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COVID-19 Update: CMS Pauses Medicare DMEPOS Prior Authorization Program and Provides Other Regulatory Relief in Response to COVID-19

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced several temporary regulatory waivers intended “to equip the American health care system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic.”  

Included in the announcement was a notice that CMS will pause the national DMEPOS prior authorization program for certain DMEPOS. Prior authorization was scheduled for implementation for six lower limb prosthesis codes L5856, L5857, L5858, L5973, L5980, and L5987) in four states (PA, MI, TX, and CA) on May 11, 2020 and nationwide on October 8, 2020. AOPA has been in communication with CMS and the DME MACS to express our concerns regarding the impact prior authorization would have on patients’ access to O&P care during the COVID-19 crisis. We believe that this pause will allow Medicare providers to continue to focus on providing medically necessary, clinically appropriate O&P care to Medicare beneficiaries without having to dedicate valuable resources to unfamiliar processes and documentation requirements.    

In addition, CMS also announced that they are temporarily waiving signature and proof of delivery requirements for Part B drugs and DMEPOS when a signature cannot be obtained due to COVID-19. In this situation, providers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19.  

The CMS announcement also discussed a previously announced relaxation of DMEPOS accreditation requirements to facilitate provider enrollment. ABC and BOC have expressed their strong concern that suspending DMEPOS accreditation requirements may expose the Medicare program to increased fraud and abuse. To address this, AOPA and its partners in the O&P Alliance are preparing a letter to CMS asking them to reconsider the suspension of DMEPOS accreditation.  

The announcement also indicated increased flexibility in the processing of appeals by both fee for service and Medicare Managed Care contractors. AOPA will look into this provision in more detail and provide additional information regarding these flexibilities in the near future.  

Finally, the announcement discussed the potential for advanced Medicare payments that may be available to providers to address immediate cash flow issues. This is a very complex issue and AOPA, in conjunction with our consultants at McGuireWoods, is developing member resources regarding how this program will be implemented.  

The CMS announcement may be viewed here.

AOPA will continue to maintain open lines of communication with CMS and the DME MACs and will relay COVID-19 developments to AOPA members as soon as AOPA is aware of them.  

Questions may be directed to Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

COVID-19 Update: Clarification on Emergency-Based Waivers Guidance

AOPA has received questions and concerns from members about CMS guidance regarding replacement of DMEPOS during COVID-19. To address these questions and concerns, AOPA has been in contact with the DME MACs to discuss actions that they will take to implement the provisions of these emergency-based waivers.

During a recent presentation the DME MACs addressed some of our questions. Specifically, they stated that the 1135 waivers only apply to replacements that are necessary as a direct result of the emergency. For example, a patient is being transported to the hospital with COVID-19 symptoms and the brace is lost in the ambulance.

A beneficiary’s inability to make an appointment or see the referring physician does not qualify under the waivers current provisions. It must also be stressed that the waivers don’t apply to new services such as socket replacements.

When providing a replacement item under the waiver, suppliers are reminded to include a narrative description explaining why the item needs to be replaced with their claims and must maintain documentation for the need of the replacement item. Suppliers must also use the CR modifier on their claims. Find more information on the waiver here.

CMS and the DME MACs continue to make sure every effort is made to ensure that Medicare and Medicaid beneficiaries continue to have complete access to clinically appropriate medical care during this emergency. And as a result, information and guidance is continually being released and revised. AOPA will continue to provide this information and guidance as it becomes available.

In the meantime, AOPA members should continue to make every effort to obtain the appropriate documentation to support the O&P services they provide.

Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

COVID-19 Update: Congress Passes CARES Act to Help Provide Financial Relief

Today, in response to COVID-19, Congress finalized the CARES Act, a massive financial relief package designed to tide the U.S. economy and its strained healthcare sector over for the next few months. In terms of tax relief and benefits for O&P, the bill:

  • Carves out $350 billion in aid for small businesses, much of which would be in loans through the Small Business Administration (SBA) and banks, guaranteed by the federal government. 
    • The loans would be forgiven provided the businesses meet certain requirements, including limiting reductions in pay and layoffs, though with some flexibility for employers. (Applicants must make good faith certifications that coronavirus has impacted their business and that the loan is necessary for continuation of their business.)
    • These loans can be used to cover payroll expenses, including salaries and compensation; various forms of paid sick, medical or family leave; group health insurance premiums; state and local taxes assessed on employee compensation; rent; utilities; and interest paid on debt. 
    • Applicants that previously received a loan from another source for the same purpose are not eligible.
    • Companies that secured an SBA loan since January 15, 2020 can refinance those recent loans under the terms and conditions of the special SBA coronavirus relief loans.
    • Language added late in the process ensures that an inspector general and congressional oversight committee (with members yet-to-be-determined) oversee how the money is spent.
    • This funding is in addition to the significant assistance provided in legislation previously passed by Congress, which authorizes approximately $2 billion worth of 100 percent guaranteed SBA loans, a portion of which SBA will forgive based on allowable expenses for the borrower. SBA is already accepting applications for these funds.
  • Provides a refundable payroll tax credit for 50 percent of wages paid by employers to employees during the COVID-19 crisis. The credit is available to employers whose gross receipts declined by more than 50 percent when compared to the same quarter in the prior year. The credit is based on qualified wages paid to the employee. For employers with greater than 100 full-time employees, qualified wages are wages paid to employees when they are not providing services due to the COVID-19-related circumstances described above. For eligible employers with 100 or fewer full-time employees, all employee wages qualify for the credit, whether the employer is open for business or subject to a shut-down order. The credit is provided for the first $10,000 of compensation, including health benefits, paid to an eligible employee. The credit is provided for wages paid or incurred from March 13, 2020 through December 31, 2020 and is NOT available to employers receiving Small Business Interruption Loans.
  • Relaxes the limitations on a company’s use of losses. Net operating losses (NOL) are currently subject to a taxable-income limitation, and they cannot be carried back to reduce income in a prior tax year. The legislation provides that an NOL arising in a tax year beginning in 2018, 2019, or 2020 can be carried back five years. The provision also temporarily removes the taxable income limitation to allow an NOL to fully offset income. Congress hopes that these changes will allow companies to utilize losses and amend prior year returns, which will provide critical cash flow and liquidity during the pandemic.
  • Allocates funding to support “short-time compensation” programs, where employers reduce employee hours instead of laying off workers and the employees with reduced hours receive a pro-rated unemployment benefit. This provision would pay 100 percent of the costs they incur in providing this short-time compensation through December 31, 2020.
  • Creates a temporary Pandemic Unemployment Assistance program to provide payment to those not traditionally eligible for unemployment benefits (self-employed, independent contractors, those with limited work history, and others) who are unable to work as a direct result of COVID-19. It also creates an additional 13 weeks of unemployment benefits to help those who remain unemployed after weeks of state unemployment benefits are no longer available.
  • Authorizes the Treasury Department to provide advance payment of tax credits that are available to private sector employers that are required to provide up to 12 weeks of coronavirus-related paid leave to their employees.
  • Clarifies the limitation on compensation during paid sick days, stating an employer shall not be required to pay more than $511 per day and $5,110 in the aggregate for sick leave or more than $200 per day and $2,000 in the aggregate.

In terms of healthcare provisions, the bill:

  • Temporarily lifts the Medicare sequester, which reduces payments to providers by two percent, from May 1, 2020 through December 31, 2020.
  • Directs the Secretary of Health & Human Services to develop a comprehensive and coordinated plan to identify workforce projection needs.
  • Prevents scheduled reductions in Medicare payments for durable medical equipment subject to competitive bidding. (This does not impact the January 1, 2021 scheduled implementation of Medicare competitive bidding for off-the-shelf orthoses.)
  • Finally, AOPA was able to include language in the bill to ensure Veterans can receive care from their choice of practitioner throughout the crisis. Specifically, the bill says “The Secretary of Veterans Affairs shall ensure that, to the extent practicable, veterans who are receiving or are eligible to receive a prosthetic appliance…are able to receive such an appliance that the Secretary determines is needed from a non-Department of Veterans Affairs provider under a contract with the Department during a public health emergency.” This is especially timely for our industry as the VA recently announced it would discontinue offering nonurgent community care referrals to veterans during the coronavirus pandemic.

AOPA stands ready to assist members with taking advantage of the applicable provisions of this $2.2 trillion-dollar bill as they are implemented. We’ll be holding a webinar next Thursday, April 2 at 2pm ET that will go into more detail on the legislation, the SBA loans, and the process for applying. Register here.  We will also update the COVID-19 Response and Resources webpage as information is made available by the SBA, the Department of Treasury, and other entities. In the meantime, if you have any questions about the legislation, please contact Justin Beland, Director of Government Affairs, at jbeland@AOPAnet.org.

COVID-19 Update: Guidance for Manufacturers on Operation During State or Local Restrictions Related to COVID-19

We have an update to yesterday’s “Guidance on Operation of O&P Businesses During State or Local Restrictions Related to COVID-19” specific to our O&P manufacturer members. AOPA has reviewed the current state and local orders and, as a general rule, there are specific exemptions that classify companies that manufacture medical devices as “essential” and therefore they are exempt from any restrictions on operating related to COVID-19.

For previous COVID-19 related guidance and resources visit AOPA’s COVID-19 Responses and Resources webpage.  

To see how other members are responding, visit the Member to Member resources on the AOPA Co-OP. We encourage all to share responses, guidelines, and resources via the Co-OP or by email to co-op@AOPAnet.org.   Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

COVID-19 Update: Guidance on Operation of O&P Businesses During State or Local Restrictions Related to COVID-19

As state and local governments begin to implement restrictions to population interaction in response to COVID-19, AOPA members have requested guidance regarding the continued operation of orthotic and prosthetic (O&P) businesses.  AOPA has been monitoring developments on this issue closely and offers the following guidance based on the current available information.

As of March 23, 2020, at least 11 states (Delaware, Kentucky, Louisiana, Ohio, California, New Jersey, New York, Illinois, Connecticut, Oregon, and Pennsylvania) and multiple local municipalities have issued orders that restrict or close “non-essential” businesses until further notice.  AOPA has reviewed each of these orders and found very consistent language that clearly considers the continued operation of healthcare facilities as “essential” services that are exempt.  This exemption applies to both patients who may continue to receive care from healthcare facilities and employees who may continue to work at these facilities.

AOPA fully expects additional state and local authorities to follow suit and implement these restrictions but expects that O&P facilities will continue to be exempt from these restrictions.  If additional restrictions are implemented that affect the continued operation of O&P businesses, AOPA will alert its members as soon as we receive the information.

AOPA urges O&P patient care facilities to carefully consider all factors when making decisions regarding the continuation of operations during COVID-19.  While there is a clear exemption that permits O&P facilities to continue to operate during state and locally implemented restrictions, the decision on how to operate and how to interact with the public must be made with the best interest of your communities, your employees and, most of all, your patients.  Additionally, AOPA highly recommends continued compliance with the latest guidelines published by the Centers for Disease Control

Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

COVID-19 Update: Impact of CMS Waivers on AOPA Members

On March 13, 2020, President Trump issued an emergency declaration under the Stafford Act and the National Emergencies Act to help address issues being caused by the spread of the coronavirus disease (COVID-19).  As part of this declaration, the Centers for Medicare and Medicaid Services (CMS) put in place certain blanket waivers to help Medicare beneficiaries impacted receive prompt care.

The two issues of importance to American Orthotic and Prosthetic Association (AOPA) members are the proposed relaxation of existing requirements for telehealth visits and the relaxation of the referring practitioner documentation requirements for replacement of orthoses and prostheses. 

AOPA has been in contact with the DME MACs to discuss actions that they will take to implement the provisions of these emergency-based waivers. While they are awaiting specific guidance from CMS on how to properly implement, they have indicated that CMS intends to make every effort to ensure that Medicare and Medicaid beneficiaries continue to have complete access to clinically appropriate medical care. In the meantime, AOPA members should continue to make every effort to obtain appropriate documentation to support the O&P services they provide.

CMS has issued the following guidance regarding replacement of DMEPOS during the state of emergency: “Where Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) is lost, destroyed, irreparably damaged, or otherwise rendered unusable or unavailable, contractors have the flexibility to waive replacements requirements such that the face-to-face requirement, a new physician’s order, and new medical necessity documentation.”

When providing a replacement item under this waiver, suppliers are reminded to include a narrative description explaining why the item needs to be replaced with their claims and must maintain documentation for the need of the replacement item. Suppliers must also use the CR modifier on their claims. CMS has also declared that the documentation waiver is retroactive to dates of service on or after March 1, 2020. Find more information on the waiver here.

For more information on telehealth, read Medicare’s Telemedicine Fact Sheet and the companion Medicaid piece.

AOPA remains committed to making sure its members can continue to provide clinically appropriate, medically necessary care with minimal interruption as a result of COVID-19.  To this end, AOPA will continue to provide additional information and resources as they become available.

Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

AOPA Message on COVID-19

Like all of you, the American Orthotic and Prosthetic Association (AOPA) leadership is closely following the coronavirus disease (COVID-19). As you have likely heard, we have made the tough decision to cancel several of our upcoming events in light of it.

We know that these are difficult and uncertain times for you and your patients. Please know, the Board and staff are here to support you so that you can continue to provide quality care to your patients.

As the situation evolves daily, we encourage you to follow the guidance being issued from the Centers for Disease Control and Prevention (CDC), the World Health Organization, and your local, state, and the federal governments. Specifically, the CDC has this webpage with resources and guidance for healthcare facilities. AOPA will continue to monitor the situation and provide guidance as appropriate.

Thank you for all you do for your patients and the O&P profession.  As always do not hesitate to contact any of the AOPA staff with questions, concerns, or needs.  

Stay safe and well.

AOPA Participates in CMS Open Door Forum Call Regarding Medicare Prior Authorization for 6 Lower Limb Prosthesis HCPCS Codes

Yesterday, March 11, AOPA participated in a Medicare Open Door Forum call that provided sub-regulatory guidance on the upcoming implementation of Medicare prior authorization for six lower limb prosthesis HCPCS codes.  The call was hosted by the Centers for Medicare and Medicaid Services (CMS) and was led by Amy Cinquegrani and Dr. Scott Lawrence of the Medicare Division of Payment Methods and Strategies.  The four DME MAC Medical Directors also participated in the call and the question and answer period that followed it.  The presentation that was used as an outline was published in advance by CMS and may be accessed here. For additional information on Medicare prior authorization read AOPA’s initial announcement from February 11.

During the call, AOPA had the opportunity to request clarification regarding several issues that CMS had previously indicated would be addressed through sub-regulatory guidance.  New information received during the call included the following:

  • DME MACs will issue decisions on initial prior authorization requests within 10 business days of receipt of the request.
  • DME MACs will issue decisions on prior authorization resubmissions within 10 business days of receipt of the request (previous Medicare prior authorization programs allowed 20 business days for prior authorization resubmissions).
  • DME MACs will issue decisions on expedited prior authorization requests within two business days of receipt.  In order to be approved, an expedited request must show that the beneficiary’s life or health is in immediate danger.
  • Prior authorization requests may be submitted through multiple channels including electronic submission, submission through the DME MAC claim portal, by fax, and by mail.
  • For the four states (PA, MI, TX, CA) scheduled for implementation of prior authorization for dates of service on or after May 11, 2020, the DME MACs will begin accepting prior authorization requests on April 27, 2020.  For national implementation for dates of service on or after October 8, 2020, the DME MACs will begin accepting prior authorization requests on September 24, 2020.
  • HCPCS codes that receive provisional affirmation will not be subject to additional medical review except for random CERT review and UPIC (fraud and abuse) review.  This only applies to the six HCPCS codes subject to Medicare prior authorization.
  • DME MACs will provide education when prior authorization requests are denied, allowing providers to correct errors and facilitate re-submission.
  • CMS and DME MACs will closely monitor efforts to adhere to established timeframes for initial decisions and re-submissions.
  • Prior authorization requests will be subject to existing Medicare policy governing coverage of lower limb prostheses.  No changes are being made to the LCD or Policy Article as a result of prior authorization.

AOPA continues to be encouraged by the communication efforts of CMS and the DME MACs regarding the implementation of Medicare prior authorization.  While some uncertainty remains, AOPA is confident that Medicare prior authorization can be beneficial to Medicare beneficiaries, providers, and the Medicare program.

AOPA will continue to communicate information regarding Medicare prior authorization to our members and will be developing educational resources that will help AOPA members to better understand the program and contribute to its success.

Questions regarding Medicare prior authorization or the CMS Open Door Forum call may be directed to Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

CMS Conference Call on Prior Authorization

On February 11, we notified you that the Centers for Medicare and Medicaid Services (CMS) had announced that six lower limb prosthetic codes will be added to the codes that require Medicare prior authorization as a condition of payment. The full notification can be found here.

AOPA has continued to monitor communications from CMS and the DME MAC contractors regarding the Medicare prior authorization process. To that end, the CMS Center for Program Integrity will hold a Special Open Door Forum – Prior Authorization Process for Certain Durable Medical Equipment Prosthetics, Orthotics and Supplies Items: Inclusion of Lower Limb Prosthetics in Prior Authorization on Wednesday, March 11 from 2 – 3pm ET. During this conference call, they will outline the process for submitting a prior authorization request to the designated DME MAC, the timeframes for the DME MAC to render their prior authorization decisions, and the process for subsequent claim submissions. Participants will be encouraged to submit questions or provide feedback.

AOPA will attend and provide updates to membership. If you want to attend, information on how to participate is available here.

AOPA remains encouraged by CMS’ transparency regarding prior authorization and will continue closely monitor developments and provide updates to the membership. Additionally, look for information on education AOPA will be providing to members regarding the prior authorization process.

Questions regarding this issue may be directed to Joe McTernan at jmcternan@aopanet.org or Devon Bernard at dbernard@aopanet.org.