Wachler & Associates Health Law Blog

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: September 2, 2020

Providers Still Waiting for Guidance on the Provider Relief Fund Reporting System

by Wachler & Associates, P.C.

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.

Published on: September 1, 2020

Private Payor Laboratory Audits

by Wachler & Associates, P.C.

During the COVID-19 crisis, many audits by private payors had been paused, but as of the last week, it seems that private payors have resumed auditing. Specifically, Wachler & Associates is aware of private payers initiating audits of laboratories. The laboratories being audited are seemingly ones doing COVID-19 GenX tests, but all laboratories doing any type of COVID-19 test should still be on notice of potential audits coming.

In addition to requesting information regarding the COVID-19 tests, the private payors have also requested a large volume of other materials in these audits. These other materials have included: Copies of CLIA certificates, CMS-116 Applications, lists of testing equipment, invoices, lists of reference labs, shipment logs, credentials for all laboratory staff, lists of daily test volume performed onsite and sent out, hours of operation, specimen processing policies, proficiency test reports, patient service center permits, and emergency use authorizations. These materials being requested go above and beyond what would normally be requested in an audit prior to the COVID-19 crisis.

Laboratories, specifically ones that have performed COVID-19 testing, should begin to review their own records for the above-listed materials in the event an audit occurs. 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 audits. Please contact Wachler & Associates if your facility has recently gotten notice of an audit, or if your facility would like to implement a compliance plan. 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.

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: June 16, 2020

New Provider Relief Fund Targeted Allocations

by Wachler & Associates, P.C.

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:

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.