CQRC to CMS on coronavirus outbreak: We need your help to remove barriers to care

Editor's note: The following letter was written by Dan Starck, chairman, Council for Quality Respiratory Care, and sent to CMA Administrator Seema Verma.

I am writing on behalf of the Council for Quality Respiratory Care (CQRC) to highlight how our members—the home oxygen, sleep, and ventilation therapy suppliers and manufacturers-are prepared to help during the COVID-19 emergency when patients diagnosed with the disease have access to the equipment and supplies they need to recover. For us to fully serve these patients, however, we need your help in trying to address some of regulatory restriction that will be a barrier to caring for these patients.

1. CQRC asks CMS to cover and reimburse equipment, supplies, and services provided to patients with a confirmed COVID-19 diagnosis who have been prescribed home respiratory therapy for the condition.

Under current law, home respiratory therapy, including oxygen, BiPAP, and ventilator, are covered and reimbursed only for beneficiaries with a diagnosed chronic condition(s). A diagnosis of COVID-19 would be defined as an acute condition. To treat confirmed cases of the virus, physicians are prescribing oxygen, Bi-PAP, and ventilators. The National Academies of Medicine had suggested using home oxygen as a way to address potential hospital overflow issues in a March 5, 2020, discussion paper. The discussion paper also notes that having access to BiPAP or mechanical ventilators will be important. Given the need to quarantine COVID-19 patients,  it is likely that rather than hospitalize all infected patients, the vast majority of patients will remain at home to receive treatment as a way to ensure the availability of hospital beds for higher acuity care patients. Having access to these home respiratory therapies at home may be particularly in rural areas, as well, especially in areas hit already by shortages due to the rural health care crisis.Therefore, we ask that CMS waive the current requirement that home oxygen, BiPAP, or ventilator coverage and reimbursement for Medicare beneficiaries be limited to patients with chronic conditions and allow for the provision and reimbursement of these services if a beneficiary has a confirmed diagnosis of COVID-19 and has been prescribed the home therapy.


2. CQRC asks CMS to reduce burdensome paperwork on physicians and suppliers, by allowing the Certificate of Medical Necessity, the test results confirming diagnosis of COVID-19, and the prescription to be sufficient documentation for determining medical necessity for patients with a confirmed COVID-19 diagnosis who have been prescribed home respiratory therapy for the condition.

During this crisis (and likely into the Fall of 2020), it is important to make sure that patients who have been prescribed home respiratory therapy as a treatment for COVID-19 and quarantined to avoid further spread of the virus receive the therapy in a timely manner. It is also important that suppliers, whose personnel will be with these patients in their homes, are reimbursed in a timely manner so that they have the resources necessary to maintain an adequate stock of equipment and supplies, are able to employ infection control protocols effectively, and can provide their workforce with appropriate personal protective equipment (PPE). 

Therefore, we ask that for purposes of determining medical necessity and auditing of claims, CMS suspend the requirements for medical record review for at least home respiratory therapy when prescribed to patients confirmed to have COVID-19 and being treated with these therapies. It would seem that the current CMN, prescription for the home respiratory therapy, and confirmation of COVID-19 diagnosis are objective documentation would meet CMS' needs for protecting against inappropriate use of the therapies. It would also be helpful during the crisis to reduce the burden on the suppliers by suspending the medical record review for home respiratory therapy when there is a properly completed CMN and prescription to avoid suppliers having to spend time chasing doctors records when they are working to treat patients during the crisis.

3. CQRC asks CMS to suspend adding non-invasive ventilators from the Round 2021 Competitive Bidding Program to protect access to this therapy.

As the Food and Drug Administration (FDA) has recognized in reaching out to manufacturers of both invasive and non-invasive ventilators to ensure that there is a sufficient supply of these pieces of medical equipment during this crisis, having access to ventilator therapy will be critically important to many patients who test positive for COVID-19. 

While we understand that the Round 2021 competitive bidding program will not take effect until Jan. 1, 2021, we are concerned that the efforts to prepare for the new rates not only in the competitive bidding areas (CBAs), but also the non-CBAs where the new rates will be applied, could result in many suppliers reducing their inventory of NIV equipment and supplies or scaling back the services they provide. In addition, reducing the number of suppliers being able to serve CBAs effective Jan. 1, 2021, may have the unintended consequence of losing bidders exiting the markets prior to that date. Even though, it is possible that the outbreak of COVID-19 may abate over the summer, it also seems likely that another significant outbreak is likely to occur in the fall and winter of 2020-21. To avoid any disruption in the supply and be prepared to meet the likely increase in demand for NIV in the home setting, we ask CMS to remove NIV from the Round 2021 competitive bidding program.

We also would like to work with CMS to make sure the competitive bidding program rollout also does not result in problems for patients who need access to home oxygen and sleep therapies for patients with COVID-19 and consider modifying the rollout, if appropriate.

4. CQRC asks CMS to extend the current blended rate in rural non-CBAs for at least home respiratory therapies in 2021 to protect access to these therapies.

While the country is correctly focused on the immediate threat of COVID-19, health care providers and suppliers are also looking ahead, as we know CMS is as well. The CDC has recently announced as the viral outbreak has evolved, being exposed to the virus will be inevitable for many Americans and many will contract it during this year or next.  

The CQRC members are also looking ahead and trying to plan.  Having a new methodology coupled with COVID-19 exposure and increasing cases could cause havoc in rural areas if more patients require home respiratory therapies to treat the virus under quarantine or near quarantine conditions. Equipping our workforce to safely engage with these patients and their families will also take more resources than anyone could have anticipated during the competitive bidding process.  Rather than risk an access issue, we encourage CMS in the current rulemaking to indicate that because of the COVID-19 emergency, it will extend the blended rate in rural non-CBAs through at least 2021 for home respiratory therapies used to treat patients infected with the virus. Taking this step now is important to allowing suppliers and manufacturers to prepare and make sure they have the equipment and supplies in place, have resources for infection control, and are able to avoid potential disruptions in supply and workforce.

5. CQRC asks CMS to prioritize the provision of personal protective equipment (PPE) for home respiratory therapy suppliers whose workforce are providing equipment and supplies to COVID-19 patients in their homes.

Even though home respiratory therapy suppliers and their employees are less exposed than some health care providers (such as those in hospital emergency departments or some physicians' offices), we know that those employees who are delivering equipment and supplies are in the unique position of having to enter a patient's home and set up the equipment or provide supplies.  CQRC members take seriously protecting these employees. Yet, many members of the workforce understandably are concerned about their own health as well.

Some of our members are already having problems accessing personal protective equipment (PPE).  To make sure that the home respiratory therapy workforce do not become sick and are available to assist patients who are infected, we ask that CMS help us by allowing home respiratory therapy supplies to have prioritized access to PPE.  We also ask that CMS work with suppliers of PPE to avoid the increasing demand to lead to higher costs that could create access problems as well.

Conclusion

On behalf of the CQRC, our patients, and our employees, I want to thank you for the efforts CMS is making to ensure that Medicare beneficiaries have access to the medical services they need during the COVID-19 outbreak. CQRC and our members would welcome the chance to discuss how we can help make sure that Medicare beneficiaries who need home respiratory therapies in relation to a diagnosis of COVID-19 have access to the therapies they need.  Please do not hesitate CQRC's executive director Kathy Lester if you would like to discuss our recommendations or there is additional information we can share with you about how ground ambulance organizations are helping during this crisis. We stand ready to help CMS, the Department, and the federal government in any way we can.

—Dan Starck, chairman, Council for Quality Respiratory Care