Knowledge Base Category -

Regular readers of our weekly newsletter are likely aware that we publish a monthly article on updates to Medicare national and local coverage policies – NCDs and LCDs.  So it should be no surprise that I found the OIG report on LCDs very interesting and enlightening.  The OIG found that LCDs have significant influence on Medicare’s coverage of items and services.  They also found that due to inconsistency between the LCDs from various contractor regions, Medicare patients’ access to items and services can depend on geography as much as their clinical indications.

 

The OIG report studied Part B LCDs but Part A LCDs that apply to hospital services have similar characteristics.  Some basic facts concerning Local Coverage Determinations:

1)    they apply only in States within the contractor’s jurisdiction;

2)    they must follow all Medicare statutes, rulings, regulations and national coverage, payment and coding policies; and

3)    they may limit coverage of an item or service to a specific diagnosis or condition, or they may prohibit coverage of an item or service completely.

 

The OIG is not the only government entity that has weighed in on LCDs.  In 2001, the Medicare Payment Advisory Commission (MedPAC) recommended the elimination of LCDs and in 2003, the Government Accounting Office (GAO) reported LCDs resulted in inequitable variations in coverage.  The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) affected LCDs in two ways.  First, it replaced Fiscal Intermediaries (FIs) and Carriers with Medicare Administrative Contractors (MACs).  Medicare Contractor Reform is continuing to refine Medicare jurisdictions as it decreases the number of MACs.  Secondly, the MMA called for a plan to evaluate new LCDs for possible national application and to increase consistency among LCDs.

 

The OIG report looked at LCDs in October 2011 and still found problems with inconsistencies.  The OIG found that the presence of LCDs was unrelated to the cost and utilization of items and services, LCDs limited coverage for items and services differently across States, and they defined similar clinical topics inconsistently.  Due to these types of inconsistencies, coverage for a given service may be restricted in one State where an LCD is in place and completely unrestricted in another State where no LCD is in place.  Forty percent of procedures with no coverage allowed in one or more States had allowed charges in other States where LCDs did not prohibit coverage. This means Medicare patients in some States did not have access to items and services that had significant use among Medicare patients in other States.  The report also noted that the State-by-State differences in coverage created by LCDs are contrary to the growing practice of evidence-based medicine that eschews local variation.

 

Also the volume of affected services varied greatly between States.  LCDs affected coverage for over 50 percent of items and services in some States (California, North Carolina, South Carolina, and Virginia) and as few as 5 percent of items and services in other States (Alabama, Georgia, and Tennessee). Over a fifth of the LCDs in effect during the OIG review restricted coverage for items and services in only 3 States—Florida, Puerto Rico, and the Virgin Islands. Remember these findings were for Part B policies, but likely similar for Part A coverage also.

 

The OIG recommended that CMS:

Ø  Establish a plan to evaluate new LCDs for national coverage consistent with MMA requirements

Ø  Continue efforts to increase consistency among existing LCDs

Ø  Consider requiring MACs to jointly develop a single set of coverage policies

Although CMS agreed with all of the OIG’s recommendation, they believe their current workgroups and other initiatives are addressing these recommendations.  The OIG maintains that pursuing a single set of coverage policies would simplify and strengthen Medicare coverage policy while lessening the administrative burden of LCDs.  So are changes in the LCD process likely – that remains to be seen.  Until then, we trudge along…

 

Most of the LCD updates for this month are related to the CPT/HCPCS coding changes for 2014.  One change of note is the removal of two drugs (Cimzia and Simponi) from Cahaba GBA’s Self-Administered Drug (SAD) list.

 

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

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.