The Covid-19 public health emergency (PHE) was always bound to conclude. The important flexibilities CMS granted during the PHE helped ensure access and continuity of care for millions of patients during the most unprecedented health crisis in living history.

Yet, given the exceptional vulnerability of America’s home respiratory patients—many of whom have chronic, complex diseases such as COPD and ALS—this population simply can’t afford to return to the pre-pandemic status quo.

A survey of the national suppliers who provide supplemental oxygen, sleep therapy, and non-invasive ventilation equipment, services, and supplies, showed an exponential increase in the need for quality home respiratory care since the pandemic’s start in 2020. That finding should not be surprising given that the country has been battling a respiratory pandemic and is now managing the triple threat of Covid-19, the flu and RSV. As novel viruses develop and threaten our health, the US must be prepared. And our health care system, especially the Medicare program, must be streamlined, efficient, and effective.

In the face of this growing demand, the Centers for Medicare & Medicaid Services (CMS) needs to address its antiquated and convoluted documentation requirements. Stakeholders fear that if CMS does not act before the end of the PHE, its decision to eliminate the objective documentation requirements will effectively backlog the system, overwhelm physicians, and potentially delay the most medically vulnerable patients from receiving their necessary therapies, especially after the PHE ends in May.

In addition, patients also face an additional threat that when the PHE ends, they will have to prove all over again that they qualify for their home respiratory therapies. This will require additional doctors’ appointments, tests, and patient copayments just to create the documentation that CMS suspended during the PHE. CMS should honor its commitment to Medicare beneficiaries, especially those who began home respiratory therapy under the PHE, without requiring them to “restart” the documentation process. Requiring requalification would also be a nightmare for physicians who are already overwhelmed with patient demands.

There simply are not enough physicians before the PHE ends to re-evaluate and re-test the estimated 1 million patients who started on oxygen therapies during the pandemic.

To further prevent this worst-case scenario, CMS could clarify that patients who began treatment during the pandemic will be allowed to continue their therapy with the documentation that was created. Prior to the pandemic, contractors required clinicians’ medical record notes to demonstrate patient need. The reliance on these notes, which have little standardization and vary from physician to physician, were the primary reason contractors denied thousands of claims. Moreover, appeals could take up to five years to resolve. During the pandemic, however, contractors only needed a physician’s prescription and Medicare’s Standard Written Order to support and process claims, enabling access to home respiratory care during the worst of the crisis.

By recognizing the unique circumstances of the pandemic and reducing the documentation requirements, Medicare helped to improve the health outcomes of our nation’s most at-risk patients. The increased access to care successfully kept many Medicare beneficiaries out of the hospital – at a time when there were barely any beds for even Covid patients – and instead, allowed them to receive care in the comfort and safety of home. These policies continue to be critical today.

Still, our systems desperately need to be updated, streamlined, and simplified. Despite high Medicare denial rates due to subjective records that vary from doctor to doctor, Medicare CERT (Comprehensive Error Rate Testing) data show that less than one percent of the oxygen improper payment rate was due to patients not meeting Medicare’s medical necessity requirement. In short: there is no documented widespread fraud or abuse problem when it comes to patients meeting the medical necessity requirements; instead, Medicare’s current policy for demonstrating need focuses on how well physicians write notes, which only creates a barrier to care for patients.

CMS should seize this opportunity to permanently eliminate medical record notes as a means of establishing medical necessity for home oxygen therapy and instead adopt an objective standard clinical data elements oxygen template to use along with a physician’s prescription and the Standard Written Order.

CMS is running out of time to fix this broken but bandaged system. By establishing clear guidance about the post-PHE transition and moving toward a more efficient and standardized template to demonstrate medical necessity, the Biden Administration can prevent disorder and protect America’s home respiratory patients.

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