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Government Discovers Extensive Overbilling of Cancer Drug to Medicare

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

It’s no surprise that the government is aggressively pursuing Medicare fraud. Recently, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), made a surprising discovery. An audit uncovered that more than three-quarters (3/4) of all Medicare claims for the breast-cancer drug Herceptin were billed incorrectly, according to Modern Healthcare. This was found during an audit conducted on physicians and hospitals from around the country between January 1, 2008, and December 31, 2010.

To read the entire Modern Healthcare article, click here.

Audit Results from Around the Country.

Three different audits were released to the public by the HHS OIG. All of these audits showed roughly the same information. Health care providers have been billing Medicare for full multiuse vials of the drug Herceptin, when patients actually only need a smaller portion. Medicare does not pay healthcare providers for any part of the drug that is discarded, because it can be preserved for up to 28 days and reused. The auditors suggest that payment from Medicare for an entire multiuse vial is likely to be incorrect. We saw a similar situation with the drug Avastin and Lucentis being used by ophthalmologists several years ago.

The results of the audits were released in January 2013. One audit found eighty-five percent (85%) of 1,073 Herceptin vials used in Ohio and Kentucky were billed incorrectly. In Illinois, Indiana, Michigan and Wisconsin, the government auditors found that seventy-eight (78%) of 713 claims investigated were wrong. The overpayment amount was around $682,000, for these audits.

Florida’s District Found to Have Overcharged 78% of Bills.

According to the report, HHS auditors found overcharges in seventy-eight percent (78%) of bills for 1,330 vitals of Herceptin submitted to First Coast Service Options, Inc. This company serves as the Medicare Administrative Contractor (MAC) for HHS District Nine, which primarily includes providers in Florida, Puerto Rico, and the U.S. Virgin Islands. The overcharges for Herceptin were $1,325,409.

In the report, the government recommends that First Coast Service Options, Inc., do a number of things. The first is to recover the more than one million dollars in overpayments. It’s also recommended that First Coast Service Options, Inc., implement system edits that review multiuse vial drugs that are billed with units of service equivalent to the dosage of an entire vial. The government also suggests that these audit results be used as an educational tool for teaching correct billing practices to physicians and hospitals.

Click here to read the entire report on District Nine.

How to Respond to a Medicare Audit.

Remember, there is no such thing as a “routine” Medicare audit. The fact is that if you find yourself or your practice at the center of a Medicare audit, there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused the audit. We’ve come up with a list of actions that we use and recommend you take when responding to a Medicare audit. Click here to view that list.

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

The best time to respond to and defeat an allegation of overpayment is at the very beginning. That is why it is essential that you obtain qualified counsel to help you through the process. 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?

Why do you think hospitals and physicians incorrectly bill for Herceptin? Are audits like these necessary? Please leave any thoughtful comments below.

Sources:

Carlson, Joe. “OIG Finds Widespread Herceptin Overcharges.” Modern Healthcare. (January 21, 2013). From: http://www.modernhealthcare.com/article/20130121/NEWS/301219959/oig-finds-widespread-herceptin-overcharges

Jarmon, Glorida. “The Medicare Contractor’s Payments to Providers in Jurisdiction 9 for Full Vials of Herceptin were often Incorrect.” Office of Inspector General (January 2013). From: http://www.thehealthlawfirm.com/uploads/Herceptin%20FL%20Overcharges.pdf

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.

Author Recommends Medicare Use ‘Procedural Triage’ to Eliminate Backlog of Appeals and Restore Faith in the System

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

IndestIn a recent law journal article being considered for publication, Author Matthew J. B. Lawrence of the Harvard University Petrie-Flom Center, makes some bold recommendations for Medicare. His hypothesis seems to be that the extremely long delay that health care providers now face in getting a Medicare appeal hearing might be negatively affecting these providers’ view of the fundamental fairness of the system. Currently, the backlog in obtaining a Medicare Appeal Hearing before an administrative law judge is up to approximately 27 months. Mr. Lawrence argues “procedural triage” may be in order.

Following is an abstract of this article:

Prior scholarship has assumed that the inherent value of a “day in court” is the same for all claimants, and so that when procedural resources (like a jury trial or a hearing) are scarce, they should be rationed in the same way for all claimants. That is incorrect. This Article shows that the inherent value of a “day in court” can be far greater for some claimants, such as first-time filers, than for others, such as corporate entities, and that it can be both desirable and feasible to take this variation into account in doling out scarce procedural protections. In other words, it introduces and demonstrates the usefulness of procedural triage.

The Article demonstrates the real-world potential of procedural triage by showing how Medicare should use this new tool to address a looming administrative crisis that it is facing. In the methodological tradition of Jerry Mashaw’s seminal studies of the Social Security Administration, the Article uses its in-depth study of Medicare to develop a theoretical framework that can be used to think through where and how other adjudicatory processes should engage in procedural triage. The Article concludes by applying this framework to survey other potential applications for procedural triage, from the Department of Veterans’ Affairs to the Federal Rules of Civil Procedure.

Blog Editor’s Comments:

The main point of the justice system is that everyone deserves a “day in court.” In this document, Procedural Triage, Matthew J. B. Lawrence argues that the value of a day is different for all claimants; it can be greater for some, so we shouldn’t treat everyone alike. Lawrence suggests some individuals deserve to have a hearing more than others, but sometimes the system compromises that rule.

One thing this article does is show how useful procedural triage can be. “Procedural triage” being a system that makes all medical institutions who are enrolled in Medicare use statistical tools for peoples to retain their right to a full “day in court.” He suggests Medicare uses the tool to face its current administrative crisis. In the end, it would benefit due process in the entire system.

Comments?

What do you think about procedural triage? Do you agree that Medicare should use it? Please leave any thoughtful comments below.

Contact a Health Care Attorney Experienced with Medicare and Medicaid Cases.

Attorneys with The Health Law Firm 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. We also handle Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S.

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

Sources:

Lawrence, Matthew J. B. “Procedural Triage.” Social Science Research Network. (June 17, 2015). From: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2619864

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.

KeyWords: procedural triage, defense attorney, defense lawyer, medical lawyer, lawsuit, medical professionals, healthcare professionals, health care attorney, health care lawyer, The Health Law Firm, Medicare, court, litigation, day in court, procedural protections, Social Security Administration, adjudicatory, procedural justice, behavioral economics, adjudication, administrative process, civil procedure, due process, justice system

“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 © 1996-2015 The Health Law firm. All rights reserved.

You Must Challenge Overpayment Demands from Medicare and Medicaid Audits

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

We have recently received numerous communications from health care professionals, including physicians, physical therapists, occupational therapists, mental health counselors, durable medical equipment (DME) providers, assisted living facilities (ALFs), group homes, and psychologists, who have been placed on prepayment review after failing to challenge Medicare or Medicaid audit results. The problem is that these providers, once placed on prepayment review, have their payments held up for many months and are often forced out of business. Sometimes it appears that this may actually be the goal of the auditing contractor or agency.

What Happens on Prepayment Review.

Failing to challenge, follow-up on, and appeal any adverse audit determinations can be very detrimental. An error rate in excess of fifteen percent (15%) will usually result in the provider being placed on prepayment review. While on prepayment review, the provider will be required to submit the documentation for medical records by mail to support each claim submitted and have that claim and its supporting medical records’ documentation audited, prior to any claims being paid. Often the auditing agency will come back to the provider again and again to demand additional information and documentation on claims instead of immediately processing them. This can hold up processing of the claim for months. Often the resulting termination of income flow will force the provider out of business. This saves the government lots of money, because the provider has then provided services to Medicare or Medicaid recipients for many months without ever getting paid for it.

These are some of the reasons why we recommend that physicians, physical therapists, occupational therapists, podiatrists, optometrists, psychologists, mental health counselors, respiratory therapists, and others always hire the Board Certified Health Law Attorney experienced in audits from the very beginning.

A Real-Life Example of the Trouble Caused by a Medicare Audit.

In one case we know of, a therapist was audited by Medicare. The audit by the Medicare administrative contractor (MAC) requested only 30 records. The therapist provided copies of the records he thought the auditors wanted. He did not number the pages or keep an exact copy of what he provided. The MAC came back and denied one percent (1%) of the claims audited. However, since the amount demanded back by the MAC was only a few thousand dollars, the therapist never hired an attorney and never challenged the results. Instead of retaining legal counsel and appealing the results, the therapist paid the entire amount, thinking that was the easy way out.

Unfortunately, because of the high error rate, the MAC immediately placed the therapist on prepayment review of all claims, assuming the prior audit had disclosed fraud or intentional false coding. Every claim the provider submitted from that point on had to be submitted on paper with supporting medical records sent in by mail. The MAC refused to make a decision on any of the claims, instead, holding them and requesting additional documentation and information from time to time. The therapist currently has most of his claims tied up in prepayment review, some for as long as five months with no decision. No decision means no review or appeal rights.

The therapist conveyed to me that he recently contacted the auditor to attempt to obtain decisions on some of his claims so that he could at least begin the appeal process if the claims are denied. He advised me that the auditor at the MAC expressed surprise that he was still in business.

Challenge Improperly Denied or Reduced Claims.

These situations are very unfair and unjust, especially to smaller health care providers. The reduced cash flow even for a month or two may be enough to drive some small providers out of business. Larger health care providers have vast resources sufficient to handle such audit situations on a routine basis. They may have similar problems but are better equipped and have more resources to promptly handle it. Rather than immediately pay whatever amount is demanded on an audit and waive any appeal/review rights, the provider should review each claim denied or reduced and challenge the ones that have been improperly denied or reduced. Otherwise you may wind up with a high error rate which will cause you to be placed into prepayment review. Once placed in prepayment review, it is difficult to get out of it. Often it takes six months or longer.

Don’t Get Caught Up in the Audit Cycle.

Another reason to challenge overpayment demands as a result of an audit is because the audit contractors will keep you on an audit cycle for a number of future audits if they are successful in obtaining any sort of significant recovery from you on the initial audit. This is similar to what happens if your tax return is audited by the Internal Revenue Service (IRS) recovers a significant payment from you because you did not have the documentation to support your deductions, you can expect to be audited for at least the next two years.

The value of competent legal representation at the beginning of an audit cannot be overestimated. It is usually long after the audit is over, and the time to appeal the audit agency’s findings has passed, that the health care provider realizes he should have retained an audit consultation.

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?

Have you ever been audited? What was the process like? Did you retain legal counsel to help with the process? Was having legal assistance worth it? 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.

Report: Florida Received an F in Medical Pricing Transparency

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

6 Indest-2008-3In Florida, it’s difficult to compare prices for medical services and procedures because the various prices are not made public. In part because of this, a recent study by a health-care advocacy group gave Florida an F for transparencies in pricing.


What Did the Analysis Look For?

The report analyzed whether or not states have laws and regulations that require health prices be made public.

Only One State Received an A.

The only state to receive an A in the study was New Hampshire. This is because of its NH Health-Cost site. The site provides consumers prices based on geography, type of insurance and other factors for everything from a basic visit to complicated medical tests. Consumers are able to go on the site and compare prices.

Florida Was Not the Only State to Receive an F.

Every state except five received the lowest grade from the Catalyst for Payment Reform and the Health Care Incentives Institute. So, if F was the average grade, I guess that means that Florida actually only received a C. Maybe there should be a “No State Left Behind” policy.

Comments?

Would you have given Florida an F? Do you think every state should have a health-cost website? Please leave any thoughtful comments below.

Contact Experienced Health Law 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:

Kassab, Beth. “Hidden prices for health care earn Florida an F for transparency.” Orlando Sentinel. (July 16, 2015). Print.

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.

KeyWords: Florida attorney, health care lawyer, health care attorney, law, health law, health care law, medical services, physician attorney, health care defense attorney, health care defense lawyer, health care, health care coverage, health law attorney, health law lawyer, The Health Law Firm

“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 © 1996-2015 The Health Law firm. All rights reserved.

Multiple States Move to Enact New Laws Related to Controlled Substances

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Prescription Drug Monitoring Programs by State.

According to the Los Angeles Times, California is looking to utilize its prescription drug monitoring program CURES to find physicians who are a little too loose with the prescription pad. Lawmakers are contemplating mining the data compiled by CURES to find physicians who are overprescribing and take action against them. Click here to read the entire Los Angeles Times article.

The Pennsylvania house recently forwarded a bill from committee to the floor for a final vote. The bill would establish a monitoring program like those in California, Florida and Kentucky. This monitoring program would be used to combat abuse and doctor shopping by identifying patients that have already received an adequate supply of medications.

Kentucky, already the home of some tough prescription drug laws, is looking to fine tune its regulatory scheme. According to The Courier-Journal, the new bill would clarify existing regulations by providing medical exemptions for patients that would otherwise be wrapped up in the enforcement provisions. To learn more on the proposed changes to Kentucky’s prescription drug laws, click here.

You Can Run, But You Can’t Hide from Prescription Drug Monitoring.

Lawmakers in all three states cited laws and regulations from other states as inspiration for the moves to consider new laws to monitor prescriptions of controlled substances. What this means is that whatever state you may be in, you should be aware that lawmakers are looking around the country at what works and are implementing similar programs and laws in their governments.

Are Databases Just a Tool for Prosecution?

Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

To read legal tips to manage pain patients, click here.

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?

Does the state where you are located have a prescription drug monitoring program? Is it similar to any of programs we mentioned in this blog? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Girion, Lisa and Glover, Scott. “Atty. Gen. Kamala Harris Urges Funding for Prescription Tracking.” Los Angeles Times. (March 3, 2013). From: http://latimesblogs.latimes.com/lanow/2013/03/attorney-general-kamala-harris-funding-prescription-database-.html

Wynn, Mike. “Kentucky Legislature Overhauls Prescription Drug Law.” The Courier-Journal. (March 4, 2013). From: http://www.courier-journal.com/apps/pbcs.dll/article?AID=2013303040093&nclick_check=1

Associated Press. “Lawmakers Mull Prescription Drug Monitoring.” Associated Press. (March 4, 2013). From: http://meadvilletribune.com/local/x986702017/Lawmakers-mull-prescription-drug-monitoring

About the Author: 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.

Zone 4 Program Integrity Contractor (ZPIC) for Medicare and Medicaid Programs is Health Integrity, LCC

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

Health Integrity, LCC, was named the Zone 4 Program Integrity Contractor (ZPIC) for the Medicare and Medicaid programs. As the ZPIC for Zone 4, Health Integrity has been performing benefit integrity activities aimed to reduce fraud, waste and abuse in Medicare and Medicaid data matching programs.

A ZPIC is a business entity that contracts with Medicare and Medicaid and works with state Medicaid agencies, the Centers for Medicare and Medicaid Services (CMS), and law enforcement officials to identify improper billing and utilization patterns throughout Zone 4.

ZPIC Zone 4 includes Texas, Colorado, New Mexico, and Oklahoma.

What is a ZPIC?

ZPICs are private companies contracted by the CMS, used to conduct audits for Medicare and Medicaid overpayments. ZPICS also detect, investigate and gather evidence of suspected fraud and abuse to be turned over to the Office of Inspector General (OIG) for criminal or civil prosecution.. When you hear “ZPIC,” think “fraud.”

ZPIC audits are initiated by:

1. Whistleblower or qui tam lawsuits,
2. Probe audits,
3. Other audit agency findings,
4. Beneficiary/patient complaints,
5. Hotline complaints, or
6. Complaints and notices from other government programs.

How to Handle a ZPIC Audit.

When a physician, medical group or other health care provider receives a notice of an audit and site visit from a ZPIC, things happen fast with little opportunity to prepare. A ZPIC will routinely fax a letter to the practice shortly before the end of a business day the day before a site visit/audit to that practice. Auditors will request to inspect the premises, will photograph all rooms, equipment, furniture, and diplomas on walls. They will usually request copies of several patient records to review later. They will request copies of practice policies and procedures, treatment protocols, all staff licenses and certifications, drug formularies, medications prescribed, and medications used in the office. ZPIC auditors will inspect any medication/narcotic lockers or storage cabinets and will request drug/medication invoices and inventories. You will usually be contacted for follow-up information and documentation after the audit and will eventually be provided a report and, possibly, a demand for repayment of any detected overpayments.

For a checklist on what to do after you receive initial notification of a ZPIC audit, read our two-part blog. Click here for part one and click here for part two.

The Health Law Firm’s Success in a North Carolina Medicaid Action.

In October 2012, The Health Law Firm assisted a North Carolina Medicaid provider in reducing an overpayment demand made by the North Carolina Medicaid program by more than ninety-eight percent (98%). We were brought on to assist the provider in challenging an initial audit. We assembled and submitted documents to the auditor and assisted the client in presenting evidence at the hearing. The final result of the hearing reduced the Medicaid overpayment amount from $1.4 million to just $24,083. To read more on this successful Medicaid action, click here.

State Included in Zone 4.

ZPIC Zones are broken up by state. Health Integrity serves as the Zone 4 ZPIC. As indicated above Zone 4 includes Texas, Colorado, New Mexico, and Oklahoma.

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?

Have you ever received notification of a ZPIC visit or audit? 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.

Why You Should Not Voluntarily Relinquish Your Medical License or DEA Registration Number

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I am often contacted by clients who are health professionals or own businesses in the health care industry who have been approached by government agents or investigators regarding possible complaints or charges. In many cases, the individuals involved do not think to consult with an attorney until many months later, and this may be too late to save the business or professional practice involved. This holds for physicians, dentists, nurses, pharmacists, pharmacies, pain management clinics, physician assistants, group homes, assisted living facilities (ALFs) and home health agencies, among others.

“Voluntary” Relinquishment Treated the Same as a Revoked License.

We have seen a trend recently, especially here in Florida, of investigators immediately offering the person being investigated the option to voluntarily relinquish his or her professional license. This is offered as an option to being investigated, even in the event of very minor or frivolous complaints. The problem is that once an investigation has been opened, then a voluntary relinquishment of a license is treated the same as if it were revoked for disciplinary reasons. It will be very difficult, if not impossible, to ever get a new license under the circumstances.

Furthermore, if the professional has other licenses or similar licenses in other states, then this will be reported to the other states and disciplinary action will probably be initiated against those other licenses.

We have heard horror stories of investigators, accompanied by police or sheriff’s deputies or Drug Enforcement Administration (DEA) agents, making all sorts of threats against a health professional in order to intimidate him or her into giving up a DEA registration number or professional license, including medical licenses, nursing licenses and pharmacy licenses.

In the case of such an incident occurring in Florida, the “voluntary” relinquishment must still be presented to the applicable professional Board and voted on at a scheduled meeting, since it is considered to be disciplinary. It may be possible to withdraw the “voluntary” relinquishment before it is voted on, so all may not be lost.

Think Long and Hard About Relinquishing DEA Registration Number.

However, in the case of the DEA, a DEA registration number is considered gone as soon as the “voluntary” relinquishment paper is signed. This is one of the reasons it is crucial to talk with a knowledgeable health law attorney before making such a decision. The ones putting pressure on you to do this will do everything they can to persuade you not to talk to an attorney. But it is your right to do so. Don’t be rushed or intimidated into making a foolish decision you will regret.

We have represented clients attempting to obtain a new DEA registration number or a new professional license many years after they did a voluntary relinquishment. In most cases, it is an extreme uphill battle and is often not successful.

Additional Consequences of Voluntary Relinquishment of a Professional License or DEA Registration Number.

The following are some of the additional consequences of voluntary relinquishment of professional license or DEA number after notice of an investigation:

1. Disciplinary action will be commenced against any other professional licenses in the state.

2. Disciplinary action will be commenced against any similar licenses in other states.

3. The matter will be reported to any national certification boards of which you are a member and they will most likely commence action against you to revoke your national certification.

4. You will be placed on the Office of the Inspector General’s (OIG) List of Excluded Entities and Individuals (LEIE) and excluded from the federal Medicare Program.

5. You will be terminated from the state’s Medicaid Program, if you are a Medicaid provider.

6. You will be terminated from the panels of any health insurers or managed care plans of which you are a provider member.

There are many other possible repercussions to such actions, so it is extremely important to be prepared if such an event occurs. To prepare you can:

1. Purchase professional licensing defense insurance coverage through Lloyd’s of London, Healthcare Provider’s Service Organization (HPSO), Nurses Service Organization (NSO) or one of the other reputable insurance companies that provide such coverage.

2. Have the names, telephone numbers and other information on good, reputable criminal defense and health law attorneys at hand at all times. Make sure your practice manager has this information as well.

3. Call as soon as an investigator walks in. Don’t wait.

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, 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?

Have you ever been approached by government agents or investigators about possible complaints or changes? What was the experience like? 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.

Tips for Medical Students and Medical Residents Accused of Irregular Behavior on the USMLE

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 frequently receive calls for consultations from students who receive a letter from the National Board of Medical Examiners (NBME) accusing the medical student or medical resident of “Irregular Behavior” on the United States Medical Licensing Examination (USMLE). In many cases these are graduates of foreign medical schools who have applied through the Examination Committee for Foreign Medical Graduates (ECFMG).

Irregular behavior can consist of many different things before, during or after taking the USMLE.  What you must know is that, in effect, you are being accused of cheating.

Examples of What The USMLE Defines  as “Irregular Behavior.”

Examples of the types of conduct which we have seen before include:

–  Attending a commercial USMLE preparation course that provides some of the actual examination questions.

–  Soliciting information on the contents or questions on the examination.

–  Using a cell phone during the examination.

–  Talking with another person during the examination.

–  Sharing information on the types of questions or cases that were on your examination with another person or on a blog over the internet.

These are just a few.  For more examples, please see an article I wrote on this by clicking here.

When Accused of Irregular Behavior Don’t Do  The Following.

We have represented students accused of irregular behavior by consulting with them before and after USMLE hearings and on appealing the results. We have represented a number of examinees at the hearings held before the NBME at its headquarters in Philadelphia, Pennsylvania.

From our experience in such cases, the following are the errors that most of you will make when accused by the USMLE of irregular behavior.

1.  You will fail to obtain an attorney experienced with such cases immediately upon receipt of a letter from the NBME accusing you of irregular behavior.  Take this as a formal charge accusing you of, in effect, cheating.  THIS IS SERIOUS.

2.  You will telephone, write or e-mail the NBME and explain “your side of the story.”  This will be full of admissions that will help prove the case against you and you will not even understand this.  (Please note that under U.S. law any statements you make, oral or written, can be used as evidence against you in any civil, criminal or administrative proceeding.  This is not the case with statements that your attorney makes on your behalf.)

3.  If you submit documents or statements to the NBME in support of your case, these will not be well-organized, well-labeled and in a form simple and easy to understand.  In many instances, you will not even understand the legal issues you are facing or how to refute them.

4.  You will fail to request or attend in person the hearing before the NBME Committee on Irregular Behavior (“The Committee”) in Philadelphia, Pennsylvania.

5.  You will fail to take an attorney experienced in such medical administrative hearings to represent you at The Committee hearing in Philadelphia.

6.  You will not know how to properly present your evidence or present your own position to The Committee, if you do attend the hearing.

7.  You will not know when or what kind of witnesses, including expert witnesses, you need to use to prove issues in your case before The Committee.

8.  You will fail to understand and correctly respond to the questions that the many different Committee members (usually 15 or more) will ask you during the hearing.

9.  You will fail to correctly follow all procedures in order to preserve your rights in the proceedings.

10.  You will falsely believe that if you lose at The Committee hearing you can win on appeal or somehow sue in court and prove you are right; this is almost never correct.  You will have only one chance at proving your case and this is at The Committee hearing in Philadelphia.

11.  You will incorrectly believe that even if you are only suspended from taking the USMLE again for a short period of time, this will have no effect on your education or career.  (Note:  Your USMLE transcript will note this fact and this will probably prevent you from ever getting into a good residency program.  See #1 above.)

 

This Is a Serious Matter, Don’t Think Otherwise.

You and your family have invested tens of thousands, if not hundreds of thousands of dollars, on your education so that you can become a physician.  You have spent years of sacrifice and studying in order to become a physician.  This is not the time to be cheap and to think that the cost of hiring an experienced legal counsel is too high.  You could lose everything you and your family has invested in this. Do not be “penny wise and pound foolish.”  You will need professional help if you are to get through this successfully.  If you don’t care about these matters or you don’t believe this is a serious matter worthy of an investment for attorney’s fees, then go ahead and ignore this advice.

If you are not reading this until after you have lost the case and been found to have committed “irregular behavior” by the USMLE Committee on Irregular Behavior, I am sorry for you, but it is probably too late to do anything about it.

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? 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.

Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

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

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

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?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

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.

Florida Man Sentenced to Prison for Role in Florida Hospital Data Theft

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

A Davenport, Florida, man was sentenced to four years in prison for paying off two Florida Hospital employees to illegally access patient records, according to the Department of Justice (DOJ). A judge sentenced Sergie Kusyakov on April 10, 2013. He was charged with conspiracy and wrongful disclosure of individual identifiable health information.

Click here to read the press release from the DOJ.

Ex-Employees Sold Patient Information to a Co-Conspirator.

Mr. Kusyakov’s sentence stems from a privacy breach at Florida Hospital back in October 2011. The breach involved thousands of patient records that were illegally accessed between 2009 and 2011. Apparently Mr. Kusyakov was paying hospital employee Dale Munroe and his wife to illegally access thousands of records of patients treated at multiple Florida Hospital locations. Mr. Munroe was sentenced in January 2013. Click here to read a previous blog on that story.

Mr. Munroe was allegedly fired in July 2011, after it was learned he accessed the records of a doctor fatally shot in a parking garage. Investigators then found that Mr. Munroe had accessed more than 700,000 patient records, most of whom had been involved in vehicle accidents. Mr. Munroe then sold the records to Mr. Kusyakov, who was associated with two chiropractic clinics. The information was then used to solicit the patients for lawyers and chiropractors. After Mr. Munroe was fired, his wife began stealing patient information. She will be sentenced in July.

HIPAA Privacy Complaints Do Result in Action.

The act of accessing patient records is a direct violation of the Health Insurance Portability and Accountability Act (HIPAA). Many individuals whose privacy is breached fail to realize how effective a HIPAA Privacy Complaint can be. These complaints, which can be filed online to the Office of Civil Rights (OCR), a federal agency, are fully investigated. Stiff civil fines and even criminal prosecutions may result. In serious cases, the FBI investigates them.

Since the time period is short for filing these (180 days), the first step you should take, if your medical privacy is breached, is to file a HIPAA Privacy Complaint with the OCR. Also file a complaint with the hospital or health care provider and with the state agency that licenses the health care provider.

Contact Health Attorneys Experienced in the Confidentiality of Medical Records.

Our attorneys provide advice and legal opinions on confidentiality of medical records and medical information, including HIPAA Privacy Regulation, and are available to testify as expert witnesses on these issues.

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 Mr. Kusyakov’s sentence? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Man Sentenced to Federal Prison for Role in Florida Hospital Theft.” Orlando Sentinel. (April 11, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-florida-hospital-patient-data-theft-20130410,0,3261544.story

Department of Justice. “Davenport Man Sentenced to 4 Years in Prison of Theft of Patient Information.” Department of Justice. (April 10, 2013). From: http://www.justice.gov/usao/flm/press/2013/apr/20130410_Kusyakov.html

About the Author: 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.

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