Knowledge Base Category -

We all learned our ABCs in kindergarten, but now we have to know Medicare’s version of the alphabet. For example this article looks at LCDs by the MACs and a new CMS NCD for coverage of CHF for CR for certain NYHA classes. And don’t forget to add the KX modifier when needed.

Cahaba, Palmetto, and First Coast - Medicare Administrative Contractors (MACs) for Jurisdictions 10, 11 and N respectively - did not have any new, retired or draft Local Coverage Determinations (LCDs) last month, but Novitas, the MAC for Jurisdictions H and L, retired a number of policies and replaced most of them with new policies. It appears Novitas is working toward having one policy on a topic for both of their jurisdictions and for both Part A and B. This will ensure consistency in coverage criteria for all providers handled by Novitas. See the table at the conclusion of this article for the list of this month’s new and retired policies.

On the national front, CMS manualized the National Coverage Determination (NCD) for coverage of congestive heart failure (CHF) for cardiac rehabilitation (CR) (see MLN Matters Article MM8758). The transmittals, to be implemented August 18, 2014, allow Medicare coverage, effective for dates of service on and after February 18, 2014, of cardiac rehabilitation services for patients with stable, chronic heart failure.

Stable, chronic heart failure is defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least six weeks. Stable patients are defined as patients who have not had recent (≤6 weeks) or planned (≤6 months) major cardiovascular hospitalizations or procedures.

In addition to CHF, Medicare covers cardiac rehab for the following conditions:

• Acute myocardial infarction within the preceding 12 months
• Coronary artery bypass surgery
• Current stable angina pectoris
• Heart valve repair or replacement
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting or
• Heart or heart-lung transplant

This is a good time to remind CR providers about the maximum number of sessions for CR and appropriate billing. MMP, as part of our 835 reviews for the HIQUP reports, consistently sees some cardiac rehab services denied with claim adjustment reason code (CARC) 151 (Payment adjusted because the payer deems the information submitted does not support this many services). This appears to be denials for cardiac rehab services exceeding the allowed maximum sessions.

Cardiac rehabilitation program sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period of time if approved by the Medicare contractor. For medically necessary CR sessions beyond 36, the provider should append a KX modifier on the claim lines as an attestation that documentation is on file verifying that further treatment beyond the 36 sessions is medically necessary up to a total of 72 sessions for that beneficiary. The Medicare contractor will accept the KX modifier and allow payment. Medicare will not cover CR sessions beyond 72 sessions, with or without the inclusion of a modifier.

The CARC for these maximum benefit denials may be changing as the Claims Processing Manual update included the following instructions:

The following messages shall be used when contractors deny CR claims that exceed 36 sessions, when a KX modifier is not included on the claim line:

Claim Adjustment Reason Code (CARC) 119 – Benefit maximum for this period or occurrences has been reached

Regardless of the denial reason code, providers need to carefully monitor their CR patients’ number of sessions and use the KX modifier when appropriate to assure proper payment. This will be even more important now that the volume of cardiac rehab will likely increase due to the inclusion of CHF as a covered indication.

On August 1st the Centers for Medicare and Medicaid Services (CMS) released the FY 2015 Inpatient Prospective Payment System (IPPS) Final Rule. Over the next few weeks we will share with you key portions of the Rule.

As with the FY 2015 IPPS Proposed Rule, the Final Rule’s main focus is on Quality. Specifically, the following three Affordable Care Act (ACA) mandated Programs:

• Hospital Readmission Reduction Program,
• Hospital Value Based Purchasing (VBP) Program; and
• Hospital-Acquired Condition (HAC) Reduction Program.

All three Programs are designed to improve quality of care to the patient during and after a hospitalization. At the national level several of the measures within these Programs are closely aligned with the Institute for Health (IHI) Triple Aim. “In 2008 Don Berwick, Tom Nolan, and John Whittington first described the Triple Aim of simultaneously improving population health, improving the patient experience of care, and reducing per capita cost. The Institute for Healthcare Improvement (IHI) developed the Triple Aim as a statement of purpose for fundamentally new health systems that contribute to the overall health of populations while reducing costs. The idea struck a nerve. It has since become the organizing framework for the US National Quality Strategy, for strategies of public and private health organizations around the world, and for many of the over 100 sites from around the world that have been involved in IHI’s Triple Aim prototyping initiative.”1

The Triple Aim of improving population health, improving the patient experience of care, and reducing per capita cost is not only the right thing for our patients it is a key framework to guide hospitals as our health care system moves forward towards pay for performance. Beyond the patient, it is also critical for hospitals to be aware of the potential payment reduction impact that these three Programs combined can have for hospitals with low quality performance.

‍Readmission Reduction Program:

Background

This Program began on October 1, 2012. In the first two years of the program hospitals with excessive 30 day readmission rates for Acute Myocardial Infarction (AMI), Heart Failure (HF) and Pneumonia (PN) were penalized a percentage of their base operating DRG payment amount for ALL Medicare discharges.

What’s New?

• Eligible hospital discharges occurring between July 1, 2010 and June 30, 2013 were used to calculate the FY 2015 Excess Readmission Rates (ERRs).
• The maximum hospital payment adjustment is increasing to 3%, as required by the ACA.
• Two new readmission measures are being added to the program.
• 30-day Risk Standardized Readmission for Chronic Obstructive Pulmonary Disease (COPD), and
• 30-day Risk Standardized Readmission following elective, primary total hip and/or total knee replacement (THA/TKA).
  To ensure that hip fracture patients are excluded from this measure, CMS finalized a refinement to the measure cohort to exclude patients with hip fracture coded as either the principal or secondary diagnosis during the index admission.
• The FY 2015 Hospital Readmission Reduction Program results are to be publically posted on Hospital Compare in December at http://www.medicare.gov/hospitalcompare/readmission-reduction-program.html.
• The rule finalized Readmissions for Coronary Artery Bypass Graft (CABG) Surgical Procedure as an new measure in FY 2017.
• Though not new it is important to note that discharge diagnoses for each applicable condition are based on specific ICD-9-CM codes for that condition. These codes can be found on the QualityNet Web site at: http://www.QualityNet.org > Hospital-Inpatient > Claims-Based Measures > Readmission Measures > Measure Methodology.

Hospital Value-Based Purchasing Program:

Background

The Hospital VBP Program also began October 1, 2012. A CMS Fact Sheet indicates that this program works by rewarding hospitals “based on the quality of care provided to Medicare patients, how closely best clinical practices are followed, and how well hospitals enhance patients’ experiences of care during hospital stays. Hospitals are no longer paid solely based on the quantity of services they provide.”

As this program matures the weighting of measures is shifting away from clinical process of care measures towards the patient experience, patient outcomes and efficiency as evidenced in the following table:

‍What’s New?

• The percent reduction for redistribution is increasing to 1.5% of the base operating DRG payment amount for all participating hospitals.
• The total estimated amount available for value-based incentive payments in FY 2015 is approximately $1.4 billion.
• As finalized in the FY 2013 Final Rule, the Efficiency Domain is being added in FY 2015. The current measure in this domain is the Medicare Spending Per Beneficiary (MSPB) measure. This measure “assesses Medicare Part A and Part B payment for services provided to a Medicare beneficiary during a spending-per-beneficiary episode that spans from 3 days prior to an inpatient hospital admission through 30 days after discharge.”
  The QualityNet MSPB web page indicates that “by measuring cost of care through this measure, CMS hopes to increase the transparency of care for consumers and recognize hospitals that are involved in the provision of high-quality care at lower cost to Medicare.”
• Six measures are to be removed from the program in FY 2017 due to them being “Topped-Out.” Topped out measures meet the two criteria of having a statistically indistinguishable performance at the 75th to 90th percentile and having a truncated coefficient variation of ≤ 0.10. The Topped-Out measures include:

 

‍

• Three new measures were finalized for FY 2017.
• Two new Outcome Measures for the Safety Domain
• Hospital-onset Methicillin-Resistant Staphylococcus Aureus (MRSA) bacteremia
• Clostridium difficile infection
• One new Clinical Process of Care Measure
• Elective Delivery Prior to 39 Weeks Gestation
• Two new measures were finalized for FY 2019.
• Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)
• This measure will assess “complications occurring after THA and TKA surgery from the date of the index admission to 90 days post date of the index admission.”
• The outcome is one or more of the following complications:
• AMI, PN, or sepsis/septicemia within 7 days of admission;
• Surgical site bleeding, pulmonary embolism or death within 30 days of admission; or
• Mechanical complications, periprosthetic joint infection or wound infection within 90 days of admission.
• PSI-90 Composite Measure which includes PSI-3 – Pressure Ulcer Rate, PSI-6- Iatrogenic Pneumothorax Rate, PSI-7-Central Venous Catheter-Related Blood Stream Infections Rate and PSI-8-Post-op Hip Fracture Rate.

Hospital-Acquired Condition (HAC) Reduction Program:

Background

The Deficit Reduction Act of 2005 (DRA) required that the Secretary identify at least two HACs by October 1, 2007. HACs are high cost and/or high volume conditions that have been designated as a complication (CC or MCC) for coding purposes, have evidence-based guidelines to prevent the condition and if it was the only secondary diagnosis driving the MS-DRG assignment to a higher paying MS-DRG it would be discounted and the hospital would receive payment as if the HAC never occurred. HACs began to impact payment for hospitals for discharges occurring on or after October 1, 2008.

What’s New?

The HAC Reduction Program is set to begin on October 1, 2014. This program is a penalty program that will reduce payments to hospitals with excessive HACs by 1% for ALL Medicare discharges.

In the FY 2014 Final Rule CMS indicated that “the HAC Reduction Program aligns with our national strategy to improve health care quality by promoting the prevention of HACs, such as “never events” and HAIs. Our goal for the HAC Reduction Program is to heighten the awareness of HACs and reduce the number of incidences that occur.” They went on to state that “we believe that our efforts in using payment adjustments and our measurement authority will encourage hospitals to eliminate the incidence of HACs that could be reasonably prevented by applying evidenced based guidelines.”

In an August 5th MLN Connects™ Provider eNews CMS indicated that “this new program builds on the progress in this area achieved through the existing HAC program, which is currently saving approximately $30 million annually.”

The measures in this program are separated into two domains and scoring for each measure will begin at the minimum value for each measure. Scoring of the measures will result in a Total HAC Score. The finalized domains, domain weight and measures are as follows:

‍

At the end of the day it really is all about the patient.

For more information:

• Additional details about all three of these programs can be found in the pre-published https://www.federalregister.gov/articles/2014/08/22/2014-18545/hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care">Final Rule (pages 722-820, 822-976 and 976 – 1,049).
• The Final Rule has a scheduled publication date of 08/22/2014 and will be available online at: http://ofr.gov/(S(pcl2zalo5cz115uiw2as4qqr))/inspection.aspx.

Reference

1Stiefel M, Nolan K. A Guide to Measuring the Triple Aim: Population Health, Experience of Care, and Per Capita Cost. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2012. (Available on www.IHI.org)

This week, March 9-15, 2014, is Pulmonary Rehabilitation Week. MMP would like to thank all of the healthcare professionals who enhance the quality of life of individuals with lung disease through a Pulmonary Rehab program. We are glad that Medicare finally recognized Pulmonary Rehab as a distinct payable comprehensive program. But along with the benefit of Medicare coverage comes the challenges of meeting all of Medicare’s requirements for coverage. And for Pulmonary Rehab, like a lot of other services, that is no easy task.

The Medicare rules for Pulmonary Rehab can be found in the Medicare manuals, specifically the Benefit Policy Manual, Chapter 15, section 231 and the Claims Processing Manual, Chapter 32, section 140.4. Also, some local Medicare Administrative Contractors (MACs) have coverage policies or articles that further define coverage, such as specific diagnosis codes. Pulmonary Rehab professionals need to be fully aware of Medicare’s requirements and ensure that their program is in compliance.

A recent medical review of Pulmonary Rehab programs by Palmetto GBA, the Part A MAC for Jurisdiction 11 (North Carolina, South Carolina, Virginia, and West Virginia) found charge denial rates of 76-93%. All PR providers could learn from the results of these reviews so I would like to share some of the major findings.

Claims were denied for the following reasons related to the requirements for:

Diagnosis

• The documentation submitted does not represent a patient with moderate to severe chronic obstructive pulmonary disease (COPD) as defined by the Gold Classification II, III, and IV per 42 CFR 410.47.
• The documentation of post-bronchodilator pulmonary function studies does not meet the requirement of FEV1 less than 80% of predicted and FEV1/FVC of less than 70%.

Physician Referral

• There is no physician’s order/referral for admission to pulmonary rehabilitation services present.

Required Program Components

• Does not contain the required components for pulmonary rehabilitation program as defined in 42 CFR 410.47
• There is no psychosocial assessment of the individual's mental and emotional functioning as it relates to their rehabilitation or respiratory condition.
• There is no outcomes assessment as a written evaluation of patient progress related to the rehabilitation.
• Does not contain mandatory individualized treatment plans as a written, established, reviewed, and signed by a physician every 30 days as defined in 42 CFR 410.47.
• There is no physician's prescribed exercise program present in the documentation.
• There is no documentation of the patient's education or training as it relates to care and treatment.

Frequency and Limits

• The documentation submitted does not meet the requirements for pulmonary rehabilitation services up to 36 and no more than two sessions per day as defined in 42 CFR 410.47.
• The documentation submitted does not meet the requirements for pulmonary rehabilitation services up to 72 sessions, with KX modifier and no more than two sessions per day as defined in 42 CFR 410.47.

Physician Oversight

• The documentation submitted does not indicate the supervising physician was available and accessible for medical consultations and emergencies at all times, when services were provided under the program as defined in 42 CFR 410.47.

As you can see, there are a lot of requirements which equals a lot of reasons for Medicare to deny your Pulmonary Rehab claim. Make sure you are following all of Medicare’s requirements so that you can continue to provide this valuable service and actually get paid for your work.

 

This month the focus is on national news instead of the local news. But this national news is not from one of the major television networks, such as NBC, CBS, ABC, or even FOX. It comes to you from the studios of CMS. In February, CMS manualized four National Coverage Determinations (NCDs) ranging from PETs and pacemakers to oral anti-emetics. These NCDs have different effective dates, but all are set for implementation on July 7, 2014.

Pacemaker NCD

The Pacemaker NCD removes the differential coverage requirements for single versus dual chamber pacemakers. Under the revised policy, both single chamber and dual chamber implanted permanent cardiac pacemakers are covered for the same indication - treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example: syncope, seizures, congestive heart failure, dizziness, or confusion). The effective date of the policy is August 13, 2013. See MLN Matters Article MM8525 for more information including non-covered indications, affected CPT codes, specific diagnosis codes required for coverage, and billing instructions. Of particular note is the requirement to include a KX modifier on the claim line(s) as an attestation by the provider that documentation is on file verifying the patient has non-reversible symptomatic bradycardia.

PET Aβ for Alzheimer’s Disease

Effective with dates of service on and after September 27, 2013 CMS will cover beta amyloid PET scans (PET Aβ) through coverage with evidence development (CED) during a clinical trial to:

1. develop better treatments or prevention strategies for Alzheimer’s Disease (AD), or, as a strategy to identify subpopulations at risk for developing AD, or
2. resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia

Claims for PET Aβ imaging, through CED during a clinical trial, must contain the following:

• Condition code 30, (for institutional claims only);
• Modifier Q0 and/or modifier Q1 as appropriate;
• ICD-9 dx code V70.7 / ICD-10 dx code Z00.6 (on either the primary/secondary position);
• A PET HCPCS code 78811 or 78814;
• A covered diagnosis code; and
• Aβ HCPCS code A9586 or A9599.

Coverage of PET Aβ is limited to one scan in a patient’s lifetime. See MLN Matters Article MM8526 for more information and a list of the covered diagnosis codes.

FDG PET for Solid Tumors

The second NCD addressing PET scans, effective June 11, 2013, revises the coverage of FDG PET scans for solid tumors to remove the requirement for coverage with evidence development (CED). Providers will no longer have to report data to the National Oncologic PET Registry (NOPR) for FDG PET or FDG PET/CT. Also these claims will no longer require the elements indicating CED: modifier Q0, condition code 30 or diagnosis V70.7. See MMP July Article "Changes to PET Coverage"for a coverage table by cancer type.

Modifiers PI and PS, indicating initial or subsequent treatment strategy are still required.  The NCD allows coverage of three subsequent treatment strategy PET scans after an initial treatment strategy PET. Coverage of any additional FDG PET scans (that is, beyond three) used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy for the same diagnosis will be determined by the local MACs. Cahaba GBA has indicated that they do not currently have a policy capping the allowed number of FDG PET scans beyond three. They stated that providers should rely on the medical judgment of the clinicians and ensure that documentation clearly supports the need for any additional scans. Providers not within Cahaba’s jurisdiction should check with their local MAC for guidance.

Billing instructions in MLN Matters Article MM8468 explain that:

• a KX modifier is required for subsequent treatment strategy FDG PET scans exceeding three (claims for fourth or more oncologic FDG PET for same diagnosis)
• claims with subsequent treatment strategy (-PS) oncologic FDG PET scans without an initial treatment strategy (-PI) claim present in claims history will be denied (Exception: prostate cancer does not require initial since it is non-covered).
• Alemtuzumab (J9010);

Aprepitant for Chemotherapy Induced Emesis

The final NCD manualized in February concerns aprepitant for chemotherapy induced emesis. Since 2005, Medicare has covered the use of the oral three-drug regimen of aprepitant, a 5HT3 antagonist, and dexamethasone for patients who are receiving certain highly emetogenic chemotherapeutic agents when the antiemetic therapy fully replaces an IV antiemetic. Effective for services on or after May 29, 2013, the following anticancer chemotherapeutic agents have been added to the list of anticancer chemotherapeutic agents for which the use of the oral antiemetic 3-drug combination of oral aprepitant, an oral 5HT3 antagonist, and oral dexamethasone is deemed reasonable and necessary:

• Azacitidine (J9025);
• Bendamustine (J9033);
• Carboplatin (J9045);
• Clofarabine (J9027);
• Cytarabine (J9098, J9100, J9110);
• Daunorubicin (J9150, J9151);
• Idarubicin (J9211);
• Ifosfamide (J9208);
• Irinotecan (J9206); and
• Oxaliplatin (J9263)

MLN Matters Article MM8418 contains all the details including a complete list of all chemotherapeutic agents.

Now the local news – Cahaba did not have any coverage updates this month, while Novitas (both JH and JL) continues to be prolific with new and revised policies and Palmetto has some updates. See the links below for the local coverage updates for your region.

Novitas JH Coverage Updates

February 27, 2014

The following JH MAC LCD has been revised to reflect the Annual CPT/HCPCS Code updates effective for dates of service on and after January 1, 2014 and has also been revised due to a reconsideration request:

Nerve Conduction Studies and Electromyography (L32723)

The following JH MAC LCD has been revised:

Pain Management (L32702)

February 6, 2014

The following JH MAC Local Coverage Determinations (LCDs) have been posted for notice. They will become effective March 27, 2014:

Bariatric Surgical Management of Morbid Obesity (L32619)

Frequency of Dialysis (L32755)

Infrared Photocoagulation (IRC) of Hemorrhoids (L34350)

Intraoperative Neurophysiological Testing (L32605)

Outpatient Sleep Studies (L32711)

Qualitative Drug Testing (L34352)

Surgery: Blepharoplasty (L32715)

Vascular Access for Hemodialysis (L32708)

Wound Care and Cellular and/or Tissue-Based Products for Wounds (CTPs) (L32687) (formerly titled Wound Care and Bioengineered Skin Substitutes)

Comments Received and Contractor Responses

Hemophilia Factor Products (L32735)

The following JH MAC LCDs have been revised to create uniform LCDs with the corresponding Novitas Solutions JL MAC LCDs. The following LCDS will also become effective March 27, 2014:

Cataract Extraction (including Complex Cataract Surgery) (L32690)

Glaucoma Treatment with Aqueous Drainage Device (L32733)

Lacrimal Punctum Plugs (L32607)

Wireless Capsule Endoscopy (L32686)

Novitas JL Coverage Updates

February 27, 2014

The following JL MAC LCD has been revised to reflect the Annual CPT/HCPCS Code updates effective for dates of service on and after January 1, 2014 and has also been revised due to a reconsideration request:

Nerve Conduction Studies and Electromyography (L29547)

February 6, 2014

The following JL MAC Local Coverage Determinations (LCDs) have been posted for notice. They will become effective March 27, 2014:

Cataract Extraction (including Complex Cataract Surgery) (L34344)

Frequency of Dialysis (L34388)

Glaucoma Treatment with Aqueous Drainage Device (L34355)

Intraoperative Neurophysiological Testing (L27499)

Lacrimal Punctum Plugs (L34358)

Outpatient Sleep Studies (L27530)

Surgery: Blepharoplasty (L34396)

Vascular Access for Hemodialysis (L32465)

Wireless Capsule Endoscopy (L34342)

Wound Care and Cellular and/or Tissue-Based Products for Wounds (CTPs) (L27547) (formerly titled Wound Care and Bioengineered Skin Substitutes)

Comments Received and Contractor Responses

Hemophilia Factor Products (L33658)

The following JL MAC LCDs have been revised to create uniform LCDs with the corresponding Novitas Solutions JH MAC LCDs.  The following LCDS will also become effective March 27, 2014:

Bariatric Surgical Management of Morbid Obesity (L34495)

Qualitative Drug Testing (L32050)

Palmetto J11 Coverage Updates

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

 

This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.

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.