Compliance

Published on: August 16, 2023

OIG Final Rule Implementing Information Blocking Penalties

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule (Final Rule) on June 27, 2023, which implements statutory provisions for specific individuals or entities subject to the information blocking requirements established by the 21^st Century Cures Act (Cures Act). The Cures Act imposes civil money penalties (CMP) of up to $1 million per violation of information blocking, which is defined as “a practice that interferes with, prevents, or materially discourages access, exchange, or use of electric health information,” except as required by law or covered by an exception.

The Final Rule authorizes HHS to impose CMPs, assessments, and exclusions on individuals and entities that engage in alleged fraud or other misconduct related to HHS grants, contracts, and other agreements, as well as increases the maximum penalties for certain CMP violations. OIG may impose CMPs of up to $1 million per violation of information blocking on a health information technology (Health IT) developer of certified health IT or a health information network or health information exchange (HIN/HIE), as those terms are defined by OIG.

Penalties may be imposed on certified Health IT developers and HIN/HIEs that do not actually interfere with access, exchange, or use of electronic health information (EHI) if the requisite intent is present. Specifically, such individual or entity may have CMP exposure under the Final Rule if it knew or should have known that a practice was likely to interfere with access, exchange, or use of EHI. Additionally, OIG has clarified that a discrete action by an actor that implicates information blocking would be viewed as a single violation. Thus, it appears that the number of violations will be directly connected to the number of discrete acts.

Published on: August 14, 2023

CMS Announces GUIDE: A Medicare Dementia Care Model

by Wachler & Associates, P.C.

On July 21, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new payment model for providers furnishing dementia care, called Guiding an Improved Dementia Experience (GUIDE). A wide range of Medicare Part-B providers and suppliers are eligible to participate, with the exception of durable medical equipment and laboratory suppliers. The model is a comprehensive package of person-centered assessments, care plans, and care coordination. Additionally, this new payment model aims to further enhance the quality of life for people living with dementia by improving dementia care, reducing strain on unpaid caregivers, and helping people with dementia remain in their homes and communities.

GUIDE’s approach to dementia care takes into account staffing considerations, quality standards, and services for beneficiaries and unpaid caregivers. Under the GUIDE model, beneficiaries are required to be screened for psychological and health-related social needs. As a GUIDE participant, providers are required to establish and maintain an interdisciplinary team consisting of a care navigator and a clinician, with the option of including additional members. The care navigator must have training in care planning and dementia assessment while the clinician is required to have dementia proficiency through experience caring for patients 65 years or older and for adults with cognitive impairment. GUIDE participants are required to provide support services alongside caregiver training.

There are two options for providers considering implementing GUIDE:

Published on: August 9, 2023

OIG Declines to Impose Sanctions on Online Healthcare Directories

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released Advisory Opinion 23-04 (Advisory Opinion) on July 11, 2023, addressing arrangements between online healthcare directories and certain third-party websites (Directories) with federal healthcare program beneficiaries. In the Advisory Opinion, the OIG declined to impose sanctions on healthcare provider Directories offering these sort of advertising services to providers.

Under the proposed arrangement, healthcare provider Directories are serving as marketplaces in which users and potential patients can book medical appointments with physicians and other healthcare providers (Providers) who are listed on the online Directories. Patients can filter their results by searching for different types of medical providers, and the Directories generate personalized results using a proprietary algorithm.

Although no fee is charged to the patients for using the directory, Providers pay a fee to be included in the directory through an array of payment methods. Whenever potential patients click on a Provider’s profile during their searches, a “per-click” fee is charged to Providers. A “per-booking” fee is also charged to Providers for each new patient the Providers receive through the Directory which may vary in amount based on location, specialty, and other factors impacting the fair market value of the marketing service. Providers can also set spending caps, which would remove the Providers from the directory once a certain amount of booking fees has been met.

Published on: August 7, 2023

CMS Proposes Extension of Virtual Direct Supervision

by Wachler & Associates, P.C.

On July 13, 2023, the Centers for Medicare & Medicaid Service (CMS) released the Calendar Year 2024 Physician Fee Schedule Proposed Rule, proposing to extend remote supervision. The proposed rule continues to define “direct supervision” by allowing supervising physicians and practitioners the ability to continue “direct supervision” through real-time audio and visual interactive telecommunications through December 21, 2024.

Typically, to be payable under Medicare Part B, specific types of services must be provided under certain levels of “direct supervision” by a practitioner or physician. These services often include many diagnostic tests and other services furnished by auxiliary personnel incident to the services of the billing physician. “Direct supervision” usually requires the “immediate availability” of a supervising professional — both in-person and physical availability. However, during the COVID-19 Public Health Emergency (PHE), CMS allowed flexibility in what constituted “direct supervision” by allowing “immediate availability” to include virtual presence using two-way, real-time audio or video technology, instead of requiring physical presence. This policy allowing remote direct supervision was originally set to expire at the end of 2023.

However, due to the increased reliance on virtual direct supervision by physicians and beneficiaries alike, CMS expressed several concerns regarding the expiration of the policy. In its proposed rule, CMS noted that, despite the new patterns of virtual direct supervision that were established and often maintained during the PHE, evidence showing that patient safety is compromised by virtual direct representation is entirely absent. Moreover, telehealth services have overall allowed individuals in rural and undeserved areas to have improved access to care. Expiration of this policy could create substantial barriers to access of many healthcare services, including those furnished incident-to a physician’s service.

Published on: July 24, 2023

OIG Audits the COVID-19 Uninsured Program

by Wachler & Associates, P.C.

HHS Office of Inspector General (OIG) has released a new analysis of claims paid under the COVID-19 Uninsured Program. OIG reportedly identified a few dozen instances where the program reimbursed healthcare providers for services provided to patients who ended up having health insurance coverage. OIG generally assigned responsibility for these payments to the private contractor who administered the program, but nonetheless encouraged audits and recovery from the healthcare providers who received payments.

The COVID-19 Uninsured Program was created in early 2020 in response to provide reimbursement for providers who treated uninsured patients for COVID-19. The program was part of the larger Provider Relief Fund and paid claims up until April 2022, when it ran out of money. Altogether the Program paid out approximately $24.5 billion in claims. The program was overseen by the Health Resources and Services Administration (HRSA), but the day-to-day administration and claims processing functions were contracted to Optum Pay, a subsidiary of Optum Bank.

According to OIG (which did not refer to Optum Pay by name in its report, referring only to “HRSA’s contractor”), the contractor processing claims under the program indicated that it would check the insurance status of patients for whom claims were submitted, but in fact only checked insurance status when the patient’s Social Security Number (SSN) was included on the claim. HRSA did not require SSNs on such claims and so the majority of claims did not include SSNs and were not screened by the contractor prior to payment. Instead, HRSA’s contractor relied on the attestation by providers that the patient did not have health insurance coverage.

Published on: June 28, 2023

U.S. Supreme Court Expands Scope of the False Claims Act, Includes What Provider Believed When It Submitted the Claim

by Wachler & Associates, P.C.

The False Claims Act (FCA) was enacted during the Civil War to impose civil liability on anyone who knowingly acts in defrauding governmental programs. Healthcare fraud has been a leading source of FCA violations for several years, leading to $1.7 billion in settlements and judgments in the last fiscal year alone. Healthcare providers and suppliers who participate in Medicare and Medicaid programs are at risk for FCA violation allegations and must take measures to ensure compliance with these programs by following proper billing procedures. Notably, violations can carry significant consequences, as they impose treble damages and significant per-claim penalties which increase each year with inflation. Cases for violations of the Anti-Kickback Statute (AKS), Physician Self-Referral Law (Stark Law), and other regulatory and compliance requirements are often brought as FCA cases.

Healthcare providers and suppliers who knowingly submit false claims or fail to pay back money owed to the government may be in violation of the FCA. The FCA also carries a whistleblower provision, which allows private citizens to bring qui tam actions against providers and suppliers who have allegedly violated the Act. The government then may intervene in the action, allowing the whistleblower to recover a portion of the recovery. Qui tam actions encompass a considerable portion of FCA litigation and have broadened the scope of the FCA significantly, increasing the risk of violation allegations for healthcare providers and suppliers.

On June 1^st, 2023, the Supreme Court issued a unanimous decision in two consolidated FCA cases, U.S. ex rel. Schutte v. Supervalu Inc. and U.S. ex rel. Thomas Proctor v. Safeway, Inc., ruling that a defendant’s knowledge of a claim’s falsity refers to a subjective standard regarding what the defendant believed at the time it submitted the claims- not what an objectively reasonable person might have known or believed or what may later become reasonable in light of later facts or analysis. This ruling can generally be seen as an expansion of the “knowing” standard under the FCA and should caution healthcare providers and suppliers to take steps to ensure their knowledge and beliefs surrounding submission of claims to Medicare and Medicaid are compliant with these programs and are documented at the time claims are submitted, especially where there is a question of regulatory interpretation or ambiguity. Documentation of this knowledge in the form of written policies and procedures may be especially salient in ensuring compliance. Furthermore, if compliance issues or potential violations are raised, healthcare providers and suppliers should take immediate action to address and rectify them.

Published on: June 26, 2023

Medicare Revocation vs Suspension vs Voluntary Disenrollment

by Wachler & Associates, P.C.

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.

Published on: June 19, 2023

OIG Announces New Work Plan Items for June

by Wachler & Associates, P.C.

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.

Published on: June 13, 2023

OIG Releases Semiannual Report to Congress

by Wachler & Associates, P.C.

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.

Published on: May 30, 2023

New FAQs Expand OIG Guidance

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently announced that it is offering a new frequently asked question (FAQ) process to provide informal feedback to healthcare providers regarding an expanded set of topics. OIG already offers FAQs and responses on a number of topics, including advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. During the beginning of the COVID-19 public health emergency (PHE), OIG also implemented a FAQ process to provide informal guidance on certain arrangements that are directly connected to the PHE and that implicate OIG’s administrative enforcement authorities. Now, OIG is expanding its informal guidance umbrella even further.

The topics that OIG is expanding its informal guidance to cover include the following:

General questions regarding the Federal Anti-Kickback Statute, the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and State healthcare program beneficiaries (Beneficiary Inducements CMP), and OIG’s administrative enforcement authorities in connection with these statutes.