Are You the Target of a Medicaid Audit? Tips Health Professionals Should Be Following

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

The Agency for Health Care Administration (AHCA), Office of Inspector General (OIG), and Bureau of Medicaid Program Integrity is the Florida agency responsible for routine Medicaid audits The agency ensures that the Medicaid program was billed correctly for services by health care professionals. Those receiving the greatest amounts of Medicaid payments are also the ones most likely to be audited.

These include pediatricians, Ob/Gyns, family practice physicians, and dentists. The Medicaid audit usually requests information in a questionnaire form. It also includes a request for copies of medical records (including X-rays and other diagnostic studies) for the patients selected for the audit.

If AHCA determines that Medicaid overpaid for services, it will use a complex mathematical extrapolation formula to determine the repayment amount. Additionally, fines and penalties can be added by the Medicaid program. However, you can eliminate or reduce the amount of any such repayment by actions taken both before and during the Medicaid audit.

Practical Tips for Your Practice.

There are ways to run the everyday practice that will help you if you are selected for a Medicaid audit.
1. Every patient record entry should be clearly dated and signed or initialed by the provider. Make sure this is always done.

2. When documenting the patient’s record, make sure that you document exactly what services were needed and completed to support what was billed to Medicaid.

3. Communicate with the person responsible for your billing so that the actual services provided are billed for. Do not bill in advance for anticipated services needed as indicated in the appointment calendar or on a treatment plan.

4. Keep the patient records organized and ready for copying, if necessary. Using only one-sided documents and securely fastening small forms (prescriptions, telephone memos, small sticky notes) onto 8-1/2″ by 11″ paper will help those still using paper charts. Scan all such documents into the patient record using an electronic health record (EHR).

5. Services provided by a physician not enrolled in the Medicaid program to a Medicaid patient may not be billed to or paid by the Medicaid program. Therefore, never allow any other physician associated with your practice who is not enrolled as a Medicaid provider to provide services to Medicaid patients. Do not allow a new physician coming into your practice to treat Medicaid patients until he or she actually has received his or her Medicaid provider number. The group may not bill for the services, nor may another physician bill for the services.

6. Ensure that all health care professionals’ licenses and permits are updated. Ensure that all X-rays, clinical lab, and diagnostic equipment are permitted and kept up to date. Ensure that any CLIA license or exemption certificate is correct and kept up to date. Services billed by unlicensed personnel or services provided by improperly-licensed facilities may not be paid by the Medicaid program.

7. Use only standard abbreviations in your medical records documentation, orders, and reports. While an abbreviation may seem familiar to you or your practice, the auditors may not recognize it if it is not a universally accepted abbreviation.

8. Make sure all records are timely made, accurate and legible. Safeguard them, and never let the original leave your office. Illegible records are treated as a non-record, and payment is wholly disallowed for an illegible note or order. A missing record, X-ray, or chart entry will result in a complete repayment being directed for those services.


The Medicaid Audit.

If you are on the receiving end of an audit, AHCA will send you a letter notifying you. AHCA will also supply you with a list of patients to be sampled. A standard sample will include a list of anywhere from 30 to 150 patient names, as a general rule, depending on the size of the practice. Regular audits routinely request 30 to 50 patients’ records. The audit letter will also include a questionnaire to be completed (Medicaid Provider Questionnaire) and a “Certification of Completeness of Records” form to complete and return with the copies of the patient records. (Please note: This will be used against you in the future if you attempt to add or supplement the copies of the records you provided.)

For more information, read a past blog that will let you know if you are the subject of an audit.

You must retain the services of an expert consultant or experienced health care attorney to correctly and accurately complete the questionnaire. The letter will also request that you provide copies of the patient records for the list of patients included with the letter. You will only be given a short time to provide these documents.

If you have been accused of Medicaid fraud and need to prepare for an audit, watch our informational video blog.

Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations and other Legal Proceedings.

Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Healthcare Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health law attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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

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

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

OIG Exclusion: Do You Know if You’re on the List?

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

Have you ever faced a disciplinary action against your professional license? Have you ever been arrested or convicted of a criminal offense? If yes, then you may have also been terminated from the federal Medicare Program or your state Medicaid Program.

Many health care professionals don’t think about the repercussions that an exclusion action by the Office of the Inspector General (OIG) can have on their professional career. Whether you are a physician, nurse, dentist, psychologist or other health professional, if you allow yourself to be excluded from the Medicare Program, devastating economic results may follow.

First, Check the List.

The first step is to check if you are on the federal government’s List of Excluded Individuals and Entities (LEIE). You can check that list here: http://exclusions.oig.hhs.gov/.

Next, to see if you are on Florida’s list of individuals and entities who have been terminated from Florida’s Medicaid Program, click here.

Collateral Consequences to OIG Exclusion or Termination.

Termination or exclusion can have many collateral consequences about which most health care professionals and providers are not aware. These Include:

– Termination for cause from all state Medicaid Programs.

– Loss of state professional licenses in other states and jurisdictions.

– Loss of hospital, ambulatory surgical center (ASC), and nursing home clinical privileges.

– Removal from the provider panels of health insurers.

– Loss of ability to contract or work for any individual or entity that contracts with the Medicare Program in any capacity. This includes physicians, medical groups, hospitals, healthcare systems, ambulatory surgical centers, skilled nursing facilities, health insurance companies, etc.

– Placement on the General Services Administration (GSA) Exclusions List (or “Debarred” List) from government contracting.

– Loss of ability to contract or work for any individual or entity that contracts with the federal government in any capacity.

To learn more on the consequences of being excluded, click here.

You’re On the List, Now What?

So, you just found yourself on a state’s excluded or terminated list or on the federal LEIE, don’t panic! All is not lost. There are ways to become reinstated.

The OIG exclusion list is a complicated regulatory program which requires experience and perseverance to navigate. It is highly recommended that you do not attempt to handle removal without qualified assistance. If your application is denied, even for hyper-technical reasons, you may be barred from reapplying for one full calendar year. Therefore, it is crucial that your application is complete and correct, and you are fully eligible for removal. To read a past blog about reinstatement after OIG removal, click here.

Contact Attorney Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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

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

KeyWords:  Office of Inspector General, OIG, OIG exclusion list, OIG reinstatement representation, representation for physicians, representation for physician reimbursement, licensure defense attorney, professional license representation, licensure defense representation, representation for health care professionals, investigations analyst, applying for reinstatement, application for reinstatement, Medicare exclusion attorney, OIG hearing, request for reinstatement, removal from list of excluded individuals and entities (LEIE), application to OIG, Medicare reinstatement representation, Medicaid reinstatement representation, healthcare fraud lawyers, Medicare defense attorney, Medicaid defense lawyer, Florida defense attorney, Florida defense lawyer, The Health Law Firm reviews, health law blog, OIG Exclusion, healthcare fraud,

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

OIG Exclusion: What You Need to Know if You’re on the List

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

Have you ever had disciplinary action against your license as a health care professional? Have you ever been arrested or convicted of a criminal offense? Have you ever been convicted of fraud or patient neglect? If so, then you may have also been terminated or excluded from the federal Medicare Program or your state Medicaid Program.

Many health professionals don’t understand the significant repercussions that an exclusion action by the Office of the Inspector General (OIG) can have on their career and employment. Whether you are a physician, nurse, dentist, psychologist or other health professional, if you allow yourself to be excluded from the Medicare Program, devastating economic results may follow.

Check the List.

To check if you are on the federal government’s List of Excluded Individuals and Entities (LEIE), click here.

To see if you are on Florida’s list of individuals and entities who have been terminated from Florida’s Medicaid Program, click here.

Collateral Consequences to OIG Exclusion or Termination.

Termination or exclusion can have many collateral consequences about which most health care providers are not aware. These Include:

– Termination for cause from all state Medicaid Programs.

– Loss of state professional licenses in other states and jurisdictions.

– Loss of hospital, ambulatory surgical center (ASC), and nursing home clinical privileges.

– Removal from the provider panels of health insurers.

– Loss of ability to contract or work for any individual or entity that contracts with the Medicare Program in any capacity (officer agent, shareholder, director, employee or independent contractor, even for non-Medicare products and services such as office supplies, building and construction services, software and systems support, etc.), including physicians, medical groups, hospitals, healthcare systems, ambulatory surgical centers, skilled nursing facilities, health insurance companies, etc.

– Placement on the General Services Administration (GSA) Exclusions List (or “Debarred” List) from government contracting.

– Loss of ability to contract or work for any individual or entity that contracts with the federal government in any capacity (officer agent, shareholder, director, employee or independent contractor, even for such services as construction projects, janitorial contracts, computer equipment and software services, real estate brokers on federally underwritten housing loans, sales of motor vehicles, products and services to the government, etc.

To learn more on the consequences of being excluded, click here.

You’re on the List, Now What?

If you find yourself on a state’s excluded or terminated list or if you find yourself on the federal LEIE, all is not lost. There are ways to become reinstated.

The OIG exclusion list is a complicated regulatory program which requires experience and perseverance to navigate. It is highly recommended that you do not attempt to handle removal without qualified assistance. If your application is denied, even for hyper-technical reasons, you may be barred from reapplying for one full calendar year. Therefore, it is crucial that your application is complete and correct, and you are fully eligible for removal. To read a past blog about reinstatement after OIG removal, click here.

Contact Attorney Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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

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

KeyWords: Exclusion list, Office of Inspector General, OIG, OIG exclusion list, OIG reinstatement representation, representation for physicians, representation for physician reimbursement, licensure defense attorney, professional license representation, licensure defense representation, representation for health care professionals, investigations analyst, applying for reinstatement, Application for Reinstatement, Medicare Exclusion attorney, OIG Hearing, Request for Reinstatement, Removal from List of Excluded Individuals and Entities (LEIE), Application to OIG, Medicare Reinstatement representation, Medicaid Reinstatement representation, healthcare fraud lawyes, Medicare defense attorney, Medicaid defense lawyer, Florida defense attorney, Florida defense lawyer, The Health Law Firm reviews

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

Copying and Pasting Clinical Notes in Electronic Health Records Could Be Considered Healthcare Fraud

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

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) is concerned about healthcare providers carelessly copying and pasting clinical notes in electronic health records (EHRs). According to an audit report released on December 10, 2013, copying and pasting in EHRs can lead to fraudulently duplicated clinical notes, which can be considered healthcare fraud. This practice is allegedly widespread across medicine, according to a Modern Healthcare article. Federal officials say there is a need to crackdown on this behavior.

Click here to read the entire audit report from the HHS OIG.

This is the first of two reports on fraud and vulnerabilities in EHR systems. The second report from the OIG will be on weaknesses in how the Centers for Medicare and Medicaid Services’ (CMS) payment contractors monitor for fraud in EHRs. This report is scheduled to be published soon.

Report Looks at Hospital Policies Regarding Copy-and-Paste Features.

The audit report studied 864 hospitals that had received subsidies for EHR systems as of March 2012. Out of those hospitals, only twenty-four percent (24%) had any policy regarding the improper use of copying-and-pasting in EHRs. The report concluded that too few hospitals actually have policies defining the proper use of copy and paste in EHRs.

According to Modern Healthcare, adoption of EHR systems has coincided with a rapid rise in higher-cost Medicare claims. This has led to officials looking into whether EHRs are enabling illegal upcoding. Officials say that EHR features such as copy and paste make it too easy to bill for work that wasn’t actually performed and help increase reimbursements, according to Modern Healthcare. Click here to read the entire article from Modern Healthcare.

In the report the HHS OIG recommends that the CMS strengthen its efforts to develop a comprehensive plan to address fraud vulnerabilities in EHRs. It was also suggested that CMS develop guidance on the use of the copy-paste feature in EHR technology.

Tips to Help Avoid Copy-and-Paste Errors.

Tools commonly available in EHRs that allow physicians to copy and paste patient information should be used with extreme care, according to an article on American Medical News. The article offers health care providers some guidelines to help avoid errors related to copying and pasting.

– Avoid copying and pasting of text from another person’s notes.

– Avoid repetitive copying and pasting of laboratory results and radiology reports.

– Note important results with proper context, and document any resulting actions. Avoid wholesale inclusion of information readily available elsewhere in the EHR because that creates clutter and may adversely affect note readability.

– Review and update as appropriate any shared information found elsewhere in the electronic record (e.g., problems, allergies, medications) that is included in a note.

– Include previous history critical to longitudinal care in the outpatient setting, as long as it is always reviewed and updated. Copying and pasting other elements of the history, physical examination or formulations is risky, as errors in editing may jeopardize the credibility of the entire note.

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

What This Means for Healthcare Providers Using EHRs.

The practice of copying and pasting previous information without checking can be considered careless and potentially dangerous to patients. It can be problematic when there are multiple teams taking care of one patient and using the chart to communicate. The right way is to make sure everything in the note you sign accurately reflects what happened on your shift.

In the report the HHS OIG stated that copy-and-paste features in EHRs will be under additional scrutiny. By knowing where the enforcement focus will be, providers can attempt to avoid copy-and-paste practices that are likely to lead to audits. Additionally, providers can beef up compliance efforts and policies.

Contact Health Law Attorneys Experienced in Handling Medicare and Medicaid Audits, Investigations and other Legal Proceedings.

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.

Don’t wait until it’s too late. If you are concerned of any possible violations and would like a consultation, contact a qualified health attorney familiar with medical billing and audits today. To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

In your practice do you use an EHR system? Have you had any issues with copying and pasting clinical notes? Does your practice have a copy-and-paste policy? Please leave any thoughtful comments below.|

Sources:

Carlson, Joe. “Fed Eye Crackdown on Cut-and-Paste EHR Fraud.” Modern Healthcare. (December 10, 2013). From: http://www.modernhealthcare.com/article/20131210/NEWS/312109965/cut-and-paste-function-can-invite-ehr-fraud-officials-say

O’Reilly, Kevin. “EHRs: ‘Sloppy and Paste’ Endures Despite Patient Safety Risk.” American Medical News. (February 4, 2013). From: http://www.amednews.com/article/20130204/profession/130209993/2/

Levinson, Daniel R. “Not All Recommended Fraud Safeguards Have Been Implemented in Hospital EHR Technology.” Department of Health and Humans Services Office of Inspector General. (December 2013). From: http://www.modernhealthcare.com/assets/pdf/CH92135129.PDF

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.

OIG Audit Finds Federal Database of Terminated Medicaid Providers Needs Improvement

LLA Headshot smBy Lenis L. Archer, J.D., M.P.H., The Health Law Firm

The Affordable Care Act (ACA) requires the Centers for Medicare and Medicaid Services (CMS) to establish a process for sharing information about terminated Medicaid providers. The federal database, called Medicaid and Children’s Health Insurance Program State Information Sharing System (MCSIS), is designed to prevent terminated health care providers from billing another state’s program. However, an audit by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), released in March 2014, states the MCSIS is not working as intended.

The MCSIS is supposed to collect data from every state Medicaid program on providers that were terminated from Medicaid for cause. However, the report found that the HHS OIG is not receiving data from 17 states or the District of Columbia. It was also found that a majority of the data does not meet the ACA criteria.

To read the entire report from the HHS OIG, click here.

Specific Issues Within Database.

According to the OIG, only 27% of the 6,439 MCSIS records involve terminated Medicaid providers. The database is filled with providers who had not been terminated, but rather had died, retired, left the state or stopped working with Medicaid of their own accord. It is also reported that about one-third of the records are not related to for-cause provider terminations. A majority of the data comes from California, Pennsylvania, Illinois and New York. According to Reuters, more than half of the records submitted did not include a National Provider Identification number, which is critical to any state trying to identify a terminated provider.

Click here to read the entire article from Reuters.

Recommendations to Improve Database.

CMS is now exploring options to implement mandatory state reporting. The agency has begun requiring that states submit termination letters for each provider entered in the MCSIS, and that CMS employees review each letter to ensure the provider belongs in the system.

What This Means for Medicaid Providers.

As CMS works to improve this database, those providers who have fallen through the cracks due to the reporting lag will now face repercussions for exclusion. Exclusion from Medicaid could mean exclusion from Medicare and other federal providers. It is important that health care providers know their status regarding exclusion, and contact an experience attorneys to assist them in having their names removed from exclusion lists.

To read more on the devastating consequences of exclusion, click here for a previous blog.

Contact Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare or Medicaid Programs.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare or Medicaid  Programs, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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 provider, do you know your status regarding exclusion? Are you aware of the consequences of being excluded? Please leave any thoughtful comments below.

Sources:

Pell, M.B. “U.S Database for Tracking Medicaid Fraud Fall Short, Auditor Says.” Reuters. (March 27, 2014). From: http://www.reuters.com/article/2014/03/27/us-usa-medicaid-database-idUSBREA2Q08D20140327

Levinson, Daniel. “CMS’s Process for Sharing Information About Terminated Providers Needs Improvement.” Department of Health and Human Service Office of Inspector General. (March 2014). From: http://oig.hhs.gov/oei/reports/oei-06-12-00031.pdf

About the Author: Lenis L. Archer is as 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 © 1996-2014 The Health Law Firm. All rights reserved.

New OIG Guidance Publishes on Permissive Exclusions from Federal Health Care Program Participation May Interest Mental Health Care Professionals

By Miles Indest, J.D./M.B.A candidate at Tulane University: Law Clerk, The Health Law Firm

On April 20, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released updated non-binding criteria that disclosed when a company or individual can be barred from participating in Medicare, Medicaid, and other federal health care programs.

The OIG has permissive authority to exclude a person or company from participation in federal health care programs for engaging in certain prohibited conduct, such as false claims or kickbacks. The OIG has consistently asserted that there is a presumption in favor of exclusion. The new guidance updates the OIG’s position by stating that its presumption in favor of exclusion is rebuttable in certain situations. Importantly, the OIG guidance outlines those situations and the risk factors that trigger an exercise of its permissive authority.

Four Factors May Affect OIG’s Decision to Exclude an Individual or Entity.

In its release, the OIG outlined four non-binding factors that signal a compliance risk and can affect its decision to pursue an exclusion: (1) the nature and circumstances of the prohibited conduct; (2) the conduct during the Government’s investigation; (3) any significant ameliorative efforts; and (4) the history of compliance.

First, the OIG will evaluate the nature and circumstances of the bad actor’s conduct. For instance, conduct that causes physical, mental, or financial harm to others increases compliance risk, thereby increasing the likelihood that the OIG will pursue an exclusion. Similar to the Department of Justice’s heightened focus on individual accountability, the OIG stressed that it will scrutinize an individual’s role in planning or leading unlawful conduct, which increases compliance risk.

Second, the OIG will assess the bad actor’s conduct during the Government’s investigation. If that person obstructed or impeded the investigation of the unlawful conduct, then the OIG will be more likely to pursue an exclusion. Notably, the OIG stated that a prompt response to a subpoena is “expected” and will not favorably affect the risk assessment.

Third, the OIG will weigh the bad actor’s ameliorative or remedial steps taken after the prohibited conduct occurred. For example, an entity that takes disciplinary action against individuals responsible or the conduct will lower its compliance risk. Similarly, individuals that receive new training or retain a mentor to improve their health care practice will face a lower risk of exclusion.

Finally, the OIG will focus on the bad actor’s history of compliance with the OIG. Importantly, the existence of a compliance program will not affect the risk assessment— likely another “expected” requirement of health care organizations. In contrast, the absence of a compliance program will increase compliance risk and the likelihood that the OIG will pursue an exclusion.

The OIG update ultimately reflects the government’s increased expectations of compliance programs and heightened scrutiny of individual wrongdoing. As federal agencies continue to prioritize the prosecution of fraud and abuse, health care organizations and practitioners would be wise to proactively address these concerns internally.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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: Miles Indest, J.D./M.B.A. candidate, will graduate in May 2016 from Tulane University Law School and the Freeman School of Business. He has served three years as a member of Tulane Law Review, and currently serves as the Writing Skills Chair of Tulane Moot Court.

Sources:

“Criteria for Implementing Section 1128(b)(7) Exclusion Authority.” U.S. Department of Health and Human Services Office of Inspector General. (2016). Web.

Dani Kass. “HHS Watchdog Lays Out New Grounds For Exclusion List.” Law360. (2016). Web.

KeyWords: Health law, Office of Inspector General, exclusion list, defense lawyer, exclusion, OIG, OIG exclusion list, Florida defense attorney, reinstatement, application for reinstatement, OIG hearing,Medicare exclusion, Medicare reinstatement, Removal from List of Excluded Individuals and Entities, LEIE, Florida defense lawyer, defense attorney, 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 © 2016 The Health Law Firm. All rights reserved.

By |2024-03-14T10:01:12-04:00May 15, 2018|Categories: Mental Health Law Blog|Tags: , , , , , , , , , , , |Comments Off on New OIG Guidance Publishes on Permissive Exclusions from Federal Health Care Program Participation May Interest Mental Health Care Professionals

OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

LLA Headshot smBy Lenis L. Archer, J.D., M.P.H., The Health Law Firm

There is an inherent risk in entering into financial arrangements where payments to a service provider are only made when a referral is generated. On August 15, 2014, the Office of Inspector General (OIG) made this perfectly clear in an unfavorable advisory opinion issued to a specialty pharmacy that wanted to pay local retail pharmacies for providing support services to it.

Background of Request for OIG Advisory Opinion.

According to the OIG, the requestor, a specialty pharmacy, dispenses specialty pharmaceuticals used to treat a variety of chronic and life-threatening illnesses. The specialty pharmacy stated that the drugs offered at its establishment are frequently unavailable to retail pharmacies. In light of this, the specialty pharmacy asked whether it would be permissible to enter into agreements with various local pharmacies in which the specialty pharmacy would provide its specialty drug prescriptions to local pharmacies’ patients. Under the proposed contractual arrangement, the local pharmacies would be required to provide various support services, including:

1. Accepting the prescription from the patient or prescriber;
2. Gathering patient and prescriber demographic information;
3. Recording patient-specific history and use, including drug names, strength and directions;
4. Patient counseling;
5. Informing the patients about access to specialty drugs, including the availability from pharmacies other than the specialty pharmacy;
6. Obtaining patient consent to forward the prescription to the specialty pharmacy;
7. Transferring prescription information to the specialty pharmacy; and
8. Providing ongoing patient assessments for subsequent refills.

The retail pharmacies would be paid a “per-fill fee” by the specialty pharmacy at the time that the initial prescription was transmitted and upon each subsequent refill.

OIG Issued Negative Opinion Due to Anti-Kickback Statute.

The OIG issued an unfavorable opinion for this proposed agreement, concluding that the federal Anti-Kickback Statute was implicated because the specialty pharmacy would pay a per-fill fee for support services each time a local pharmacy referred a specialty drug prescription. After evaluating the arrangement, the OIG concluded that the per-fill fees were inherently subject to abuse because they were paid only when the support services provided by the retail pharmacy resulted in a referral to the specialty pharmacy. Thus, the OIG found that such a per-fill fee is directly linked to business generated by the local pharmacy for the specialty pharmacy, and could influence the local pharmacy’s referral decisions. OIG noted that the Anti-Kickback Statute is implicated if one purpose of the remuneration is to generate referrals.

Click here to read OIG Advisory Opinion No. 14-06.

Exceptions to Anti-Kickback Laws.

Like many other regulatory frameworks, the Anti-Kickback Statute has exceptions. The law provides a number of safe harbors to the rule which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Anti-Referral and Anti-Kickback Laws.

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.

We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws.

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.

Sources:

Department of Health and Human Services Office of Inspector General. “OIG Advisory Opinion No. 14-06” (August 15, 2014). From: https://oig.hhs.gov/fraud/docs/advisoryopinions/2014/AdvOpn14-06.pdf

Ciesla, Frank, Christian, Beth, and Burd, Ari. “Office of Inspector General (OIG) Issues Unfavorable Advisory Opinion to Specialty Pharmacy for Support Service Payments.” The National Law Review. (August 18, 2014). From: http://www.natlawreview.com/article/office-inspector-general-oig-issues-unfavorable-advisory-opinion-to-specialty-pharma

About the Author: Lenis L. Archer is as 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 Ave., 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.
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