This week in Medicare updates—9/26/2018
Hurricane Florence and Medicare Disaster Related North Carolina, South Carolina, and the Commonwealth of Virginia Claims
On September 14, CMS published Special Edition MLN Matters 18014 regarding special services provided to Medicare providers, suppliers, and beneficiaries in North Carolina, South Carolina, and Virginia who were impacted by Hurricane Florence. CMS issued several blanket waivers in those areas to prevent gaps in access to care for beneficiaries impacted by the storm. The article instructs providers on how to utilize the waivers and other provisions enacted as part of the public health emergency in those states.
Effective date: N/A
Implementation date: N/A
Proposed Rule: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction
On September 17, CMS published the Display Copy of a proposed rule regarding changes to various Medicare requirements, Conditions of Participation, and Conditions for Coverage in an effort to simplify and streamline current regulations while increasing provider flexibility and reducing burden. These changes would affect a wide range of provider types and healthcare areas, including (but not limited to) the following:
- Emergency preparedness - would allow facilities to review their emergency program every two years unless facilities wish to do so more often, and would give facilities greater discretion in determining/conducting training requirements and testing requirements
- Hospitals - would allow hospitals to establish medical staff policy for utilizing a pre-surgery/pre-procedure assessment for an outpatient instead of a comprehensive history and physical
- Ambulatory surgical centers - would remove certain provisions regarding written transfer agreements and remove requirements that physicians/qualified practitioners conduct a complete comprehensive history and physical on each patient within 30 days before a scheduled surgery
- Transplant centers - would remove requirements that inadvertently resulted in transplant programs avoiding performing transplants on certain patients
CMS published a Press Release and a Fact Sheet on the same date. The fact sheet contains a lengthy overview of the specific changes proposed in the rule. The rule was published in the Federal Register on September 20.
Comments on the rule are due by 5 p.m. on November 19, 2018.
Updated Civil Monetary Penalties and Affirmative Exclusions
On September 17, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions agreements, including:
- On September 5, Sonata Biosciences, Inc., of Auburn, California, reached a $37,716.30 settlement agreement with the OIG to resolve allegations that Sonata knowingly presented HHS with claims under an NIH Small Business Innovation Research Grant for costs unrelated to the grant.
- On September 6, Milind V. Tilak, M.D., Suwarna Tilak, M.D., Doctor’s Inlet Pediatrics and Primary Care, P.A., and Avenues Pediatrics and Internal Medicine, of Middleburg and Jacksonville, Florida, reached a $58,370 settlement agreement with the OIG to resolve allegations that it received improper remuneration from Millennium Health, LLC in the form of point of care test cups which resulted in prohibited referrals.
Updated OIG Work Plan
On September 17, the OIG updated its Work Plan with the following new item:
OIG Advisory Opinion 18-10
On September 17, the OIG published an Advisory Opinion regarding a surgical device and wound care product manufacturer’s proposal to offer hospitals a refund under certain circumstances for the aggregate purchase price of three of the manufacturer’s products (a total knee or total hip implant, a wound therapy system, and an antimicrobial dressing). The requester asked whether this arrangement would violate the anti-kickback statute. The OIG determined that, for reasons discussed in the Opinion memo, the proposed arrangement would not generate prohibited remuneration under the anti-kickback statute and the OIG would therefore not impose administrative sanctions.
Comment Request: Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration
On September 19, CMS published a Comment Request in the Federal Register regarding an information collection titled, “Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration.” Comments on the information collection are due to the OMB desk officer by October 19, 2018.
Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data
On September 20, the OIG published a Review of Medicare payments for lab tests paid under the clinical laboratory fee schedule. The review provides the fourth set of annual baseline analyses of the top 25 lab tests. The OIG found that Medicare paid $7.1 billion under Part B for lab tests in 2017, which is similar to payments for lab tests throughout the four-year period from 2014-2017. Total spending for these tests was concentrated among a small number of tests and labs; 1% of labs received 55% of all Medicare payments for the top 25 lab tests in 2017. The top five tests, which have stayed consistent with previous years, accounted for $2.2 billion of the total $7.1 billion Medicare paid for Part B lab tests in 2017.
Privacy Act of 1974: Notice of New Matching Program
On September 20, CMS published a Notice in the Federal Register regarding a new computer matching program between CMS and the Department of Homeland Security/United States Citizenship and Immigration Services, “Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.” This program will be used by DHS/USCIS to provide CMS with status information necessary to make enrollment and exemption eligibility determinations.
Comments on the notice are due by October 22, 2018.
Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019
On September 20, CMS published a Notice in the Federal Register to announce the annual adjustment to the amount in controversy threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The 2019 AIC threshold amounts are $160 for ALJ hearings and $1630 for judicial review.
Dates: The adjustment is effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019.
Revisions to State Operations Manual, Chapter 2, Certification Process
On September 21, CMS published State Operations Provider Certification Transmittal 181 regarding revisions to the ESRD sections of Chapter 2 (Certification Process) to reflect the 2008 Conditions for Coverage for dialysis facilities and associated guidance. The revisions also improve the clarity and precision of survey and certification activities for ESRD facilities.
Effective date: September 21, 2018
Implementation date: September 21, 2018
New Waived Tests
On September 21, CMS published Medicare Claims Processing Transmittal 4137 to inform contractors of the new CLIA waived tests. There are 16 newly added waived complexity tests listed in the transmittal. CPT codes for these tests should include modifier -QW to identify the waived test.
Effective date: January 1, 2019
Implementation date: January 7, 2019
CMS Awards Funding for Quality Measure Development
On September 21, CMS published a Press Release to announce that it awarded seven organizations with cooperative agreements through MACRA to help CMS fill gaps in the Quality Payment Program (QPP) measure set and ensure measures are valuable, clinically appropriate, reduce provider burden, and enhance patient care. These agreements represent the first funding initiative supporting public-private efforts to develop measures for the QPP.
Credentials of Reviewers
On September 21, CMS published Medicare Program Integrity Transmittal 825 to instruct MACs, Comprehensive Error Rate Testing (CERT) contractors, and Medical Review Accuracy Contractors (MRAC) to ensure that medical record reviews for coverage determinations are performed by RNs, therapists, or physicians. Current Licensed Practice Nurses (LPN) can be grandfathered in, but contractors should not hire new LPNs to perform medical record reviews.
Effective date: October 22, 2018
Implementation date: October 22, 2018
Update to Chapter 4, Section 4.18.1.4 and Exhibit 16 in Medicare Program Integrity Manual
On September 21, CMS published Medicare Program Integrity Transmittal 826 regarding an update to Chapter 4 of the manual to replace the OIG/Office of Investigations (OI) Case Referral Fact Sheet Format and OIG/OI Case Summary Format with the updated Referral Fact Sheet Template.
Effective date: October 22, 2018
Implementation date: October 22, 2018