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Compliance Update
Failure to Abide by Corporate Integrity Agreement Can Trigger Additional Woes Print E-mail
Written by The Health Law Offices of Anthony C. Vitale   
Tuesday, 23 June 2020 09:54

On June 1, the Departmental Appeals Board (DAB) voted to uphold an order issued by the Department of Health and Human Services Office of the Inspector General (HHS-OIG) against a group of Tennessee-based home health companies to pay $1,322,500 in stipulated penalties for breaches of their Corporate Integrity Agreement (CIA).

OIG negotiates Corporate Integrity Agreements as part of settlements resulting from federal healthcare program investigations that arise under a variety of civil false claims statutes. Providers or entities agree to certain obligations laid out in the CIA, and in exchange, OIG agrees not to seek their exclusion from participating in Medicare, Medicaid or other federal healthcare programs. CIAs can be used to address matters relating to quality of care or corporate integrity.

In this case, Friendship Home Health Inc. et al. and its owner Theophilus Egbujor, paid $6.5 million, plus interest, to resolve allegations that they improperly billed TennCare, Medicare and TRICARE for home health services, according to a news release. As part of the agreement, which was reached in June 2015, Friendship, and its owner, also agreed to be bound by the terms of a CIA with the HHS-OIG in an effort to avoid future fraud and compliance failures.

However, on November 19, 2018, OIG sent the Friendship entities a demand for $1,322,500 in stipulated penalties for failing to uphold its end of the CIA by not repaying overpayments identified in their second and third annual reports. Friendship appealed and requested a hearing with a DAB Administrative Law Judge. On October 31, 2019, the ALJ upheld OIG’s demand. The Friendship Entities then appealed to the DAB.

In its decision, the DAB agreed with the administrative law judge’s conclusions that the CIA’s auditing and repayment provisions created independent obligations to repay overpayments to Medicare and Medicaid, and that each time the Friendship entities violated those obligations to repay overpayments, it created a separate basis for OIG to demand stipulated penalties.

The DAB also agreed that the Friendship entities were properly subject to stipulated penalties arising from those failures and further held that the CIA authorizes per-day stipulated penalties to run concurrently for each failure to make timely repayment.

As in the case of Friendship, CIAs include breach and default provisions allowing the OIG to impose monetary penalties for failing to comply with those obligations included in the CIA.

While CIAs generally come at the end of a government investigation, it’s important to note that it does not mean your obligations to comply are over.

While CIAs address specific facts to each case, they also have common elements.  A comprehensive CIA typically lasts 5 years and includes requirements to:
  • Hire a compliance officer/appoint a compliance committee
  • Develop written standards and policies
  • Implement a comprehensive employee training program
  • Retain an independent review organization to conduct annual reviews
  • Establish a confidential disclosure program
  • Restrict employment of ineligible persons
  • Report overpayments, reportable events, and ongoing investigations/legal proceedings
  • Provide an implementation report and annual reports to OIG on the status of the entity’s compliance activities.
A material breach of the CIA constitutes an independent basis for the provider’s exclusion from participation in federal healthcare programs.

For healthcare providers and entities considering a CIA, it is important to understand that HHS will continue to monitor compliance and failure to comply with those terms agreed upon will, as evidenced by the Friendship case, result in additional penalties.
The Health Law Offices of Anthony C. Vitale can help you to develop an effective compliance program that allows you to identify and correct any problems before you become the target of an investigation. Should you or your company become the target of an investigation, an effective compliance program may help you to mitigate or eliminate potential sanctions, penalties, and program exclusions. Give us a call at (305) 358-4500 or email You can also access more great articles on health law and compliance by visiting the Vitale Health Law blog.
Last Updated on Tuesday, 23 June 2020 16:10
Can Healthcare Workers Be Forced to Work, During the Pandemic? Print E-mail
Written by Ben Assad Mirza, Esq., LLM, CPA, MPHA, CHC   
Monday, 01 June 2020 00:00

Healthcare workers are today’s soldiers against Covid-19. They are self-sacrificing, hardworking, usually over extended, and have much to be concerned about including their families. When dealing with Covid-19, many healthcare workers are wondering if they have the right to not work, much like most of society. Long gone are the days of indentured servitude. However, generally, employees do not have the right to refuse work at their discretion or else they can potentially face disciplinary actions or even termination. However, under exceptional circumstances Covid-19 may trigger the Occupational Safety and Health Act (OSHA):

1) Lack of Safety Equipment – depending on the level of exposure, the lack of basic safety measures such as disinfectants, sanitizers, safety masks and equipment may cause an imminent risk of life or health to the employee, which an employer is responsible for providing. Depending on the level of exposure to the worker and the availability of safety equipment, this situation could trigger OSHA issues.

2) Employee Disability - if an employee has a known disability that puts them at higher risk for contracting Covid-19 then the employer is required to make reasonable accommodation, like letting them work outside of the risky environments. 

The two above conditions are something to be mindful of in today’s environment. Another issue affecting workers might be a family member who is seriously ill.

3) Family Medical Leave Act (FMLA), may be an obligation that an employer should be mindful of.  If it is triggered, employees may get up to 12 weeks of relief so they can take care of their spouse, child, or parent with a serious medical condition. FMLA is very specific and it does not apply to all situations. FMLA is only triggered if the employee has worked more than 1250 hours in the last 12 months and the employer employs over 50 employees at or near the location of work. Serious medical condition is something that is documented; it may require hospitalization or continuous medical care, etc. it depends.  Note: Caring for a child for lack of not being able to find childcare is typically not deemed a qualifying condition to invoke FMLA.

An employee does have the right to ask for safety equipment and for policies and procedures in place from an employer concerning the issues pointed out above. 

The general public has much heart felt gratitude for today’s healers. 
Ben Assad Mirza, Esq., LLM, CPA, MPHA, CHC
Healthcare Law Partners, LLC
Fort Lauderdale

Last Updated on Tuesday, 02 June 2020 16:44
State Surgeon General Issues Order 20-007 Print E-mail
Written by Susan St. John   
Monday, 11 May 2020 00:00

In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner's ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician's ability to recertify an existing qualified patient's use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.

Last Updated on Tuesday, 12 May 2020 17:44
DOJ's First Antitrust Criminal Prosecution of a Health Care Provider in 25 Years May Signal a New Era for Health Care Antitrust Print E-mail
Written by Mitchell D. Raup & Herbert F. Allen   
Friday, 08 May 2020 18:36

Antitrust enforcement against physicians and hospitals is common, but criminal antitrust prosecutions of health care providers are very rare. There were none for over 50 years, between 1940 and 1990.  The Antitrust Division of the U.S. Department of Justice brought two criminal cases in 1990 and 1995, charging dentists and optometrists with price-fixing. Then for 25 years, DOJ did not charge a provider with an antitrust crime. Until now.

On April 30, 2020, DOJ charged a Florida oncology clinic with a criminal antitrust conspiracy. The one-count criminal information in US v. Florida Cancer Specialists & Research Institute LLC ("FCS") alleges that FCS conspired with another oncology clinic, 21st Century Oncology, and other unnamed co-conspirators, to allocate markets in southwest Florida. They agreed that FCS would do medical oncology and 21st Century Oncology would do radiation oncology, and the two would not compete against each other. This conspiracy continued for 17 years, from 1999 to 2016.

The case settled with a deferred prosecution agreement, in which FCS agreed to pay $100 million (the maximum criminal fine for a corporation convicted of a single antitrust violation) and to cooperate in DOJ's prosecution of others involved in the conspiracy. In a separate settlement with the State of Florida, FCS agreed to pay Florida another $20 million.

Last Updated on Thursday, 25 June 2020 08:36
CARES Act Funding Creates Dilemma for Some Healthcare Providers Print E-mail
Written by Vitale Health Law   
Monday, 04 May 2020 00:00

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief and Economic Security (CARES) Act which provides $100 billion in relief funds to hospitals and other healthcare providers who are on the front lines of the COVID-19 response. Many providers have been receiving these funds without having applied for them. However, in order to keep the monies, providers must attest to the Terms and Conditions. After reading through some of the provisions, some are now concerned about whether to accept the funding or send it back. Among some of the key provisions:
  • The recipient must certify they are not currently terminated from participating in Medicare, Medicaid or other federal healthcare programs and do not currently have Medicare billing privileges revoked.
  • The recipient must certify that the payment is used only to prevent, prepare for and respond to COVID-19 and/or its complications and that the patients identified on the claim form were uninsured individuals at the time the services were provided.
  • The recipient must certify that the money will not be used to reimburse expenses or losses that have been reimbursed from other sources, or that other sources are obligated to reimburse.
Last Updated on Tuesday, 05 May 2020 15:07
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