Articles Posted in Compliance

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Despite the ongoing public health emergency from the 2019 Novel Coronavirus (“COVID-19” or “COVID”), the Centers for Medicare & Medicaid Services (“CMS”) were encouraged by the Center for Program Integrity (“CPI”) to resume conducting Recovery Audit Contractor (“RAC”) and Medicare Administrative Contractor (“MAC”) audits. Some of the audits that are of high priority are post-payment reviews of COVID claims submitted prior to March 1, 2020. CMS has not yet stated when they will be auditing claims submitted after March 1, 2020 and throughout the current public health emergency, but experts expect these audits to begin in the coming months.

In fact, the CMS “Coronavirus Disease 2019 Provider Burden Relief FAQ” states that even if the public health emergency continues, it will lift the suspension of audits beginning on August 3, 2020 (though most providers will not see requests for review until at least a month after that). The audits will be done pursuant to existing statutory and regulatory provisions, but any waiver or flexibility allowed for any date of service which is under review will be considered in the audit.

In addition to those audits, CMS has also announced a new requirement to obtain reimbursement for COVID patients. Beginning on September 1, 2020, in order to receive the 20% Medicare reimbursement add-on payment for a COVID patient, the provider must document a positive COVID test in the patient’s chart. This new guidance applies only to Inpatient Prospective Payment Systems (“IPPS”), Long-Term Care Hospitals (“LCTHs”), and Inpatient Rehabilitation Facilities (“IRFs”). The guidance states that CMS will continue to automatically apply the 20% add-on payment for COVID-19 claims and will enforce the requirement through post-payment audits. The 20% add-on payment will be recouped if no positive COVID test is found in the patient’s chart.

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On July 31, 2020, the Department of Health and Human Services (“HHS”) announced that it would be reopening the application for providers who did not originally receive funds from the $50 billion general distribution of the Provider Relief Fund (“PRF”). The PRF was created in response to the 2019 Novel Coronavirus (“COVID-19”) pandemic, because the pandemic caused many providers to either lose a significant portion of patients or providers had to care for many more patients in unprecedented ways. The first phase of the general distribution was initially distributed in two “tranches” back in April, but many providers either failed to apply quick enough or were just rejected. The first tranche of $30 billion was automatically distributed, but the second tranche of $20 billion had to be applied for by providers. The second phase covered those providers who did not qualify for the first phase.

Between August 10 and August 28, 2020, providers who missed the application period or were rejected from the second tranche can once again apply to receive funding. Providers can receive funding up to 2 percent of the applying provider’s annual patient revenue.

As mentioned above, the first tranche was automatically distributed based on 2019 CMS payment data. Because it was solely based on 2019 data, some practices that changed ownership at the beginning of 2020 were not permitted to receive payments—yet they were still severely impacted by the COVID-19 crisis. Additionally, any previous owner who was distributed funds but no longer owned the medical practice was not permitted to transfer the general distribution funds to the new practice owners but could only return the payments to HHS. Thus, between August 10 and August 28, 2020, providers who experienced a change in ownership may submit their revenue information along with all documentation showing the change in ownership in order to receive funding from the PRF.

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On June 9, 2020, the Department of Health and Human Services (“HHS”) announced that two additional targeted allocations from the Provider Relief Fund will be made to Medicaid and the Children’s Health Insurance Program (“CHIP”) providers and to safety net hospitals. The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was enacted as a response to the ongoing 2019 Novel Coronavirus worldwide pandemic. The CARES Act has already dispersed a general distribution, as well as various targeted allocations.

The general distribution initially provided payments to around 62% of Medicaid and CHIP providers, and this new targeted allocation will provide payments to the remaining 38%. Approximately $15 billion will be distributed those Medicaid and CHIP providers who have not already received a payment from the general allocation of the Provider Relief Fund.

An enhanced Provider Relief Fund payment portal is now accessible to Medicaid and CHIP providers, where they will report their annual patient revenue. Each provider will receive a payment of at least 2% of reported gross revenue from patient care, subject to increase or decrease according to the amount of Medicaid patients the providers serve. In order to be eligible, these Medicaid and CHIP providers:

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The Centers for Medicare and Medicaid Services (“CMS”) expanded its Targeted Probe and Educate (“TPE”) program on October 1, 2017. The goal of the TPE program is to help providers be more cognizant of their billing practices so that they may provide improved services in the future.

TPE review is a process where providers who have high denial rates or unusual billing practices compared to other providers in their field are reviewed. Simple claim errors are typically why providers have high denial rates. Some examples of these errors include: missing a physician signature, encounter notes not fully supporting eligibility, documentation not meeting medical necessity, or missing/incomplete certifications or recertification.

When a provider is chosen for the program, they receive a letter from their Medicare Administrative Contractor (MAC). The TPE process involves an initial review, or “probe,” of 20-40 claims. If it is determined that the provider is non-compliant, a targeted, one-on-one education session will be offered to address errors found in the claims reviewed. Conversely, providers who are found to be compliant will not be reviewed again for at least one year. After the education session, providers have 45 days to make changes and improve. Those providers who continue to have high error rates after the first round must then proceed with a second round of reviewed claims and education. If high error rates continue, a third round will commence. After three rounds of TPE, if the provider continues to be non-compliant, they will be referred to CMS for further action. A provider can be removed from the review process at any point if they sufficiently demonstrate a significant reduction in their error rates.

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The Centers for Medicare and Medicaid Services (“CMS”) has released its Final Rule regarding the disclosure of affiliations in the provider enrollment process. This rule took effect on November 4, 2019. This rule permits the Secretary to revoke or deny enrollment based on the disclosure of any affiliations that CMS determines poses an undue risk of fraud, waste, or abuse. Although this rule will eventually be applicable to all providers, CMS is starting out with a phase-in approach, where the rule will only be applied to initially enrolling or revalidating providers that CMS has specifically determined may have one or more applicable affiliations.

The Final Rule requires providers and suppliers to disclose any current or previous direct or indirect affiliation with a provider or supplier that has a “disclosable event.” The Final Rule defined a disclosable event as: (1) when the provider or supplier has an uncollected debt; (2) the provider or supplier has been or is currently subject to a payment suspension under a federal health care program; (3) the provider or supplier has been or is currently excluded by the Office of Inspector General (“OIG”) from Medicare, Medicaid, or CHIP; or (4) the provider or supplier has had its Medicare, Medicaid, or CHIP billing privileges denied or revoked.

If an entity or individual is affiliated with a provider or supplier with any of the above-mentioned disclosable events, the Secretary is authorized to deny enrollment when it is determined that this affiliation poses an undue risk of fraud, waste, or abuse. To determine the existence of undue risk, CMS will consider: (1) the length and period of the affiliation; (2) the nature and extent of the affiliation; and (3) the type of disclosable event and when it occurred.

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The Office of Medicare Hearings and Appeals (“OMHA”) has been updating the OMHA Case Processing Manual (“OCPM”) since the Medicare appeals final rule became effective on March 20, 2017. As an effort to regulate and codify procedures for adjudicative functions through statutes, regulations, and OMHA directives, the OCPM is regularly revised to stay up-to-date with the Medicare appeals process.

The first major recent revision to the OCPM was eliminating the four divisions: Part A/B Claim Determinations, Part C Organization Determinations, Part D Organization Determinations, and SSA Determinations. The revised OCPM is no longer divided and consists of twenty consecutive chapters. In May 2018, the OCPM added new chapters 1 and 20, and revised chapter 19. In July 2018, the OCPM revised chapters 5, 6, and 7.  Most recently, on November 30, 2018, OMHA published new chapters 17 and 18.

Chapter 17 is entitled “Dismissals.” It addresses reasons why an ALJ or attorney adjudicator may dismiss requests for hearings or a review of reconsideration dismissal. For example, the reasons an ALJ may dismiss a case include, without limitation, an untimely filing, failure to cure a defect in the request for hearing, or failure to appeal.  On the other hand, an attorney adjudicator may dismiss a request for hearing only when the appellant withdraws the request for hearing.  The chapter also outlines the information that must be contained within a dismissal order, the impact of a dismissal on a case, and the circumstances in which an adjudicator may vacate his or her dismissal. Lastly, the chapter addresses the right to appeal an ALJ’s or attorney adjudicator’s dismissal order.

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On September 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced plans to commence a review demonstration of Home Health Agencies (“HHAs”) in Illinois, Ohio, North Carolina, Florida, and Texas, with the option to expand to other states in the JM jurisdiction. CMS invited public comment on CMS’ new proposal in the Federal Register by October 29, 2018. The Pre-Claim Review Demonstration (“PCRD”) was re-named the Review Choice Demonstration (“RCD”) and began in Illinois on December 10, 2018.

The RCD is a revised version of the PCRD. The PCRD went into effect in August 2016 but was short-lived, as it was halted in April 2017 due to wide backlash among Home Health Industry providers. Thus, the new RCD should be more welcomed HHAs, as it is much more flexible than the previously rigid PCRD.

The Secretary is authorized to “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established under [the Act].” Based on this authority, CMS implemented the RCD to help identify, investigate, and prosecute potential fraud occurring within HHAs who are providing services to Medicare beneficiaries. The RCD is intended to ease the burden on CMS by reducing the number of audits while protecting the Medicare Trust Fund by ensuring that payments for home health services are appropriate.

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On November 1, 2018, a U.S. District Court ordered the United States Department of Health and Human Services (“HHS”) to eliminate the Medicare appeals backlog by the end of fiscal year 2022.  There are currently 426,594 backlogged appeals. The recent ruling imposes a timetable for reducing the backlog of appeals. Specifically, 19% of the appeals must be cleared by the end of fiscal year 2019; 49% of the appeals must be cleared by the end of fiscal year 2020; 75% by the end of fiscal year 2021; and the backlog must be eliminated entirely by 2022. To demonstrate its progress, HHS must file quarterly status reports beginning on December 31, 2018.

The Court’s order arises from a lawsuit that was filed by the AHA in 2014. AHA alleged that HHS was violating federal law by failing to process appeals within 90 days from the date of the Office of Medicare Hearings and Appeals’ receipt of the request for hearing.  In 2016, the District Court entered summary judgment in favor of the AHA and ordered HHS to comply with a timetable to eliminate the backlog of appeals by 2020.  In 2017, the D.C. Circuit reversed the District Court and ordered the District Court to evaluate HHS’ claim that compliance with the timetable would be impossible.

HHS has implemented some backlog-reduction efforts to try complying with the previous ruling to eliminate the backlog by fiscal year 2020. Settlement Conference Facilitations (“SCF”) are an example of one of these initiatives. Medicare Part A and Part B providers and suppliers who have appeals pending before an ALJ are encouraged to participate in SCF. SCF uses a facilitator to help the appellant and CMS find a mutually agreeable resolution. Initiatives like SCF are a step forward in reducing the backlog, as it takes people out of the long waiting period and resolves cases in a simpler matter.

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In 2015, Anthem, Inc. (“Anthem”) discovered that criminal hackers had breached its electronic database and gained access to over 79 million records, including the records of at least 12 million minors.  The protected health information obtained by the hackers included, among other information, names, addresses, dates of birth, medical IDs, and Social Security numbers. The hackers were able to gain access to the information by using a “spear phishing” email technique. At least one employee received a phishing email and responded to it, allowing the hackers to gain remote access to the employee’s computer and at least 90 other systems, including Anthem’s data warehouse.

Although the massive data breach was first discovered in January 2015, the breach actually began on February 18, 2014 – meaning the breach went undetected for almost a whole year.   “Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who gained access to their system to harvest passwords and steal people’s private information,” said Office of Civil Rights (“OCR”) Director Roger Severino.

Anthem has agreed to pay $16 million to the Department of Health and Human Services’ (“HHS”) OCR and take corrective action to prevent potential violations of HIPAA rules in the future.  While other breaches like this have occurred in the past, this was the largest health data breach in U.S. history, and the $16 million settlement is now the largest HIPAA settlement in history.

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The Centers for Medicare & Medicaid Services (“CMS”) recently announced a review of Inpatient Rehabilitation Facilities (“IRFs”) that will focus on the “reasonable and necessary” requirement that IRFs are required to meet. An IRF provides rehabilitation services to patients who have suffered an injury, illness, or surgery that has left them in need of intensive rehabilitation.  Services provided by IRFs include physical therapy, occupational therapy, rehabilitative nursing, speech-language pathology, and the procurement of prosthetic and orthotic devices.

IRF services are considered “reasonable and necessary” if: (1) the patient requires therapeutic intervention in multiple therapy disciplines, (2) the patient actively participates in and benefits from the therapy program, (3) the patient is sufficiently stable at the onset of the program, (4) the patient is supervised by a physician, (5) the patient’s chart has the correct documentation within it, and (6) the patient requires an interdisciplinary team approach to care and the team has weekly meetings.

IRFs are not meant to be used as an alternative to a full course of treatment.  Patients who are still completing their treatment in the hospital and cannot fully participate in intensive rehabilitation therapy will not have their IRF service determined to be reasonable or necessary. Furthermore, IRF is not appropriate for patients who have finished their hospital treatment and no longer need intensive rehabilitation.

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