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Archive for the ‘Telemedicine and Telehealth’ Category

The Joint Commission COVID-19 Information Page for Health Care Providers

Thursday, April 23rd, 2020

The Joint Commission has issued a Coronavirus (COVID-19) guidance page for hospitals and other organizations who are accredited through that organization. The page contains a letter and a video from the CEO of the Joint Commission, Mark R. Chassin, MD, FACP, MPP, MPH.

the joint commission covid-19 guidance

The Joint Commission Offers Useful Resources on the COVID-19 Pandemic.

The page also contains a variety of statements from the Joint Commission, Frequently Asked Questions about the Joint Commission’s statement on use of face masks brought from home, a statement on universal masking, a public statement on the shortage of critical equipment.

The page contains an interesting section highlighting stories from health care workers who are working on the front lines of the battle against the virus.

The Joint Commission page contains topical coverage of a variety of COVID-19 issues that are being faced by health care providers. The Joint Commission offers some really good content. There are informative articles, videos, training material and a wide variety of resources related to the COVID-19 virus, organized by category.

Some of the information on the Joint Commission site includes:

Visit the Joint Commission COVID-19 Resource Page, but plan to spend a while over there. There is a lots of really nice content.

For continual coverage of COVID-19 Legal Issues, Visit our Coronavirus Resources and Blog

Telemedicine IT Donations and the Anti-kickback Statute – OIG Opinion 18-03

Monday, October 29th, 2018

IT Donation to Facilitate Telemedicine Consultations – Low Risk of Fraud says OIG

telemedicine donation it The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) with the requisite intent to induce or reward referrals of federal health care programs, the OIG would exercise its discretion and not sanction the Provider or the County Clinic (collectively the “Requestors”).

The OIG’s analysis and conclusion of the Proposed Arrangement provides new insight into the government’s position on these type of donations that facilitate telemedicine encounters.  Specifically, how the government views these type of donations with the continued expansion of coverage and reimbursement of telemedicine services under federal health care programs.  The Advisory Opinion indicates support for the development of collaborative telemedicine affiliations and that the potential remuneration from the future referrals can be outweighed by the access to health care services and benefits actually received by rural or remote communities.

The County Clinic is a division of the County Department of Health that furnishes certain confidential sexually transmitted infection testing, treatment and counseling. The Provider has an existing referral relationship with the County Clinic but the facilities are separated by about 80 miles making it difficult for patients to access the Provider.  Under the Proposed Arrangement, the Provider would donate information technology-related equipment and services to the County Clinic to facilitate telemedicine encounters between the Provider and the County Clinic’s patients for certain HIV prevention and treatment services.  The Provider would cover the costs of the equipment, its set up, and maintenance through grant-funding from the State Department of Health.  The Provider would bill the Medicare program for the professional services delivered in the telemedicine encounters.  The County Clinic would house the equipment and bill the state Medicaid program an originating site fee related to the telemedicine encounters. The originating site is not required to provide any personnel or equipment in order to bill for the facility fee (Q3014) (which is only a coverage requirement to provide the telehealth consult).

 

OIG Analysis

Under the Proposed Arrangement, the County Clinic would receive remuneration of the free equipment and services and the Provider would have the opportunity to bill for the telehealth consultation referred by the County Clinic.  As such, the OIG acknowledged that the Proposed Arrangement could potentially generate prohibited remuneration under the federal AKS with the requisite intent to induce or reward referrals of services payable by a federal health care program.  However, the OIG identified the following factors as minimizing the potential risk of fraud and abuse:

  • There are safeguards in place to prevent patient steering to the Provider for treatment; namely use of technology with any other provider is not restricted and patients are given the option to have either a virtual or in-person consultation
  • Not likely to result in patient steering for prescriptions to any pharmacy operated by the Provider or County Clinic
  • There would be no increased cost to any federal health care program
  • Patients would benefit by having increased access to treatment; making it more likely that patients will seek out and receive such services

It is important to keep in mind that under the Proposed Arrangement the County Clinic would not obtain ownership of the equipment, as the Provider would use grant funds awarded by the State Department of Health to cover the costs of the equipment and services and the state agency would retain title and have the authority to recover the equipment at any time.  This could prove to be an important distinction concerning whether and how donating providers can provide information technology-related equipment and services to referring facilities in the other arrangements.

In prior Advisory Opinions (99-14, 04-07 and 11-12) concerning donations of information technology-related equipment and supplies, the OIG similarly concluded that it would not pursue sanctions; however, those proposed arrangements would not have directly resulted in a service payable by a federal health care program, but rather would only potentially result in other items or services to the patient by the donating provider. Under the Proposed Arrangement, both the County Clinic and the Provider would be in a position to submit claims to a federal health care program as a result of the telemedicine encounter and follow-up services.  Nevertheless, the OIG concluded that there would be no increased cost to any federal health care program because the County Clinic would have performed the preliminary tests and referred clinically appropriate patients for in-person consultations and, potentially, follow-up items and services regardless of the Proposed Arrangement.

While the analysis acknowledges the additional reimbursement the County Clinic would receive for serving as the originating site (i.e., the location of the Medicaid beneficiary when the service furnished via a telecommunications system occurs), there is no actual analysis of this facility fee and why it is not considered an increased cost.  To be clear, the County Clinic does not provide the HIV preventative services to be delivered by the Provider via the telemedicine consultation, and therefore, would not have previously received any payments if and when the patient was referred to the Provider for an in-person consultation.

Again, it appears that the OIG is willing to prioritize the health benefits to patients over any secondary or tertiary benefits to the referring provider; especially when such subsequent benefits are unlikely to result in over-utilization and have the potential to decrease costs to federal health care programs.

Friday, May 25th, 2018

Complying with Michigan’s New Controlled Substance Laws – The Bona-Fide Prescriber-Patient Relationship Requirement

The state of Michigan has enacted a number of separate pieces of legislation to address the opioid epidemic.  Most of these laws are directed at controlling the prescribing relationship between a physician and a patient.

Generally, Michigan requires a controlled substance license to prescribe controlled substances in the state. A holder of a controlled substance license may administer or dispense a schedule 2 to 5 controlled substance without a separate controlled substance license covering those substances. Additional requirements will attach to the prescribing relationship commencing at various intervals.

This article covers the new requirement regarding the establishment of a bona-fide prescriber-patient relationship.  Starting on the sooner of March 31, 2019 or the date that regulations are issued, a licensed prescriber will be required to have a “bona-fide prescriber-patient relationship” in order to prescribe a schedule 2 to 5 controlled substance.  In order to be considered a “bona-fide prescriber” the prescriber must review relevant medical/clinical records, complete a full assessment of medical history and current medical condition, conduct a relevant medical evaluation either in person or through telehealth, and maintain records of the patient’s condition to medically accepted standards.

All of these factors should be supported by the patient’s medical record.  There are a lot of lose ends on the definitions applicable to each of these requirements.  It is possible that additional details will be forthcoming when regulations are finalized.  Because these requirements a condition precedent to being able to prescribe schedule 2 to 5 controlled substance, it is critical that physicians and other prescribers review their documentation standards to be certain that these requirements are reflected in the patient’s chart in each instance.  Provider entities will need to consider adopting policies and procedures setting the standards for documentation and integrating the other requirements of Michigan’s new laws.  Appropriate training should also be conducted to assure that prescribers and their support staff are aware of the detailed documentation requirements.  Additionally, appropriate monitoring and auditing should be conducted to assure that prescribers are meeting the requirements.

Health Law Firm Opens Green Bay Office

Tuesday, May 1st, 2018

Green Bay Health Care Lawyer – Opening Office in Green Bay Wisconsin

I just wanted to let readers of our health care blog know that Ruder Ware will be opening a Green Bay office and that three Green Bay attorneys will be joining our firm. This will provide us with a presence in the Green Bay/Appleton Markets that will enhance our community presence and enable us to better serve our client in eastern Wisconsin. Our health care and compliance practice with be greatly enhanced as a result of this move.

This move will provide a local platform through which we can better serve our health care clients.

Health Care Law Practice – Green Bay Health Lawyers Ruder Ware

Ruder Ware has a long history of representing health care clients.  The firm recognizes that the highly regulated and complex nature of the industry demands the attention of a team of attorneys who, as a group, monitor constantly evolving laws and regulations and their impact on our health care clients.  At Ruder Ware, we offer a full-service solution to clients as our focus team consists of health care, business, employment, and litigation attorneys with knowledge of the health care industry.   As a result, we are able to take best practices from other industries and apply them to the health care industry, thereby increasing the ability to respond promptly to the rapidly changing health care environment.

Members of the focus team have served on the governing bodies of various health care organizations.  This service has provided our attorneys with the opportunity to counsel the health care community.  

Our dedicated team of attorneys represents health care providers in various matters including:

 Health Care Business Transactions and Corporate Law

Our attorneys have substantial expertise representing various health care providers such as:

Below is the official press release:

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

For Immediate Release

Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz to join
Ruder Ware at its new Green Bay Office

WAUSAU, WI – April 27, 2018 – Ruder Ware is pleased to announce the opening of its Green Bay office and that Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz will be joining the firm. The new office will be located at 222 Cherry Street, Green Bay, Wisconsin, which is the current location of Metzler, Timm, Treleven, S.C.

Attorney Ron Metzler – Having practiced law for over 30 years, Ron is a well-respected and well-known commercial attorney with close ties to the banking industry.

Attorney Chris Pahl – With his strong ties to the Green Bay community, Chris has built his practice around real estate development and condominium law as well as commercial transactions and estate planning.

Attorney Chad Levanetz – A seasoned litigation attorney, Chad counsels clients in the areas of real estate, construction, and general business disputes.

Stew Etten, Ruder Ware managing partner, stated, “Ruder Ware is always looking for outstanding attorneys to join our firm. With the opportunity to add Attorneys Metzler, Pahl, and Levanetz, the time was right to open a Green Bay office. We’re very excited to have attorneys of their caliber join our team of professionals.”

About Ruder Ware
Founded in 1920, Ruder Ware is the largest law firm headquartered north of Madison. With offices in Wausau, Eau Claire, and Green Bay over 40 attorneys provide legal and business advice to clients with operations of all sizes. Areas of practice include: Employment, Benefits & Labor Relations, Litigation & Dispute Resolution, Business Transactions, Trusts & Estates, and Fiduciary Services. Ruder Ware, Business Attorneys for Business Success. www.ruderware.com

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

Telemedicine Medicare Reimbursement Expansion Proposed

Friday, September 9th, 2016

Telemedicine Reimbursement; 8 New Codes Proposed by CMS

The Center for Medicare and Medicaid Services (CMS) has released proposed regulations that would increase telehealth coverage. The proposed regulations would add 8 new CPT codes to the list of Medicare covered telehealth encounters. If adopted, the new codes would be available beginning January 1, 2017. by 8 new Current Procedural Terminology (CPT) codes for services beginning January 1, 2017. This is part of the proposed rule making for Part B physician and practitioner services. Four of the new codes involve services related to end-stage renal disease (90969, 90970, 90968, 90967). Two new temporary codes are proposed for critical care evaluation and management (GTTT1, GTTT2). Lastly, two codes are proposed related to explanation and discussion of advance directives (99497, 99498).

The rue has a comment period and the new codes are not effective until January 1, 2017 even if adopted in final form.

300 Pages of New Regulations Ruining Health Care Attorney Lives Across the Country

Wednesday, November 18th, 2015

 

Mountain of New Regulations Issued By CMS

Health Care Regulations 2016Just a tip to my colleagues in health care law.  Do not send these new regulations to printer before giving them an eyeball.  They are long and if you share a printer you will be buying coffee for your colleagues for at least a week.

True to their nature, there are a number of things that are unrelated to physician payment scattered throughout this poorly indexed document.  We have new Stark Law exceptions, changes to “incident to” billing rules, telemedicine reimbursement standards, and a whole host of additional little morsels that we health care attorneys need to locate, study, and update our clients on; all before the next guy down the street beats us to the rap.On November 16, 2015, the Department of Health and Human Services officially published their final rules Revising Payment Policies Under the Physician fee Schedule and Other Revisions to Part B for CY 2016.

Have a pleasant rest of your week gang.  Anyone who does not want to wade through all of these regulations can come on back to this blog as we post articles on various pieces of the new rules.

And remember; here at Ruder Ware, Health Care Never Sleeps!

Medicaid Reimbursement for Telehealth In Wisconsin Mental Health Programs

Tuesday, August 11th, 2015

Wisconsin Medicaid Reimbursement for Telehealth In Mental Health Programs

A Medicaid enrolled certified mental health or substance abuse treatment program may be eligible for Medicaid reimbursement for telehealth services if it is also certified to provide treatment via telehealth.  Medicaid-covered services provided via telehealth are reimbursed in the same way Medicaid reimburses for face-to-face contacts between providers and consumers.  The Medicaid Handbook Update #2004-88 at  https://www.forwardhealth.wi.gov/kw/pdf/2004-88.pdf, described coverage requirements.

1.            The agency must be a certified program under one of the specified program standards: Wis. Admin. Code DHS34, 35, 36, 40, 61, 63, or 75 (except for the provision of opioid treatment under DHS 75.15).

2.            Persons providing mental health or substance abuse treatment services via telehealth must be a rostered staff member of one of these certified programs.

3.            Medicaid will not accept claims from individual professional staff.

4.            The certified program also is certified for telehealth by the Division of Quality Assurance.

5.            The treatment service must be a covered service under one of the Medicaid mental health or substance abuse benefits.

6.            The treatment service may not be group therapy.

7.            The provider must indicate the “GT” modifier on the claim detail for the specific procedure code. The “GT” modifier definition is “Via interactive audio and video telecommunication systems.”

8.            Providers must continue to follow all Medicaid coverage policies and all other requirements for each underlying service in the same manner as if the service was provided on  face-to-face basis.

For more information concerning telehealth program issues for mental health care or other provider types, contact John Fisher at through the contact information on this site.

Telehealth Certification In Wisconsin Mental Health Programs

Tuesday, August 11th, 2015

Process for Telehealth Certification In Wisconsin

Only certified mental health and/or substance abuse programs, or agencies planning to be certified as a mental health and/or substance abuse provider, may apply for telehealth certification. The first step in the process is for the agency to write a plan addressing each section in the attached template. The plan is then sent to the Behavioral Health Certification Section of the Division of Quality Assurance.

Provider’s must demonstrate compliance with their approved plan to the Division of Quality Assurance surveyor(s) during a site review or other unannounced focus visits.

Requirements for Telehealth Certification

There are several requirements that must be met in order to maintain certification.  Many of these requirements will need to be reflected in compliance policies and made operational as part of the telehealth program. These requirements fall in the following areas subject to additional detail in each area:

  • applicable regulatory requirements for the provider’s specific program (Administrative Code DHS 34, 35, 36, 40, 41, 61, 63, and 75)
  • requirements related to clinical supervision/collaboration for program staff who provide treatment services via telehealth, background checks, maintenance of professional liability insurance, documentation into the consumer’s record in a timely manner, and other requirements.
  • requirements regarding the locations for staff other than the main office of certified program or a certified branch office. Patients must receive the telehealth services at the main office or a certified branch office of the certified program.
  • Restriction against providing the telehealth services to consumers who are in-home or in-community.
  • minimum transmission standards established by the American Telemedicine Association (see http://www.americantelemed.org/resources/telemedicine-practice-guidelines/telemedicine-practice-guidelines)
  • compliance with vendor requirements for the telehealth hardware/software to ensure that the telehealth service is of high quality and as close to a face to face visit as possible.
  • orientation and ongoing training to staff on the use of the telehealth equipment, the clinical application of telehealth, safety and security during telehealth visits, privacy and confidentiality, back-up procedures if there is equipment failure, and consumer preparation for telehealth.
  • Assuring that patients are informed about the provision of services provided through telehealth, the history of telehealth, success rate of telehealth services, how telehealth sessions are conducted, and the extent to which the program is able to provide treatment services face-to-face versus via telehealth.
  • an ongoing method for obtaining consumer satisfaction on telehealth visits and evaluating the results of this survey process for quality assurance purposes
  • patient choice of having a face to face visit with a professional or seeing this person via telehealth, to the extent feasible.
  • workspaces must be secure, private, reasonably soundproof, and have a lockable door to prevent unexpected entry.
  • Efforts to ensure privacy so provider discussion cannot be overheard by others outside of the room where the service is provided.
  • If other people are in either the patient or the professional’s room, both the program staff and the consumer must be made aware of the other person and agree to their presence.
  • Program staff must verify for the consumer the identity of the staff member who is providing the treatment services via telehealth and verify for the staff member providing the treatment services theconsumer’s identity.
  • policy/procedure for technology breakdown that causes a disruption of the session.
  • System to Ensure secure upload and download with the vendor’s server.  At least 128 bit encryption software must be used.
  • assure that no information from a transmission of a telehealth services is stored on the vendor’s servers.
  • use of HIPAA Business Associate Agreement if information is transmitted via the vendor’s servers.

How Does Wisconsin Medicaid Reimburse for Telehealth?  Check Out The Article Here: Telemedicine Reimbursement Mental Health Programs

New Memorandum On Telehealth In Mental Health and Substance Abuse Programs

Tuesday, August 11th, 2015

 

On August 5, 2015 the  the Wisconsin Division of Quality Assurance (DQA), issued new DQA Memo 2015-011 (the “Telehealth Memorandum”) to provide background information and update a previous memo (Memo #2004-14, issued in September 2004) on the use of telehealth in certified mental health and substance abuse treatment programs/services in the State of Wisconsin.

Recognizing that significant technological advances have been made since the earlier memo, the DQA details revisions to the minimum requirements for telehealth certification by mental health and substance abuse programs in the State of Wisconsin.  The new standards for certification purport to permit use of hardware and software that may be less costly and easier to use.  This may result in facilitating broader use of telehealth to benefit patients with the state of Wisconsin.

The Telehealth Memorandum outlines basic certification requirements and references the application form for Mental Health and Substance Abuse Telehealth certification for additional detail.  Specific requirements are outlined  that certified mental health and substance abuse treatment programs must follow in order to use telehealth technology as a means of service provision for counseling, psychotherapy, medication management or related clinical consultation.  Services may include outpatient services, crisis services, community support services, comprehensive community services, day treatment programs, inpatient, and other services.

Some of the requirements that must be met in order to achieve certification of a telehealth program in Wisconsin include the following:

  • All staff employed by these programs may provide services using telehealth technologies provided they have received the necessary training and meet program and telehealth certification standards.
  • The certified program should identify specific staff providing the services in its telehealth plan and policies as required in the certification process.
  • Telehealth services cannot be provided in Wisconsin by narcotic treatment services certified under Chapter DHS 75.15 or mental health inpatient services certified under Chapter DHS 61.71 and Chapter DHS 61.79.
  • Telehealth technology cannot be used in lieu of the face-to-face assessment for continuing use of the restraint/seclusion in an inpatient setting.
  • Telehealth equipment may be used for the purpose of clinical supervision and clinical collaboration.
  • All the requirements for supervision and collaboration continue to apply such as transmission quality, ensuring that the transmitted information is not stored, and other requirements and restrictions outlined in DQA guidance.
  • The memo cautions providers regarding the use of telehealth equipment for clinical supervision for substance abuse counselors which require at least one in-person meeting per month.

Is your EHR Donation Agreement in Compliance?

Friday, May 23rd, 2014

The EHR donation regulations allow certain qualified entities to provide nonmonetary remuneration to physicians and other health care providers to obtain electronic health information systems without violating the Anti-Kickback Statute or the physician self referral laws.  Hospitals and other organizations have structured EHR donation programs around the existing exception.  The regulations that permitted hospitals to make payments on behalf of physicians for EHR technology was set to expire on December 31, 2013.

The Center for Medicare and Medicaid Services released final regulations on December 27, 2013, which extended the protections of the EHR donation regulations through December 31, 2021.  However, it is important that providers examine their EHR donation agreements to determine whether continued payments under the agreement comply with federal law.  Many EHR donation contracts contain automatic expiration clauses that terminated the agreement on December 31, 2013.  If those agreements have not been properly extended, payments that may have occurred under those agreements following expiration may raise compliance issues.

Providers should not assume the continued payments are protected under the extended EHR donation expiration date.  In many instances, entering a new agreement or amendment of existing agreements will be required in order to continue to qualify donation amounts under the application exceptions.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.