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SMRC audits can be a difficult and baffling ordeal for a provider. They can last for months or years with very little information provided to the healthcare provider but can have devasting impacts. The Supplemental Medical Review Contractor, or SMRC, is a contractor with the Centers for Medicare & Medicaid Services (CMS) that performs a variety of Medicare and Medicaid audit and medical review tasks. Noridian Healthcare Solutions, which is also a Medicare Administrative Contractor (MAC), was selected as the SMRC in 2018 and remains the current SMRC.  The SMRC conducts nationwide medical reviews of Medicare Parts A and B, DMEPOS, and Medicaid claims for compliance with coverage, coding, payment, and billing requirements.

The SMRC’s audit areas are chosen by CMS and are referred to as “projects.” The focus of the medical reviews may include areas identified by CMS data analysis, the Comprehensive Error Rate Testing (CERT) program, professional organizations, and federal oversight agencies. At the request of CMS, the SMRC may also carry out other special projects. Not every SMRC project is created equal. Some SMRC projects are intended as program integrity audits to identify suspected fraud or are intended as medical necessity reviews to identify overpayments, while other SMRC projects are simply data collection and analysis meant to inform future CMS policy. Where a provider is subject to a SMRC audit, knowing which project the audit falls under can provide valuable information.

Where CMS assigns a project to a SMRC, the SMRC first sends targeted providers an Additional Documentation Request (ADR) letter, usually  in a distinctive green envelope with the Noridian SMRC logo. Upon receipt of the requested medical records and/or supporting documents, the SMRC conducts the review based on the analysis of national claims data, statutory and regulatory coverage, and coding, payment, and billing requirements. Once the review is complete, the provider should receive a Review Results Letter. A provider may sometimes be given 14 days to request a voluntary Discussion and Education session with the SMRC. The provider generally also can appeal the SMRC’s findings directly to the SMRC. Where a SMRC denies an appeal, it may refer the matter to the local MAC to collect the alleged overpayment, which is generally subject to the Medicare claims appeal process. If the SMRC suspects fraud, it may also refer the matter to CMS or other government agencies.

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Healthcare providers are often required to collect co-pays, deductibles, or coinsurance payments from patients. These requirements may be imposed by participation agreements with commercial insurers or, in the case of Medicare and Medicaid, federal and state laws or regulations. It can be tempting to waive copays and other amounts due from patients because it improves patient relationships and may lead to more business. However, waiving copays and the like can implicate beneficiary inducement laws, the Anti-Kickback Statute, the Civil Monetary Penalties Statute, the False Claims Act, and other laws.

While there are some legitimate reasons to waive copays, in most cases, the provider must attempt to collect from the patients. Where a provider attempts to collect copays and other amounts from patients but is unsuccessful and there is no other legitimate reason to waive the copay, what collection efforts are providers required to use to comply with the laws listed above and avoid accusations of waiving copays?

In general, a healthcare provider must use “reasonable collection efforts” to collect copays and the like from patients. Some actions that a provider may consider are: sending multiple bills or invoices to the patient, collections or demand letters, phone calls to or personal contact with the patient, use of a collections agency, threats of litigation, drafts of litigation documents to send to the patient, and initiation of litigation against the patient. Some of these measures are draconian and may well cost more than the copay to be collected. While the size of the amount to be collected can be a factor in determining what collection efforts are “reasonable,” in nearly every case, the provider must make some attempt to collect. That is, a provider generally cannot refuse collection efforts simply because the amount due is small.  Further, a provider’s collection policy generally must be the same for all patients, regardless of the payor.

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A new study supports the growing perception that clinical laboratories will see an increase in audits from commercial insurance companies as the COVID-19 pandemic recedes. These audits will likely focus on a few particular areas of the COVID-19 testing services that clinical labs have developed and provided over the past two years.

The study reviewed lab revenue in Hawaii from May to December 2020 and is likely applicable to labs in other insurance markets. The study indicated strong growth in lab revenue from PCR tests and significant profit margins from PCR tests. Because federal law, namely the CARES Act, requires commercial insurers to cover COVID-19 testing without co-pays or other costs to the beneficiary, this increase in lab revenue will generally translate to higher costs for insurance companies. Further, when Congress passed the CARES Act, it did not provide funding to insurance companies for this coverage mandate. Many have long predicted that this would lead to increased costs for insurers, which would likely be passed on to members through higher premiums. Many insurance companies have pushed back against this coverage mandate since it was enacted.

Part of the pushback from commercial insurance companies has been to audit labs in an effort to deny claims for COVID-19 testing and to claw-back funds paid to labs for COVID-19 testing. These audits tend to focus on one or more of several issues: testing for a covered purpose, testing for travel, individualized clinical assessments, standing orders, posted cash prices, and collection codes. Some labs are particularly vulnerable to these audits because, during the pandemic, many labs rushed to invest and develop COVID-19 testing capability and capacity. Meanwhile, guidance regarding the CARES Act and the circumstances under which insurance companies are required to cover COVID-19 testing came out piecemeal and changed frequently as it developed. Due to these factors, labs may have high volumes of tests that represent a good-faith, best effort at complying with the CARES Act at the time the tests were performed, but may have compliance vulnerabilities as the law is currently understood.

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CMS uses a tool known as Comparative Billing Reports, or CBR, to analyze a provider’s billing or prescribing patterns. After collecting each provider’s patterns in a certain Medicare Fee-for-Service area, these patterns are then compared to those of peers in the same state, in the same specialty, and across the country. Accumulating these patterns allows CMS to estimate average billing and prescribing patterns are for providers. It also helps determine which providers may be outliers. These outliers are often informed of their status in order to encourage adjustments in billing practices if necessary. Sometimes, CMS develops “Special Edition” CBRs which give more extensive resources to a particular subset and could include up to 4 letters. Though the CBR letters generally require no response from the provider, it is important to take the information into consideration to avoid complications or possible audits in the future. Under some circumstances, a provider may also choose to follow-up or refute any inaccurate information in a CBR letter.

Recently, CMS released a new CBR letter to critical care providers who were considered after the latest CBR data accumulation. This data came from all dates of service during the year 2021 and the trend was established by looking at cumulative data from 2019 to 2021. According to the letter, the criteria for receiving the latest CBR are that a provider:

    • 1. Is significantly higher compared to either state or national averages in any of the three metrics (i.e., greater than or equal to the 90th percentile), and
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For decades, both health professionals and patients alike have suffered from the consequences of prior authorization requirements. Important treatments and procedures are often put on pause for the sake of the finances or administrative inefficiencies of insurance companies. These treatment delays could even cause treatment abandonment after long periods of time. Michigan legislators sought to resolve this issue by approving a law that tightens the standards of authorization for insurance providers and accelerates the approval process, saving time, money, and even lives.

On March 23, 2022, the Michigan House of Representatives passed Senate Bill 247 by a vote of 103-2. The bill states that starting June 2023, health insurers must act on urgent prior authorization requests within 72 hours and non-urgent prior authorization requests within nine days, which will be narrowed to seven days by 2024. If the insurer fails to act within this nine- or seven-day period, the non-urgent prior authorization will be considered automatically granted. The decision on these prior authorization requirements must also now be based on peer-reviewed clinical review criteria.

In addition to these time and material restrictions, the law also requires insurers to implement an electronic process for prior authorization requests, making them more efficient. If any changes or additions arise on the existing requirements for health care providers, insurers must give notice.

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There are many types of Medicare audits, conducted by many types of Medicare contractors: Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs), Unified Program Integrity Contractors (UPICs), the Supplemental Medical Review Contractor (SMRC), and others. Sometimes, where a Medicare audit results in a relatively small overpayment demand, a healthcare provider may consider simply paying it and moving on. However, there are several reasons why Medicare audits should be appealed, regardless of the dollar amount at issue, that providers should consider.

First and foremost, the audit results and overpayment determinations issued by Medicare contractors are often erroneous. This may be because the contractor either misunderstands Medicare requirements, misapplies them to a provider’s records, or misapprehends the medical documentation in the first place.

Second, a provider who does not appeal a Medicare audit result may unwittingly signal to the contractors a tacit admission that the audit findings were correct, and that the provider is non-compliant in some way. This may expose the provider to additional, larger audits on the same issues. Further, some contractors are paid a percentage of the overpayments they demand from providers and may have an incentive to conduct further audits. On the other hand, appealing an audit signals that the provider believes it is following Medicare requirements and are entitled to payment.

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Healthcare providers have long struggled under the administrative burden of prior authorization requirements imposed by Medicare Advantage (MA, also known as Medicare Part C) plans, as well as arbitrary prior authorization denials, utilization controls, and coverage denials by MA plans. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently took note of some of the issues providers are having with MA plans and may present a new avenue for providers dealing with these issues.

A recent OIG review of MA prior authorization requirements revealed that an estimated 13% percent of prior authorization requests which were denied by MA plans in fact met Medicare coverage rules and likely would have been approved under fee-for-service Medicare. OIG also determined that about 18% of MA claim denials in fact met Medicare coverage and Medicare Advantage billing rules. Further, OIG found that, on appeal, MA plans only reverse about 3% of prior authorization denials and about 6% of claim denials within three months. According to OIG’s analysis, advanced imaging services such as MRIs and CT scans, post-acute care following hospital stays, and pain relief injections were the most commonly affected services.

MA plans are generally required to follow Medicare coverage rules and their standards can’t be more restrictive than Medicare’s traditional national or local coverage determinations. However, MA plans often deny claims for arbitrary reasons, impose coverage criteria that do not exist under Medicare, or attempt to force provider to alter their utilization of medically necessary services to meet the MA plan’s arbitrary expectations. Moreover, the appeals processes offered by MA plans are often poorly defined and inconsistently administered.

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The COVID-19 pandemic has brought seismic changes to the clinical lab industry. High demand for COVID-19 testing services, tremendous amounts of funding, and rapidly changing government regulations have created opportunity for clinical labs, but also new compliance and audit challenges. As the dust settles and government entities and commercial insurers review lab claims for COVID-19 testing over the past two years, these are some of the audit and compliance challenges labs may face.

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. Under the federal coverage mandate, insurers are generally required to cover tests that are for the diagnosis of COVID-19 where there is an “individual clinical assessment” by an authorized provider that testing is appropriate. Testing for travel, return to work/school, and general screening purposes is generally not required to be covered, although insurers may choose to cover it. Insurers that chose to cover only what they are legally required to cover may audit labs for providing testing for an uncovered purpose. Testing for travel is sometimes a contentious issue because, depending on the circumstances, it may constitute uncovered general screening, or, in the case of people who were exposed while travelling or who were unable to social distance per CDC guidelines while traveling, may constitute circumstances where testing would be covered.

Further, 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, and what rules apply where a state does not or did not require an order for COVID-19 testing.

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As telemedicine becomes an increasingly popular method for connecting patients with healthcare providers, many providers are becoming interested in expanding the reach of their telehealth practices across state lines. Although technological advancements have helped providers communicate with patients remotely, state and federal regulations add additional considerations for practicing across multiple states.

Generally, healthcare providers will provide telehealth services to patients located within their own state. Most states allow for telehealth services and will allow state-licensed providers to provide telehealth services within the state in which they are licensed. State licensure requirements become more complex when an out-of-state provider wishes to provide telehealth services to a patient located in another state.

Telehealth services are generally considered to be performed at the patient’s physical location, which usually means that the provider must be licensed in the patient’s home state. Although the COVID-19 pandemic caused several states to temporarily waive some licensing requirements for cross-state telehealth services, many of those waivers has since expired.

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Following a temporary suspension in pre-payment reviews under the Targeted Probe and Educate (TPE) audit program in response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) announced in August 2021 that it would be resuming TPE reviews. Review under the TPE program is intended to be different than other audit reviews because the main goal is intended to be claim accuracy improvement through the use of several rounds of one-on-one education. However, a TPE audit can also have severe consequences for the provider. A provider or supplier navigating a TPE review should take care to comply with the program’s requirements and timelines and should be aware of the potential consequences of a review.

The TPE process is generally initiated when a provider receives an initial Notice of Review letter from their Medicare Administrative Contractor (MAC) which notifies the provider that they have been selected for a TPE review. This initial letter typically does not include any specific records requests, but indicates that the MAC will request records at a later date. The letter may briefly describe the TPE process as involving three rounds of claims review with education after each round. This letter will likely warn that, if a provider/supplier fails to improve the accuracy of its claims after three rounds, the MAC will refer the provider/supplier to CMS for additional action, such as prepayment review, extrapolation of overpayments, referral to a RAC, or other disciplinary action, up to and including revocation of Medicare billing privileges.

After the Notice of Review, the MAC will send Additional Documentation Requests (ADR) for 20-40 claims. These ADRs may be indistinguishable from any other document requests, likely with no indication that they are pursuant to a TPE audit. The ADRs must be responded to within 45 days. After the provider submits the documentation, the MAC is required to provide direct one-one-one education to the provider. The MAC will then issue a letter that outlines its findings. If a high number of claims are denied, the MAC will proceed to a second round of claims review and education. If a high number of claims are again denied, the MAC will proceed to a third round.

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