New Regulatory Changes May Help Expand Telehealth Usage
January 14, 2021
The COVID pandemic has changed the way that healthcare delivery is viewed. Telehealth services, although used prior to the pandemic, really increased when states had stay at home orders and restrictions. People still needed to get medical care, and telehealth stepped up.
One of the driving issues behind lower usage of telehealth in the past has been the CMS restrictions on the ability to bill for these services.
Prior to the COVID-19 outbreak, Medicare had specific guidelines on what it considered a payable telehealth service that included where the patient was located. The physician would not be paid by Medicare if they provided the telehealth service to the patient in his/her own home. When the public emergency was declared, CMS relaxed some of the restrictions so more patients could obtain medical care from home and physicians could get paid for providing that care. CMS will keep these relaxed guidelines in place until the public emergency has ended. So, what happens then?
There are also federal regulations, such as the Stark Law and Anti-Kickback Statute, that made providing telehealth services more difficult for some practices. But there have been some things that have come into the picture that may change that. One is a Final Rule, and another is a new proposed law.
A Final Rule for Medicare and State Health Care Programs, 42 CFR Parts 1001 and 1003, will take effect January 19, 2021. The Final Rule has introduced new safe harbors and modified some existing ones. The Stark Law was enacted by Congress in 1989 as part of the Ethics in Patient Referrals Act, with an intent of disallowing physicians from referring Medicare patients to labs that the physician had a financial stake (ownership, partnership, etc.). For example, a physician could not become a partner in an MRI center and then refer his patients to that center only for MRIs.
The Anti-Kickback Statute was part of the Social Security Amendment in 1972. The intent was to prohibit offering, soliciting, or accepting any type of gift or remuneration for patient referrals. There are exceptions, or "safe harbors" that include payment and/or business practices that are not treated as offenses under the Anti-Kickback Statute (OIG.hhs.gov). The Safe Harbor Exceptions list the safe harbor, and then list the standards necessary to meet the safe harbor.
For example, space rental is not considered remuneration (a violation under the Statute) if:
The lease agreement is in writing and signed by both parties.
The lease states the terms for the lease and the premises covered.
The lease states the schedule of access to premises if not on a full-time basis.
The lease term is not less than one year.
The rental charge must be at fair market value.
The leased space does not exceed what is reasonably necessary for accomplishing its purpose of the rental.
Due to the move toward value-based care, the new rules were created to update the laws to keep up with the new arrangements for delivery and payment of healthcare services today, accounting for the movement from fee-for-service payments to value-based care systems. The Final Rule creates new safe harbors and modifies other existing ones. This will allow practices to enter into business arrangements with other companies that are currently prohibited. For instance, a remote glucose monitoring company could enter into a value-based payment arrangement with a practice and offer to provide a staff member to help set up and monitor patients at no charge.
The new safe harbors are as follows:
Value-based arrangements with substantial financial risk: protects both in-kind and monetary remuneration among participants that share a substantial financial risk;
Value-based arrangements with full financial risk: allows for more flexibility for in-kind and monetary remuneration than the safe harbor above for substantial financial risk;
Care coordination: protects in-kind remuneration among participants for care coordination and management (includes digital health technology);
Patient engagement: focuses on patient engagement and support tools provided by a participant in a target population;
Safe harbor for CMS-sponsored models: focuses on payment and delivery models sponsored by CMS;
Cybersecurity technology and services: focuses on improved cybersecurity in healthcare;
Telehealth technologies for in-home dialysis: allows for certain telehealth technologies to be provided to beneficiaries with end-stage renal disease that are receiving in-home dialysis.
The revised safe harbors are as follows:
Local transportation: allows for expansion of transportation for residents in rural areas, and removes the 25-mile limit on transportation of a patient to his/her home upon hospital discharge;
Personal services, management contracts, and outcomes-based payment arrangements: eases the existing Anti-Kickback Statute for personal services arrangements;
Warranties: redefines warranty and includes protections for warranties;
ACO beneficiary incentive program: allows for remuneration.
The Interstate Medical Licensure Compact is an agreement made between participating U.S. states to work together to streamline the process for licensing physicians that want to practice in multiple states, including by telehealth. The IMLC includes 29 states, the District of Columbia, and Guam. This issue is causing one of the biggest barriers to telehealth expansion; some states still restrict or prevent physicians from using telehealth to treat patients in other states. But that is another thing that lawmakers are trying to change.
There has also been a new bill introduced in Congress in October of 2020 regarding the Interstate Medical Licensure Compact (IMLC). The bill (HR 8723) would block states from receiving funding from the Bureau of Health Workforce if they do not join the IMLC. In addition, the bill would prevent state licensing boards from getting certain federal grants unless they've joined the compact within the next three years.
When the pandemic hit, about half of the states enacted emergency measures that allow for license portability, which enabled them to use telehealth across state lines. There have also been two other bills put before Congress; one that would allow physicians in any state to treat a patient via telehealth in any other state, and another that would enable physicians in good standing to use connected health to treat patients during the pandemic.
While telehealth cannot replace every type of office visit, it can be beneficial to home bound or disabled patients that could benefit from not travelling to an office. And, with the pandemic, there are times when no one may be able to travel to their physician's office. No one knows where telehealth will land after the pandemic. Congress and the new Federal Rule have taken steps to broaden accessibility to patients to any physician from any state. We'll all have to keep watch to see what happens. To keep up with the progress of the Bills, they can be tracked on the govtrack.us website. The three mentioned in this article are Bill HR 8723, The Equal Access to Care Act, and the Temporary Reciprocity to Ensure Access to Treatment Act. The new Final Rule discussed can be found on the Federal Register website at the following link: https://public-inspection.federalregister.gov/2020-26072.pdf.
Betty Hovey, CCS-P, CDIP, CPC, COC, CPMA, CPCD, CPB, CPC-I, is a nationally recognized healthcare consultant and speaker. She is an expert auditor and loves to help practices stay compliant and profitable. Betty states, "Physicians work hard for their practices and they should be paid properly for what they do."
Betty brings over thirty years of healthcare experience. She has worked for practices both large and small with the same intensity and attention. She has spent years on the "front lines" for practices handling medical billing, coding, claims, and denials. She has also managed practices and directed healthcare system departments. Her areas of expertise include Evaluation and Management, Primary Care, Dermatology, Plastic Surgery, Cardiology, Cardiothoracic Surgery, General Surgery, GI, E/M and procedural auditing, and ICD-10-CM.
As a speaker and trainer, Betty brings a welcoming mannerism that her attendees relate to and enjoy. She brings humor and real life experience to her educational sessions that allow her to ensure that everyone understands the training and has a good time. Betty has educated medical coders, managers, health plans, administrators, physicians and non-physician practitioners all across the country. She has co-written manuals on ICD-10-CM, ICD-10-PCS, and CPT specialty areas. She most recently authored a chapter for the soon to be released book, Telemedicine in Orthopedics and Sports Medicine: Development and Implementation in Practice.
Betty is a Certified Coding Specialist-Physician based (CCS-P) and a Certified Documentation Improvement Practitioner (CDIP) through the American Health Information Management Association (AHIMA). Through AAPC she holds certifications as a Certified Professional Coder (CPC), Certified Outpatient Coder (COC), Certified Professional Medical Auditor (CPMA), Certified Professional Coder for Dermatology (CPCD), Certified Professional Biller (CPB), and a Certified Professional Coder Instructor (CPC-I). Betty is also a member of Sigma Beta Delta-an International Honor Society for Business, Management, and Administration.