Articles Posted in Compliance

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On September 19, 2020, the Department of Health and Human Services (HHS) released the much-anticipated reporting requirements for providers who received payments under the Provider Relief Fund (PRF). The PRF is a $175 billion fund created Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS previously amended the reporting requirements to require that any provider who received more than $10,000 from the PRF must file a report by February 15, 2021 and indicated that further details on reporting would be released at a later date. The new reporting system opens to payment recipients on October 1, 2020.

HHS breaks down the new reporting requirements into four date groups of data elements. First, providers must report Demographic Information, such as the Reporting Entity (whether the entity is reporting for a PRF payment it received or is reporting for a payment its subsidiary received), TIN, NPI, fiscal year-end date, and federal tax classification.

Second providers must report “expenses attributable to coronavirus not reimbursed by other sources.” Expenses attributable to coronavirus may be incurred in treating confirmed or suspected cases of coronavirus, preparing for possible or actual coronavirus cases, maintaining healthcare delivery capacity, etc. Providers who received between $10,000 and $499,999 in aggravated PRF payments need only report their net expenses that are attributable to coronavirus and not reimbursed by another source. These expenses need only be reported in two aggregate categories: (1) General and Administrative expenses and (2) other healthcare related expenses.  However, providers who received $500,000 or more in aggregate PRF funds must report in significant detail on sub-categories of these expenses.

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On September 14, 2020, Wachler & Associates posted a blog detailing all of the speculation surrounding recoupment of the CARES Act Advanced and Accelerated Payments (“AAP”) Program. As of then, CMS had not yet made a statement on when CMS would begin AAP loan recoupments. Originally, providers were told to expect to see recoupments on these loans 120-days from issuance of the loan. Many providers, however, had surpassed their 120-day time limit but did not see any indication that payments were being recouped to repay the loan.

On Friday, September 18, 2020, CMS Administrator Seema Verma confirmed that CMS would not begin recouping AAP loans until Congress passes legislation on the matter. This timely statement comes just before the House passed H.R. 8337, FY 2021 Continuing Resolution, through December 11, 2020 (Appropriations), on September 22, 2020. This bill would give providers with AAP loans one year from issuance before CMS begins recoupment, instead of the original time limit of 120-days from issuance. This bill would also lower the recoupment rate and the interest rate. It is not yet known when there will be a vote in the Senate on the bill, but the bill is expected to pass the Senate.

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 the CARES Act and when to expect accelerated payment recoupment to begin. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.

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On September 17, 2020, technology company Glow, Inc. (“Glow”) settled with the California attorney general in response to a data breach on Glow’s fertility-tracking app. This app was created so that women could compile their personal medical information as it relates to cycle and ovulation tracking. Between the years of 2013 and 2016, this app was subject to numerous allegations regarding its security.

According to the California attorney general, the app failed to require authorization from any user who would share their information with another user. This led to data sharing without proper consent. It also did not require a user to enter its old password before creating a new one, so any user could be locked out of their own account by someone attempting to steal data. The California attorney general alleged that these, among other privacy issues, violated California’s consumer protection and privacy laws. The settlement will require Glow to pay $250,000 and increase the privacy and security on the app. The settlement also requires Glow to obtain affirmative consent from all users before sharing any personal medical information.

Although this state case focused on issues from 2013-2016, this settlement is very timely and accurately reflects issues currently facing healthcare providers. During the 2019 Novel Coronavirus (“COVID-19”) pandemic, the Office of Civil Rights (“OCR”) has decided to temporarily stop giving penalties for noncompliance with HIPAA. The purpose of this is so that providers can continue to care for their patients while maintaining social distance protocol and implement telehealth in place of in-person office visits.

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The Department of Health and Human Services (“HHS”) is setting up a new reporting system through which recipients of payments under the Provider Relief Fund (“PRF”) will be required to submit reports on their use of the payments. The reporting system is set to become available for reporting on October 1, 2020. Despite the reporting system opening in less than 30 days, providers are still waiting to learn what specific information they will be required to report.

On July 20, 2020, HHS amended the reporting requirements for PRF payment recipients. Pursuant to this amendment, any recipient of more than $10,000 in aggregate payments from the PRF will be required to file a single report regarding all expenditures of PRF payments in calendar year 2020. This report will be due February 15, 2021. A second report regarding any expenditures of PRF payments in calendar year 2021 will be due on July 31, 2021. At the time, HHS indicated that additional details regarding data elements that recipients would be required to report would be released by August 17, 2020.

However, HHS has since indicated that instead it will release reporting instructions and a data collection template on an unspecified date after August 17, 2020. HHS has also indicated it will release these instructions “well in advance” of the reporting system being made available. The system is set to become available on October 1, 2020, although HHS now characterizes this as a “targeted” date to make the reporting system available. HHS recommends providers simply continue to check their website for more updates regarding the reporting system.

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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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