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Compliance Update
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Written by Sponsor   
Wednesday, 24 July 2019 00:00
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Last Updated on Tuesday, 23 July 2019 10:29
Genetic Testing Scams on OIG Radar Print E-mail
Written by Jacqueline Bain   
Tuesday, 23 July 2019 10:24

On June 3, 2019, the Department of Health and Human Services Office of the Inspector General (the “OIG”) issued a Fraud Alert titled: Genetic Testing Scam. Though the alert is short, the fact that the alert itself was issued is important. The OIG doesn’t often issue fraud alerts, so taking an affirmative step like this shows an increased likelihood of regulatory action.

Physicians, take note. If you are working with a laboratory providing genetic testing services, be sure that laboratory is (1) running those specimens on its own equipment; (2) only sending out testing equipment after receiving your order; and (3) has in place policies and procedures designed to accurately bill for the services it performs and other compliance matters.

Laboratories, take note. You are working in a risky space. Prior to entering into new relationships with consultants or marketers for new tests or specialized tests, take the time to understand where these samples originate. Ensure that your relationships with these persons are compliant. Ensure that you are entering into partnerships based in trust and compliance.

Marketers, take note. If you are working with a laboratory providing genetic testing services, invest in learning how to structure a compliant relationship. You must not (1) target Medicare beneficiaries; (2) offer anything of value in exchange for a person utilizing your laboratory; or (3) be compensated per specimen referred or a percentage of revenue earned based on your efforts.

Genetic laboratory schemes are big money. Just recently (June 27, 2019) the OIG issued a press release detailing that a federal jury in Florida found a Tampa marketer guilty for his role in an over $2.2 million Medicare fraud scheme involving the payment of kickbacks to medical clinics in exchange for the referral of DNA swabs that were obtained from Medicare beneficiaries. Sentencing will be in October.

Importantly, scams like these can apply across the laboratory space (in addition to anywhere in the healthcare spectrum). These practices are likely to be subject to sanctions and penalties even if they are not based in genetic testing. Allergy testing, toxicology testing, and blood tests are all subject to the same laws. As recently as yesterday (July 8, 2019), a laboratory owner was sentenced to 30 months in prison and must pay nearly $3.5 million in restitution for paying illegal kickback to marketers for urine and saliva specimens.

The bottom line is this: if you (a lab owner, a physician, a marketer) are approached to add any specific tests to your line of services, consult with legal counsel first. A small investment at the outset could save you your license, your finances and your freedom later on.
Jacqueline Bain is part of a highly select group of Florida licensed attorneys with both deep healthcare industry experience and a certification in healthcare compliance by the Health Care Compliance Association. To learn more about the author, click HERE.
HIPAA Violations Result in More Than Fines: Beware of Jail Time Print E-mail
Written by Vitale Health Law   
Monday, 01 July 2019 00:00

Late last month, the U.S. Department of Justice announced that a 62-year-old woman would be spending a year behind bars after being convicted of disclosing the health information of two people "with the intent to cause them embarrassment and mental distress."
Linda Sue Kalina worked from March 7, 2016 through June 23, 2017 as a patient information coordinator at Tri Rivers Musculoskeletal Centers, an affiliate of University of Pittsburgh Medical Center (UPMC). It was alleged she accessed the medical records of former classmates, friends and people she had a grievance with. In all, she is said to have accessed health information of more than 100 UPMC patients who had not been provided services at Tri Rivers Musculoskeletal Centers where she worked and therefore had no reason to access.
It also was alleged that she used the medical records to get back at a former employer, where she had worked for 24 years, before losing her job to a younger woman. Kalina admitted to accessing and disclosing personal health information of two employees from her previous job.
In March, Kalina pleaded guilty in federal court to one count of wrongfully disclosing the health information of another individual. Her year in prison is to be followed by three years' supervised release.

Last Updated on Tuesday, 02 July 2019 17:19
Incident-to Billing Investigation Ends in $118,000 Fine Print E-mail
Written by Vitale Health Law   
Thursday, 30 May 2019 00:00

A physician in Texarkana, Texas recently agreed to pay $118,000 to settle allegations he engaged in improper billing practices for his Medicare patients at three of his clinics. According to the allegations, Dr. Donald S. Douglas' advanced practice nurses (APNs) were hired to assist him with seeing patients in his clinics. By law, if the services are provided with proper physician supervision, they may be billed to Medicare at the full physician rate. Without direct supervision, APNs may bill Medicare, under their own national provider identifiers (NPIs) at a reduced rate. It was alleged that Dr. Douglas billed Medicare for services provided by his APNs at the full physician rate, even when a physician was not available to supervise the APNs' services.

Last Updated on Friday, 31 May 2019 11:01
Always Be Prepared: How to Effectively Respond to Commercial Payer Audits Print E-mail
Written by Scott R. Grubman & Gregory A. Tanner, Chilivis, Cochran, Larkins & Bever, LLP   
Wednesday, 17 April 2019 00:00
No matter the size, type, or specialty, all healthcare providers should anticipate and be prepared to be audited by commercial payers. Such audits are typically initiated when a payer sends a request for records to a provider. The records request could be for a random sample of patient charts, or it could be targeted at a specific billing pattern or procedure code. Either way, by requesting records, the payer has put the provider on notice that it is going to examine the documentation and evaluate whether the provider’s records justify the claims submitted for reimbursement. The following are tips to follow when dealing with commercial payer audits:

·         Be Proactive: Do not wait until a payer sends a records request. Be familiar with the rules and requirements that the payer expects providers to follow. Use resources such as the provider agreement, provider manual, and any specific guidance or payment determinations that the payer has published. After gaining an understanding of what each payer expects and requires, providers should establish and implement policies and procedures to properly and completely document their services according to the payers’ rules. The payers’ rules and the provider’s policies for complying with the rules should also be regularly reviewed and updated.  Additionally, providers should consider options for performing self-audits (either conducted in-house or by an outside auditor) to identify and mitigate any potential issues prior to a payer initiating an audit.

·         Comply with Document Requests: It is standard for a commercial payer to reserve the right to conduct audits as a condition of a provider’s agreement with the payer. Specific information about how a commercial payer conducts such audits are usually contained in the payer’s Provider Agreement and/or Provider Manual. The payer is entitled to the records, and such disclosure does not violate HIPAA (although the provider should be sure to send in a HIPAA-compliant secured fashion). Additionally, whether the provider can charge the payer for making copies of the records depends on the payer’s specific policies and the provider agreement, although it is unlikely that the provider may charge the payer for such copies.

·         Do Not Submit Original Records: The records should be produced in electronic format (e.g., PDF files). If some or all of the requested records are contained in hardcopy form, scan the records and make electronic copies to send instead of the originals. The provider should retain the original records. 

·         Know Your EMR System: There are numerous electronic medical records (EMR) systems on the market, and they are not all the same, but they are all customizable. Providers should be familiar with the specific options and customizable features of an EMR system and should ensure that the system’s output settings are properly configured so that copies of electronic records will accurately reflect what the provider intended to document. 

·         Identify Potential Issues: Do not wait for the payer to conclude the audit to find out if there are any issues with the records that were submitted. While gathering the records, try to determine potential weaknesses needing corrective action, and implement changes accordingly.

·         Do Not Alter Patient Records: Sometimes when gathering documents requested for an audit, providers discover an issue in the documentation that may be viewed as problematic. Sometimes such issues could be easily addressed by altering the documents by adding something minor or taking out something that clearly was not intended. In such cases, providers should resist the temptation and NOT alter the records. Adding an addendum may be appropriate, but such an addendum must accurately indicate the date it was added.

·         Do Not Rely on E/M Calculators: Many EMR systems include built in “E/M Calculators” that automatically determine the code level for an office visit depending on the information selected when charting the encounter into the system. Do not trust such electronic calculators to sufficiently support the complexity of a physician’s medical decision-making or other elements considered when selecting the appropriate E/M level. Be sure the record contains all key components required to justify the appropriate E/M level to mitigate the risk of the auditor down-coding or disallowing the level of service billed.  

·         Provide Complete Records:  It is important to note that a records request for a specific date of service potentially could involve other records that need to be included with the requested documents. These might include lab test results, other diagnostic services, orders for these services, referrals, consultation reports, and other documents. Consider whether other documentation should be included that would support the services billed.

·         Timely Produce the Documents: Be mindful of response deadline imposed by the payer. Do not risk having to pay back an overpayment just because the records are sent late. Start preparing to submit the records as soon as the request arrives, and if more time is needed to respond then reach out to the payer and ask for an extension. They are typically willing to give at least one reasonable extension. 

Disclaimer: The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the reader. Access more Mutual Matters articles here.

Last Updated on Thursday, 18 April 2019 10:27
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