The Facilities for Medicare and Medicaid Companies (CMS) expanded Medicare coverage for constant glucose monitoring (CGM) products in 2018. This led to a substantial increase in Medicare reimbursement requests for these devices—which in switch led to increased scrutiny of the health care vendors, pharmacies, and other entities publishing these reimbursement promises. 1 unique place of issue which is proving problematic for quite a few Medicare contributors in 2021 is the classification of CGM products as resilient healthcare machines (DME).
“There are numerous probable stumbling blocks for Medicare members when it will come to billing for CGM—including problems with regard to the classification of CGM as DME. CGM billing compliance is now a nationwide enforcement precedence, and entities that are unsuccessful to create and retain compliance can confront sizeable legal responsibility in the party of an audit or investigation.” – Dr. Nick Oberheiden, Founding Lawyer of Oberheiden P.C.
The Very long and Winding Highway to Limited Medicare Approval for CGM Equipment
Continuous glucose checking was 1st introduced in 1999. Even though the science of glucose monitoring as a signifies of prognosis dates again to the mid-1800s, it took a while for health care scientists to create a tests methodology that could use a small ample blood sample for at-household screening. The U.S. Food stuff and Drug Administration (Fda) issued its initially approval for a CGM unit in 1999, and considering the fact that then several producers have launched devices that can keep track of patients’ glucose amounts without a finger prick.
Even so, the Centers for Medicare and Medicaid Services (CMS) remained resistant to the thought of CGM properly into the 21st century. In 2017, CMS formally took the situation that CGM does not qualify for Medicare coverage as a standalone indicates of prognosis. In a Ruling dated January 12, 2017, it wrote, “Medicare does not cover CGMs accepted by the Food and drug administration for use as adjunctive devices to complement, not replace, information acquired from blood glucose monitors [because] these products are not applied for creating diabetes cure decisions, this sort of as transforming one’s diet program or insulin dosage primarily based only on the readings of the CGM . . . [and therefore] are not viewed as to provide the health care goal of earning diabetic issues therapy selections.”
CMS expanded Medicare protection for CGM gadgets in 2018, allowing for protection for smartphone use with CGMs. Although not an growth of the purposes for which use of CGM equipment is reimbursable below Medicare, this was a important adjust nonetheless—as authorizing billing for smartphone know-how opened up the market for at-household screening substantially. In fact, currently CMS nonetheless analyzes the exact same five standards outlined in its January 12, 2017 ruling when identifying whether CGMs are qualified for Medicare reimbursement as DME. These conditions are:
“The beneficiary has diabetic issues mellitus . . .
“The beneficiary is insulin-treated with numerous (three or additional) each day administrations of insulin or a Medicare-covered constant subcutaneous insulin infusion (CSII) pump
“The beneficiary’s insulin procedure regimen calls for recurrent adjustment by the beneficiary on the basis of BGM or CGM screening results
“Within six (6) months prior to purchasing the CGM, the dealing with practitioner has an in-individual stop by with the beneficiary to examine their diabetes handle and decided that standards (1-3) previously mentioned are met and,
“Every 6 (6) months pursuing the preliminary prescription of the CGM, the dealing with practitioner has an in-person visit with the beneficiary to evaluate adherence to their CGM program and diabetic issues remedy strategy.”
CMS’s assistance goes on to make distinct that, “If any of [the] protection criteria . . . are not met, the CGM and associated offer allowance will be denied as not fair and essential.”
What Do Companies Will need to Do to Keep away from Federal Scrutiny for Medicare Fraud Connected to CGM Equipment?
Specified that federal authorities are particularly concentrating on well being care providers, pharmacies, and other people for Medicare fraud related to CGM gadgets, now is the time for these people and entities to make positive their tactics and procedures are compliant. Among other measures, this indicates that Medicare members that bill for CGM equipment ought to:
Make Guaranteed They Know Which CGM Units are Medicare-Compliant
Not all CGM devices are Medicare-compliant, and Fda approval does not equate to Medicare compliance. Prior to billing Medicare for a CGM unit, it is imperative to ensure that the unit is suitable for reimbursement. Companies and pharmacies should not count on manufacturers’ representations, but in its place make their have unbiased determinations based on the data that is offered straight from CMS.
Exercise Warning With Regard to DME Classification for CGM Units
Underneath the latest Medicare billing pointers, a machine only qualifies as reimbursable DME if it is made to final and function as supposed for a minimum amount of 3 many years. Lots of CGM equipment do not satisfy this definition. Although failure to qualify as DME does not essentially indicate that a CGM unit is ineligible for reimbursement, it does necessarily mean that Medicare members require to be particularly thorough to bill for these units at present. This is a unique focus for CMS auditors, the U.S. Office of Health and Human Expert services Place of work of Inspector General (HHS OIG), and the U.S. Section of Justice (DOJ), so faults here are significantly probably to lead to federal scrutiny.
Evaluation Their Tips for CGM Billing
Presented the challenges of improperly billing for CGM as DME and committing other Medicare billing violations linked to continuous glucose checking products, suppliers, pharmacies, and other people really should diligently critique their suggestions for CGM billing to make sure that they are compliant. Inadvertence is not a protection in Medicare fraud investigations, and CMS, the HHS OIG, and the DOJ all be expecting Medicare individuals to do what is essential to meet up with their compliance obligations proactively and on an ongoing foundation.
Evaluate Their Fiscal Associations with Other Entities
Providers’ and pharmacies’ associations with DME suppliers can also lead to difficulty in the party of a Medicare fraud investigation. Incorrect referral and marketing and advertising relationships are ripe for federal prosecution, and illegal rebates and “kickbacks” can guide to civil or legal penalties for functions on equally sides of the transaction. Numerous seemingly innocuous monetary relationships that would be permissible under usual business situation are prohibited underneath the Anti-Kickback Statute (AKS) and the Reducing Kickbacks in Restoration Act (EKRA), so Medicare members will need to address these concerns with their exceptional statutory obligations in thoughts.
Audit Their CGM Unit Billing Histories Beneath Medicare
Medicare contributors have an obligation to proactively deal with any earlier billing issues. If uncovered throughout an audit or investigation, earlier-unknown errors can lead to not only recoupment legal responsibility, but also liability for fines, treble damages, and other penalties beneath the Untrue Claims Act. With this in brain, entities that have fears about their CGM system billing histories need to conduct thorough audits with the oversight of their authorized counsel and, if the audit uncovers any Medicare billing violations, they must address these concerns with their authorized counsel’s steerage as nicely.
Monitor for Updates to CMS’s Recommendations for CGM Product Eligibility
Given that CGM is however a fairly new know-how in just the Medicare context, vendors, pharmacies, and other people should check for updates to CMS’s tips. In the celebration that CMS variations the billing codes or eligibility of CGM equipment (which includes, but not minimal to, these qualifying as DME), all entities that bill Medicare for these equipment should assure that they immediately adhere to the current advice.
What Must Vendors Do When Contacted by CMS (or An additional Federal Authority) Relating to Their CGM Product Billing Background?
With CMS, the HHS OIG, and the DOJ all prioritizing enforcement with regard to Medicare billing for CGM products, entities that invoice Medicare for CGMs need to have to be ready for the risk of an audit or investigation. If contacted by auditors or federal brokers, vendors, pharmacies, and other people should really be organized to:
Identify Relevant Documentation and Initiate an Inner Compliance Audit
Instantly upon learning of an audit or investigation, it is very important to discover and maintain all suitable documentation. This contains Medicare compliance insurance policies and methods, client records, and billing data pertaining to DME and non-DME constant glucose monitoring units. An inner compliance audit wants to be conducted at this time as perfectly, as it will be vital to ascertain regardless of whether (and to what extent) auditors or investigators are going to uncover Medicare billing violations.
Set up Apparent Strains of Conversation and a Chain of Command
All inner staff should really be instructed not to talk with auditors or brokers directly. There should really be a clear chain of command, and all communications with federal authorities really should be routed via the practice’s or company’s defense counsel.
Oberheiden P.C. © 2021 Nationwide Legislation Assessment, Quantity XI, Quantity 215