Knowledge Base Category -

Some of you may remember the television series Columbo that featured an unkempt cigar-smoking detective in a long beige raincoat. Columbo seemed to ramble on aimlessly when questioning suspects and just as they thought he was finally leaving, he would turn back to them with “just one more thing…” This month CMS added or reminded providers of several “just one more thing” items in relation to existing National Coverage Determinations (NCDs).

TAVR Hospital Program Volume Requirements

Effective May 1, 2012, Medicare covers Transcatheter Aortic Valve Replacement (TAVR) procedures under coverage with evidence development (CED) for the treatment of symptomatic aortic stenosis when:

• Furnished according to a Food and Drug Administration (FDA) approved indication; and
• Certain conditions are met including requirements for individual hospitals in which TAVR procedures are performed.

Hospitals must meet the volume requirements specified in the TAVR national coverage determination (NCD 20.32) in order for the TAVR procedure to be eligible for Medicare coverage. These requirements apply to each hospital site individually and hospitals that do not meet these volume requirements are not eligible for waivers or exceptions.

1. To begin a TAVR program, the hospital (without TAVR experience) must have:
2. ≥ 50 total aortic valve replacements (AVRs) in the previous year prior to TAVR, including ≥ 10 high-risk patients; and
3. ≥ 2 physicians with cardiac surgery privileges; and
4. ≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.
5. To continue a TAVR program, the hospital (with TAVR experience) must maintain:
6. ≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and
7. ≥ 2 physicians with cardiac surgery privileges; and
8. ≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

See MLN Matters Article SE1515 for complete information.

Hepatitis C Virus (HCV) Screening

Effective June 2, 2014, Medicare covers screening for HCV as described below:

1. Once in a lifetime for individuals not at high-risk born from 1945 to 1965.
2. Use HCPCS code G0472
3. Individuals born prior to 1945 and after 1965 that do not have risk factors are not eligible for this screening
4. Once in a lifetime for individuals at high-risk of HCV regardless of birth year. “High risk” is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992.
5. Use HCPCS code G0472
6. ICD-9 diagnosis code V69.8 (ICD-10 code Z72.89) “other problems related to lifestyle” is required
7. Annually for high-risk individuals who have had continued illicit injection drug use since the prior negative screening test.
8. Use HCPCS code G0472
9. Diagnosis codes required - ICD-9 code V69.8 (ICD-10 code Z72.89) AND
10. ICD-9 diagnosis code 304.91 (unspecified drug dependence continuous) (ICD-10 code F19.20)

Rural Health Clinics (RHCs), Federally Qualified Health Centers (FQHCs) and Method II Critical Access Hospitals (CAHs) are not valid facilities for HCV screening services. See MLN Matters Article MM9200 for more information. CPT code 86803, HCV rapid antibody test, is not appropriate for reporting HCV screening – use HCPCS code G0472.

Coverage of MTWA Using Non-SA Methods

Medicare has covered Microvolt T-wave Alternans (MTWA) diagnostic testing for sudden cardiac death (SCD) from ventricular arrhythmias since March 2006 but only when analyzed by spectral analysis (SA) method.

• Effective for claims with dates of service on and after January 13, 2015, CMS removed the national non-coverage of the MMA method and now allows Medicare Administrative Contractors (MACs) to determine coverage at their discretion of MTWA diagnostic testing for the evaluation of patients at risk for SCD using analysis methods other than SA.
• Providers should report CPT 93025 (MTWA for assessment of ventricular arrhythmias) with the –KX modifier to attest that documentation is on file verifying the MTWA was performed using a method of analysis other than SA for the evaluation of patients at risk for SCD from ventricular arrhythmias and that all other NCD criteria were met. (Claims for MTWA using spectral analysis do not require the KX modifier).
• MLN Matters Article MM9162 contains a list of the diagnosis codes approved by CMS – this list may or may not be complete based on the discretion of the MACs.
• The MACs will not automatically adjust previously denied claims based on the new coverage guidelines but providers may bring these to the MAC’s attention within timely filing.

Medicare can be fastidious – picky, particular, specific, precise, even downright finicky in their coding, billing, and documentation requirements. By now, most of us are used to their demands for precision. For example, we are all aware that the units billed must match the dosage, amount, or time specified in the physician’s order. But in the July 2015 OPPS Update, CMS points out an instance related to hyperbaric oxygen treatments (HBO) where this does not hold true.

When a physician orders a 90-minute HBO treatment, he or she expects that the patient will be placed at 100% oxygen for 90 minutes. In billing for HBO treatments, providers are allowed to include not only the time at 100% oxygen but also the time for descent, air breaks, and ascent. In that case, the units billed for HBO will be greater than the units equivalent to the 90 minutes specified in the order.

Effective January 1, 2015, CMS discontinued the old code that had been used to report HBO for years (C1300) and replaced it with new HCPCS code G0277 which has the same description as the old code - Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval. Here are the key points to keep in mind when billing G0277 for HBO services:

• The total number of billable 30-minute intervals would not be based solely on the amount of time noted on the physician order.
• The total number of 30-minute intervals billable under G0277 should be calculated by including:
• Time spent by the patient under 100% oxygen,
• Time for descent,
• Time for air breaks, and
• Time for ascent.
• You must go at least 16 minutes into the next 30-minute interval in order to bill an additional unit. For example:
• 46-75 minutes = 2 units
• 76-105 minutes = 3 units
• 106-135 minutes = 4 units
• HBO is typically prescribed for an average of 90 minutes (at 100% oxygen)
• A common scenario to fulfill an HBO order for 90 minutes of treatment would be 90 minutes of therapeutic HBO, 10 minutes descent, 10 minutes air breaks and 10 minutes ascent for a total of 120 minutes which would equal 4 units of G0277.
• In general, CMS does not expect that a physician order for 90 minutes of HBO therapy would exceed 4 billed units of HCPCS code G0277.

And one more thing Medicare is picky about is their coverage requirements. In addition to getting the correct units on the claim, providers need to be sure the patient qualifies for HBO services in accordance with Medicare’s National Coverage Determination and any Local Coverage Determinations or Articles. The NCD for Hyperbaric Oxygen Therapy (20.29) includes a long list of covered conditions and an even longer list of non-covered indications. HBO is used as an adjunctive treatment and /or after conventional therapy has failed for a number of the covered conditions so review the policy carefully. Be sure that documentation in your medical record provides the details of any conservative or standard treatments in order to support the use of HBO as an adjunctive therapy.

HBO covered conditions include:

1. Acute carbon monoxide intoxication,
2. Decompression illness,
3. Gas embolism,
4. Gas gangrene,
5. Acute traumatic peripheral ischemia. HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened.
6. Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened.
7. Progressive necrotizing infections (necrotizing fasciitis),
8. Acute peripheral arterial insufficiency,
9. Preparation and preservation of compromised skin grafts (not for primary management of wounds),
10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management,
11. Osteoradionecrosis as an adjunct to conventional treatment,
12. Soft tissue radionecrosis as an adjunct to conventional treatment,
13. Cyanide poisoning,
14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment,
15. Diabetic wounds of the lower extremities in patients who meet the following three criteria:
16. Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
17. Patient has a wound classified as Wagner grade III or higher; and
18. Patient has failed an adequate course of standard wound therapy.

A 2014 review of HBO claims by Medicare’s Supplemental Medical Review Contractor revealed an error rate of 58%. Although over half of the denials were for lack of response to the document request, other medically reviewed claims lacked documentation in the submitted medical records to support the HBO services as medically reasonable and necessary. The documentation did not include:

• Specific timelines and goals for therapy. For example, the documentation simply stated “continue HBO” or “until healed”
• Radiology and pathology reports confirming diagnosis such as osteomyelitis or gas gangrene
• Monitoring for improvement or lack of improvement

In addition, when documentation was provided, descriptions of diabetic wounds did not meet Wagner Criteria for Grade three (III) or four (IV) wounds and therapy was provided beyond the 30 days allowed under Medicare coverage guidelines.

So before you bill for HBO make sure your patients meet the criteria for coverage and that you correctly calculate the number of units to report. If not, picky Medicare may decide to “pick” on you!

In 1735, Benjamin Franklin noted that “an ounce of prevention is worth a pound of cure.” Although Franklin was actually addressing fire safety, this axiom is also true in reference to health. The Centers for Disease Control (CDC) in an article about the National Prevention Strategy states that “Increasing the focus on prevention in our communities will help improve America's health, quality of life and prosperity.” And in the long run, prevention reduces health care costs for patients, providers, and insurers. So it is not surprising that CMS is continuing to expand Medicare preventive and screening services.

On April 13, 2015, CMS released a Final Decision Memorandum expanding the coverage of HIV Screening for Medicare beneficiaries. Medicare has offered coverage of HIV screening since December 2008, but only covered the screening for individuals with certain high-risk factors or during pregnancy. This latest decision memo expands coverage to an annual screening for all Medicare beneficiaries between the ages of 15-65.

The complete list of covered conditions for HIV screening includes:

• A maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk;
• A maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection. Increased risk for HIV infection is defined as follows:
• Men who have sex with men
• Men and women having unprotected vaginal or anal intercourse
• Past or present injection drug users
• Men and women who exchange sex for money or drugs, or have sex partners who do
• Individuals whose past or present sex partners were HIV-infected, bisexual or injection drug users
• Persons who have acquired or request testing for other sexually transmitted infectious diseases
• Persons with a history of blood transfusions between 1978 and 1985
• Persons who request an HIV test despite reporting no individual risk factors
• Persons with new sexual partners
• Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection.
• A maximum of three, voluntary HIV screenings of pregnant Medicare beneficiaries: (1) when the diagnosis of pregnancy is known, (2) during the third trimester, and (3) at labor, if ordered by the woman’s clinician.

In addition to the list of covered conditions, testing for HIV screening must also meet the following requirements.

• An FDA approved laboratory test or point of care test
• Testing in accordance with FDA approved labeling and compliant with CLIA regulations
• Ordered by the patient’s physician or practitioner within the context of a healthcare setting
• Performed by an eligible Medicare provider or supplier for these services

Remember that Medicare Administrative Contractors’ (MACs) claims processing systems may not yet be ready to accept claims under the new coverage conditions. Within a few months, Medicare will publish a transmittal updating the National Coverage Determination Manual and claims processing instructions if needed, with an effective date by which MACs should be prepared to accept claims under the new guidelines.

In related news, Medicare released a proposed decision memorandum on April 16, 2015 that proposes the coverage of Human Papillomavirus (HPV) testing for screening for cervical cancer. The memo recommends HPV testing once every five years for asymptomatic beneficiaries aged 30 to 65 in conjunction with the Pap smear test. CMS is currently accepting comments on this proposal and will respond to public comments in a final decision memorandum.

Moving healthcare towards a focus on prevention will hopefully improve the physical and financial health of America. Unfortunately today, the US spends more per capita on healthcare than many other nations, but does not have better health outcomes to show for it. Maybe this “ounce of prevention” will bring forth that “pound of cure.”

I love my cats – sometimes… If there was ever an animal with a mind of its own, it is a cat. One minute they are kind and loving and the next they don’t want to be held or even touched (and watch out –some even bite). It is also impossible to direct their activity, thus the expression about herding cats. Sometimes dealing with Medicare and all their coverage policies is as hard as herding cats.

Remember LMRP’s? I had just started in Corporate Compliance when hospital representatives from around our state met to discuss the big concern – our Medicare Fiscal Intermediary (FI) would deny CT scans and other tests if they did not contain a diagnosis that supported “medical necessity” based on the new Local Medical Review Policies (LMRPs). There have been a lot of transitions since that time – no more FIs – they are now known as Medicare Administrative Contractors (MACs) and LMRPs are now LCDs (Local Coverage Determinations). There has also been a shift in the focus of “medical necessity.” There are more LCDs than ever, but a recent focus on procedures instead of simply diagnostic tests. For example, this month Cahaba finalized the draft policy for lumbar spinal fusion.

When medical necessity was simply a matter of checking for an appropriate diagnosis, the process was simpler. Providers could install upfront edits to check against the approved diagnoses lists. Today, as policies contain more coverage indications and limitations, meeting the coverage guidelines is a bigger challenge.

So what should hospitals do to ensure they are meeting Medicare’s coverage guidelines? Here are some suggestions to assist you in meeting this challenge.

• Be familiar with the different coverage policies – LCDs and National Coverage Determinations (NCDs). That is the reason we at MMP do a monthly article addressing coverage guidelines and listing new and retired policies of the MACs within our clients’ regions. For an idea of the scope of coverage policies:
• There are 338 NCDs
• There are 2773 LCDs overall
• Cahaba GBA (JJ MAC) has 64 active Part A LCDs
• First Coast (JN MAC) has 171 active LCDs (Part A and B)
• Novitas (JH MAC) has 84 active LCDs (A and B)
• Novitas (JL MAC) has 83 active LCDs (A and B)
• Palmetto (J-11 MAC) has 48 active Part A LCDs

To access a comprehensive list of the policies, use the Indexes tab on the Medicare Coverage Database website. Read the policies carefully – some still contain lists of covered diagnoses, but also remember that all indications and limitations within the policies must be considered.

• Policies that contain list of “covered” diagnoses are still adjudicated with automatic edits.
• For these, front end systems that identify the covered diagnoses are helpful – they allow a provider to request additional diagnostic information from the ordering physician prior to submitting a claim or obtain an Advance Beneficiary Notice (ABN) from the patient.
• Reviewing your Medicare denials by Claim Adjustment Reason Code (CARC) will identify those services that deny for lack of medical necessity. CARC 50 indicates “These are non-covered services because this is not deemed a ''medical necessity'' by the payer. Example: A diagnosis code was not submitted to support medical necessity based on Medicare's criteria.” Knowing the volume and financial impact of your medical necessity denials will help you determine which issues you need to address.
• Evaluate coverage policies for services your facility offers that are “at risk.” You will want to consider the volume of the services you offer, the reimbursement amounts for these services, and the conditions of the policy. For example, if your facility performs implantation of Automatic Implantable Cardiac Defibrillators, the reimbursement is significant and the requirements are detailed. Also, there has been a lot of review activity of these services by government agencies, such as the Department of Justice, which brings us to our next suggestion –
• Monitor review activity of Medicare contractors and affiliates. MACs are now required to post their planned pre- and post-payment reviews and the findings from these reviews. Recovery Auditors and the Supplemental Medicare Review Contractor also post their planned reviews on their websites. The Office of Inspector General (OIG) has an annual Work Plan of their planned review activities, publishes reports of their reviews, and posts enforcement actions. Medicare has a Quarterly Compliance Newsletter, Medicare Compliance Fast Facts and many other educational resources that target at risk areas. Also numerous newsletters from consultants, list-serves, etc. are available – for example, we hope you find our weekly newsletter helpful in identifying issues that you need to address.
• Have a robust process to address Additional Documentation Requests (ADRs) and monitor denial reasons. Sometimes this involves tracking the ADR outcome through FISS but the information is often worth the effort.

As you can see, there is a lot of information available to help providers ensure their services pass Medicare’s medical necessity criteria, but as you can also see, it will take some time and effort to sort it all out, develop plans, and take actions to ensure compliance. No one promised it would be easy – in fact, it is as hard as herding cats!

See the table below for recent Coverage Policy updates. Also a reminder that the Medicare Probe and Educate program that is examining providers’ compliance with the inpatient admission two-midnight rule will continue through April 30, 2015. There is pending legislation in Congress to address a number of expiring provisions, including the Probe and Educate program.

I love making lists – all sorts of lists: daily to-do’s, grocery lists, my favorite songs/books, long-term goals, etc. There is something satisfying about organizing things into a list format. For those fellow list-lovers out there, the long-awaited instructions on billing of pacemakers to Medicare should be right up your alley. There are lists of covered conditions, non-covered conditions, HCPCS codes, CPT codes, ICD-9 procedure codes, covered diagnosis codes, and sometimes allowed diagnosis codes.

Medicare has finally issued the manual guidance concerning the new guidelines for coverage of single chamber and dual chamber permanent cardiac pacemakers. Under the new guidelines, effective for dates of service on and after August 13, 2013, Medicare covers implanted permanent single chamber or dual chamber cardiac pacemakers for:

1. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction.
2. Documented non-reversible symptomatic bradycardia due to second degree 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 list of conditions for which implanted cardiac pacemakers are not covered is much longer than the list of covered indications. Diagnosis codes for a few of the non-covered indications (exceptions) may be accepted on claims that also contain a covered diagnosis for the bradycardia. The non-covered conditions include:

1. Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia.
2. Asymptomatic first degree atrioventricular block. *(exception)
3. Asymptomatic sinus bradycardia.
4. Asymptomatic sino-atrial block or asymptomatic sinus arrest. *(exception)
5. Ineffective atrial contractions (for example, chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia. *(exception)
6. Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle (a component of the electrical conduction system of the heart).
7. Syncope of undetermined cause. *(exception)
8. Bradycardia during sleep.
9. Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block. *(exception)
10. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy.
11. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia. *(exception)
12. A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged.

Hospital Claim Requirements

For outpatient claims, implantable cardiac pacemakers are reported with the following -

Pacemaker device HCPCS Codes

• C1785 – Pacemaker, dual chamber, rate-responsive (implantable);
• C1786 – Pacemaker, single chamber, rate-responsive (implantable);
• C2619 – Pacemaker, dual chamber, nonrate-responsive (implantable);
• C2620 – Pacemaker, single chamber, nonrate-responsive (implantable);

CPT Procedure Codes

• 33206 – Insertion or replacement of permanent pacemaker with transvenous electrode(s) – atrial
• 33207 – Insertion or replacement of permanent pacemaker with transvenous electrode(s) –ventricular
• 33208 – Insertion or replacement of permanent pacemaker with transvenous electrode(s) – atrial and ventricular

A –KX modifier must be appended to the procedure claim line(s) to attest that documentation is on file verifying the patient has non-reversible symptomatic bradycardia, with symptoms such as syncope, seizures, congestive heart failure, dizziness, or confusion. Claims with one of the above listed pacemaker insertion CPT codes without the KX modifier will be returned to the provider.

Report pacemaker insertion procedures on a hospital inpatient claim with one of the following procedure codes:

• 37.81 Initial insertion of single chamber device, not specified as rate responsive
• 37.82 Initial insertion of single chamber device, rate responsive
• 37.83 Initial insertion of single chamber device

Both inpatient and outpatient claims require one of the following diagnosis codes for the services to be covered by Medicare:

• 426.0 Atrioventricular block, complete (I44.2)
• 426.12 Mobitz (type) II atrioventricular block (I44.1)
• 426.13 Other second degree atrioventricular block (I44.1)
• 427.81 Sinoatrial node dysfunction (I49.5)
• 746.86 Congenital heart block (Q24.6)

There are diagnoses from the “non-covered” indications (exceptions) that the Medicare Administrative Contractors may decide to accept on claims, but only when reported with one of the above “covered” diagnosis codes. The claim must contain one of the covered diagnosis codes in addition to one of the following diagnosis codes. Also note, this coverage is at the discretion of the MAC. One more note - after ICD-10 implementation, the presence of code R55 (syncope and collapse) will result in denial. These codes are:

• 426.10 Atrioventricular block, unspecified/ I44.30 Unspecified atrioventricular block;
• 426.11 First degree atrioventricular block/ I44.0 Atrioventricular block first degree;
• 426.4 Right bundle branch block/ I45.10 Unspecified right bundle-branch block/ I45.19 Other right bundle-branch block;
• 427.0 Paroxysmal supraventricular tachycardia/ I47.1 Supraventricular tachycardia;
• 427.31 Atrial fibrillation/ I48.1 Persistent atrial fibrillation/ I48.91, Unspecified atrial fibrillation;
• 427.32 Atrial flutter/ I48.3 Typical atrial flutter/ I48.4 Atypical atrial flutter or I48.91 Unspecified atrial fibrillation; or
• 780.2 Syncope and collapse/R55 Syncope and collapse (R55 is the ICD-10 dx code but is not payable upon implementation of ICD-10 and is only included here for information purposes). 

For additional information, please refer to the MLN Matters Article MM9078, Transmittal R3204CP, and Transmittal R179NCD. This includes instructions on professional billing, listing of I-10 procedure codes, and coverage not addressed by the NCD that is left to the discretion of the Medicare Administrative Contractors.

Now you have Medicare’s lists… When hospitals implement these instructions, they will want to have a checklist of their own to make sure they have addressed all the requirements for coverage.

Other recent coverage updates include:

Can you sometimes tell by the tone of someone’s voice or the way they drag out the words, that there is a condition to their answer? “Well, nooo…” You just know the conjunction “but” is coming. Medicare generally communicates with providers in writing, but experience tells us there is often a condition to Medicare’s answers.

A few years ago there was a lot of discussion in Medicare billing circles about whether a physician’s signature is required on a laboratory requisition. And in typical Medicare fashion, the answer was a clear, “No…, but…” The “but” being that although the signature of the ordering physician is not required on the requisition, there has to be an order or documentation of intent to order the lab tests that is signed by the physician. This documentation can be located in the physician’s office chart, but needs to be submitted to the Medicare contractor in the case of a medical review of the claim. And the provider being reviewed (i.e. the testing lab), whose payment is at risk, is the one ultimately responsible for submitting the supporting documentation.

With all the reminders of these requirements that circulated back then, surely most hospital-based and independent laboratories understood what was expected. Therefore, I was a bit surprised to see an announcement back in December concerning a significant increase in pathology and laboratory service errors identified by data analysis of the Comprehensive Error Rate Testing (CERT) program findings. In response to the increase in errors, CERT published a document addressing the lab and pathology errors.

CERT identifies insufficient documentation and incorrect coding as the reasons for the significant errors, but the main issue addressed in the publication is missing or incomplete documentation.

“If a physician’s order for a diagnostic test is not included in the medical record, the physician must document the intent to order the laboratory service.” This documentation must state the specific tests the physician is ordering. Simply stating “ordering lab” is not sufficient. Also the documentation of intent must be signed by the physician or there must be a signed physician’s order for the lab tests. A signed order or signed documentation of intent to order must be sent to the Medicare contractor reviewing the record to support the services billed. Without this documentation, the claim will be denied.

“Documentation must support the medical necessity for the services performed.” Per the Medicare Claims Processing Manual, Chapter 16 , section 120.1 – “Diagnoses are required on all claims” and such diagnostic information must be supplied to the performing laboratory by the ordering physician. There are twenty-three National Coverage Determinations (NCDs) for lab services and individual Medicare Administrative Contractors (MACs) often have Local Coverage Determinations (LCDs) for other lab services. Both the NCDs and LCDs require certain diagnoses to support the medical necessity of the lab tests; additional indications and documentation may also be required by the coverage policies. Two examples of required lab documentation from the CERT document include:

• Blood Glucose - The ordering physician must include evidence in the patient’s clinical record that an evaluation of history and physical preceded the ordering of glucose testing and that manifestations of abnormal glucose levels were present to warrant the testing.
• Thyroid Function tests - When thyroid function tests are billed at a greater frequency than the norm (two per year), the ordering physician’s documentation must support the medical necessity of this frequency.

One more requirement – signatures must meet the Medicare signature guidelines as described in the Medicare Program Integrity Manual, Chapter 3, section 3.3.2.4.

In summary, if the CERT contractor reviews your laboratory claims, be sure to:

1. Respond timely to the CERT medical record request
2. Providers have 75 days to submit requested records
3. CERT will accept late documentation
4. Include all necessary documentation
5. A signed order or documentation of intent to order labs signed by the ordering physician
6. Signatures must meet Medicare signature requirements
7. Documentation to support the medical necessity of the services
8. Lab results/reports
9. Appeal unfavorable decisions to your local MAC
10. Include additional supporting documentation

That “no signature” thing comes with a huge conditional “but”!

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.

On January 26th, Health and Human Services Secretary Sylvia M. Burwell “announced measurable goals and a timeline to move the Medicare program, and the health care system at large, toward paying providers based on the quality, rather than the quantity of care they give patients.” According to the CMS Press Release, “this is the first time in the history of the Medicare program that HHS has set explicit goals for alternative payment models and value-based payments.”

This call to action by Secretary Burwell brings to mind the Institute for Health Improvement’s (IHI) Plan-Do-Study-Act (PDSA) cycle that involves planning a test or observation, trying out the test on a small scale, analyzing data and studying the results and finally, refining the change based on what was learned.

Plan-Do-Study

Long before the Affordable Care Act, it was obvious that the current state of healthcare in the United States was more reactive than proactive and that the current Prospective Payment System was not financially sustainable.

In a related Fact Sheet to the January 26th announcement, CMS indicated that “the Affordable Care Act offers many tools to improve the way providers are paid to reward for quality and value instead of quantity, to strengthen care delivery by better integrating and coordinating care for patients, and to make information more readily available to consumer and providers. Doing so will improve coordination and integration of health care, engage patients more deeply in decision-making and improve the health of patients – with a priority on prevention and wellness.”

While not an all-inclusive list, specific examples of progress attributed to the Affordable Care Act by CMS include:

• Years 2011, 2012 and 2013 saw the slowest growth in real per capita national healthcare expenditures on record in part due to slow growth in per-beneficiary spending across Medicare, Medicaid, and the private insurance beneficiary population.
• “Looking forward, due primarily to the persistent slowdown in health care costs, the Congressional Budget Office now estimated that Federal spending on Medicare and Medicaid in 2020 will be $188 billion below what it projected as recently as August 2010.”
• The Partnership for Patients has been instrumental in “patient harm falling by 17%, saving 50,000 lives and billions of dollars.”
• The Affordable Care Act tied Medicare payment for hospitals to readmission rates. Since 2012 the efforts made by hospitals “translates into an 8 percent reduction in the rate and an estimated 150,000 fewer hospital readmissions among Medicare beneficiaries between January 2012 and December 2013.”
• Providers are engaged as evidenced by the fact that currently “there are 424 organizations currently participating in Medicare ACOs, serving over 7.8 million Medicare beneficiaries” and the “ACOs participating in the Shared Savings Program and the Pioneer ACO Model combined generated over $417 million in savings for Medicare.”
• The three mandated quality programs for hospitals (Hospital Value-Based Purchasing Program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program) reward hospitals for the quality of care they provide to patients.
• Improvement in the availability of information to guide the beneficiary in their decision-making has been made available through Physician Compare, updates to Hospital Compare, and the May 2013 release of Charge Data for Hospital and Physician Services by CMS.

Act

Again, Secretary Burwell made the HHS call to action by setting explicit alternative payment model goals and value based payment goals to “help drive the health care system towards greater value-based purchasing – rather than continuing to reward volume regardless of quality of care delivered.”

Alternative Payment Models Goal

By the end of 2016 have 30 percent of Medicare payments in alternative payment models.

By the end of 2018 have 50 percent of Medicare payments in alternative payment models.

The Medicare Shared Savings Program (MSSP) and Pioneer Accountable Care Organizations (ACOs), the Bundled Payment for Care Initiative, and the Comprehensive Primary Care Initiative are examples of current Alternative Payment Models. “HHS is working with private payers, including health plans in the Health Insurance Marketplace and Medicare Advantage plans, as well as state Medicaid programs to move in the same direction toward alternative payment models and value-based payment to providers and to meet or exceed the goals outlined above wherever possible.”

Value Based Payments Goal

By 2016 have 85 percent of Medicare fee-for-service payments tied to quality of value.

By 2018 have 90 percent of Medicare fee-for-service payments tied to quality of value.

The Hospital Value Based Purchasing Program, Hospital Readmission Reduction Program and the Hospital-Acquired Condition Program are the three Affordable Care Act Mandated Quality Programs that have begun to tie a hospitals payment to quality of value.

How to Reach the Goals

Secretary Burwell also announced the creation of a Health Care Payment Learning and Action Network. This Network “will accelerate the transition to more advanced payment models by fostering collaboration between HHS, private payers, large employers, providers, consumers, and state and federal partners. Working together, Learning and Action Network partners will:

• Serve as a convening body to facilitate joint implementation and expansion of new models of payment and care delivery
• Identify areas of agreement around movement toward alternative payment models and define how best to report on these new payment models
• Collaborate to generate evidence, share approaches, and remove barriers
• Develop common approaches to core issues such as beneficiary attribution, financial models, benchmarking, and risk adjustment
• Create implementation guides for payers and purchasers

Alignment between HHS, private sector payers, employers, providers, and consumers will help health care payments transition more quickly from pure fee-for-service to alternative payment models – a critical step toward better care, smarter spending, and healthier people.” The first Network meeting is set for March 2015.

As health care in this country is propelled towards new payment models and payment for quality instead of quantity, there are a couple of valuable resources that hospitals should be familiar with.

First is the CMS Innovation Center. Per the Affordable Care Act, “the purpose of the [Center] is to test innovative payment and service delivery models to reduce program expenditures…while preserving or enhancing the quality of care furnished to individuals under such titles.” I encourage you to visit their website to find out where and what Innovation is Happening in your state and while there check out the November 10, 2014 CMS Innovation Center Update Webinar that featured Dr. Patrick Conway, CMS Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer.

A second resource is the Health Care Transformation Task Force. On January 28, 2015, just two days after the CMS announcement, this group “whose members include six of the nation’s top 15 health systems and four of the top 25 health insurers, challenged other providers and payers to join its commitment to put 75 percent of their business into value-based arrangements that focus on the Triple Aim of better health, better care and lower costs by 2020.”

Resources:

Fact Sheet: Better Care, Smarter Spending, Healthier People: Why It Matters: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-2.html

Fact Sheet: Better Care, Smarter Spending, Healthier People: Paying Providers for Value, Not Volume: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html

Fact Sheet: Better Care, Smarter Spending, Healthier People: Improving Out Health Care Delivery System: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26.html 

American Hospital Association Response to January 26th Announcement:

http://www.aha.org/presscenter/pressrel/2015/150126-pr-medicare.shtml

American Medical Association Response to January 26th Announcement: http://www.ama-assn.org/ama/pub/news/news/2015/2015-01-26-hhs-shifting-medicare-reimbursements-volume-value.page

Yes, it is true that in this age of electronic health records (EHRs) that most Physician notes are no longer written with a pen. However, in the January 2015 release of the Medicare Quarterly Compliance Newsletter, there are two Comprehensive Error Rate Testing (CERT) review findings that share the denial commonality of “the physician’s failure to document a reasonable expectation that the beneficiary would require a hospital stay that would cross 2 or more midnights.” So hand written or electronic, it is a fact that the denials were due to the Physician’s pen.

First, for those that may still be unfamiliar with this newsletter, it is a resource provided by the CMS to serve as an “educational product, to help providers understand the major findings identified by MACs, Recovery Auditors, Program Safety Contractors, Zone Program Integrity Contractors, the Comprehensive Error Rate Testing (CERT) review contractor and other governmental organizations, such as the Office of Inspector General.” If you are interested in viewing past issues, the CMS maintains a Newsletter Archive of all of the newsletters to date.

The January edition of the newsletter includes findings from the Office of Inspector General (OIG), Recovery Auditor and CERT. This article focuses on two of the CERT findings.

Surgical Procedures Related to Hemodialysis being billed as an Inpatient
Provider Types Affected: Physicians and Hospitals

Background

Placement of an arteriovenous fistula (AVF) is the best option for beneficiaries requiring hemodialysis for end-stage renal disease (ESRD). The procedure is typically an outpatient procedure. “Inpatient hospital admission is appropriate when the beneficiary has some other acute problem requiring inpatient care or when a serious post-operative complication arises.”

Medicare payment to a hospital for surgical procedures includes the procedure itself and all normal post-op recovery and monitoring even if the monitoring extends overnight. Also, hemodialysis and a beneficiary’s need for chronic hemodialysis “does not justify an inpatient hospital admission for a vascular access-related procedure.”

Review Finding

Most improper payments identified by the CERT were due to the hospital inappropriately billing Medicare for the surgery and post-op care as an inpatient hospital admission.

Denial due to the Physician’s Pen

The CERT asserted that the most common denial for an inpatient hospitalization spanning less than 2 midnights “is the physician’s failure to document a reasonable expectation that the beneficiary would require a hospital stay that would cross 2 or more midnights.”

What You Should Know

“Physicians do not need to include a separate attestation of the expected length of stay; rather, this information may be inferred from the physician’s standard medical documentation, such as his or her plan of care, treatment orders, and physician’s notes. Expectation of time and the determination of the underlying need for medical care at the hospital are supported by complex medical factors such as history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event, which are expected to be documented in the physician’s assessment and plan of care.”

The 2 Midnight Rule and Elective Procedures
Provider Types Affected: Physicians Facilities and Hospitals

Background

The 2014 IPPS Final Rule (CMS-1599-F) 2-Midnight Rule provision maintains that an inpatient admission and payment under Medicare Part A is generally appropriate when the physician:

1. “Expects the beneficiary to require a stay that crossed at least two midnights; and
2. Admits the beneficiary to the hospital based upon that expectation.”

Medicare Administrative Contractors (MACs) have been performing reviews under the Probe and Educate Program that began with admissions on or after October 1, 2013 and is currently set to end on March 31, 2015.

This review focuses on the review findings “as they pertain to admissions for elective procedures.”

Exception to the 2 Midnight Rule and Unforeseen Circumstances

When the Expected Length of Stay was Less Than 2 Midnights

It would not be appropriate to admit a beneficiary as an inpatient when they present for an elective surgical procedure that is not designated as Inpatient Only by Medicare and the physician does not expect to keep the patient in the hospital beyond 2 midnights.

Contractors will deny this type of claim unless there is documentation in the record of an approved exception. Currently the only approved exception is “newly initiated mechanical ventilation (excluding anticipated intubations related to minor surgical procedures or other treatment).”

When the Expected Length of Stay was 2 or More Midnights

There are times when a physician expects a beneficiary to require a 2 midnight or longer hospitalization but due to unforeseen circumstance the stay is less than 2 midnights. CMS approved examples of unforeseen circumstances includes “unexpected death, transfer to another hospital, departure against medical advice, clinical improvement, and election of hospice care in lieu of continued treatment in the hospital.”

Denial due to the Physician’s Pen

The CERT again asserted in this review that the most common denial for an inpatient hospitalization spanning less than 2 midnights “is the physician’s failure to document a reasonable expectation that the beneficiary would require a hospital stay that would cross 2 or more midnights.”

Two examples of Medicare Part A Inpatient Denied Claims provided in this review include a vascular procedure where the documentation did not support the inpatient admission and a urologic procedure where there was no inpatient order and the documentation did not support a 2 midnight expectation.

What You Should Know

Just as in the first CERT review findings, this article asserts that what you should know is that “Physicians do not need to include a separate attestation of the expected length of stay; rather, this information may be inferred from the physician’s standard medical documentation, such as his or her plan of care, treatment orders, and physician’s notes. Expectation of time and the determination of the underlying need for medical care at the hospital are supported by complex medical factors such as history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event, which are expected to be documented in the physician’s assessment and plan of care.”

I encourage you to take the time to read this entire newsletter as it provides the issues, what you should know as well as valuable links to resources to find more information about each review type.

The human race continues to make amazing strides in technology that are wondrous and change the very ways we live and even how long we may live. There are devices that monitor how many steps we take in a day, that allow us to control our home electrical systems from our smart phones and that track our “global positioning” wherever we go. And in the medical realm, there is a new FDA-approved device to clip mitral valve leaflets together and potentially prevent the heart failure that could result from mitral regurgitation. This device is inserted via a Transcatheter Mitral Valve Repair (TMVR) procedure.

A National Coverage Determination (NCD) for coverage of TMVR was announced in MLN Matters Article MM9002 effective for dates of service on and after August 7, 2014. Medicare will cover TMVR for treatment of Mitral Regurgitation (MR) when furnished under Coverage with Evidence Development (CED). This means that patients receiving this procedure must be entered into a national qualified registry or part of a FDA-approved, randomized clinical trial.

Some of the requirements for coverage of TMVR for mitral regurgitation include:

• The TMVR procedure must be performed by an interventional cardiologist and/or cardiac surgeon
• For treatment of significant, symptomatic, degenerative mitral regurgitation for FDA-approved indication or for non-listed indications for MR within context of approved clinical trial
• Face-to-face examination and evaluation of patient prior to TMVR by cardiac surgeon and cardiologist experienced in mitral valve surgery with documentation of their decision and rationale
• Performed in a hospital with appropriate infrastructure and with a surgical program, interventional cardiology program, and heart team that meets certain specific requirements. There are numerous and very detailed requirements that the hospital must meet – refer to the NCD for the specifics of these requirements.

TMVR is non-covered for the treatment of MR when not furnished under CED according to the NCD criteria. TMVR used for the treatment of any non-MR indications are non-covered by Medicare.

Hospital Claim Requirements

This is an inpatient-only procedure. Hospital inpatient claims (11x type of bill) must contain:

• ICD-9 Procedure Code - 35.97 - Percutaneous mitral valve repair with implant
• ICD-9 Diagnosis Code for TMVR for MR Claims is - 424.0 – Mitral valve disorder
• Secondary ICD-9 diagnosis code V70.7
• Condition Code 30
• An 8-digit National Clinical Trial Number

For complete information, including instructions for physician claims, see the MLN Matters article referenced above.

This month’s coverage updates include a number of retired LCDs from the MACs within our client regions and Palmetto finalized the LCD on Wound Debridements. Please refer to our coverage article from July 2014 for more information about the various wound care/debridement local coverage policies.

Having undergone back surgery at the age of twenty-seven, I would tell you that yes I needed that back surgery. Whether or not my chart demonstrated that need or not, who knows. That was then and this is now and in the current Medical Review Contractor environment, if the documentation in a medical record does not support the medical necessity of the procedure, claims submitted by hospitals and in some instances the surgeon can and are being denied.

There are countless types of back surgeries but for this article the focus is on documentation required to support the medical necessity of lumbar spinal fusions that code to DRGs 459 (Spinal Fusion Except Cervical with Major Co-morbidity or Complication) and DRG 460 (Spinal Fusion Except Cervical without Major Co-Morbidity or Complication).

Who is Looking?

The CMS Inpatient Hospital Reviews webpage indicates that despite the current Medicare Administrative Contractor (MAC) Probe & Educate Program, “MACs, Recovery Auditors and the Supplemental Medical Review Contractors will continue other types of inpatient hospital reviews” including “reviews for the medical necessity of a surgical procedure provided to a hospitalized beneficiary.”

MACs

Jurisdiction-N (J-N): First Coast Services Options, Inc.

First Coast is the MAC for Florida and in the absence of a National Coverage Determination (NCD) they were the first and to date the only MAC to have a Local Coverage Determination (LCD) for Spinal Fusions. LCD L32074: Lumber Spinal Fusion for Instability and Degenerative Disc Conditions had an original effective date for services performed on or after October 16, 2011.

Key LCD Guidance

• It is “when conservative therapy (non-surgical medical management) is unsuccessful after at least 3 to 12 months, depending on the diagnosis, lumbar spinal fusion may be considered for certain conditions.”
• “The hospital records are the primary source of information for the audit of hospital/procedure services. Therefore, any historical data supporting the medical necessity of the fusion (for example, duration and outcome of physiotherapy, injection therapy, anatomic factors influencing the decision for surgery, etc.) must be included in the inpatient medical record as noted in the history and physical examination, operative note and/or copies of office notes. For example, fusion of iatrogenic instability (i.e., surgical resection of facet as essential portion of the required decompression rendering an unstable segment) should be documented in a pre-operative note and/or an operative note.”
• “To meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives & the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition). Lacking compelling arguments for an exception in the supporting documentation, the hospital (FISS claim) and physician services (MCS claim) can be denied.”
• Physician documentation must support the need for surgery and “must include the following:
• Office notes/hospital record, including history and physical by the attending/treating physician
• Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management) when applicable. Failure of non-surgical medical management can be historical and does not have to be under the direction of the operating surgeon.
• Interpretation and reports for X-rays, MRI’s, CT’s, etc.,
• Medical clearance reports (as applicable)
• Documentation of smoking history, and that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted (if applicable)
• Complete operative report outlining operative approach used and all the components of the spine surgery

Medical record documentation must be made available to Medicare upon request. When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.”

Jurisdiction-11 (J-11) Palmetto GBA

Palmetto, the MAC for North Carolina, South Carolina, Virginia and West Virginia posted the YouTube Presentation Clinical Updates: DRG 459, 406earlier this year on August 11th. The most common reason cited by Palmetto for denials was a lack of information in the medical record about the conservative care provided prior to the surgical intervention.

Palmetto goes on to list documentation examples of conservative treatment that when clearly documented may help support payment for spinal fusion-related hospital care. Physical therapy, joint injections, neurologic deficits and upper and lower extremity strength are just a few of the examples provided.

Cahaba GBA, the MAC for Alabama, Georgia and Tennessee, has on more than one occasion indicated that simply documenting “failed outpatient therapy” for a total joint replacement is not sufficient to support the surgery. Similarly, Palmetto notes in this presentation that “failed outpatient therapy, admit for spinal fusion” is not sufficient evidence of Medical Necessity for a spinal fusion.

Supplemental Medicare Review Contractor (SMRC)

Transmittal 508 had an Effective and Implementation date of April 8, 2014 and added the Supplemental Medicare Review Contractor (SMRC) to the already long list of “Review Contractors” (MACs, CERT, RAC, PSCs, and ZPICs) performing medical review activities.

Strategic Health Solutions, LLC was awarded the SMRC Contract and they have been busy this year fulfilling one of their primary tasks of “conducting medical review based on the analysis of national claims data versus data that is limited to a specific jurisdiction as performed by Medicare Administrative Contractors (MACs).”

One such Project was a review of Medicare Part A Inpatient Services for Spinal Fusions. As part of the Project Background they noted that “analysis of Medicare claims data for calendar years 2012 and 2013 indicated a significant increase in billing and payment in Inpatient Hospitals Stays of Diagnosis-Related Group (DRG) Codes 459 (Spinal Fusion, except cervical spine, with major complications or comorbidities) and 460 (Spinal Fusion, except cervical spine, without major complications or comorbidities).”

The purpose of this project was to determine if claims had been appropriately adjudicated according to Medicare regulations and guidelines. At the end of the project 986 claims had been reviewed. Of those claims 589 were denied due to no response from the hospital and 374 claims were denied after review with a resultant overall Error Rate of 49%.

Project findings also included Specific Denial Reasons and Ways to Prevent Denials.

Denial Reasons

• Providers not responding to Additional Documentation Request (ADR) within the 45 day time frame
• Lack of documentation supporting the medical necessity of the procedure.
• Lack of documentation showing that conservative treatment was done prior to the surgical intervention.

Ways to Prevent Denials

• “Responding timely to SMRC ADR letters,
• Submit all documentation related to the services billed which support the medical necessity of services billed.”

Moving forward, hospitals need to be aware of NCD and LCD requirements to ensure records support the medical necessity of a procedure, be mindful of all of the Review Contractors that could be requesting records and submit requested information within the allowed time frame.