This week in Medicare updates—1/6/2021

January 6, 2021

Medicare Insider

Complying with Laboratory Services Documentation Requirements

On December 21, CMS revised an MLN Fact Sheet regarding documentation requirements for laboratory services. Updates include additional information on how medical review contractors audit records to align the information in the fact sheet with regulatory updates. It also provides clarification on the term “standing orders.”

Hospice Provider Compliance Audit: Hospice Compassus, Inc., of Tullahoma, Tennessee

On December 21, the OIG published a Review of whether hospice services provided by Hospice Compassus, Inc., of Tullahoma, Tennessee, complied with Medicare requirements. The OIG found that Tullahoma did not comply with Medicare requirements for 35 of the 100 claims. Errors involved claims for which the clinical record did not support the beneficiary’s terminal diagnosis, claims for services that were not documented, and claims for which the notice of election was not filed timely with the MAC. The OIG estimates that Tullahoma received at least $3.4 million in Medicare reimbursement for noncompliant hospice services.

The OIG originally questioned 68 claims, but Tullahoma argued that all but four claims were compliant. After an independent medical review contractor reassessed the claims, the OIG overturned its original ruling on 35 of those 68 claims. Two of the claims remained noncompliant for different reasons, but 34 claims were determined to support the terminal diagnosis and one claim was determined to meet the level of care reported. For the remaining 35 claims that were deemed noncompliant, the OIG recommends Tullahoma identify, report, and return any overpayments and strengthen its procedures to ensure hospice services comply with Medicare requirements.

Billing Information for Most Favored Nation (MFN) Model Drugs

On December 21, CMS published an MLN Fact Sheet regarding information on how to bill MACs for MFN Model drugs. The model starts on January 1, 2021, and it runs through December 31, 2027. The fact sheet provides a summary of how the model works, instructions on how to bill HCPCS code M1145 for the MFN per-dose add-on amount, how to apply the add-on amount, and more.

Proposed Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds

On December 21, CMS published a Proposed Decision Memo to announce it will cover autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds. Coverage of autologous PRP for all other types of chronic non-healing wounds will be determined by MACs. By issuing the proposed decision memo, CMS initiates a 30-day public comment period. Comments are due by January 20.

CMS published a Press Release on the proposed decision memo on the same date.

Despite Savings on Many Lab Tests in 2019, Total Medicare Spending Increased Slightly

On December 22, the OIG published a Review regarding Medicare payments for lab tests in 2019, which was the second year of rate reductions under PAMA. The OIG found that Part B lab test spending increased by $93 million to a total of $7.68 billion in 2019. Of the top 25 lab tests by Medicare spending, a total of 17 tests received payment reductions under PAMA in 2019. Those 17 tests had an overall increase in utilization, but spending still decreased by $175 million for that group from 2018. For the eight tests with payment rates that did not change, increases in utilization led to increases in Medicare spending for those tests. Because those eight tests had high payment rates, increased spending for that group of tests overtook the savings achieved by the 17 tests with PAMA rate reductions. The OIG said it will continue to monitor the effect of PAMA changes but anticipates that the 2020 spending on lab tests will be heavily impacted by the COVID-19 pandemic.

CMS Releases 2020 Measures Under Consideration List

On December 22, CMS published a Press Release to announce its 2020 list of quality and efficiency measures under consideration is now available. A majority of these measures rely on digital reporting, which CMS said should ease physician burden. The list includes three measures pertaining to COVID-19 vaccination among health care personnel, clinicians, and patients in ESRD facilities.

Acute Hospital Care At Home Program FAQs

On December 22, CMS updated an FAQ on the Acute Hospital Care At Home program. The FAQ provides information on general requirements and billing processes. It also contains links to resources for programs looking to take part in this initiative.

On December 31, CMS updated a List of approved hospitals participating in the program as of December 31, 2020. The program has expanded to add 18 additional hospital systems in addition to the six systems already participating.

Instructions to MACs on COVID-19 Emergency Declaration Blanket Waivers for Medicare-Dependent, Small Rural Hospitals (MDH) and Sole Community Hospitals (SCH)

On December 23, CMS published One-Time Notification Transmittal 10530 regarding waivers for MDHs and SCHs during the COVID-19 PHE. These waive requirements such as distance requirements, market share requirements, eligibility requirements, and more.

CMS published MLN Matters 12070 on the same date to accompany the transmittal.

Effective date: January 26, 2021

Implementation date: March 29, 2021

Medicare FFS Claims: 2% Payment Adjustment (Sequestration) Suspended Through March

On December 28, CMS published a Special Edition MLN Connects to announce that a policy in the CARES Act which had suspended the payment adjustment percentage of 2% applied to FFS claims from May 1 through December 31 would be extended through March 31, 2021, by the Consolidated Appropriations Act, which was signed into law on December 27.

Home Health Agency Provider Compliance Audit: Tender Touch Health Care Services

On December 28, the OIG published a Review of whether Tender Touch Health Care Services complied with Medicare requirements for billing home health services. The OIG found that Tender Touch billed Medicare incorrectly for 21 of the 100 home health claims reviewed. These issues pertained to services provided to beneficiaries who were not homebound or did not require skilled services. The OIG estimated that Tender Touch received overpayments of at least $478,780 for the audit period.

The OIG recommends Tender Touch refund Medicare the portion of the estimated overpayments that were for claims incorrectly billed during the 4-year reopening period; identify, report, and return any overpayments in accordance with the 60-day rule; and strengthen procedures to ensure full compliance with home health billing requirements. Tender Touch challenged the OIG’s original findings in which the OIG found 27 of the 100 sampled claims were incorrectly billed, and after further review, the OIG lowered its findings to incorrect billing for 21 of 100 claims and adjusted the findings for 12 claims.

Advisory Opinion No. 20-07

On December 28, the OIG published an Advisory Opinion regarding an arrangement in which health care facilities and clinicians would use an existing web-based platform to remit to patients and the patients’ payors a portion of claims for services paid by Medicare as a secondary payor. The requestor was inquiring as to whether the arrangement would violate prohibitions on inducements to beneficiaries or implicate the federal anti-kickback statute. The OIG said that while the arrangement could implicate the beneficiary inducements CMP and the federal anti-kickback statute, the OIG would not impose sanctions in this case because the arrangement has a low risk of increasing costs to federal health care programs through inappropriate or overutilization, the structure of the payments from certain members to the requestor would reduce potential for inappropriate or overutilization and would reduce the potential for interference with clinical decision-making, the arrangement would mitigate provider incentives to increase prices as an inducement to members, the anti-competitive effect of the arrangement is low, and neither the requestor nor the platform would steer members to certain providers.

Advisory Opinion No. 20-08

On December 30, the OIG published an Advisory Opinion regarding an arrangement in which a federally qualified health center would offer $20 gift cards to incentivize pediatric patients who have missed two or more preventive and early intervention care appointments within the past six months to attend rescheduled appointments. The requestor was inquiring as to whether the arrangement would violate prohibitions on inducements to beneficiaries or implicate the federal anti-kickback statute. The OIG stated that the arrangement does implicate the beneficiary inducements CMP and the federal anti-kickback statute. It also acknowledged that the agreement does not satisfy the Promotes Access to Care exception or the Preventive Care Exception, but the OIG said it would exercise discretion in this case and would not impose sanctions. This decision is due to the arrangement’s minimal risk of inappropriate steering, unlikely chance of increasing costs to federal health care programs or patients, unlikely chance of harming competition, and a tailored scope that would appear to accomplish the goal of improving attendance rates at care appointments.

Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care

On December 30, CMS published a Memorandum to state survey agency directors regarding updates to the non-long term care (NLTC) focused infection control survey tool for acute and continuing care providers. These updates include changes to COVID-19 guidance, update CMS regulatory tag considerations, and clarifications on certain information such as screening processes.

Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state agency/CMS branch location training coordinators immediately.

Clarifying the Use of As-Needed/PRN Orders for DMEPOS

On December 30, CMS published Medicare Program Integrity Transmittal 10538, which rescinds and replaces Transmittal 10492, dated November 25, 2020, to revise business requirement 11997.3.1. The original transmittal was published regarding changes to the manual to remove frequency from the standard written order for DMEPOS as a result of a recent regulatory change.

Effective date: January 1, 2020 - The effective date is 1-1-2020 to align with the effective date of CMS regulation 1713-F

Implementation date: December 29, 2020

Advisory Opinion No. 20-09

On December 31, the OIG published an Advisory Opinion regarding an arrangement in which a pharmaceutical manufacturer would provide financial assistance for travel, lodging, and other expenses to certain patients who are prescribed the manufacturer’s drug. This drug is a personalized medication made from the patient’s own cells, is potentially curative, and is only available at certain infusion centers, which the patient must stay within two hours of for at least four weeks after infusion of the drug. The requestor was inquiring as to whether the arrangement would violate prohibitions on inducements to beneficiaries or implicate the federal anti-kickback statute. The OIG stated that the arrangement does implicate the beneficiary inducements CMP and the federal anti-kickback statute. However, the arrangement does meet the Promotes Access to Care exception to the beneficiary inducements CMP, and the OIG also said it would not impose sanctions under the anti-kickback statute in this case. This decision was reached due to seven circumstances specific to the arrangement that are listed in the Opinion document.

CMS Could Improve Its Wage Index Adjustment for Hospitals in Areas With the Lowest Wages

On December 31, the OIG published a Data Brief regarding an audit that was done to analyze certain characteristics of hospitals with average wage indexes (AWI) in the bottom quartile for 2020 as a way to provide information to CMS and other stakeholders during implementation of CMS’s new bottom quartile wage index adjustment. The OIG determined that 53% of bottom quartile hospitals were rural, and 55% of rural hospitals in the IPPS had wage indexes in the bottom quartile. The bottom quartile hospitals were located in 24 states overall, but 41% of these hospitals were located in just six states. Most states that did not expand Medicaid under the ACA had hospitals in the bottom quartile, and most states with hospitals in the bottom quartile had the lowest possible state minimum wage. The OIG recommends that, once post-pandemic conditions allow, CMS should consider focusing the bottom quartile wage index adjustment more precisely toward hospitals that are least able to raise wages without that adjustment.

January 2021 Update of the OPPS

On December 31, CMS published Medicare Claims Processing Transmittal 10541 regarding changes to and billing instructions for various policies implemented through the 2021 OPPS update. These changes include multiple new COVID HCPCS and CPT codes which were effective in either October or November but were issued too late to include in the previous OPPS update. It also includes new codes for monoclonal antibodies, COVID-19 vaccines, and more.