represent you. The stakes are too high to gamble on handling it yourself.

Contact Experienced Health Law Attorneys Today.

The attorneys of The Health Law Firm provide legal representation to medical students, residents, interns and fellows in academic disputes, graduate medical education (GME) hearings, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.

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

Comments?

Have you faced the Committee? What was the experience like? Did you retain experienced legal counsel? 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.

Hawaii Hospital to Pay More Than $451,000 to Resolve Whistleblower/Qui Tam Allegation of Improper Claims

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

Wahiawa General Hospital in Honolulu, Hawaii, agreed to pay $451,428 to settle two lawsuits alleging that the hospital improperly billed Medicare, Medicaid and Tricare. The settlement stemmed from a civil whistleblower/qui tam lawsuit. The lawsuit was filed by a doctor who allegedly worked at an outpatient clinic operated by Wahiawa General Hospital, according to the Department of Justice (DOJ). Wahiawa General Hospital signed the settlement agreement on August 29, 2013.

To read the press release from the DOJ, click here.

Whistleblower Receives Money in Settlement and Attorneys’ Fees Paid by Hospital.

According to the DOJ, the federal and state governments alleged that Wahiawa General Hospital wrongfully submitted claims to Medicare, Medicaid and Tricare from April 2008 through March 2011. The investigation was initiated after a doctor alleged the hospital submitted bills for services provided by resident doctors without the level of supervision required by law.

On top of the more than $451,000 settlement, Wahiawa General Hospital agreed to pay $75,000 in attorneys’ fees and costs to the attorneys who represented the doctor. The doctor will also receive more than $84,600 as part of the settlement, under the False Claims Act. To learn more on whistleblower/qui tam cases, read our two-part blog. Click here for part one, and click here for part two.

Most Qui Tams Filed by Doctors, Nurses and Employees.

From our review of whistleblower/qui tam cases that have been unsealed by the government, it appears most of these are filed by physicians, nurses or hospital staff employees who have some knowledge of false billing or inappropriate coding taking place. Normally the government will want to see some actual documentation of the claims submitted by the hospital or other institution. Usually physicians, nurses or staff employees have access to such documentation. Whistleblowers are urged to come forward as soon as possible. In many circumstances, documentation that shows the fraud “disappears” or cannot be located once it is known that a company is under investigation.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases both in defending such claims and in bringing such claims. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

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

Comments?

Individuals working in the health care industry often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government. Has this ever happened to you? Please leave any thoughtful comments below.

Sources:

Associated Press. “Wahiawa General Hospital to Pay $450K Settlement.” Star Advertiser. (August 30, 2013). From: http://www.staradvertiser.com/news/breaking/221856781.html

Department of Justice. “Community Hospital Pays $451,428 to Resolve Allegation of Improper Claims.” Department of Justice. (August 30, 2013). From: http://www.justice.gov/usao/hi/news/1308wgh.html

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.

CMS Delays Stage 3 Meaningful Use for Medicare and Medicaid EHR Incentive Programs

MLS Blog Label 2By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On December 6, 2013, the Centers for Medicare and Medicaid Services (CMS) announced a revised timeline for the implementation of Stage 3 meaningful use measures for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

According to CMS, Stage 2 will be extended through 2016, and Stage 3 will begin in 2017 for those hospitals, physicians and other eligible providers that have completed at least two years of Stage 2 meaningful use. These changes affect two groups of eligible providers: providers who started Stage 1 in 2011, and who are currently scheduled to start Stage 3 in 2016, and those providers who started Stage 1 in 2012, and who are scheduled to start Stage 3 in 2016.

This announcement does not change when providers must start Stage 2, nor does it affect the requirement for hospitals and critical access hospitals to upgrade to EHR technology to receive incentive payments. The Medicare and Medicaid EHR incentive programs are staged in three steps with increasing requirements for participation. Eligible providers who do not meet meaningful use requirements will still be penalized with reduced Medicare reimbursement starting January 1, 2015.

To read more from CMS, click here.

Reasons for the Timeline Change.

According to Modern Healthcare, CMS stated that the goal of the timeline change is two-fold. First, to allow CMS and the Office of National Coordinator (ONC) to focus on assisting providers to meet Stage 2 demands for patient engagement, interoperability and information exchange, as well as use data collected during the phase to inform policy decisions for Stage 3.

CMS expects that it will release a notice of proposed rulemaking for Stage 3 in the fall of 2014, and the corresponding ONC notice for proposed rulemaking for the 2017 Edition of the ONC Standards and Certification Criteria will also be released at that time. Click here to read the entire article from Modern Healthcare.

What this Means for You.

If you begin participation with your first year of Stage 1 for the Medicare EHR Incentive Program in 2014:

– You must begin your 90 days of Stage 1 of meaningful use no later than July 1, 2014 and submit attestation by October 1, 2014 in order to avoid the 2015 payment adjustment.

If you have completed one year of Stage 1 of meaningful use:

– You will demonstrate a second year of Stage 1 of meaningful use in 2014 for a three-month reporting period fixed to the quarter for Medicare or any 90 days for Medicaid.
– You will demonstrate Stage 2 of meaningful use for two years (2015 and 2016).
– You will begin Stage 3 of meaningful use in 2017.

If you have completed two or more years of Stage 1 of meaningful use:

– You will still demonstrate Stage 2 of meaningful use in 2014 for a three-month reporting period fixed to the quarter for Medicare or any 90 days for Medicaid.
– You will demonstrate Stage 2 of meaningful use for three years (2014, 2015 and 2016).
– You will begin Stage 3 of meaningful use in 2017.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians and medical groups on EHR issues. It also represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, 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.

Comments?

What do you think of the revised timeline for the implementation of Stage 3 meaningful use? Will this affect you? If so, how? Please leave any thoughtful comments below.

Sources:

Conn, Joseph. “Meaningful-Use Deadline Pushed Back One Year.” Modern Healthcare. (December 6, 2013). From: http://bit.ly/1kkAtsC

Tagalicod, Robert and Reider, Jacob. “Progress on Adoption of Electronic Health Records.” Centers for Medicare and Medicaid Services. (December 13, 2013). From: http://www.cms.gov/eHealth/ListServ_Stage3Implementation.html

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 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. http://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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