In the CY2020 End-Stage Renal Disease/Durable Medical Equipment Final Rule (the "Final Rule"), CMS harmonized three preceding rules addressing face-to-face visits (FTF), written orders prior to delivery (WOPD), and prior authorization (PA):
The new rules establish a singular master list of products eligible for inclusion on subordinate lists that require specific conditions of payment.
[Trouble keeping up with all of these billing changes? No worries. With (K)notes, you can copy our homework.]
New Master List
In order to capture all of the regulatory requirements asserted by the preceding three rules, CMS changed the basis for adding items to the Master List. Additions now include:
New HCPCS
Using the new criteria, CMS added 212 new codes to the Master List. Additions include:
Deleted HCPCS
CMS removed 101 HCPCS from the Master List that were formerly subject to ACA requirements including:
As a result of the change, suppliers need not secure a 5-element order before delivery of the deleted HCPCS. Instead, suppliers should secure a new standardized order prior to billing.
While medical necessity must be supported, CMS will not require an FTF visit within six months of the order for removed HCPCS.
New Required Lists
Inclusion on the Master List makes HCPCS eligible for (but not automatically subject to) FTF, WOPD, and PA. Only eligible codes on the Master List published to one of the following required lists are subjected to applicable conditions of payment:
We predict CMS will push the same 45 codes currently subject to prior authorization to the new Required Prior Authorization List. Power mobility and support surface providers should experience no disruption or modification to the prior authorization process already in place.
We anticipate CMS might shake things up a bit with the Required Face-to-Face Encounter and Written Order Prior to Delivery List. We could end up with a mixed result where new codes migrate to WOPD and FTF for the first time, while others that have been subject to these same conditions under ACA fall off the list.
Notwithstanding, the Final Rule allows CMS to suspend any condition of payment for any item at any time. CMS can remove individual items or individual suppliers from either condition of payment. These permissions give the agency much more latitude in how it rolls out or scales back a condition of payment.
The Transition
When CMS posts the two required lists, the effective date will be at least 60 days from the date of public notification. CMS has the authority to establish a later effective date, and may do so if the agency believes suppliers need more time to educate referral sources and implement internal procedures.
On January 2, 2020, the MACs posted a revised Standard Documentation Policy Article to introduce the new Standard Written Order (SWO) effective January 1, 2020. CMS will provide the MACs and other contractors with written directives via updates to the Program Integrity Manual and subregulatory guidance. The MACs will be busy updating LCDs, website materials, educational resources, and tutorials.
Even after these changes are finalized, we always recommend suppliers secure orders and medical records prior to delivery for their own protection. Medical records are the only way to justify medical necessity in the event of an audit.
Why This Matters
Streamlining these disparate conditions of payment should reduce documentation burdens for suppliers across the board. Suppliers of power mobility products stand to benefit the most from a simplified order and FTF visits that remain viable for six months instead of 45 days. Under these guidelines, more customers will be served with fewer return office visits and fewer rounds of order corrections.
Despite the positives for mobility suppliers, it is impossible to determine the aggregate burden on suppliers. The dust hasn’t quite settled yet. A bigger Master List doesn’t necessarily mean that all products will require a WOPD and FTF visit, but until we know how many HCPCS will fall under this condition, we wait.
SOURCE LINKS
https://www.govinfo.gov/content/pkg/FR-2019-11-08/pdf/2019-24063.pdf (Pages 60648, 60650, 60651, 60742 - 60777, 60788, 60789, 60800,60801, 60802, and 60807-60808)
42 CFR §410.38
April 2006 Final Rule
November 2012 Final Rule
December 2015 Final Rule
- April 2006 Final Rule / Medicare Modernization Act of 2003 (MMA):
- Requires an FTF visit within 45 days of prescribing a power mobility device (PMD).
- Requires a 7-element written order prior to delivery.
- Covers 69 different PMD HCPCS.
- November 2012 Final Rule / Affordable Care Act of 2010 (ACA):
- Requires an FTF visit within six months.
- Requires a 5-element written order prior to delivery.
- Covers 164 different HCPCS.
- December 2015 Final Rule / Prior Authorization establishes:
- Master list of 135 eligible HCPCS for prior authorization.
- Required Prior Authorization List of 45 PMD and support surface HCPCS where authorization is mandatory as a condition of payment.
The new rules establish a singular master list of products eligible for inclusion on subordinate lists that require specific conditions of payment.
[Trouble keeping up with all of these billing changes? No worries. With (K)notes, you can copy our homework.]
New Master List
In order to capture all of the regulatory requirements asserted by the preceding three rules, CMS changed the basis for adding items to the Master List. Additions now include:
- Items that statutorily require an FTF visit, WOPD, or PA.
- Items that:
- Have a fee schedule with an average purchase price of $500 or average rental price of $50 (both adjusted for inflation), or
- Account for at least 1.5% of Medicare expenditures for all DME items in a recent 12-month period and are:
- Flagged by the OIG or GAO after 2014 as potentially fraudulent or overutilized, or
- Identified as having a high improper payment rate in a CERT annual report issued in 2018 or later.
- Items with:
- At least 1,000 claims and $1 million in payments during a recent 12-month period, and
- Aberrant billing patterns without explanatory factors such as a new LCD or newly approved technology, where:
- The percentage change in payment for the item from the current and preceding 12-month period is greater than the doubled percentage change for all DME payments in the same time frame, or
- Payments in the current 12-month period for the item exceed a 30% increase in payments for the same item in the preceding 12-month period.
New HCPCS
Using the new criteria, CMS added 212 new codes to the Master List. Additions include:
- 96 new orthoses.
- 46 new lower limb prostheses.
- 36 new wheelchair accessories.
- Six oxygen codes, including E1392 and K0738.
- One new catheter code, A4351.
- One new ventilator code, E0465.
- Test strips and two specialty meters.
- Custom breast prostheses.
Deleted HCPCS
CMS removed 101 HCPCS from the Master List that were formerly subject to ACA requirements including:
- Several wheelchair accessories.
- Lymphedema items.
- Group 1 support surfaces.
- Cervical traction units.
- Discontinued ventilator HCPCS.
- Oxygen contents.
- Standard glucose meters.
- TENS units.
- Seat lifts.
- Nebulizers.
- Several other low utilization products.
As a result of the change, suppliers need not secure a 5-element order before delivery of the deleted HCPCS. Instead, suppliers should secure a new standardized order prior to billing.
While medical necessity must be supported, CMS will not require an FTF visit within six months of the order for removed HCPCS.
New Required Lists
Inclusion on the Master List makes HCPCS eligible for (but not automatically subject to) FTF, WOPD, and PA. Only eligible codes on the Master List published to one of the following required lists are subjected to applicable conditions of payment:
- Required Face-to-Face Encounter and Written Order Prior to Delivery List.
- Required Prior Authorization List.
We predict CMS will push the same 45 codes currently subject to prior authorization to the new Required Prior Authorization List. Power mobility and support surface providers should experience no disruption or modification to the prior authorization process already in place.
We anticipate CMS might shake things up a bit with the Required Face-to-Face Encounter and Written Order Prior to Delivery List. We could end up with a mixed result where new codes migrate to WOPD and FTF for the first time, while others that have been subject to these same conditions under ACA fall off the list.
Notwithstanding, the Final Rule allows CMS to suspend any condition of payment for any item at any time. CMS can remove individual items or individual suppliers from either condition of payment. These permissions give the agency much more latitude in how it rolls out or scales back a condition of payment.
The Transition
When CMS posts the two required lists, the effective date will be at least 60 days from the date of public notification. CMS has the authority to establish a later effective date, and may do so if the agency believes suppliers need more time to educate referral sources and implement internal procedures.
On January 2, 2020, the MACs posted a revised Standard Documentation Policy Article to introduce the new Standard Written Order (SWO) effective January 1, 2020. CMS will provide the MACs and other contractors with written directives via updates to the Program Integrity Manual and subregulatory guidance. The MACs will be busy updating LCDs, website materials, educational resources, and tutorials.
Even after these changes are finalized, we always recommend suppliers secure orders and medical records prior to delivery for their own protection. Medical records are the only way to justify medical necessity in the event of an audit.
Why This Matters
Streamlining these disparate conditions of payment should reduce documentation burdens for suppliers across the board. Suppliers of power mobility products stand to benefit the most from a simplified order and FTF visits that remain viable for six months instead of 45 days. Under these guidelines, more customers will be served with fewer return office visits and fewer rounds of order corrections.
Despite the positives for mobility suppliers, it is impossible to determine the aggregate burden on suppliers. The dust hasn’t quite settled yet. A bigger Master List doesn’t necessarily mean that all products will require a WOPD and FTF visit, but until we know how many HCPCS will fall under this condition, we wait.
SOURCE LINKS
https://www.govinfo.gov/content/pkg/FR-2019-11-08/pdf/2019-24063.pdf (Pages 60648, 60650, 60651, 60742 - 60777, 60788, 60789, 60800,60801, 60802, and 60807-60808)
42 CFR §410.38
April 2006 Final Rule
November 2012 Final Rule
December 2015 Final Rule
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