On August 4, 2020, the Centers for Medicare & Medicaid Services (CMS) published the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule (CMS-1736-P). The proposed policies support the President Trump Executive Order: “Protecting and Improving Medicare for Our Nation’s Seniors,” which aims to expand services and lower out-of-pocket costs for patients. The changes in proposed rule expand Medicare payment for additional services and reduce provider burden by allowing greater flexibility for operation of the hospitals and ASCs. Some key proposed changes that may impact access to your #medtech Products are summarized below:
- Proposed Elimination of the Inpatient Only List. CMS proposes to eliminate the Inpatient Only (IPO) list over a three-year transitional period with the list completely phased out by CY 2024. Almost 300 services related to musculoskeletal conditions will be removed from the IPO list. These procedures will then be eligible to be paid by Medicare in the hospital outpatient setting when outpatient care is appropriate in addition to the existing ability for payment in the hospital inpatient setting when inpatient care is appropriate, as determined by the physician. The two-midnight rule used to determine admission eligibility will apply to these procedures removed from the IPO list. These procedures also will be exempt for two years from medical review activities relating to patient status, according to a CMS. CMS is soliciting comments on several related issues.
- ASC Covered Procedures List. For CY 2021, For CY 2021, CMS proposes to add eleven procedures to the ASC covered procedures list (CPL), including total hip arthroplasty (CPT 27130). Additionally, CMS is proposing two alternatives to further expand services payable in ASCs that would give beneficiaries more choices on where to get care.
- CY 2021 OPPS Payment Methodology for 340B Purchased Drugs: Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. Beginning January 1, 2018, Medicare adopted a policy to pay an adjusted amount of ASP minus 22.5 percent for certain separately payable drugs or biologicals acquired through the 340B Program that had been subject to ongoing litigation and was upheld by the D.C Circuit Court on July 31, 2020. CMS proposes to further reduce payment for these drugs by adopting a net proposed rate of ASP-28.7 percent for separately payable 340 B drugs or biologicals. Additionally, CMS proposes that rural sole community hospitals, children’s hospitals, and PPS-exempt cancer hospitals be excepted from either of the proposed 340B payment policies and that these hospitals would continue to report informational modifier “TB” for 340B-acquired drugs, and continue to be paid ASP+6 percent.
CMS is also soliciting comment on an alternative proposal of continuing the current Medicare payment policy of paying ASP-22.5 percent for 340B- acquired drugs for CY 2021 and subsequent years.
- Updates to OPPS Payment Rates: CMS proposes to increase OPPS payment rates by 2.6% for 2021, amounting to a $7.5 billion increase.
Comments on all sections of the proposed rule must be received by CMS no later than 5 p.m. on October 5, 2020. For more information, review the Proposed Rule and the Fact Sheet.
Why review the proposed 2021 changes in the OPPS and ASC Rules?
If your drugs, medical devices, biologics, diagnostics, and associated services are impacted by the proposed CMS changes, it is important to review the proposed changes to:
- comment on the specific changes during the comment period before the changes are finalized.
- understand the potential impact of these changes on your company revenues, market access, and patient access.
- develop and update 2021 marketing and reimbursement strategies, and
- update your Billing Guides for 2021 based on the final changes.
Why partner with GIRS
- GIRS has assisted our clients to remove services from the IPO list to the outpatient setting that is more cost effective than the inpatient setting.
- We have successfully helped our clients with ASC reimbursement strategies and provider contracting with ASCS.
- We have assisted our clients with commenting on proposed policy changes and implementing the final changes with all related stakeholders including providers, professional societies, and patients.
Please contact us at info@girsinc.com or avail of our Complimentary Review of your reimbursement needs at girsinc.com
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.
Sources:
- Proposed Rule
- Fact Sheet
- https://www.aha.org/fact-sheets/2020-01-28-fact-sheet-340b-drug-pricing-program
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).