Compliance

Published on: October 31, 2022

OIG Releases Medicare Telehealth Program Integrity Report

Recently, the US Department of Health and Humans Services (HHS) Office of the Inspector General (OIG) released a data brief analyzing telehealth services covered by Medicare and related program integrity risks. OIG sought to evaluate the impacts on program integrity due to the regulatory flexibilities implemented during the COVID-19 pandemic and the corresponding spikes in utilization rates for telehealth services by Medicare beneficiaries. Of the 742,000 providers that OIG evaluated, 1,714 had “concerning billing” on at least one of the seven measures that OIG considers to be potential indicators of fraud, waste, and abuse. The data brief represents OIG’s latest effort to use data analytics to identify program integrity concerns and includes specific proposals to improve data quality to aid in program integrity efforts.

OIG identified seven measures that it views as posing high risk for fraud, waste, and abuse. It is worth noting that these integrity measures are related to, but different from, the seven measures OIG identified in a special fraud alert issued in July 2022 with respect to provider arrangements with telehealth companies. The seven measures that OIG identified in the data brief are as follows:

Billing for both a telehealth service and a facility fee for most visits

Published on: October 25, 2022

HHS OIG Releases Template for Requests for Advisory Opinions

by Wachler & Associates, P.C.

The Office of Inspector General (OIG) for the United State Department of Health and Human Services (HHS) recently released a template to assist with preparing advisory opinion requests. This template can be used to ensure that requestors include the information required for the advisory opinion process. The template lays out the basic information required for an advisory opinion request and leaves an optional section for legal analysis. Although providing a legal analysis is not required, most requests include significant legal analysis regarding why OIG should approve the arrangement and it is often the most detailed and insightful portion of a successful advisory opinion request.

Advisory opinions issued by HHS OIG are legal opinions that are issued to the requesting parties that apply OIG’s fraud and abuse authorities to the requesting parties’ current or proposed business arrangement. Since the advisory opinion is tailored to and binding on a requesting party’s current or proposed business arrangement, OIG will not advise on any hypothetical or other arrangements that the party does not actually intend to engage in. Although most advisory opinion requests seek guidance regarding the Anti-Kickback Statute (AKS) and its safe harbors, OIG is also authorized to issue advisory opinions on the application of exclusion authorities, civil monetary penalty authorities, and criminal penalties.

OIG also declines to issue opinions on general questions of interpretation, the fair market value of goods, services, or property, or the application of the Stark law or the Eliminating Kickbacks in Recovery Act (EKRA). Although advisory opinions can provide valuable guidance, requesting an advisory opinion is a completely voluntary process. Accordingly, failure to seek an advisory opinion regarding a business arrangement cannot be introduced as evidence as proof that the party violated the law.

Published on: October 10, 2022

A Primer on Opting-Out of Medicare

by Wachler & Associates, P.C.

With low rates of Medicare reimbursement, complex and unclear regulations, tremendous administrative burden, and the often arbitrary actions of Medicare contractors, a growing number of physicians and healthcare providers may wonder if there is an alternative to participation in Medicare. There is. Some providers have the option to “opt-out” of Medicare. Opting-out of Medicare refers to the process by which a healthcare practitioner foregoes any right to bill Medicare and collect reimbursement from Medicare. Instead, the practitioner is reimbursed directly by his or her patients. Opting-out of Medicare can be part of a larger concierge medicine model. Not every provider type is eligible to opt-out of Medicare, but for those who may opt-out, it can be an intriguing option.

Unfortunately, opting-out of Medicare cannot be accomplished by simply not enrolling in the Medicare program. Because the entitlement to Medicare services technically belongs to the beneficiary, a provider who provides Medicare-covered services to Medicare beneficiaries generally must either bill Medicare for the services or opt-out. The provider generally cannot bill the beneficiary (other than co-pays, etc.) for Medicare-covered services because, among other reasons, the beneficiary may then be entitled to bill Medicare themselves for the covered services. These rules generally do not apply to services that are not covered by Medicare.

Therefore, a healthcare practitioner who intends to bill Medicare beneficiaries directly for services that would otherwise be covered by Medicare must undergo the formal process of opting-out of Medicare. First, the practitioner must submit a set of documents, including an affidavit, to the Medicare Administrative Contractors (MACs) in any jurisdiction in which they would otherwise submit Medicare claims. Second, the practitioner must enter into a “private contract” with every Medicare beneficiary to whom he or she provides Medicare-covered services. These “private contracts” are required to contain several specific terms in order to be effective. Once a provider opts-out, the opt-out is generally effective for two years. While a practitioner must opt-out for all patients and all services, opting-out generally does not affect a practitioner’s ability to order other items or services that are covered by Medicare or the practitioner’s group’s ability to bill Medicare.

Published on: October 3, 2022

More Changes to No Surprises Act Final Rule

by Wachler & Associates, P.C.

On Friday, August 26, 2022, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS), Department of Labor, and Department of Treasury (collectively, the Departments) issued a new Final Rule updating key regulations pertaining to the No Surprises Act. The Final Rule addresses disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (QPA) for out of network services, as well as establishing the factors and information which certified federal independent dispute resolution (IDR) entities must consider in arbitrating disputes for out of network services or items. The Final Rule takes effect October 25, 2022 and covers services and items rendered during plan years beginning on or after January 1, 2022.

The July 2021 interim final rule initially required group health plans and health issuers to make certain disclosures. When the QPA serves as the recognized amount or the amount that serves as the basis for cost sharing with respect to out of network services, plans and issuers must disclose the QPA and certain related information, as well as certain additional information at the request of the provider or facility. When a plan or issuer down-codes the billed claim, the plan or issuer must automatically provide additional information about the QPA with an initial payment or notice of denial. The additional information must include a statement that the claim was down-coded, an explanation of why the claim was down-coded, and the amount that would have been the QPA had the claim not been down-coded.

In October 2021, the Departments issued their first attempt at establishing the information an IDR entity must consider, however these rules were challenged in court and subsequently vacated. Under the most recent Final Rule, a Federal IDR entity must weigh specific considerations and select the offer that “best represents the value of the qualified IDR service or item” as the out of network rate. Specifically, the IDR entity must consider the QPA for the same or similar qualified IDR service or item for the applicable year, as well as additional information submitted by a party related to:

Published on: September 28, 2022

HHS OIG Issues New Advisory Opinion Regarding Speaking Engagements

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued OIG Advisory Opinion No. 22-14 that applied its November 2020 special fraud alert targeting remuneration associated with speaking arrangements funded by pharmaceutical and medical device companies.

The November 2020 special fraud alert addressed potential Anti-Kickback Statute (AKS) risks arising from paying physicians to speak at educational programs and providing benefits to attendees. OIG outlined several factors that, if present, would increase the risk of an AKS violation.

OIG’s No. 22-14 Advisory Opinion was issued in response to an ophthalmology practice’s proposed continued education program. The practice intended to offer continued education programs to local optometrists, who may be responsible for referring approximately half of the practice’s surgical patients. Although many of the local optometrists refer their patients to the practice, the program would be available to all optometrists in the area, and there would be no obligation to refer patients to the practice after attending the program.

Published on: September 6, 2022

OIG Updates Work Plan for August 2022

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced several new changes in its Work Plan update in August 2022. The OIG Work Plan forecasts the projects that OIG plans to implement over the foreseeable future. These projects usually include OIG audits and evaluations. Below are the highlights from the Work Plan update of which providers and suppliers should take notice.

First, OIG will perform an audit of selected HHS divisions to evaluate the effectiveness of security controls to determine whether service providers are identifying and reporting cybersecurity events. The audit seeks to ensure HHS’s compliance with the Federal Information Security Management Act and OMB Circular A-130 which requires Federal agencies to ensure that service providers meet the security requirements for transmitting, processing, or storing Federal information.

Second, OIG will perform a nationwide review of skilled nursing facility (SNF) costs for services, facilities, and supplies furnished by entities with common ownership with the SNF. Medicare regulations require that the cost of services, facilities, and supplies furnished to a provider by an organization under common ownership or control be the same or lower than the cost of comparable services and supplies purchased elsewhere. Accordingly, the review will compare these costs to determine whether skilled nursing facilities are reporting these related-party costs in accordance with the Medicare regulations. The review will also consider how a skilled nursing facility’s allocation of Medicare funds can impact beneficiary care.

Published on: August 31, 2022

HRSA Starting Audits for COVID-19 Testing

by Wachler & Associates, P.C.

More of the long-promised enforcement actions related to COVID-19 pandemic relief and healthcare programs have started to unfold. This time it is demands from the Health Resources and Services Administration (“HRSA”) that providers repay funds they have received for providing COVID-19 testing to the uninsured during the pandemic.

As part of the response to the COVID-19 pandemic, Congress provided funding for testing of patients without health insurance. The funding of testing for the uninsured was overseen by HRSA under the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program. HRSA contracted with Optum to administer the program directly. Generally referred to as “HRSA funding” for testing of the uninsured, this system functioned as a claims reimbursement program wherein eligible healthcare providers submitted claims to HRSA/Optum for reimbursement, made certain attestations, and Optum reimbursed providers’ claims.

Recently, healthcare providers who billed and received reimbursements under this program have begun to receive “assessment” letters from HRSA. HRSA has generally insisted that these are not “audits,” but “assessments.” These letters generally indicate that HRSA made payments to the provider in error and demand that the provider make immediate repayment. The letters generally do not provide denial reasons or explain the nature of the “error,” and do not contain allegations of fraud. They simply demand repayment. The letters also generally do not provide for an appeal process. Where a provider receives a letter, HRSA generally also suspends payment to the provider, pending the completion of an assessment.

Published on: August 17, 2022

HHS and DOJ Release Guidance Regarding Accessibility of Telemedicine Services

by Wachler & Associates, P.C.

The use of telemedicine has exploded over the last few years. The COVID-19 pandemic spurred a shift from in-person services to services provided by telemedicine. As healthcare providers and patients experience the added convenience of telemedicine in some circumstances, some of the large-scale shifts to telemedicine will likely become permanent. However, with increased use comes increased scrutiny from regulators. The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) and the Department of Justice (DOJ) recently released guidance regarding the provision of telehealth services to individuals with disabilities or with limited English proficiency.

Collectively, several federal laws generally prohibit discrimination on the basis of disability, race, color, and national origin, among other bases. Federal regulations also generally require covered health programs or activities provided by covered entities through electronic or information technology to be accessible to individuals with disabilities unless doing so would result in undue financial and administrative burdens or fundamental alteration of the health program. According to the joint guidance, “A health care provider’s failure to take appropriate action to ensure that care provided through telehealth is accessible can result in unlawful discrimination.”

HHS and DOJ’s guidance generally directs providers to make exceptions to their telemedicine policies or to make special accommodations to individuals with disabilities or limited English proficiency, such as allowing extra time for familiarization with the telemedicine platform or for communication with the provider, allowing caregivers or others to be present during a telemedicine visit, adding additional capabilities or support for functions like real-time captioning or screen reader software, and use of language assistance services. A provider’s obligation to accommodate disabilities over telemedicine is generally the same as when providing in-person services.

Published on: August 10, 2022

Commercial Payor Audits of Labs for COVID-19 Growing

by Wachler & Associates, P.C.

As the COVID-19 pandemic continues to recede, efforts by commercial insurance carriers to claw back millions of dollars paid out for COVID-19 testing services are steadily increasing, creating an ongoing audit risk for healthcare providers, especially clinical labs. In many cases, efforts to get people tested, slow the pandemic, and ask questions later have turned into accusations of over-billing and demands that providers repay the insurance carriers.

Early in the pandemic, Congress required commercial insurers to cover certain claims for COVID-19 testing. However, Congress did not provide the insurers with funds to cover the cost of this mandate and some insurers have pushed back against lab claims for COVID-19 testing. As public opinion and political fervor over the urgency of testing has subsided, commercial insurers are taking advantage of the opportunity to audit COVID-19 testing claims, dispute payments they have made to the labs, and demand that labs make repayment, often for significant portions of the lab’s COVID-19 testing volume. These disputes generally focus on the same issues.

First, insurers may audit labs based on the requirement for an “individualized clinical assessment,” including whether the practitioner was authorized, whether the order for testing was within the scope of state law, whether the assessment was conducted by telemedicine or by a questionnaire, whether the ordering provider used a standing order, and what rules apply where a state does not or did not require an order for COVID-19 testing.

Published on: August 4, 2022

Contours of EKRA Still Forming

by Wachler & Associates, P.C.

One of the largest areas of debate in healthcare regulatory compliance is the Eliminating Kickbacks in Recovery Act (EKRA). Despite the many question marks by healthcare providers around how to comply with EKRA, the statute also carries some of the stiffest penalties for failing to do so. Enacted in 2018, EKRA provides criminal penalties for paying, receiving, or soliciting any remuneration in return for referrals to recovery homes, clinical treatment facilities, or laboratories. Although initially intended to apply only to substance abuse and recovery, EKRA was written so broadly that it applies to all clinical laboratory services, not just in connection with substance abuse and recovery. It is unclear if Congress intended this effect, as the expansion to all lab services was included a mere 6 days before the final version of the law passed. Regardless, a violation of EKRA may be punished by fines up to $200,000, imprisonment of up to 10 years, or both, for each occurrence.

EKRA is often compared to other federal regulatory statutes, such as the Physician Self-Referral Law (commonly called the Stark Law) and the Anti-Kickback Statute (AKS). However, EKRA is written incredibly broadly and may prohibit conduct that might otherwise be permissible under the Stark Law and AKS. The Stark Law and AKS also have volumes of regulations and decades of enforcement, such that it is generally well understood how these statutes function, how government agencies view and enforce them, and how to structure arrangements to comply with them. EKRA, on the other hand, has no regulations and few enforcement actions, often leaving healthcare providers with only the bare text of what is potentially a very broad statute.

Recent enforcement actions are beginning to show that EKRA is likely as broad as it appears. Initially, enforcement actions under EKRA were limited to allegations regarding substance abuse and recovery services, as originally intended. But this summer, the Department of Justice (DOJ) charged a clinical lab with an alleged multi-million-dollar healthcare fraud scheme, which included allegations that the lab violated EKRA by paying for referrals for COVID-19 testing, showing a willingness to enforce the full breadth of EKRA on clinical lab services.