Medicare

Published on: September 4, 2020

Medicare Coverage of Innovative Technology Proposed Rule

On August 31, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released an announcement regarding their newest proposed rule, the Medicare Coverage of Innovative Technology (“MCIT”). Department of Health and Human Services (“HHS”) Secretary Alex Azar assured that the proposed rule “would give Medicare beneficiaries faster access to the latest lifesaving technologies . . . by delivering Medicare reimbursement at the same time as FDA approval.”

Currently, it takes an excessive amount of time after FDA approval of a medical technology before Medicare covers the technology. This significant lag presents serious detriments to seniors who are denied access to lifesaving technologies because Medicare has failed to cover the technology in a timely manner. Under the MCIT proposed rule, when the FDA deems a technology a “breakthrough technology,” Medicare will provide simultaneous coverage with no waiting period. A breakthrough technology must be a technology which provides more accurate testing or treatment for life-threatening diseases or it must offer a treatment option for which no other approved treatment currently exists.

This new method of simultaneous coverage would last for a trial period of four years. It seems that CMS believes that the four-year limit will incentivize manufacturers to rapidly develop lifesaving technologies and breakthrough devices. Additionally, it would force manufacturers to develop evidence to show how these devices do, in fact, help Medicare beneficiaries. The four-year time limit would also streamline local coverage determinations across the country, such that all Medicare Administrative Contractors would allow reimbursement for these technologies. If these four years result in positive benefits for Medicare beneficiaries, CMS may consider extending the rule. Though this rule is primarily forward-looking, the MCIT proposed rule would also have Medicare covering breakthrough technologies developed in 2019 and 2020.

Published on: August 27, 2020

CMS Audits Resume During Public Health Emergency

by Wachler & Associates, P.C.

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.

Published on: August 17, 2020

Proposed Rule for CMS to Implement COVID-19 Telehealth Waivers

by Wachler & Associates, P.C.

Throughout the onset of the 2019 Novel Coronavirus (“COVID-19”) pandemic, the Centers for Medicare and Medicaid Services (“CMS”) issued a variety of temporary waivers that expanded reimbursement under Medicare, Medicaid, and CHIP for telehealth services. Allowing reimbursement for telehealth encourages patients to reduce the amount of in-person medical encounters, which in turn helps reduce the spread of COVID-19.

In response to the success of the temporary telehealth reimbursement waivers, CMS has released a proposed rule to update the physician fee schedule for the 2021 calendar year. The proposed rule would make these telehealth reimbursement waivers permanent. CMS is accepting comments from the public until 5 pm (EST) on October 5, 2020.

Because so many temporary waivers have been issued, CMS is seeking to streamline which telehealth services will be included in the proposed rule—CMS has suggested a three-category system to achieve this goal. Currently, there are two categories by which CMS evaluates new services for reimbursement by Medicare. Category 1 services typically include things such as consultations and office visits. These services are already on the Medicare telehealth services list. Category 2 services are generally more complex than an office visit or other Category 1 services but could be delivered via telehealth when accompanied with a proper code.

Published on: August 11, 2020

HHS Extends Provider Relief Fund Application

by Wachler & Associates, P.C.

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.

Published on: June 29, 2020

MIPS Extreme and Uncontrollable Circumstances

by Wachler & Associates, P.C.

The Centers for Medicare & Medicaid Services (“CMS”) is required to implement a quality payment incentive program. One of the primary programs set forth by CMS is the Merit-based Incentive Payment System (“MIPS”). MIPS evaluates qualifying clinicians based on (1) quality; (2) promoting interoperability; (3) improvement activities; (4) and cost. The purpose of the MIPS program is to encourage higher quality and more efficient care.

On June 24, 2020, and in response to the 2019 Novel Coronavirus (“COVID-19”) pandemic, CMS announced the “MIPS Program Extreme and Uncontrollable Circumstances Exception.” If a MIPS-eligible clinician has been affected by an extreme or uncontrollable circumstance, they may submit an application for the re-weighting of the above-four MIPS performance categories. This re-weighting will offset the negative impacts COVID-19 has had on MIPS clinicians’ reimbursements. CMS defines an extreme and uncontrollable circumstance as a circumstance that would:

Cause a clinician to be unable to collect information necessary to submit for a MIPS performance category;

Published on: March 20, 2020

State Utilization of 1135 Waivers

by Wachler & Associates, P.C.

The Coronavirus is causing many changes and uncertainties about how our healthcare is treated. With the utilization of 1135 waivers, states can assist enrollees in Social Security Act programs in obtaining sufficient health care items and services. Under the Stafford Act or National Emergencies Act, the President has the authority to declare a national disaster or emergency. The Secretary of the Department of Health and Human Services (“HHS”) can then temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (“CHIP”) requirements. Under these waivers, providers are expected to act in good faith, can be reimbursed for, and be exempted from sanctions—absent any determination of fraud and abuse.

1135 waivers last up until the termination of the emergency period, or 60 days from the date the waiver was approved, whichever comes first. The Secretary may extend the waiver for additional periods of up to 60 days if it is deemed necessary. While the 1135 waivers only apply to Federal program requirements, states should also consider altering their licensure or conditions or participation requirements.

On March 16, 2020, Florida was the first state to have an 1135 waiver approved by the Centers for Medicare and Medicaid Services (“CMS”). Florida addressed concerns of federal requirements hindering the state’s ability to continue to deliver proper health care. The 1135 waiver changed five main things. First, Florida is temporarily allowed to enroll providers who are not currently enrolled with another State Medicaid Agency (“SMA”) or Medicare if the state meets some minimum requirements. Second, CMS is temporarily waiving all pre-approval requirements. Third, pre-admission screening and annual resident reviews (“PASRR”) for both Level 1 and Level 2 can be waived for the next 30 days. Fourth, facilities are temporarily allowed to be fully reimbursed for services rendered during an emergency evacuation to an unlicensed facility. And lastly, the fifth waiver is the temporary delay of scheduling Medicaid Fair Hearings and the issuance of Fair Hearing Decisions during the emergency period.

Published on: March 19, 2020

CMS Expanding Telehealth to Combat COVID-19

by Wachler & Associates, P.C.

Beginning on March 6, 2020, the Centers for Medicare and Medicaid Services (“CMS”) has temporarily expanded telehealth services for Medicare beneficiaries and cut back on HIPAA enforcement to help combat the COVID-19. This expansion will last until the end of the public health emergency as declared by the Secretary of HHS. Telehealth, the remote delivery of healthcare services, often by video conference between patient and provider, is a growing frontier in the age of digital healthcare. However, Medicare was slow to adopt the new technology.

Until recently, Medicare only covered telehealth services provided to beneficiaries in designated rural areas and only if they received the services at a hospital, clinic, or other medical facility. Virtual check-ins and e-visits were reimbursed at a much lower rate. Virtual check-ins encompass brief communications between physicians and patients, such as text messages or emails, where a patient can send images and discuss symptoms and treatment options with their physician. E-visits are conducted through a patient portal and are not face-to-face. This temporary expansion will now reimburse physicians who perform virtual check-ins and e-visits at the rate of an in-person visit.

The expansion was made in pursuant to an 1135 waiver. The Coronavirus Preparedness and Response Supplemental Appropriations Act, as signed into law on March 6, 2020 authorized the Department of Health and Human Services (“HHS”) to waive certain traditional Medicare telehealth requirements during this national emergency. Spurred by the calls for self-quarantine and social distancing, these waivers have led to an expansion of Medicare coverage for telehealth services.

Published on: January 17, 2020

Approaching the New Targeted Probe and Educate Program

by Wachler & Associates, P.C.

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.

Published on: December 30, 2019

CMS Final Rule on Affiliations for Provider Enrollment

by Wachler & Associates, P.C.

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.

Published on: December 7, 2018

Latest Updates to the OCPM

by Wachler & Associates, P.C.

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.