AMARILLO, TX – In the years leading up to the pandemic, health care delivery had been shifting towards telehealth. This made sense because many health care encounters did not need to be face-to-face. A number of ailments can be diagnosed via a live video conference with the physician. A number of treatments can be ordered via a live video conference with the physician.

A patient’s vital signs can be monitored with remote technology. A DME supplier can utilize technology to (i) assist the patient in setting up his equipment and (ii) educate the patient on how to use the equipment. In short, there are many scenarios in which a patient should not have to leave the confines of his home to receive health care.

Pre-pandemic, the shift towards telehealth had been led by commercial insurers, not by Medicare. Commercial insurers were more open to telehealth than the Medicare program. Insurers recognized the cost saving benefits of telehealth; Medicare was slow to follow the private sector’s lead.

But then COVID changed everything. In March 2020, the health care delivery system went into triage mode. The focus was to keep as many patients as possible out of the hospitals…so as to free up hospital beds for the sickest. The focus was to diagnose and treat patients as rapidly as possible. Many physicians had to close their offices and/or limit their availability for face-to-face encounters with patients. DME suppliers had to figure out how to take care of their patients without having face-to-face contact.

Out of necessity, technology had to be relied on…and third party payors (“TPPs”), including Medicare, had to accept the reality of relying on telehealth. And so this is the point where the law had to scramble to keep up with the unfolding events on the ground. The pandemic is a “game changer.” What this means is that COVID greatly accelerated the shift to telehealth. COVID accomplished in months what would normally have taken years to accomplish if the pandemic never occurred.

Medicare, DME and Telehealth
Pre-pandemic DME suppliers were limited in their ability to rely on physicians’ orders resulting from telehealth encounters between Medicare beneficiaries and physicians. Pre-pandemic, in order for Medicare to recognize a physician’s order for DME, resulting from a telehealth encounter, several limiting elements had to be met. The beneficiary had to reside in a rural area.

The beneficiary had to leave his residence and drive to an “originating site” (e.g., critical access hospital). Once inside the originating site, the patient was required to have both a visual and audio telehealth encounter with the physician. These limitations were laid bare by Operation Brace Yourself in which DME suppliers, lead generation companies, telehealth companies and telehealth physicians were targets of kickback investigations because payments to the physicians (who prescribed braces) emanated from the DME suppliers that sold the braces…and billed Medicare.

In addition to the criminal cases, a number of DME suppliers (i) were subjected to recoupment actions and/or (ii) had their Medicare payments suspended. The recoupments/suspensions were based on the fact that the three elements set out in the preceding paragraph were not met. That is (i) many Medicare beneficiaries resided in non-rural areas, (ii) most of the beneficiaries never left the confines of their homes, and (iii) most of the beneficiaries only had telephone conversations with the prescribing physicians.

There is no question but that the back brace/lead generation/telehealth arrangements “gamed the system” and had to be stopped. And yet, when the pandemic hit Medicare determined that the telehealth restrictions needed to be relaxed during the pandemic. It was obvious that DME suppliers had an important role in keeping patients out of the hospital. If DME suppliers could take care of patients in their homes with a combination of equipment and services, then undue restrictions should not be placed on the suppliers.

Medicare Policy Changes

Policy Changes
Since early March 2020, CMS has issued a number of waivers, regulations and rules pertaining to telehealth. In doing so, CMS (i) expanded the health care workforce by removing barriers to providing care; (ii) removed regulatory barriers with the goal of ensuring that hospitals can handle a surge of COVID patients; and (iii) removed regulatory barriers with the goal of ensuring that patients have access to care while remaining at home.

Coronavirus Preparedness and Response Supplemental Appropriations Act (March 6, 2020)
Pursuant to this Act, Congress authorized HHS to waive certain Medicare telehealth requirements. The Act expands coverage to (i) patients outside of rural areas; (ii) patients in their homes; and (iii) new (not just established) patients.

Coronavirus Preparedness and Response Supplemental Appropriations Act (March 27, 2020)
This Act allows HHS to waive statutory coverage requirements for telehealth. The Act further increased funding for e.g., remote care technologies. The Act is effective through the end of the Public Health Emergency (“PHE”).

New CMS Rules
CMS issued rules (CMS-1744-IFC, CMS-5531-IFC) and FAQs addressing telehealth expansion during the PHE. Medicare now pays for telehealth services at the same rate as in-office visits for all diagnoses, not just services related to COVID. Physicians can reduce or waive Medicare beneficiary cost-sharing for telehealth visits, virtual visits, e-visits, and remote monitoring services.

Medicare Telehealth Changes
Patients can receive telehealth and other technology-based services wherever the patients are located. Telehealth services can be provided to new or established patients. Certain evaluation and management (“E & M”) services, behavioral health visits, and educational services can be provided via audio only. Other services must be furnished with audio and video technology, but IT and location requirements have been relaxed.

CMS has expanded the types of practitioners who may provide telehealth services. Telehealth can now be billed by all provider types who are eligible to bill Medicare for their professional services. CMS can add new CPT codes to the list of services that can be provided via telehealth on a sub-regulatory basis, which will result in the quicker addition of CPT codes to the list of codes that may be provided by telehealth. Clinicians can provide (i) remote evaluation of patients and (ii) virtual check-in services to both new and established patients. Medicare payment for telephone E & M codes are equivalent to payment for office and/or outpatient visits with established patients. Clinicians can provide remote patient monitoring services to both new and established patients and these services can be provided to patients with only one disease. To the extent that an NCD or LCD would require a face-to-face visit for evaluations and assessments, clinicians do not have to meet those requirements for the duration of the PHE. This, however, does not apply to power mobility devices.

Q&As from the DMEPOS Ask the Contractor Teleconference – Respiratory Policy Focus

• Question – If a beneficiary is receiving a virtual set-up and equipment is shipped to his house, is the date of service the ship date or the visit date?
  Answer – Suppliers should reference the Standard Documentation Article which indicates that the date of service may be either the ship date or the date the beneficiary receives the item.
• Question – We are attempting to obtain telehealth visits as much as possible for PAP, oxygen etc. for non-COVID beneficiaries. Should we be obtaining video and audio in order to use the telehealth visits as face-to face? I realize they are not required but if a beneficiary is able to participate, we are requesting the visit.
  Answer – If the beneficiary can have the video and audio visit, this meets the relaxed telehealth criteria, and this is recommended. If the beneficiary is not able to, you should be confirming that the medical records contain the reasonable and necessary information, including the documented telehealth visit that took place. These medical records must be available to Medicare on request.

• Question – What if the beneficiary is in a rural area and does not have access to video for a telephone visit?
  Answer – Regardless of where the beneficiary is located, for the duration of the PHE, visits are not required except for PMD. However, in order to qualify as a face-to-face visit, under the “relaxed” telehealth rules during the PHE there must be both audio and visual interaction between the beneficiary and the prescribing practitioner.

• Question – We are having a sleep lab that sometimes uses telephone-only to provide compliance follow-ups when beneficiaries cannot do an audio/video visit. Is this acceptable?
  Answer – Because the face-to-face requirements are not being enforced during the PHE, audio only will be accepted during the emergency. However, audio only does not meet the telehealth requirements for a true face-to-face. As such, suppliers need to follow instructions for actions to be taken when the PHE ends.
• Question – We are in a rural area so a visual and audio conference would be sufficient for a face-to-face, but what about audio-only?
  Answer – If you just have an audio call, then that would be allowed because the face-to-face is not required during the PHE. However, you will want to watch for direction on how to manage these cases when the PHE has ended. If it was audio and video and the beneficiary was compliant during the first 90 days, then all of the criteria would have been met.

• Question – In our scenario, the beneficiary did not meet compliance in the 90 days. Normally, we would have a beneficiary return the device or go back to the sleep lab. With the PHE, the physician still wants the beneficiary to use the PAP device. Do we continue to bill and hope that the beneficiary becomes compliant by month five (for example) or do we stop billing until he becomes compliant?
  Answer – If the beneficiary is unable to obtain a face-to-face or return to the sleep lab as a result of the PHE, there are waivers and flexibilities in place to allow non-enforcement of the standard clinical indications for coverage and not require the face-to-face. Suppliers must ensure that the medical records show that the equipment is medically reasonable and necessary.

• Question – If we get a telehealth visit, and it contains all of the information we need, do we know whether the beneficiary will need to go back for a subsequent face-to-face?
  Answer – A telehealth visit with both audio and video components will meet the requirements of a face-to-face visit for DME.

Beneficiary consent can be obtained remotely. Physician supervision of other health care professionals can be performed remotely for services that require it. There is a temporary waiver of the requirement that a practitioner be licensed in the state where he is providing services (note that state requirements still apply). The CARES Act permanently allows mid-level providers, including nurse practitioners and physician assistants, to prescribe DME for patients. In many instances, these changes apply to Medicaid. Commercial payors have adopted many of these changes and have expanded access to telehealth in significant ways.

Office for Civil Rights (“OCR”) Relaxation of Technology Requirements
Historically, telehealth requirements limited access to telehealth to those with access to advanced technologies. OCR relaxed HIPAA requirements for the use of technology to facilitate the relaxed CMS guidelines for telehealth, including standards of good faith for the HIPAA requirements when using alternate technology.

This allows providers to utilize other mediums including Zoom, FaceTime, WebEx, Skype, and other platforms that did not meet the previous OCR requirements for telehealth. Public-facing technologies like Facebook Live, Twitch and TikTok remain prohibited. Providers that wish to seek additional privacy protections should identify technology providers that will enter into HIPAA compliant Business Associate Agreements. Examples of such providers include Skype for Business and Zoom for Healthcare.

Future of Telehealth
Most experts anticipate that the expansion of telehealth is here to stay. The best analogy may be that we are experiencing 10 or more years of progress towards telehealth in a matter of months. It is unlikely that all of this progress will be reversed. President Trump signed multiple executive orders with an intent to expand telehealth and to make some of these changes permanent. HHS has demonstrated a willingness to make some of these changes permanent.

State Regulation of Telehealth

State Regulation
Notwithstanding the recent enactment of federal statutes and regulations during the PHE, telehealth continues to be primarily regulated by the states. This makes sense. Regulation of professionals – physicians, attorneys, accountants, engineers, etc. – almost exclusively lies in the domain of the states. Because telehealth is primarily connected to physician services, regulation of the space logically should come from the states. The following are examples of state regulation of telehealth.

Florida
Health care practitioners licensed outside of Florida must obtain an “Out of State” telehealth provider registration from the Florida Board of Medicine (“Board”). A telehealth provider may use telehealth to perform patient evaluations. If a telehealth provider conducts a patient evaluation sufficient to diagnose and treat the patient, the telehealth provider is not required to research the patient’s medical history or conduct a physical examination before using telehealth to provide health care services.

Ohio
Effective March 9, 2020, providers can use telemedicine in place of in-person visits. Throughout the PHE, the State Medical Board of Ohio (“Board”) will not enforce in-person visit requirements normally required by Board rules. Providers must document their use of telemedicine and meet minimal standards of care. The Board will require advanced notice before resuming enforcement of standard regulations when the state emergency orders are lifted.

Other States

• Missouri – Any physician who is licensed in Missouri can practice telehealth. The telehealth encounter must be both visual and audio.
• New York – A New York licensed physician can provide telehealth services. New York law requires a telehealth encounter to be both visual and audio.
• Tennessee – Tennessee law requires a telehealth encounter to be both visual and audio. A Tennessee licensed physician can provide telehealth services. The previous requirement that a patient must go to a “qualified site” for a telehealth encounter has been removed.

Federal vs. State Regulation
When a DME supplier receives a physician order for DME, and if the order emanates from a telehealth encounter, then the supplier should consider the following:

• Is the patient covered by traditional Medicare? If so, are the PHI-relaxed rules still in place?
• Assume that the patient is covered by traditional Medicare and the PHI-relaxed rules are in place. Are there any state rules that are more restrictive than the Medicare rules? If so, the DME supplier should determine if the state has formally or informally relaxed its telehealth rules to be consistent with the Medicare rules.
• The state may have decided to follow Medicare’s lead, but (i) the state legislature has not had time to pass a new law and/or (ii) the state Medical Board has not yet promulgated new regulations. If this is the case, informal guidance from the Medical Board may be sufficient.

Commercial Insurers
In addition to being aware of federal and state regulations, if the DME supplier is billing commercial insurers the supplier should be aware of the insurers’ coverage policies regarding telehealth. This applies to straight commercial insurance plans (group health insurance offered by an employer), Medicare Advantage, and Medicaid Managed Care.

Value-Added Services vs. Prohibited Inducement
It is permissible for a DME supplier to provide value-added services to its patients. Conversely, the supplier is prohibited from providing prohibited inducements to patients. There can be a fine line between these two activities. Over the last couple of years, the OIG has relaxed restrictions imposed on providers and suppliers regarding services offered to patients. Initially, this relaxation was set out in OIG Advisory Opinions. And then the loosening of the restrictions was codified in final rules released by CMS and the OIG on November 20, 2020.

Importance of Value-Added Services
Ancillary providers (such as DME suppliers, pharmacies and home health agencies) play a key role in healing patients, keeping patients healthy, and keeping patients out of the hospital. For example, the DME supplier normally has a much closer relationship with the patient and his caregiver than the treating physician does. Unlike the physician, the DME supplier has (i) regular communications with the patient/caregiver and (ii) an understanding of the patient’s living conditions. The DME supplier is in a unique position to encourage the patient to take his medications as prescribed, see his physician when scheduled, and hydrate. The supplier is in the position to coordinate these efforts with the patient’s caregiver. These basic steps will go a long way to keeping the patient out of the hospital.

Importance of Monitoring
An important service that the DME supplier can provide is to monitor key components of the patient’s health. The supplier can place devices with the patient in order to monitor the patient’s oxygen level, heart rate, blood pressure, weight and other vital signs. The supplier can report to the physician and the caregiver if (i) the patient’s signs are abnormal and/or (ii) the patient is not using the monitoring devices. Before offering monitoring services, the supplier needs to confirm with its liability insurance carrier that such services are covered by the liability policy.

Value-Added Services and Marketing
By offering value-added services, the DME supplier can set itself apart from its competitors. The supplier can encourage physicians to refer to the supplier on the basis that the physicians and the supplier will work together to keep the patients healthy. The supplier can encourage hospitals to enter into a preferred provider agreement with the supplier in which, subject to patient choice, the hospital will refer soon-to-be-discharged patients to the supplier. The motivation for the hospital to enter into such a relationship is the DME supplier’s commitment to provide value-added post-discharge services to the hospital’s patients…with the goal of keeping the patients from being readmitted within 30 days.

The supplier can encourage commercial insurers to sign contracts with the supplier…based on the supplier’s commitment to provide value-added services to the insurer’s covered lives…so as to reduce the incidents of the covered lives having to see their physicians and being admitted into hospitals. This is a cost saving for the insurers. The supplier can market directly to prospective patients that if they choose the supplier, then in addition to providing quality products and related services, the supplier will provide value-added services designed to keep the patients healthy.

Cost Savings Resulting from Technology
Cost Savings – Education and Set-Up

When a patient orders a product from the supplier, it is time consuming and expensive for the supplier to send an employee to the patient’s residence in order to set the product up and educate the patient on how to use the product. Instead of an onsite visit to the patient’s residence, the supplier can (i) virtually guide the patient and his caregiver on how to set up the product and (ii) virtually educate the patient and his caregiver on how to use the product. Of course, if the virtual communications do not work for a particular patient, the supplier will need so send a person to the patient’s home; however, the number of onsite visits should be noticeably reduced. Virtual communications with patients/caregivers may be by video, Zoom, FaceTime, smart phone, and other means. It is important that the supplier document the virtual communications.

Cost Savings – Repairs

When a product (previously delivered to the patient) malfunctions, and the patient calls the DME supplier about the malfunction, then often the supplier will take the following steps:

• The supplier will send an employee to the patient’s residence with a replacement loaner.
• The employee will set up the loaner and show the patient how to use it.
• The employee will bring the malfunctioning product back to the facility.
• The facility will repair the product, an employee will take the repaired product back to the patient’s residence, the employee will set up the repaired product, and the employee will bring the loaner back to the facility.

The steps set out in the preceding slide are costly to the supplier. An alternative is for the employee to drop off the loaner and pick up the malfunctioning product. But instead of going inside the patient’s residence to set up the loaner and educate the patient, the supplier can virtually (i) guide the patient/caregiver on how to set up the loaner and (ii) educate the patient/caregiver on how to use the loaner. And when the employee returns the repaired product to the patient, the same virtual steps will be taken.  

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].

2021 Look Ahead for DME Suppliers

Presented by: Andrea Stark (pictured), MiraVista, LLC and Jeffrey S. Baird, Esq., Brown & Fortunato, P.C.
Moderated by: Liz Beaulieu, HME News

Date & Time: Thursday, February 4, 2021 at 1:00 p.m. EST 

Pick your metaphor: tornado, flood, forest fire. No one is shedding tears at the passing of 2020. There is, however, a silver-lining. A new year is an opportunity for a fresh start with the experience and wisdom to make the most of it. Hello, 2021. To help DME suppliers thrive in the brave new world, Andrea Stark (MiraVista), Jeff Baird (Brown & Fortunato), and Moderator Liz Beaulieu (HME News) are hosting the 11th annual 2021 Look Ahead for DME Suppliers on Thursday, February 4, 2021, at 1:00 PM (ET).

In this session, the trio spotlights:

• Provider Relief Fund reporting deadlines and potential liabilities.
• New risks (and opportunities) related to the Stark anti-kickback laws.
• Audit developments, including pandemic respiratory claims and the return of TPE.
• Exit strategies for the end of the public health emergency.
• The future of telehealth.
• Anticipated changes to ventilator coverage and reimbursement rates.
• The 2021 competition’s impact on the next round of bidding.
• … and much more!

After the presentation, attendees have open access to the presenters’ expertise during the live Q&A session. Register for the event.