This week in Medicare updates—5/16/18
Advisory Opinion No. 18-02 Regarding Free Sample Ostomy Products
On May 7, the OIG published an Advisory Opinion regarding an arrangement in which a company who manufactures, distributes, and sells medical devices/pharmaceutical products would provide a limited number of free samples of ostomy products to patients while contracting with a third party to conduct follow-up customer satisfaction surveys. The entity seeking the opinion asked whether the arrangement would lead to sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries or the civil monetary penalty provision related to the federal anti-kickback statute.
The OIG determined that the arrangement would not violate the inducements to beneficiaries prohibition, but it could lead to violations of the anti-kickback statute. However, in this scenario the OIG would not impose sanctions, as the arrangement presents a low risk of fraud and abuse under the anti-kickback statute. This determination was made because the arrangement would not cause patients nor federal health care programs to incur costs for the sample products, would have a low risk of steering patients to the products under the arrangement, would only provide enough free samples for a few days, and would include safeguards to limit the risk that the contractor is paid for product referrals.
Hospital Appeals Settlement Process Update
On May 8, CMS posted an Update on its Hospital Appeals Settlement Process page to announce that it executed settlements with an additional 612 hospitals under the 2016 Hospital Appeals Settlement Process. Those 612 hospitals represented approximately 72,000 claims. CMS has executed settlements with 2,414 unique hospitals representing approximately 419,000 claims overall.
CMS Announces Agency’s First Rural Health Strategy
On May 8, CMS published a Press Release regarding its new Rural Health Strategy, which is intended to take a proactive approach to provide quality and affordable healthcare for beneficiaries in rural areas. The initiative has five objectives:
- Apply a rural lens to CMS programs and policies
- Improve access to care through provider engagement and support
- Advance telehealth and telemedicine
- Empower patients in rural communities to make decisions about their healthcare
- Leverage partnerships to achieve the goals of the CMS Rural Health Strategy
CMS published a Fact Sheet on the same date to further describe the policy initiative.
Updated Corporate Integrity Agreement Documents
On May 8, the OIG published information on two new and three closed Corporate Integrity Agreements. The new agreements include:
- Arc of Anchorage, of Anchorage, AK
- Gamma Healthcare, Inc., of Poplar Bluff, MO
The closed cases include:
- GlaxoSmithKline, LLC, of Philadelphia, PA
- James P. Ralabate, M.D.; Primary Care Associates, P.C., of Stratford, CT
- Weiner, Ronald I., D.O.; Skyline Cardiovascular Institute, PLC, of Jackson, TN
Updated Civil Monetary Penalties and Affirmative Exclusions
On May 9, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusion agreements reached in April, including:
- Covenant Medical Center, of Waterloo, Iowa, reached a $90,000 settlement agreement with the OIG on April 30 to resolve allegations that Covenant violated the Emergency Medical Treatment and Labor Act (EMTALA) by failing to provide an adequate medical screening examination and stabilizing treatment for a patient and inappropriately transferring the patient to another hospital.
Meeting Announcement: Transcatheter Aortic Valve Replacement
On May 11, CMS published an Announcement in the Federal Register regarding a meeting about an NCD covering Transcatheter Aortic Valve Replacement (TAVR). The meeting will take place on July 25, 2018, when CMS will convene a MEDCAC panel to seek the panel’s recommendations regarding procedural volume requirements for hospitals and team members to begin and maintain TAVR programs. Written comments for the meeting must be submitted by 5 p.m. on June 18, 2018.
Interim Final Rule: Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
On May 11, CMS published an Interim Final Rule with Comment Period in the Federal Register regarding adjustments to the Durable Medical Equipment (DME) Fee Schedule. The rule increases fee schedule rates for certain DME items and services as well as enteral nutrition furnished in rural and non-contiguous areas of the country not subject to the DMEPOS Competitive Bidding Program (CBP).
The move will revert Medicare payments for supplies in the affected areas to the 50/50 blended rate used during the 2016 transitional year. This change could increase reimbursement for certain items by 30% - 231% of the 2018 rural fee schedule amounts. The change takes effect on June 1, 2018, and will continue through December 31, 2018. CMS also continues to seek comments on the methodology for adjusting fee schedule amounts for items for these areas.
On May 9, CMS published a Press Release and Fact Sheet to accompany the interim final rule.
Effective date: June 1, 2018
Comment date: Comments must be received at one of the addresses provided within the interim final rule by no later than 5 p.m. on July 9, 2018.
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - July 2018 Update
On May 11, CMS published Medicare Claims Processing Transmittal 4048, which rescinds and replaces Transmittal 4025, dated April 20, 2018, to update the policy section for HCPCS code Q9995 (injection, emicizumab-kxwh, 0.5 mg). The original transmittal was issued regarding the quarterly updates to drug/biological HCPCS codes.
Effective date: July 1, 2018
Implementation date: July 2, 2018
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
On May 11, CMS published Medicare Claims Processing Transmittal 4049, which rescinds and replaces Transmittal 4016, and Medicare National Coverage Determinations Transmittal 207, which rescinds and replaces Transmittal 206, both dated April 3, 2018, to remove business requirements 10295.04.1.1 and 10295.04.1.1.1 and to insert appropriate policy language in the Medicare Claims Processing Manual and Medicare National Coverage Determinations Manual. The original transmittal was issued to inform contractors that an NCD covering SET for treatment of PAD was effective May 25, 2017.
Effective date: May 25, 2017
Implementation date: July 2, 2018 - for MAC local edits and for Shared System edits
Intent to Reopen
On May 11, CMS published Medicare Program Integrity Transmittal 796 to instruct MACs to provide notification of the reopening process and notify the provider or supplier of their intent to reopen a specific claim when requested documentation has been received following a denial.
Effective date: August 13, 2018
Implementation date: August 13, 2018
Updates to Publication 100-04, Chapters 1 and 27 to Replace Remittance Advice Remark Code (RARC) MA61 with N382
On May 11, CMS published Medicare Claims Processing Transmittal 4047 to initiate changes to the manual and operational changes related to the new Medicare Beneficiary Identifier issued with the new Medicare Cards. References to the Health Insurance Claim Number (HICN) will be removed and replaced with a generic reference (Patient Identifier).
Effective date: August 13, 2018 - effective date is process date
Implementation date: August 13, 2018
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
On May 11, CMS published Medicare Claims Processing Transmittal 4045 to provide instructions for the quarterly updates to the clinical laboratory fee schedule. The transmittal includes instructions on how to access the data file for the quarterly update, pricing information, and new codes.
Effective date: July 1, 2018
Implementation date: July 2, 2018