5 legal issues for home medical equipment suppliers in 2022

Well the last couple of years have been strange. COVID-19 has been a game-changer. In a silver lining, the home medical equipment (MCH) industry has seen vibrant colors during the pandemic. The industry has been urged to take care of patients at home and prevent patients from going to hospitals – and EHM suppliers and manufacturers have responded admirably.

From a public health perspective, the country will continue to face uncertainty. HME suppliers will be at the forefront of these uncertainties. Let’s discuss some hot legal issues that HME vendors will face over the next 12 months.

1. Vaccines

In early November 2021, the Centers for Medicare & Medicaid Services (CMS) issued an Interim Final Rule (IFR) that requires employees of certain healthcare providers to be vaccinated. HME suppliers were not specifically included in the rule. As of press time, two federal courts have barred CMS from enforcing the rule, and the agency has announced a pause in enforcement action.

Also in early November, the Occupational Safety and Health Administration (OSHA) released a Temporary Emergency Standard (ETS) requiring employers with 100 or more employees to either force vaccinations or require COVID-19 testing. This mandate applied to large EHM suppliers. The Court of the Fifth Circuit of
The appeals directed the application of the ETS. In response, OSHA announced that
he will not apply the ETS pending future court decisions.

Notwithstanding the CMS IFR and OSHA ETS, private sector employers have the legal right to require that employees be vaccinated, with two exceptions: the employee has a medical condition that could cause medical problems for the employee. The employee and / or employee has a bona fide religious objection to taking the vaccine.

2. Managed care

Today, approximately 39% of Medicare beneficiaries are covered by Medicare Advantage (MAP) plans and approximately 70% of Medicaid patients are covered by Medicaid managed care plans (MMCP). PADs and MMCPs pose many challenges for MCH providers, including the prevalence of closed panels in managed care.

HME providers try to determine what their rights are when dealing with MAPs and MMCPs that implement policies that are unfair to the providers. The challenge is that federal law governing MAPs does not focus on the rights of providers and providers; the focus is more on registrants. There is an interesting dynamic when it comes to MMCP. They are governed by both federal law and state law. State regulators appear to be saying, “It’s not our responsibility, it’s Medicare’s responsibility,” while federal regulators say, “It’s not our responsibility, it’s the program’s responsibility. State Medicaid. “

Federal laws and regulations governing MAPs and MMCPs are quite extensive. However, only a small part of the regulations deal with the relationship between schemes and providers / providers. Typically, provider and provider regulations aim to protect registrants’ access to care and ensure that plans have basic health care coverage and an adequate provider network.

Recognizing the challenge faced by HME providers, the American Association for Homecare formed the Payer Relations Council, which focuses exclusively on the challenges that MAP and MMCP pose to HME providers.

3. Telehealth

Before COVID-19 hit, HME providers were limited in their ability to rely on physician orders resulting from telehealth encounters for HME. Before the pandemic, in order for CMS to pay for the MCH resulting from a telehealth doctor’s prescription, three things had to happen. The Medicare beneficiary had to reside in a rural area, the beneficiary had to go to a “home site” (for example, a critical access hospital) to have the telehealth meeting with the doctor, and the telehealth meeting was to be both audio and visual.

These requirements were relaxed during the public health emergency (PHE). Now, the Medicare beneficiary can reside in any region of the United States and the beneficiary can have the telehealth meeting from their home. In most cases, the telehealth encounter should continue to be both visual and aural.

The question is whether this easing of telehealth restrictions will last after the PHE ends. While there is no clear answer to this question, many industry players believe the easing of restrictions will remain permanent.

4. Value-added services vs. prohibited inducement

One way for an HME provider to differentiate itself from its competitors is to offer patients value-added services that the provider’s competitors do not. This is legally acceptable.

However, it is important that in offering value-added services, the HME provider does not cross the line by offering prohibited incentives.

Recently, the industry has witnessed a relaxation of restrictions imposed by CMS and the Office of the Inspector General (OIG). CMS and OIG recognize the importance of providing value-added services that are designed to make healthcare more accessible to people who normally face barriers to care. In 2017 and 2019, the OIG issued advisory opinions that discussed the difference between a legally acceptable value-added service and a prohibited inducement. For example, the OIG has stated that it is acceptable for a hospital to provide free child care to a parent who wants to drop off a child for a few hours while the parent takes another child to an appointment with. doctor. On the other hand, the OIG has said it would not be acceptable for the hospital to reward a parent with movie tickets after the parent takes a child to a doctor’s appointment.

In November 2020, CMS released changes to exceptions to the Federal Physician Self-Referral Act (the Stark Law) and the OIG released changes to the safety rules of the Federal Anti-Kickback Act. In line with the 2017 and 2019 advisory opinions, the changes are designed to allow healthcare providers more flexibility in delivering value-added services.

5. The “60 days” rule

The Affordable Care Act sets out the “60 day” rule. This rule states that when a supplier or supplier determines (or should have determined) that it has been paid for claims by a federal health care plan when it should not have been paid, then it is obligated to take six months or less to investigate the issue and they must voluntarily report the matter to CMS and reimburse the claims within 60 days of the six months. If the supplier or supplier does not take these steps, the claims can become bogus claims under federal false claims law, resulting in potentially significant penalties.

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