Articles Posted in Medicare

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The many ways in which a provider might be removed from the Medicare program are often a source of confusion and consternation for Medicare-enrolled healthcare providers and suppliers. Sometimes a Medicare revocation or suspension may occur unexpectedly and devastate a provider’s business. Sometimes a provider will voluntarily leave the Medicare program in an attempt to avoid inevitable sanctions. Each of these is a distinct mechanism and should be considered separately.

A revocation of Medicare billing privileges, commonly called a “Medicare revocation,” is a forced removal of a provider’s participation in and ability to bill the Medicare program. There are approximately two dozen grounds on which a provider’s billing privileges may be revoked, from noncompliance with Medicare program requirements (as simple as a missed signature on an insurance policy) up to abuse of billing privileges and patient harm. A revocation may be retroactive and take effect sometime in the past, before the provider is notified, or it may take effect sometime in the future, such as 30 days after the provider is notified. A Medicare revocation will be accompanied by a reenrollment bar of one to twenty years and often placement on the CMS Preclusion List. A Medicare revocation is subject to an appeals process, but most of the process is stacked heavily against the provider and it is important for the provider to be active in their response as early in the process as possible.

A suspension of Medicare billing privileges, commonly called a “Medicare suspension,” is a temporary suspension of a provider’s ability to bill the Medicare program. They are often imposed pursuant to a review or an audit where a Medicare contractor has alleged that the provider has committed some form of fraud. Suspensions are often imposed with immediate effect and sometimes without prior notice to the provider. Although suspensions are meant to be temporary, they are of undefined duration and often last for months without a specific end date, suffocating a provider’s business as effectively as a revocation. Medicare suspensions are technically subject to a truncated appeals process, but, although the suspension appeal process should still be pursued, the process is effectively meaningless and suspensions are generally best addressed through contesting the audit that supposedly identified fraudulent claims. However, it is worth noting that Medicare will often suspend a provider long before giving the provider the results of the underlying audit or the opportunity to appeal those results.

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) regularly performs risk and priority analyses of the various HHS programs and identifies areas of focus on a monthly basis. Amongst the items released in June, OIG has included: Nationwide Audits of Medicare Part C High-Risk Diagnosis Codes, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2022, State Medicaid Agencies’ Perspectives of Managed Care Plans’ Referral of Fraud, and Audit of Selected, High-Risk Medicare Hospice General Inpatient Services. Providers should be prepared for the potential of increased audits and scrutiny based on these OIG projects.

Nationwide Audits of Medicare Part C High-Risk Diagnosis Codes have been deemed a work plan item due to the alleged risk of improper payment amounts as a result of miscoded diagnoses. Medicare Advantage (Medicare Part C) organizations are required by law to submit risk adjustment data to CMS, and payments to these organizations are based on this data. Miscoding of diagnoses can result in increased payments to Medicare Advantage organizations. OIG states it will be focusing its audit on diagnoses that it believes are high risk for being miscoded.

OIG has identified Medicare Payments for Clinical Diagnostic Laboratory Tests in 2022 as a work plan item in order to ensure compliance with the Protecting Access to Medicare Act of 2014 (PAMA). PAMA requires CMS to set payment rates for lab tests, which are based on current private health care market rates. PAMA also requires CMS to publish annual analyses of the top 25 tests based on Medicare Part B spending. OIG plans to review the published CMS data and issue its yearly report by 2024.

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The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) recently released the Semiannual Report to Congress for the 6-month period ending from October 1, 2022, to March 21, 2023. The report can provide insight regarding OIG’s current focus and enforcement priorities. Currently, OIG appears to be focused on skilled nursing facilities, COVID-19 related enforcement, and cybersecurity. In the OIG’s report, the OIG presented OIG expected recoveries, criminal and civil actions, and other statistics, including accomplishments for the fiscal year 2023 to date.  Specifically, in its strategic plan, OIG focused on the following: 1)  combatting alleged fraud, waste, and abuse and holding alleged wrongdoers accountable; 2) promoting quality, safety, and value in HHS programs and for HHS beneficiaries; and 3) advancing excellence and innovation.

During this reporting period, the OIG issued 62 audit reports and 19 evaluation reports, with expected recoveries by audit work at $200.1 million and $277.2 million in questioned costs based on OIG’s findings of alleged violations, costs not supported by proper documentation, or unreasonable and unnecessary expenditures of funds. OIG also made 213 new audits and evaluation recommendations. Additionally, the OIG’s investigative work led to $892.3 million in expected investigative recoveries, 345 criminal actions, civil actions against 324 individuals and entities, and exclusions of 1,365 individuals and entities from Federal health care programs.

A top priority for the OIG was to improve nursing home care to better protect nursing home residents by understanding what drives nursing home performance, prioritizing quality of care and quality of life for residents, and establishing that the entities responsible for oversight both detect and remedy any problems quickly. Another goal of the OIG is to protect enrollees from prescription drug abuse and safeguard health care services for individuals suffering from substance abuse disorders.

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The Centers for Medicare & Medicaid Services (CMS) recently announced that it is planning to launch a new iteration of PECOS in Summer 2023. Dubbed “PECOS 2.0”, the new provider system aims to make the Medicare enrollment and revalidation processes faster and more efficient.

According to CMS, PECOS 2.0 will modernize Medicare enrollment management and allow providers to accomplish more tasks electronically. Some of these changes include faster applications using pre-population information, one application to update multiple enrollments, faster and easier revalidation processes, and the ability to track application status in real-time. CMS has also stated that provider data and records in current PECOS will transfer to PECOS 2.0 seamlessly. Applications currently in progress can be continued in PECOS 2.0, and applications previously closed will be available but will include limited information. All records transferred from current PECOS to PECOS 2.0 will be noted as such to make them easily identifiable. Additionally, providers’ login credentials will not be affected, and providers will still be able to log in to PECOS 2.0 using their Identity & Access (I&A) username and password.

With PECOS 2.0, providers will gain the benefit of consolidated applications, which is a combined application that updates and handles multiple enrollments. Consolidated applications will make it easier for providers to submit changes across multiple similar enrollments and multiple Medicare Administrative Contractors (MACs). When a provider submits a consolidated application that would normally require sending information to two different MACs, PECOS 2.0 will automatically separate the application and send the appropriate information to the relevant MACs. To ensure compliance with varying state requirements, PECOS 2.0 is also introducing a smart error process check which reviews and validates information for correctness as applications are completed. Moreover, there is no additional fee for consolidated applications. Whether providers choose to submit a consolidated application that covers multiple enrollments or an individual application for each enrollment, the fees will be the same and application fees will be automatically determined by each application.

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Under the Medicare Part C or Medicare Advantage (MA) program, the Centers for Medicare & Medicaid Services (CMS) contract with Medicare Advantage Organizations (MAOs), typically private insurance companies, that administer MA health plans to Medicare beneficiaries as an alternative to traditional Medicare. Enrollment in MA plan has steadily grown in the last several years, and currently roughly half of all Medicare beneficiaries are enrolled in an MA plan. Further, federal authorities recently accused MAOs of overcharging the Medicare program by millions of dollars. Increased scrutiny of MAOs could lead to more stringent review of claims submitted by providers and MAOs may take greater action against providers through overbearing audits in an effort to offset losses. In any event, providers can likely expect MA plans to increase their audit activity of healthcare providers.

Some of the most popular MA health plans are administered by Humana, UnitedHealthcare, Aetna, BlueCross BlueShield, and Cigna. Audits by MA plans differ from audits conducted by Medicare or those conducted pursuant to commercial insurance plans, but MA plans are governed primarily by the provider’s participation agreement with the MA plan. As part of a provider’s participation contract, MA plans generally have the right to audit a provider’s claims. MA plans may audit providers for a number of reasons, such as suspicions of alleged upcoding, overutilization, irregularities, or fraud and abuse. A provider’s contract with the MA plan will generally prescribe a limited lookback period that restricts how far back in time the plan can review claims for audit purposes. The contract will generally also prescribe the policies and procedures which the plan must follow when conducting audits. However, state laws may affect the extent to which MA plans can audit providers by providing for conflicting maximum lookback periods or imposing other limitations. Notably, health plans may use these audits to retroactively deny a number of claims, which may then be extrapolated over several years of service, resulting in significant alleged overpayments against the provider. This may further result in serious actions such as recoupment, mandatory prior authorization, or even removal from the MA plan’s network of providers. Additionally, certain adverse actions imposed by MA plans may serve as the basis for even further consequences from CMS, such as suspension or termination from the Medicare program. Given the rapid growth of MA plans, providers should be aware of their rights and responsibilities regarding the most common MA plan audits, as well as be proactive in their compliance efforts.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining to Medicare Advantage audits or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.

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Under the Medicare Advantage (MA) program, the Centers for Medicare & Medicaid Services (CMS) makes monthly payments to Medicare Advantage Organizations (MAOs), typically private insurance companies, according to a system of risk adjustment that depends on the health status of each enrollee. Accordingly, MAOs are paid more for providing benefits to enrollees with more severe diagnoses associated with more intensive uses of healthcare resources than to healthier enrollees who would be expected to require fewer resources. To determine the health status of enrollees, CMS relies on MAOs to collect diagnosis codes from their providers and submit these codes to CMS. While the MA plans conduct audits of the claims submitted to them by providers, CMS conducts audits of MAOs because some diagnosis codes are at higher risk for being miscoded, and MA audits that allegedly identify any improper coding may result in overpayment demands from CMS.

Since MAOs receive additional payments when they cover patients with more severe health conditions, this structure presents a potential for fraud and abuse whereby some MAOs may use additional diagnoses to attain high-risk scores, while not necessary reflecting these diagnoses in any documentation. In fact, MA plans have come under scrutiny recently after a Freedom of Information Act (FOIA) lawsuit revealed millions of dollars in overcharges by certain MAOs, specifically health insurers that issue MA plans. A common allegation involves “chart reviews” wherein MA plans find additional diagnosis that are supported by the medical records but were not previously reported or coded. Federal authorities tend to take issue with such diagnoses where they lead to higher cost for the Medicare program but not additional service being provided to the beneficiary. Healthcare providers have historically also encountered significant issues with MA programs. Payment, audits of providers, and claim adjudication are usually governed by contracts that are not necessarily the same amongst MA plans, and which most likely differ from the rules and regulations applicable to traditional Medicare. This is, where providers are audited by MA plans, the audits tend to resemble the commercial insurance audits, rather than traditional Medicare audits.

To provide oversight of the MA program, CMS performs audits of MA plans through the Risk Adjustment Data Validation (RADV) program. RADV audits are designed to identify improper risk adjustment payments made to MAOs in situations where medical diagnoses submitted for payment allegedly were not supported in the beneficiary’s medical record, ensuring that MAOs do not game the system and claim more money than they should. Each year, CMS selects several MA plans for RADV audits to ensure that medical record documentation supports diagnoses submitted for risk adjustment. The RADV audit process generally requires MAOs and their providers to submit a sample of medical records to validate risk adjustment data, in addition to other requirements. In a recently issued final rule, CMS stated that it will only extrapolate audit findings beginning with the plan year 2018 RADV audit, and will not extrapolate audit findings prior to 2018. As MA plans are becoming increasingly popular amongst Medicare beneficiaries while at the same time drawing more scrutiny from government regulators, providers should make efforts to ensure compliance with MA program requirements, as well as be prepared to appeal any denials.

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The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule that would require disclosure of private equity (PE) or real estate investment trusts (REITs) ownership, managerial, and other disclosable information for Medicare skilled nursing facilities (SNFs). The proposed rule also includes recommendations for comparable requirements for Medicaid nursing facilities (NFs) at the state level. If finalized, the proposed rule would likely increase the complexity of transactions involving PE or REIT ownership of SNFs and increase the reporting burden of PE or REITs with existing ownership interest in these facilities.

The timing of this proposed rule, according to CMS, is purposefully aligned with the Biden Administration’s recent initiative to improve the safety, quality, and accountability of nursing homes. The proposed rule also complements other recent CMS efforts intended to strengthen provider enrollment rules to “stop fraud before it happens” and stop playing “pay and chase” with individuals and organizations that the agency views as posing an undue risk of fraud, waste, or abuse to the Medicare and Medicaid programs. CMS stated that this proposed rule is necessary to obtain important data about the owners and operators of Medicare SNFs and Medicaid NFs, enabling CMS and states to better monitor the ownership and management of these providers. Given allegations of quality issues and differences in outcomes of these facilities with certain types of owners, CMS views this as an especially critical consideration.

If finalized, the proposed rule would require disclosure of the following information for all Medicare SNFs and Medicaid NFs:

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As part of the Inflation Reduction Act (IRA) of 2022, the Centers for Medicare & Medicaid Services (CMS) is required to establish the Medicare Drug Price Negotiation Program (Negotiation Program) to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biologicals. In accordance with the IRA’s requirements, CMS recently issued an initial guidance memorandum for implementation of the Negotiation Program for initial price applicability year 2026, as well as solicitation of comments.

The initial guidance memorandum describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (January 1, 2026 to December 31, 2026), and specifies the requirements that will be applicable to manufacturers of Medicare Part D drugs that are selected for negotiation and the procedures that may be applicable to manufacturers of Medicare Part D drugs, Medicare Part D plans (both Prescription Drug Plans (PDPs) and Medicare Advantage Drug Plans (MA-PDs)), and providers and suppliers (including retail pharmacies) that furnish Medicare Part D drugs.

Additionally, the IRA creates several new sections under the Social Security Act (Act) to administer and govern the Negotiation Program. Specifically, in accordance with the IRA and the newly created provisions under the Act, CMS’ initial guidance provides that with respect to each initial price applicability year, CMS shall:

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The Centers for Medicare & Medicaid Services (CMS) recently announced updates to the voluntary self-referral disclosure protocol (SRDP), including revisions to streamline SRDP submissions. The SRDP process allows providers and suppliers to report certain violations under the Physician Self-Referral Law, commonly known as the Stark Law, by submitting information to CMS about actual or potential Stark Law violations. The decision to utilize the SRDP and the complete process of an SRDP disclosure are both complex and warrant careful and detailed consideration by a healthcare provider and their counsel.

The revised SRDP process introduces three key changes designed to reduce burdens of filing on self-disclosing providers by permitting such providers to:

  • Use a single Group Practice Information Form to report noncompliance with the Stark Law’s group practice definition, rather than completing separate forms for each individual physician in a group that had a prohibited referral due to such noncompliance;
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Under the Consolidated Appropriations Act (CAA), a new Medicare provider type, the rural emergency hospital (REH), has been created with the goal of preserving access to outpatient hospital services in rural communities. Rural providers already face numerous financial and operational challenges, and the high number of recent closures of rural hospitals has only compounded the health disparities in rural communities. The introduction of this new provider type offers a targeted solution for small rural providers that cannot continue to operate a full-service hospital.

Under the new classification, an REH is a Medicare-enrolled provider that must furnish emergency department services and observation care. REHs may also provide other outpatient services, but may not provide inpatient services, except for certain skilled nursing facility services. Currently, for outpatient services, an REH’s annual per patient average length of stay cannot exceed 24 hours. Additionally, REHs benefit from two basic payment policies: a monthly facility payment of $272,866 per month in 2023 and payment at 105% of the Outpatient Prospective Payment System (OPPS) rate for services that qualify as REH services.

To enroll as an REH, eligible providers must submit a Form CMS-855A change of information application, rather than an initial enrollment application. This process avoids the gap in payment that typically accompanies initial enrollment and helps ease the burden that would otherwise fall on prospective REHs. The provider must also submit an action plan for initiating REH services, including a transition plan that lists the services the provider will retain, modify, add, and discontinue. The action plan must also include a description of the services the REH elects to provide, in addition to the required emergency department services and observation care, and a description of how it will use the facility payment. An eligible provider may only become an REH by converting from a critical access hospital (CAH) or rural hospital. Only providers that were a CAH or rural hospital with 50 beds or less on the enactment date of the CAA (December 27, 2020) are eligible to convert to an REH.

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