monthly, DermWorld It covers the legal issues of “Legally Speaking”. This month’s author is a medical lawyer at Powers Pyles Sutter & Verville in Washington, DC. Portman is also a corporate lawyer for the American Academy of Dermatology and the American Academy of Dermatology.
The federal government has several laws to combat health fraud and abuse, including fraudulent claims (FCA), anti-kickback (AKS), and prohibition of doctors’ self-introduction (widely known as the Stark Act). Was enacted. The FCA applies to all parties who have deliberately (or deliberately ignorantly or recklessly disregard) false claims or have them filed for refunds or payments made by the Federal Medical Program.
In general, the most common way to induce FCA-based liability for a healthcare provider is to violate either the AKS or Stark Act. The FCA, which can be combined with these other anti-fraud laws, allows private organizations to take action on behalf of the federal government as whistleblowers. qui tam Case.
This section describes new risk areas that dermatologists should be aware of and the general steps that dermatologists can take to minimize compliance risks.
Are there any new risk areas of concern?
Healthcare is an ever-changing industry, and new compliance concerns arise accordingly. In the last few months and years, there are three areas of interest to dermatologists. Telemedicine, compliance with the COVID-19 Stark Act exemption requirements, and changes to the productivity bonus rules under the Stark Act.
Prior to the COVID-19 Public Health Emergency (PHE), the provision of telemedicine dermatological services was restricted. In addition, federal and state medical programs have strict restrictions on both (1) where services can be refunded and (2) the amount of refunds. One of the silver linings of PHE is the rapid expansion of the use of telemedicine, which makes it easier for individuals to access medical care in a safe environment. The dramatic rise in telemedicine services has issued multiple exemptions from regulatory requirements and implemented flexibility to allow providers to continue to serve during PHE. Exemptions and mitigations include mitigation of HIPAA enforcement, allowing healthcare providers to reduce or exempt the cost share of telemedicine visits in the event of financial difficulties for Medicare beneficiaries, and the application of Medicare telemedicine services. Includes removing certain restrictions on the range.
This expansion has also led to heightened concerns about potential abuse of telemedicine services. To that end, OIG has announced at least seven different national audits, assessments, and tests for telemedicine services under the Medicare and Medicaid programs. OIG’s goal in auditing is to provide objective findings and recommendations that can further inform policy makers and other stakeholders when considering which telemedicine flexibility should be permanent. Is to provide.
It is important for dermatologists to be aware of the evolution of telemedicine regulation. Many federal exemptions and flexibility are set to expire at the end of PHE. Federal and state agencies and private payers need to understand how to move forward and what guardrails need to be installed to prevent telemedicine-related fraud and abuse. Dermatologists who have begun providing telemedicine services during PHE can review policies and procedures to maintain compliant telemedicine programs that adequately meet federal and state telemedicine requirements prior to COVID-19. You should consider doing.
In connection with the telemedicine exemption, OIG has also issued a specific comprehensive exemption for Stark Law requirements during PHE. The exemption is intended for healthcare providers who provide products or services in good faith to Medicaid and Medicaid beneficiaries, but who are unable to comply with Stark Law requirements as a result of the COVID-19 pandemic. Such breaches usually make refunds for items and services impossible, but under exemptions, claims can be filed and paid without sanctions. Most of these changes are probably inclusive for dermatologists who may have signed new arrangements with the hospital during PHE, or who had existing arrangements prior to COVID-19 whose conditions were changed during PHE. Covered by exemption-this certainly needs to be confirmed. In addition, upon termination of PHE, the exemption-based violation tolerance is terminated and the terms of the ongoing arrangement must comply with the requirements of the Stark Act.
Can the relationship between the dermatologist and the patient also create responsibility?
Unfortunately it is. In particular, HIPAA is an individual or entity that provides value to OIG for program beneficiaries who know or should know to influence the beneficiary’s decision to order or receive an item or service covered by Medicare. Empowers you to impose a civil fine (CMP) on you. Or Medicaid from a specific provider, practitioner, or supplier. These CMPs add to the responsibilities that can occur under AKS for the same action. Prohibition of beneficiary incentives applies to the waiver of beneficiary cost sharing and the transfer of non-free or fair market value items or services. However, the definition of remuneration does not include, among other things, the incentives given to promote out-of-pocket and deduction exemptions and the provision of preventive care in certain situations (mainly low-income beneficiaries). “Incentives given to promote the provision of preventive care” cover preventive screening provided to potential patients, including screening for skin cancer, as long as certain criteria are adhered to. Is widely understood as.
Here are some important factors to consider when deciding whether you are allowed to offer or participate in a free screening service:
- Incentives must have a reasonable relationship with preventive care services, unless they have nominal value.
- If follow-up non-preventive care appointments are made in conjunction with screening tests, it is possible that free screening tests may have been an incentive to select a test sponsor as a provider of other eligible services. there is.
- It is permissible to reduce the price of eligible preventive services, including exemptions from the out-of-pocket obligations for preventive care services, or by providing care as a free community service.
- Incentives to promote preventive care should not be excessive with respect to the value of the preventive care service itself, or future medical costs that are reasonably expected to be avoided as a result of preventive care. ..
- Before the beneficiary chooses a provider for a particular service, they need to know the incentives they are eligible for. Incentives that are not advertised or disclosed to beneficiaries before the service is provided are not subject to the rules.
Therefore, dermatologists who offer free skin cancer screening should be careful not to regularly schedule participants who are beneficiaries of Medicaid or Medicaid for follow-up treatment. Rather, these individuals should be encouraged to meet their regular dermatologist. Alternatively, the screening dermatologist may provide the participant with a list of dermatologists in the area, which may include a screening dermatologist.
What general steps can a dermatologist take to minimize compliance risk?
As mentioned earlier, many arrangements that pose a risk to dermatologists are subject to the Stark Act. In these arrangements, it is important to identify and meet the requirements of the applicable Stark exception. For many of Stark’s exceptions, compliance standards include signed written agreements and fair market value rewards that do not change or are not considered depending on the amount or value of referrals or other businesses that occur between the parties. Is required. For arrangements that do not include DHS, compliance analysis is more complicated based on the specific facts and circumstances of the arrangement. The key considerations for assessing compliance risk are:
- “Rewards” are not only monetary rewards, but also valuable ones.
- If even one purpose of the arrangement is to guide referrals to sources of reward, AKS may be involved, even if other purposes are also intended.When
- The reward must be sufficient to actually act as an incentive to make or guide referrals.
This can be a very difficult analysis, and the best step doctors can take to ensure compliance when concluding a new arrangement is to seek the help of a lawyer when considering a proposal. .. For existing arrangements, ensuring ongoing compliance can be assisted by an annual review to ensure that they do not expire and maintain fair market value.
What should I do if a problem is found?
First and foremost, the dermatologist should immediately contact a lawyer to review the arrangement and assess whether there is a problem. If the arrangement is determined to be non-compliant, an attorney can provide recommendations for the next step.
In general, Medicare and Medicaid programs are subject to 60-day reporting and repayment requirements. Under the 60-day rule, providers with credible evidence that overpayments exist, such as when a contract turns out to be non-compliant with Stark Law or when AKS does not pay a particular claim, The survey can take up to 6 months and 60 days. Refund the specified overpayment. To comply with these requirements, physicians have two main options. Voluntary refunds by physician Medicare management contractors or self-disclosure to CMS or OIG via protocol. Legal counsel can help dermatologists determine the best course of action.
Conclusion
Compliance with federal fraud and abuse laws can be complicated, but very important. This article touches on some of the important issues for dermatologists, but it does not adequately cover the width and depth of either the Stark method or AKS, and state laws that may apply. Does not cover. For dermatologists with many external arrangements, investing in a lawyer may be the best insurance policy. For dermatologists who have less need for ongoing support, recognizing potential pitfalls is the first step in avoiding them.
This article is provided for informational and educational purposes and is not intended to provide legal advice and should not be so trusted. Readers should consult an individual lawyer for legal advice on the subject matter of this article.
You can read Part 1 of this feature here..
