Knowledge Base Category -

Do you know the difference between a National Coverage Determination (NCD) and a Coverage Decision Memorandum? And most importantly, which is binding on Medicare contractors and therefore on providers?

This is addressed in the Medicare Program Integrity Manual, Chapter 13, section 13.1.1:

National Coverage Determinations (NCDs) are developed by CMS to describe the circumstances for Medicare coverage nationwide for an item or service. NCDs generally outline the conditions for which an item or service is considered to be covered (or not covered). Once published in a CMS program instruction, an NCD is binding on all Medicare Administrative Contractors (MACs), Quality Improvement Organizations (QIOs), Program Safeguard Contractors (PSCs) (now known as ZPICs) and beginning 10/1/01 are binding for Medicare+Choice organizations.

“CMS prepares a decision memorandum before preparing the national coverage decision. The decision memorandum is posted on the CMS Web site, that tells interested parties that CMS has concluded its analysis, describes the clinical position, which CMS intends to implement, and provides background on how CMS reached that stance. Coverage Decision Memos are not binding on contractors or ALJs. … The decision outlined in the Coverage Decision Memo will be implemented in a CMS-issued program instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.”

This month, I would like to point out a revision to the Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity, NCD 100.1. Effective for dates of service on and after September 24, 2013, facility certification will no longer be required for coverage of covered bariatric surgery procedures. A complete discussion of the policy revisions can be found at MLN Matters Article MM8484.

There is also an interesting Decision Memorandum that was published August 13, 2013 concerning coverage of Cardiac Pacemakers. The memo combines the covered indications (documented non-reversible symptomatic bradycardia) for both single and dual chamber pacemakers. Remember however, that as stated above this decision is not binding until it is published as a CMS program instruction updating the NCD manual. We will provide additional information when this occurs.

Polices and articles can be viewed on the Medicare Coverage Database by entering the policy number in the Document ID search.

On November 12th CMS hosted a third, follow-up Special Open Door Forum (ODF) to allow hospitals and practitioners to ask questions regarding the Hospital Inpatient Admission Order and Certification and the 2 Midnight Benchmark for Inpatient Hospital Admissions. While you wait for CMS to post the transcript here is a run down from the Question and Answer (Q&A) portion of the call:

Question(s): More than one caller sought clarification on when care started in the Emergency Department for the 2 Midnight Benchmark. Specific “scenarios” provided by callers:

• What if a triage nurse does more than simply take vital signs and begins to initiate orders and/or treatment protocols that were designed by Physicians. Is this when care starts?
• What if a patient begins receiving treatment in an Ambulance prior to reaching the hospital at the direction of an Emergency Department Physician? Is this when care starts?

Answer: Pre-hospital care time does not count towards the 2 Midnight Benchmark. To meet the spirit of the regulation a Provider (MD, NP or PA) would need to initiate the care to start the time. Of note, CMS is currently considering when a triage nurse initiates a treatment protocol designed by a Physician.

Question: Will claims submitted with date of service from October 1, 2013 through March 31, 2014 later be audited by Recovery Auditors?

Answer: These claims are “off the table” for Recovery Auditors to perform “patient status reviews.” CMS went on to remind callers that they can request claims from this time for Coding Validation and Medical Necessity of Surgical Procedure reviews. This caller asked when this would be put in writing. CMS indicated that this was answered in the first question of the most recently released Questions and Answers on the CMS website.

Question: Regarding the Probe and Educate Program, a caller asked what would happen if the records were not reviewed timely and based on those findings the MAC requests additional records for review.

Answer: CMS indicated that the initial sample will be complete in entirety from October 1 – December 31 dates of service claims. After a review is complete the MACs will identify the denial rate and provide education. The Goal with the program is that a follow up sample would be from claims with dates of services after education had been provided to a hospital.

Question: A caller recognized that in recent information made available on the CMS website it was unclear whether or not Critical Access Hospitals would be part of the Probe and Educate Program and asked for clarification.

Answer: CAHs are not included in the Probe and Educate Program but are still subject to the rules.

Question: A caller provided an example of a patient presenting to the Emergency Department at 10:00 pm who was subsequently admitted as outpatient with observation services. The following morning the patient was no better, no sicker and not safe for discharge. At this point would it be appropriate to write the Inpatient order?

Answer: Yes, update to an Inpatient status.

Question: In regards to the medical review process, will MACs and RAs consider that a verbal order for inpatient admission written by a Nurse Practitioner or Resident that is co-signed by the Attending meets the Physician Certification Requirement?

Answer: Yes, as long as the Inpatient admission is conducted pursuant to an Inpatient order.

Question: One caller requested additional guidance regarding how to treat patient transfers to their hospital in regards to the 2 Midnight Rule.

Answer: CMS indicated that they are still working on this guidance and did note that they are excluding transfer cases from the Probe and Educate Review until the further guidance has been issued.

CMS has identified “rare and unusual” (exceptions) circumstances when a patient would not remain in the hospital greater than 2 Midnights but still be appropriate as an Inpatient. Current exceptions include patient death, patient transfer, patient left AMA or a patient who rapidly improves and is stable for discharge. The last call to be accepted during the ODF was an additional suggestion for an exception. When a patient is admitted and is receiving medically necessary inpatient services but the family requests Hospice care prior to the 2nd Midnight and the patient is discharged home with Hospice. CMS requested that this suggestion be sent to them to take a closer look at this.

CMS indicated during the ODF that they will soon be adding additional guidance regarding the patient order and certification to the website. MMP strongly recommends that you read these two downloads and continue to check the Inpatient Hospital Review page on the CMS website frequently for updates.

Link to Inpatient Hospital Review page:  http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medical-Review/InpatientHospitalReviews.html

Transcatheter Aortic Valve Replacement (TAVR - also known as TAVI or Transcatheter Aortic Valve Implantation) is a new technology for use in treating certain patients with aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

Effective for dates of service on or after May 1, 2012, Medicare will cover TAVR under Coverage with Evidence Development (CED) when specific requirements are met.

1. CMS covers TAVR for the treatment of symptomatic aortic valve stenosis under CED with the following conditions:
2. there is FDA approval of the indication and corresponding system,
3. two cardiac surgeons are involved,
4. the patient is under the care of a heart team, and
5. the hospital and heart team meet certain requirements including participation in a prospective, national, audited registry.
6. For indications that are not approved by the FDA, CMS covers TAVR under CED when patients are enrolled in qualifying clinical studies.

Currently, CMS has approved only one registry and two clinical studies. The approved registry is the Transcatheter Valve Therapy Registry operated by the Society of Thoracic Surgeons and the American College of Cardiology. Approved registries and qualifying clinical studies can be viewed at TAVR CED.

Inpatient Hospital Claims Coding/Billing Requirements

Note that the TAVR procedures are all on the Medicare inpatient-only list and therefore should only be performed on patients formally admitted as inpatients.

• Type of Bill (TOB): 11X
• Effective date: for discharges on or after May 1,2012
• ICD-9 procedure codes: 35.05(Endovascular replacement of aortic valve) or 35.06(Transapical replacement of aortic valve)
• Secondary diagnosis code: V70.7(Examination of participant in clinical trial)
• Condition code: 30 (qualifying clinical trial).

There are numerous, detailed requirements for coverage for this procedure. For complete information regarding the NCD requirements and Claims Processing instructions please refer to MLN Matters Article MM7897.