PhRMA submits comments to CMS on policy changes for in-home care under Part B during COVID-19

The COVID-19 pandemic has caused a number of disruptions in our health care system, one of which is the ability for seniors to access their infused or injected Part B medicines normally administered in a physician office or hospital outpatient setting. Many seniors are confined to their home during the pandemic because either their age or their health condition makes it far too dangerous to travel to a doctor’s office, clinic or hospital. These seniors, suffering from complex diseases like multiple sclerosis, kidney disease, cancer, osteoporosis and immune disorders, among others, that require regular care, are among the most vulnerable to COVID-19 and must be protected from the risk of exposure.

PhRMA applauds the Administration for taking initial steps to address these concerns through the Interim Final Rule with Comment Period (IFC) Response to the COVID-19 Public Health Emergency released by CMS on March 30, but there is far more that could and should be done to help this vulnerable population during this public health crisis. For example, the IFC relies on physician supervision via telemedicine, but there are limitations with telemedicine that are overlooked. As stated in PhRMA’s comments, “We are concerned that many physician practices will not be able to overcome the operational and financial barriers to implement the IFC’s telemedicine-based model. Additionally, we recognize that there may be potential limitations for patients to interface with telemedicine platforms at the point of care, including challenges in coordinating sessions.”

To address these concerns, PhRMA provided a number of alternative solutions for the Administration to consider to ensure Part B beneficiaries can access the medicines they need during this pandemic.

• The Administration should take steps to temporarily expand the list of providers eligible to buy, bill and administer Part B medicines. “To provide as much support as possible for physicians during the public health emergency, CMS should allow for physicians, when they deem it is safe and appropriate, to refer patients to new qualified entities: nurse practitioners, home health agency, a home infusion therapy supplier, a durable medical equipment supplier, any other individual/entity determined by Secretary through guidance, which could include entities such as Specialty Pharmacies that often employ qualified nurse practitioners. These entities should be allowed to bill Medicare directly for both the drug and the administration.”
  
  
• The Administration should clarify its temporary expansion of coverage of medicines administered through the durable medical equipment (DME) benefit under Part B. “In particular, the IFC does not explain whether CMS is expanding coverage: (1) to additional indications for the drugs listed in the local coverage determinations (LCD); or (2) to additional indications for the listed drugs, plus to external infusion pumps and additional drugs that can be administered through infusion pumps but are not currently listed in the LCD. We recommend that CMS clarify in its final rule (or in guidance) that during the public health emergency Medicare will cover drugs and biologicals that can safely be administered through external infusion pumps (as well as the pumps themselves) for all reasonable and necessary indications, regardless of whether the drugs and indications are currently listed in the External Infusion Pump LCD.” 
  
  
• The Administration should clearly state the flexibilities for blood draws and other specimen collection conducted in patients’ homes during the public health crisis. “Various drugs for Medicare beneficiaries require some level of clinical laboratory monitoring for their safe and effective use. Often, whole blood counts or other assays are required to titrate dosing or monitor for toxicity which necessitates patients having blood drawn. … The expansion of the definition of ‘homebound’ should now permit expanded coverage for Part B payment for a specimen collection fee and travel allowance for a laboratory technician to draw a specimen from homebound patient.”

Additionally, PhRMA called attention to the increased burden COVID-19 is putting on providers and suggested the Administration consider ways to temporarily increase reimbursement under Part B for providers working to continue to safely administer these medicines during the pandemic. “We recognize that there will be some situations where drug administration in a beneficiary’s home is not the safest or best option. Physicians and infusion centers may choose to continue to administer medicines to patients at their offices. In addition, ensuring broad capacity for drug administration in as many sites of services as possible, as determined to be appropriate by a patient’s provider, will help relieve pressure on high-acuity hospital settings in regions where COVID-19 is more prevalent. However, in order to do so safely, physicians may need to purchase PPE or stay open longer in order to space out patients. ... CMS should consider either special allocation or prioritization of providers that administer Part B medicines, infusion centers, and additional entities providing home infusions to receive support from the Provider Relief Fund.”

Read PhRMA’s full comments here.