Compliance

Published on: December 7, 2022

Clinical Laboratory Updates in 2023 Physician Fee Schedule

On November 2, 2022, the Centers for Medicare & Medicaid Services (CMS) published its Final Rule implementing changes to the Medicare Physician Fee Schedule for CY 2023. Included within this Final Rule are important changes for clinical laboratories that will take effect on January 1, 2023.

There are two notable changes affecting clinical labs included in the Final Rule. First, CMS is implementing congressionally mandated changes to the Protecting Access to Medicare Act (PAMA) reporting regulations, which updates reporting timelines and limits the phase-in of laboratory test payment reductions. Laboratories should take steps to have their 2019 data accessible and prepare to report before the March 31, 2023 deadline. Second, CMS is issuing regulations to both codify and modify policies on billing Medicare for specimen collection fees and travel allowances. The changes also increase specimen collection payment rates that had previously remained unchanged for years. Specifically, as it relates to specimen collection, the changes may affect codes 36415, G0471, P9612, and P9615, but do not appear to relate to codes G2023 and G2024. As the regulations relate to travel allowances, the changes may affect codes P9603 and P9604.

Following the implementation of PAMA in 2014, Medicare has set the clinical laboratory fee schedule (CLFS) rates based on data reported by applicable laboratories on the payment rates they receive from commercial payors. The initial reporting period occurred in early 2017 based on data from 2016. However, the second reporting period was delayed due to the COVID-19 public health emergency, which was intended for early 2020. Thus, CMS is revising the definitions of “data collection period” and “data reporting period” to specify that for the data reporting period of January 1, 2023 through March 31, 2023, the data collection period is January 1, 2019 through June 30, 2019. Moreover, CMS clarified that data reporting is required every three years beginning January 2023. As a result, CLFS payment rates for CY 2024 through CY 2026 will be based on data collected in the first half of 2019 and reported in early 2023.

Published on: November 21, 2022

OIG Updates Work Plan for November 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 for November 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 conduct a targeted audit of Medicaid nursing facilities’ use of funds related to direct patient care. In carrying out this audit, OIG plans to select three facilities in selected states to determine what percentage of Medicaid nursing facility revenue is being expended on direct patient care. The three facilities selected for review will be composed of one of each of the following types: for-profit, not-for-profit, and governmental.

Second, OIG will perform a nationwide audit of inpatient rehabilitation facilities (IRFs). In prior years, IRF claims audits and Hospital Compliance audits that include IRF claims have revealed alleged high error rates related to IRF stays which did not support that the IRF care was reasonable and necessary in accordance with Medicare requirements. In response to these findings, IRF stakeholders have asserted that Medicare audit contractors and OIG have misconstrued the IRF coverage regulations. OIG plans to utilize this planned nationwide audit to better understand which claims IRFs believe are properly payable by Medicare and whether there are areas in which CMS can clarify Medicare IRF claims payment criteria. This audit will be an independent performance audit in accordance with Generally Accepted Government Auditing Standards.

Published on: November 14, 2022

NPDB Reporting Obligations Reinforced by Recent Court Decision

by Wachler & Associates, P.C.

Recently, a federal court in Oregon held that healthcare entities, including hospitals, are legally obligated to report to the National Practitioner Data Bank (NPDB) where a practitioner surrenders their clinical privileges while under investigation, even if the physician did not know that he or she was under investigation.

The Department of Health and Human Services (HHS) originally established the NPDB pursuant to the Health Care Quality Improvement Act of 1986 (HCQIA) in order to collect and release certain information relating to the professional competence and conduct of physicians, dentists, and other healthcare practitioners. Under the Act, healthcare entities, particularly hospitals, are generally required to disclose the acceptance of the surrender of clinical privileges of a physician while the physician is under an investigation by the hospital relating to alleged incompetence or improper professional conduct. The overarching goal of this provision was to close a loophole where physicians under investigation and healthcare entities would resort to “plea bargains” in which a physician agreed to such a surrender in return for the healthcare entity’s promise not to inform other healthcare entities about the circumstances of the physician’s surrender of privileges.

In the recent case, a hospital reported to the NPDB that a physician surrendered his privileges with the hospital while the physician was under investigation. The physician sought a preliminary injunction ordering the hospital to withdraw the report and argued that the report was false because he was not under investigation when he surrendered his privileges since the hospital officials allegedly failed to comply with the hospital’s policies before an investigation had begun. The court stated that for NPDB reporting purposes, the term “investigation” is not controlled by how that term may be defined in a healthcare entity’s bylaws or policies. Rather, that term is viewed expansively for NPDB reporting purposes, and is considered to run from the start of a general inquiry until a final decision on a clinical privileges action is reached. Notably, the court implied that the result would be the same even if the physician was not aware that he was under investigation, since there is no requirement in the context of NPDB reporting that the healthcare practitioner be notified or aware of the investigation. Thus, the court ultimately disagreed with the physician and upheld the hospital’s report.

Published on: November 9, 2022

CMS Focuses Enforcement on Poorly Performing Nursing Homes

by Wachler & Associates, P.C.

In a recent news release, the Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) announced revisions to the Special Focus Facility Program (SFFP), which addresses poor nursing home performance, that will have the effect of increased scrutiny of these troubled facilities. According to CMS, nursing homes that consistently perform poorly in comparison to their peers will be required to comply with stricter standards and demonstrate systemic quality improvements in order to avoid enforcement actions, including exclusion from the Medicare and Medicaid programs.

The increased scrutiny stems from the Biden Administration’s recently announced plan for reforms to nursing home conditions and complicated ownership structures that HHS contends impede oversight of skilled nursing facilities. The focus of the reforms is to increase nursing home quality and safety by requiring minimum staffing levels, enhanced infection control measures, and oversight of nursing homes owned by for-profit companies, among other policies. There are currently 88 nursing homes with persistent records of noncompliance participating in the SFFP in 2022, representing about 0.5% of all nursing homes. In order to complete the program, nursing homes must pass two consecutive inspections that occur approximately every six months. Under the revised program, nursing homes will not be allowed to exit the program if inspections reveal more than a certain number of deficiencies, or if facilities have not significantly improved.

CMS recommends that skilled nursing facilities work with quality improvement organizations and external consultants to implement evidence-based interventions and make meaningful changes to staffing and leadership. State Survey Agencies are also advised to take nursing homes’ staffing levels into consideration, in addition to their compliance histories, when selecting candidates for the SFFP. If nursing homes demonstrate continued noncompliance with the quality rules or fail to demonstrate efforts to improve, CMS has indicated that it will impose severe enforcement sanctions, such as discretionary denials of payment for new admissions, civil monetary penalties, or directed plans of correction. Importantly, any facilities cited for “immediate jeopardy” deficiencies in two surveys while participating in the SFFP may be terminated from the Medicare and Medicaid programs. Lastly, CMS is extending the monitoring period for possible enforcement actions against nursing homes that have successfully completed the SFFP if their performances decline after they are no longer subject to the extra oversight. Nursing homes participating in the SFFP should be aware of the heightened scrutiny that they will be subject to and take actions to ensure compliance with the quality standards, staffing requirements, and other key focus areas under the revised program.

Published on: November 2, 2022

OIG Recommends UPICs Conduct More Medicaid Audits

by Wachler & Associates, P.C.

On October 3, 2022, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report detailing OIG’s findings related to the efficacy of the Unified Program Integrity Contractor (UPIC) program. As many healthcare providers may know, UPICs are the primary program integrity contractors for the Centers for Medicare & Medicaid Services (CMS) and the only program integrity contractors with authority to review both Medicare and Medicaid claims. UPICs are tasked with investigating instances of suspected fraud, waste, and abuse in the Medicare and Medicaid programs. However, much of their work amounts to medical review and payment recovery, as their investigations rarely identify meaningful fraud, although it can cause tremendous damage to a provider when the UPIC accuses a provider of fraud

OIG conducted a qualitative study of each of the five UPICs’ 2019 activities, including surveying each UPIC to find out about the challenges they faced in performing program integrity activities. OIG also solicited input from CMS about the effects of the unification of Medicare and Medicaid program integrity activities, how CMS measures the effectiveness of UPICs, and any challenges UPICs face in conducting their work. Notably, OIG did not assess whether UPICs were appropriately targeting providers with audits and suspensions, or whether UPIC findings were upheld on review by other contractors or Administrative Law Judges in the administrative appeals process. Rather, OIG’s report seems to imply that more auditing is always better, regardless of its efficacy or its impact on healthcare providers.

As a result of the study, OIG found that UPICs conducted substantially more Medicare program integrity work compared to Medicaid work. The study revealed that UPICs conducted only minimal activities related to Medicaid managed care, even though most Medicaid enrollees receive services through managed care. OIG further noted that UPICs reported no data analysis projects completed or vulnerabilities identified related to Medicaid managed care in 2019. Overall, UPICs conducted disproportionately fewer Medicaid activities compared to the levels of funding they receive from CMS for Medicaid program integrity activities.

Published on: October 31, 2022

OIG Releases Medicare Telehealth Program Integrity Report

by Wachler & Associates, P.C.

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.