Interagency Fraud Enforcement Action Highlights Telepharmacy Compliance Risks

Todd Collis, Brian Murray and Dan Zinsmaster

In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S. Postal Services (USPS), the Federal Bureau of Investigation (FBI), the Office of Personnel Management (OPM), and the Department of Homeland Security (DHS). The sheer depth of the investigation, as well as the breadth of the federal agencies involved, indicate that HHS/OIG and other federal agencies are becoming increasingly aggressive in enforcing health care fraud, waste, and abuse laws in the pharmacy and telemedicine industries.

At its core, the suspect business model involved a telemarketing/pharmacy entity that solicited patients’ insurance information using a platform to arrange for telemedicine visits with physicians. During these telemedicine visits, physicians would issue prescriptions for items such as pain creams, vitamins, and other prescription drugs, which the telemarketing/pharmacy entity then sold to pharmacies for mail-order fulfillment at marked-up prices. The sale and fulfillment of these prescriptions resulted in substantial volumes of false claims being filed with pharmacy benefits managers (PBM), and also generated a quid pro quo kickback for the telemarketing/pharmacy entity (i.e., the pharmacy would pay the telemarketing/pharmacy entity for the opportunity to fill lucrative telemedicine prescriptions). The individuals involved in the scheme were primarily located in the state of Florida, although individuals and entities in Tennessee, Mississippi, and Texas were also implicated.

Although this particular OIG case is similar to recent pharmacy fraud cases involving marketing agencies, the case suggests the federal government is growing increasingly sophisticated in the manner in which it investigates and enforces fraud, waste, and abuse laws. For example, individuals involved in the case were charged with an extensive set of crimes including, but not limited to, mail fraud, conspiracy to commit health care fraud, wire fraud, and the introduction of misbranded drugs into interstate commerce. Moreover, the individuals initially faced possible prison terms of up to 33 years for their conduct, and one individual also faced over $24 Million in restitution. Sentencing of these individuals will take place in October 2021.

In light of this case, it is important for stakeholders in the pharmacy and telemedicine industries to understand that seemingly innocuous activity can result in significant penalties. Further, participation in health care fraud schemes, even unknowingly, can result in significant criminal, civil, and administrative sanctions as a result of multi-agency investigative activities.

It is crucial stakeholders in the pharmacy and telemedicine industries educate themselves on, and observe, compliant business arrangements and practices, and periodically evaluate whether their current and future business arrangements are susceptible to possible fraud, waste, and abuse investigation and enforcement. Further, industry stakeholders should also consider the benefit of conducting enterprise-wide compliance training and adopting policies and procedures in order to prevent fraudulent activity.

If you or your organization are involved in the delivery of pharmacy, telemedicine, or other health care services, please contact Dinsmore’s health care practice group to learn more about how you can address and prevent health care fraud, waste, and abuse.

Admissions to Board Investigator Can Be Used Against Physician in Criminal Trial

On December 15, 2020, the Ohio Supreme Court ruled 6-1 that a physician’s admissions made to an Ohio Medical Board investigator can be used against the physician in his criminal trial.

In 2017, three patients accused Dr. James Gideon of inappropriate touching during office visits.  Gideon told Bluffton police he did not inappropriately touch any patients.  Subsequently, however, an Ohio Medical Board investigator made an unannounced visit to Gideon’s office.  Gideon, who was aware of the Ohio Medical Board legal requirement to cooperate with and provide truthful answers to the investigator, admitted to “touching certain areas on the patients and succumbing to temptation”. The investigator provided these admission to Bluffton police.

Gideon was charged with three misdemeanor counts of sexual imposition.  At trial, he argued that the statements he made to the investigator should be suppressed based on the Fifth Amendment protection from being forced to incriminate himself.

The trial court did not suppress Gideon’s incriminating statements because it found that Gideon voluntarily made the statements to the investigator.  Gideon was found guilty in all three cases and was sentenced to 180 days in jail.

On appeal, the appeals court ruled that the trial court should have suppressed the incriminating statements because his statements were not voluntary.

Upon review, the Ohio Supreme Court reviewed that the Fifth Amendment to the U.S. Constitution includes the right to remain silent where a person’s replies might be used against the person in future criminal proceedings.

The Ohio Supreme Court held that, in order to determine that Gideon’s statements were coerced in violation of his Fifth Amendment rights, Gideon had to demonstrate that (i) he subjectively believed that failure to cooperate with the investigator would lead to the loss of his license, and (ii) his belief that he was being threatened was objectionably reasonable by providing some evidence of pressure beyond merely directing him to cooperate in the investigation.  The Ohio Supreme Court found that Gideon’s belief that he was being threatened was not objectively reasonable under the facts and circumstances of the investigation.

Health care and other professional licensees in Ohio must be aware that information provided to an investigator – whether that is an investigator employed by the Medical Board, Nursing Board, Pharmacy Board, or any other board or agency – can be used against the licensee in a disciplinary action and in a criminal proceeding.  Legal counsel is recommended for any licensee in connection with any Board investigation or disciplinary action.

If you have any questions about this article or the State Medical Board of Ohio, please feel free to contact attorney Beth Collis at (614) 628-6945, or attorney Todd Collis at (614) 628-6962.

Reporting by Physicians Enrolled in Medicare

Physicians enrolled in Medicare are required to report to Medicare the following events as soon as possible, but not later than 30 days following the event:

Change in Practice Location: A change in practice locations including, but not limited to  a new practice location, moving an existing practice location, or closing an existing practice location must be reported.

Change in Final Adverse Action: A change including, but not limited to, debarment or exclusion by a federal or state health care program, medical licensure suspension or revocation by a licensing board, conviction of a felony in the last 10 years, or revocation of Medicare privileges must be reported.

Physicians enrolled in Medicare are required to report to Medicare the following events as soon as possible, but no later than 90 days following the event:

Change in Business Structure: A change in business structure, for example, from a sole proprietor to a corporation must be reported.

Change in Legal Business Name or Employer Identification Number: A change in a company legal business name or IRS Employer Identification Number must be reported.

Change in Practice Status: A change in practice status including, but not limited to, retirement or voluntarily withdrawal from Medicare must be reported.

There are other reportable events.  Failure to timely report a reportable event may jeopardize a physician’s participation in Medicare.

If you have a question concerning your responsibilities to report a particular event to Medicare, contact Todd Collis or Beth Collis.

Ohio Counselor, Social Worker, and Marriage and Family Therapist Board Issues Emergency Rule 4757-5-13 Regarding Teletherapy

On April 6, 2020, the Ohio Counselor, Social Worker, and Marriage and Family Therapist Board (“CSWMFT Board”) filed emergency rule 4757-5-13. The rule will remain in effect until August 4, 2020. In its announcement, the CSWMFT indicated that the emergency amendments to the rule expand access to teletherapy services for clients by:

• clarifying that no training is required prior to providing teletherapy, however, the rule requires that licensees provide services only if they can competently provide such services
• waives the requirement to hold a face to face meeting in-person or via video prior to rendering services;
• allows for verbal consent when written consent cannot be obtained; and
• follows federal guidance regarding HIPAA compliant technology.

In its announcement, the CSWMFT Board also indicated that licensees should consider the following questions if they are going to provide teletherapy:

1. Do I have the skills and competencies necessary to provide teletherapy? If the answer is no, what do I need to do to develop those skills?
2. Do I have the right recordkeeping practices in place?
3. Does my liability insurance allow me to provide teletherapy?
4. Is my employer supportive of my doing teletherapy?
5. Are insurers whom I will be billing allowing for teletherapy?
6. If you are planning to continue to provide services to existing clients, who among your clients might benefit from teletherapy? Who might face challenges?
7. If you are working with new clients via teletherapy, are you prepared to assess the appropriateness of video or phone therapy with the clients?
8. How do you ensure equitable opportunities for all clients? Are you prepared to refer out any clients whom you cannot serve because of insurance issues, the presenting problem, or client issues with being served via video or phone?
9. Do the presenting problems you often treat translate well over teletherapy?

For the full CSWMFT Board Statement, go here.

As always, if you have any questions about this post or about the Ohio Board of Nursing in general, feel free to contact Beth Collis or Todd Collis.

Ohio Board of Pharmacy Takes Additional COVID-19 Response Efforts

On March 24, 2020, the State of Ohio Board of Pharmacy (“OBP”) took additional COVID-19 response efforts to protect the health and safety of Ohioans during the COVID-19 outbreak. These efforts include, but are not limited to:

• Authorized expedited licensure of drug distributors; and
• Authorized sale and shipment of non-reportable dangerous drugs that are in shortage by unlicensed, out-of-state facilities.

The OBP also reminded its licensees that pharmacies and terminal distributors of dangerous drugs are not required to submit a notification to the OBP for any temporary closures or reduction in operating hours. If modifying operating hours, a pharmacy must update signage to reflect the change in store hours.

Read more HERE and HERE.

As a reminder, the OBP also implemented required infection control procedures effective March 19, 2020.

Read more HERE.

If you are seeking guidance concerning obtaining expedited licensure as a drug distributor or have questions concerning OBP requirements during COVID-19, contact Todd Collis.

State of Ohio Board of Pharmacy Implements Infection Control Procedures in Face of Corona Virus

Updated 3/19/2020

The State of Ohio Board of Pharmacy issued new requirements to implement safeguards to allow pharmacy professionals employed by a terminal distributor to practice pharmacy in a safe and effective manner.

The Ohio Pharmacy Board issued the following (emphasis added):

Section 4729.55 of the Revised Code requires a pharmacy to implement adequate safeguards that allow pharmacy professionals employed by a terminal distributor to practice pharmacy in a safe and effective manner. This includes implementing safeguards to protect pharmacy professionals (pharmacists, interns, technician, and support personnel) and patients during a public health emergency.

To comply with the requirements of section 4729.55 of Revised Code, the Board has determined the following steps shall be implemented by all pharmacies located in Ohio starting no later than 5 p.m. on Thursday, March 19, 2020 to ensure the practice of pharmacy can be conducted in a safe and effective manner:

• For pharmacies open to the public, consider developing a process for older adults (60+), pregnant women, and individuals with chronic health conditions to pick up medications without waiting in line (i.e. post signs directing to drive-thru, offer curb-side delivery, mail delivery, senior hours, etc.).
• Implement infection control procedures, especially for waiting areas, to include the following:
• Pharmacies with workspaces that currently allow patients to get closer than the minimum recommended distance of 3 feet should post signage or utilize other methods to ensure patients who are waiting are maintained at a safe distance. NOTE: This does not apply to patients who must interact with pharmacy staff (i.e. for purposes of payment, immunizations, etc.) or pharmacies that are not open to the public.
• Pharmacists and pharmacy interns shall no longer be permitted to administer immunizations or other injections without standard protective measures, which includes gloves and proper hand hygiene (i.e. routinely washing hands with soap and water for at least 20 seconds). Standard protective measures do not include the use of masks or gowns.
• Pharmacists and pharmacy interns shall not administer any immunizations or other injections to patients displaying or reporting symptoms of respiratory illness, including any of the following:
  • Fever (NOTE: This does not require mandatory temperature checks);
  • Cough; or
  • Shortness of breath.
• Pharmacy professionals who are older adults, pregnant women, or individuals with chronic health conditions shall not be prohibited from wearing appropriate PPE to operate within a pharmacy.
• Regularly clean and disinfect counters, credit/debit card devices, waiting areas, and other spaces where public interaction occurs with an EPA-approved disinfectant. Clean at least every hour or after every 10 patients, whichever is more frequent. If cleaning and disinfecting products are in short supply, the Ohio Department of Health has developed the following guidance. Read here.
• If available, place alcohol-based hand sanitizer next to the checkout window so people can sanitize their hands after using common items, like the pen used to sign for prescriptions or devices used to process credit/debit card transactions. REMINDER: Manual signatures from patients are not required by Board of Pharmacy rule (see Important COVID-19 Reminders section of this guidance document for more information).
• Provide regular breaks for staff to engage in proper hand hygiene (i.e. routinely washing hands with soap and water for at least 20 seconds). 
• Monitor pharmacy staff for symptoms of respiratory illness, including any of the following:
  • Fever (NOTE: This does not require mandatory temperature checks. However, the Ohio Department of Health recommends pharmacies take staff temperatures once per shift);
  • Cough; or
  • Shortness of breath.

Staff exhibiting or reporting any of these symptoms must be sent home.

Failure to comply with the requirements set forth in this document may result in administrative discipline for the pharmacy and the pharmacy’s responsible person.

As always, if you have any questions concerning this post, contact Todd Collis or Beth Collis.

Ohio Counselor, Social Worker, and Marriage and Family Therapist Board Responds to Corona Virus

In connection with the Corona Virus, we have received numerous inquiries from our Ohio counselor and social worker clients concerning teletherapy services.

The Ohio Counselor, Social Worker, and Marriage and Family Therapist Board (“CSWMFT Board”) recently posted the following information on its website:

The Board’s rules regarding providing teletherapy are established in Ohio Administrative Code Chapter 4757-5-13. Licensees who are considering offering services via teletherapy should be mindful of the following:

• Independent licensees (LISW, LPCC, IMFT), dependent licenses (LSW, LPC, MFT) working under supervision, and trainees (SWT, CT, MFTT) working under supervision, can all provide teletherapy provided they have training and experience in teletherapy. Examples of training include the completion of continuing education, supervised experience, and peer consultation.
• Services must be provided to ensure the highest level of confidentiality. Video-conferencing software should be HIPAA compliant.
• Licensees should carefully consider whether teletherapy is an appropriate means of providing services to individual clients.
• Licensees must be mindful that ORC 4757 and OAC 4757 apply regardless of how services are provided.
• Licensees who voluntarily choose to suspend providing services must properly terminate with clients and provide referrals as required in the rules. If a licensee is suspending services in response to a public order to do so, the licensee or their employer is advised to provide information, for example on outgoing voicemail messages or websites, regarding resources in the event a client is in crisis.
• Insurers establish which services are eligible for reimbursement. Be sure to verify whether you can bill for teletherapy before providing services to a client. The Board has no authority to direct insurers to pay for teletherapy services.
• Agencies and practices may set their own rules regarding teletherapy. The Board can exercise no authority over these employment/business related decisions.

While the Board staff want to be as helpful as possible, we are not able to provide specific guidance regarding implementing teletherapy. Please consult with peers and supervisors. Additionally, Board staff cannot recommend specific software, nor can the Board recommend specific training programs.

• As the State of Ohio’s response to COVID-19/Corona Virus evolves, the Board will share information with licenses.

---

PLEASE ALSO NOTE: The CSWMFT Board also recently posted the following update on its website:

Teletherapy Update – Emergency Rule in Progress

The CSWMFT Board is working with Governor Mike DeWine’s office as well as other State agencies on an emergency rule that will provide flexibility for licensees who are seeking to provide teletherapy. We anticipate the proposed rule will be issued soon and will align with the rules being proposed by the Ohio Department of Medicaid and Ohio Department of Mental Health and Addiction Services. Once the rule is issued, we will provide an update and additional guidance.

Below are some additional resources about teletherapy and COIVD-19:

State of Ohio

https://coronavirus.ohio.gov/wps/portal/gov/covid-19/

https://cswmft.ohio.gov/Home/COVID-19

 Counseling

AMHCA Code of Ethics
http://www.nymhca.org/AMHCACodeofEthics.pdf

NBCC
https://www.nbcc.org/Assets/Ethics/NBCCPolicyRegardingPracticeofDistanceCounselingBoard.pdf

ACA
https://www.counseling.org/knowledge-center/mental-health-resources/trauma-disaster/mental-health-professional-counseling-and-emergency-preparedness

ACA
https://www.counseling.org/knowledge-center/mental-health-resources/trauma-disaster/working-with-your-clients?utm_source=informz&utm_medium=email&utm_campaign=covidresources

CACREP
https://www.cacrep.org/for-programs/updates-on-covid-19/

 Social Work

NASW Ohio Chapter
https://www.naswoh.org/page/telehealth2020

NASW
https://www.socialworkers.org/Practice/Infectious-Diseases/Coronavirus

NASW
https://www.socialworkers.org/includes/newIncludes/homepage/PRA-BRO-33617.TechStandards_FINAL_POSTING.pdf

NASW
https://naswassurance.org/malpractice/malpractice-tips/treading-through-teletherapy-treatment-topics/

Marriage and Family Therapy

AAMFT
http://www.aamft.org/iMIS15/AAMFT/Content/Legal_Ethics/Code_of_Ethics.aspx

AAMFT
https://www.aamft.org/Events/Coronavirus-Event-Status-Updates.aspx?WebsiteKey=8e8c9bd6-0b71-4cd1-a5ab-013b5f855b01

NIMH
https://www.nih.gov/health-information/coronavirus

APA
https://www.apa.org/practice/programs/dmhi/research-information/social-distancing

American Telemedicine Association
http://www.americantelemed.org/resources/telemedicine-practice-guidelines/telemedicine-practice-guidelines#.VS_Go40tGUk

http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10875.pdf

Medicaid
https://www.medicaid.gov/medicaid/benefits/downloads/medicaid-telehealth-services.pdf

HHS
https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html

Medicare
https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet

In consideration of the rapidly-changing situation in which we find ourselves, we recommend and encourage Ohio counselors, social workers, and marriage and family therapist licensees to frequently visit the CSWMFT Board website. As always, if you have questions about this post or the CSWMFT Board, please contact Todd Collis or Beth Collis.

Physicians: Pay Attention to Supervision Agreements

A supervision agreement must provide that the physician agrees to supervise the physician assistant and the physician assistant agrees to practice under that physician’s supervision.

A supervision agreement must provide that the supervising physician is legally responsible and assumes legal liability for the services provided by the physician assistant.

A supervision agreement must be signed by the physician and the physician assistant.

a. If a physician assistant will practice within a health care facility, the supervision agreement must include terms that require the physician assistant to practice in accordance with the policies of the health care facility; and/or

New Rules for Reporting Abuse, Neglect, or Exploitation of Adults

On September 29, 2018, the Ohio Department of Job and Family Services (JFS) issued a new version of Rule 5101.63 that expands the list of individuals required to report suspected elder abuse. Now, any individuals licensed under Chapter 4731, those licensed to practice medicine and surgery, or Chapter 4723, registered nurses and licensed practical nurses, who have reasonable cause to believe that an adult is being abused, neglected or exploited shall immediately report such belief to their county JFS department, or they may face criminal charges.

The report can be oral, but the department may request a more formal, written report. Anyone who makes a report of abuse is immune from civil or criminal liability, unless they act in bad faith or with malicious purpose. ORC 5101.63(E) provides that an employer may not discharge, reduce benefits/work privileges, or take any other detrimental action against an employee for making a report of abuse.

You can download the related guides through JFS Forms Central (http://www.odjfs.state.oh.us/forms/) using these form numbers: JFS 08097 – Understanding Elder Abuse: A Guide for Medical Professionals and JFS 08098 – Understanding Elder Abuse: A Guide for Ohioans. ODJFS will develop training materials about identifying and reporting elder abuse.

The county JFS departments will be available to receive reports of abuse 24/7. If you have any questions about this new rule change, please contact Beth or Todd Collis at (614) 486-3909.

The Differences Between Suspension, Permanent Revocation and Non-Permanent Revocation of a Medical License by the State Medical Board of Ohio

The State Medical Board of Ohio (“Medical Board”) is authorized to take disciplinary action against a licensee based on a violation of Ohio Revised Code Section 4731.22(B). Discipline can include, but is not limited to, suspension, permanent revocation and non-permanent revocation of a medical license.

A suspension results in the loss of the license to practice medicine for either an indefinite or a specified period of time.  The licensee may apply for reinstatement of the medical license following completion of all terms and conditions required by the Medical Board for reinstatement of the license.

A non-permanent revocation results in the loss of the license to practice medicine.  The licensee may re-apply for licensure.

A permanent revocation results in the loss of the license to practice medicine.  The licensee is forever barred from being licensed to practice medicine.

The Medical Board’s Disciplinary Guidelines provide maximum and minimum penalties for certain offenses: http://med.ohio.gov/Portals/0/Disciplinary%20Guidelines%20rev.%2006-13-2018.pdf?ver=2018-06-13-143928-823.  However, the Medical Board is not bound by the Disciplinary Guidelines and may impose any sanction authorized by law including, but not limited to, permanent revocation.

Although a licensee whose license to practice medicine has been non-permanently revoked may re-apply for licensure, a non-permanent revocation is viewed as a higher level of discipline than a suspension.  The Medical Board typically imposes non-permanent (and permanent) revocation for the most serious violations of its laws or rules.

The Medical Board meets the second Wednesday of each month and reviews all disciplinary matters in an open forum.  The Medical Board’s monthly Agenda can be found at the Medical Board’s website at: http://med.ohio.gov/The-Board/Board-Meetings-Minutes.

If you have any questions about this post or the State Medical Board of Ohio in general, please feel free to contact one of the attorneys at Collis Law Group LLC at (614) 486-3909 or email me at Beth@collislaw.com.