Medicare Provides Guidance on Billing for Implantable Automatic Defibrillators

Medicare has found that approximately 85% of improper payments relating to the billing of implantable automatic defibrillators were due to insufficient documentation.

This is according to a recent issue of Medicare Quarterly Provider Compliance Newsletter (pdf), a newsletter from CMS developed to help providers to avoid common billing errors and other erroneous activities when dealing with the Medicare Program.

The figure was determined through a Comprehensive Error Rate Testing (CERT) program's special study of Healthcare Common Procedure Coding System (HCPCS) code 33249 (Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber).

The Centers for Medicare & Medicaid Services (CMS) calculates the Medicare Fee-for-Service (FFS) improper payment rate through the CERT program. Each year, CERT evaluates a statistically valid random sample of claims to determine if they were paid properly under Medicare coverage, coding, and billing rules.

Implantable automatic defibrillators are electronic devices designed to detect and treat life-threatening rapid heart rates. The device consists of a pulse generator and electrodes for sensing and defibrillating, and they are commonly referred to as Automatic Implantable Cardioverter Defibrillators (AICDs).

Insufficient Documentation and Medical Necessity Errors

Insufficient documentation means that required information is missing from the medical records or is inadequate to support payment. The CERT study found that approximately 85 percent of the improper payments were due to insufficient documentation, and this included lack of:

  • Physician's signature on the procedure note;
  • Signature log or attestation for cases in which the physician's signature was illegible;
  • Electronic record protocol/policy that documents the process for electronic signatures, if applicable;
  • Hospital records;
  • Records for the specified date of service;
  • Records that support the clinical indication for the procedure; or
  • Records to support that the beneficiary was enrolled in a clinical study/trial.

In the CERT study, medical necessity errors caused approximately 12 percent of the improper payments. A medical necessity error occurs when the CERT reviewer receives adequate documentation from the medical records submitted to make an informed decision that the services billed were not medically necessary, based upon Medicare coverage policies.

For example,

1. For all AICDs, the beneficiary must not have irreversible brain damage from preexisting cerebral disease; also

2. For primary prevention of sudden cardiac death, criteria include that the beneficiary must not have:

  1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
  2. Had a Cardiopulmonary Artery Bypass Graft (CABG) surgery or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 3 months;
  3. Had an acute Myocardial Infarction (MI) within the past 40 days;
  4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
  5. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

Examples of Improper Payments for AICDs

Example 1: Improper Payments due to Insufficient Documentation for AICDs

A physician billed for insertion of an AICD using HCPCS 33249 and modifier Q0 (Investigational clinical service provided in a clinical research study).

Review of the documentation found that the following was missing:

1. Clinical documentation supporting a previous Myocardial Infarction (MI) (documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction);

2. Clinical documentation supporting the defibrillator implantation for primary prevention is enrolled in either:

  1. A Food and Drug Administration (FDA) approved category B investigational Device Exemption (IDE) clinical trial;
  2. A trial under the CMS Clinical Trial Policy; or
  3. A qualifying data collection system including approved clinical trials and registries.

The CERT reviewer also received a device implant report for the correct date of service showing implantation of two leads, removal of a previous pacemaker, and threshold testing of the device with induced ventricular fibrillation and shock. The physician signed the report and authenticated the electrophysiology report. Additional information was requested and several unauthenticated clinical records were received that supported the beneficiary's history of heart disease.

However, the beneficiary's condition did not meet the criteria for Medicare coverage of an AICD. Although AICDs that are not covered based on Medicare coverage criteria are covered under Category B IDE trials and the CMS routine clinical trials policy, there was no documentation of enrollment in a clinical trial in this case.

There was no support for the use of the Q0 modifier in the documentation received, so this claim was scored as an insufficient documentation error and the Medicare Administrative Contractor (MAC) recouped the payment from the provider.

Example 2: Improper Payments due to Insufficient Documentation for AICDs

A physician billed for HCPCS 33249 at time of initial AICD implantation. The submitted documentation showed that the 73 year-old beneficiary had a past medical history of pulmonary hypertension, severe left ventricular dysfunction, non-ischemic dilated cardiomyopathy, dyslipidemia, and congestive heart failure (New York Heart Association Class III). The patient's symptoms included shortness of breath, fatigue, intermittent swelling in his feet, and he was unable to sleep lying flat. He was on maximal medical therapy that included Beta blockers, Angiotensin-Converting Enzyme (ACE) inhibitors, and diuretics. His cardiac catheterization showed an ejection fraction of 30 percent.

An operative report showed that he had an AICD implanted; however, the date on the report did not match the billed date of service. Medicare payment rules do not allow reviewers to accept documents with dates that are significantly different from the billed date of service.

This claim was scored as an insufficient documentation error , and the MAC recouped the payment from the provider.

Example 3: Improper Payments due to Medical Necessity Errors for AICDs

A cardiac surgeon billed for HCPCS 33249. He/she submitted medical records showing that the beneficiary had dilated ischemic cardiomyopathy with paroxysmal atrial fibrillation and that he had a Coronary Artery Bypass Graft (CABG) procedure 16 days prior to the AICD implantation.

There was no documentation of a prior MI or of an investigational research study. Documentation included an unsigned post-operative history and physical examination note. The CERT reviewer requested additional documentation to support this claim and received a copy of the previously unsigned post-operative history and physical examination note to which a signature had been added without a signature date.

Note: Providers should not add late signatures to the medical record (beyond the short delay that occurs during the transcription process), but instead should make use of the signature authentication process.

The related NCD requires that the beneficiary must not have had a CABG within 3 months prior to the AICD implantation.

The submitted documentation did not support the NCD requirements for reasonable and necessary services. This claim was scored as a medical necessity error and the MAC recouped the payment from the provider.

Amendments, Corrections and Delayed Entries in Medical Documentation

Providers are encouraged to enter all relevant documents and entries into the medical record at the time they are rendering the service.

A provider may discover that certain entries related to actions that were actually performed at the time of service but not properly documented, need to be amended, corrected, or entered after rendering the service. When making review determinations, the Medicare review contractors consider all submitted entries that comply with the widely accepted Recordkeeping Principles described in the "Medicare Program Integrity Manual," (Section 3.3.2.5 (Amendments, Corrections and Delayed Entries in Medical Documentation), Section B (Recordkeeping Principles); see the Resources section below). MACs, CERT, Recovery Auditors, and Zone Program Integrity Contractors (ZPICs) DO NOT consider any entries that do not comply with the principles listed in Section B, even if such exclusion would lead to a claim denial. For example, Medicare review contractors exclude from consideration undated or unsigned entries handwritten in the margin of a document.

Source: CMS

Cardiology billing is complex, requiring a high level of experience and knowledge for appropriate coding and general medical billing procedures. Billing specifics such as checking medical necessity verification and component coding require ever increasing levels of billing expertise and efficiency.

PGM has over thirty years of experience in cardiologist billing. Contact PGM to learn how we can manage all aspects of your practice's billing to help ensure you receive proper reimbursement for services provided.

Key Points Of The Health Care Reform Bill

After months of debate, the health care reform bill finally passed and has been signed into law by President Obama. It is legislation that is slated to cover millions of Americans who don't have health insurance and drive down insurance costs that have been on the rise since the start of the millennium.

So what does it all mean?

The reform bill has two phases. First, here are some things that Americans saw change change in the first 6 months the bill was in effect:

  • Senior citizens became eligible for up to $250 in prescription drug rebates to close the "doughnut hole," the costly gap for prescription pills. In 2011, a 50% discount on prescription drugs was enacted.
  • Lifetime caps on insurance coverage were removed.
  • Insurance companies lost the ability to deny coverage if you became sick or cancel coverage already issued except in the case of fraud.
  • Prohibition of coverage denial or rate adjustment for children who have pre-existing conditions.
  • High risk pools were created for adults with pre-existing conditions to buy into until 2014 when they will also not be denied or have rates adjusted for pre-existing conditions.
  • Tax credits for small businesses when purchasing coverage.
  • Consumers gained protections against insurance company abuses through the Patients' Bill Of Rights.
  • Children were able to stay under parents' plan until they are 26 years old.
  • Consumers had a guaranteed choice of doctors and plans.
  • Free preventative care for all.
  • All insurers were required to post their balance sheets on the Internet and fully disclose administrative costs, executive compensation packages, and benefit payments.  

The second phase of the bill is set to be complete by 2014. Here's what the bill will do then:

  • All adults will not be denied coverage or have their rates adjusted if they have a pre-existing condition.
  • Tax credits will be offered to families to help offset the cost of health care premiums.
  • Individuals who get insurance through their employer will be able to purchase a state-run option of health insurance instead when their current premiums are more than 9.5 percent of their income or when their current plan doesn't cover 60 percent of the cost of their benefits. Certain middle-income families who pay more than 8 percent but less than 9.5 percent will be eligible for vouchers from their employers to purchase insurance from where the employer normally would have.
  • All Americans must carry health insurance or face a fine, but there are special exceptions for economic hardship, religious beliefs and other special cases. These exceptions include if a couple makes less than $19,000, they are not required to carry health insurance.
  • Medium-sized and large-sized companies will be fined if they do not provide coverage for their employees or if they do not meet a minimum standard of coverage.
  • States set up insurance pools to help small companies come together to pay for insurance coverage of their employees and offer tax credits if they participate. They must insure their employees and meet a minimum standard of coverage or pay a fine.
  • Flexible spending accounts used for health care costs will have a cap at $2,500 starting in 2013. There currently is no cap by law, but employers generally impose a cap around $4,000.
  • Those who itemize their tax returns will have their deductible medical expenses shrink. The new bill only allows you to deduct medical expenses that exceed 10 percent of your adjusted gross income, the current law has it at 7.5 percent.
  • 32 million Americans who were not covered before the bill was passed, will now be covered through subsidies averaging $6,000 per person to help pay premiums and other medical charges. This will also happen through the extension of Medicaid.

So now that you know how your coverages might change, how much will your payments change?

  • If you get your insurance through your company, your premiums will not change. 
  • If you get insurance privately and you make under $88K, your premiums are likely to go down with the assistance of subsidies.
  • If you get insurance privately and you make over $88K, your premiums are likely to go up to help cover the cost of the expanded coverage and subsidies.

The bill is projected to cost around $940 billion, so how are we going to pay for it?

  • The bill is a big investment now, but its projected by the Congressional Budget Office to cut the national deficit by over $130 billion in the first 10 years and by $1.3 trillion over 20 years.
  • Individuals earning more than $200,000 a year, or couples earning $250,000 or more, would be hit with a 3.8% surcharge on investment income and a higher Medicare payroll tax to help pay for the bill.
  • A medical plan tax that includes several different provisions to increase multiple taxes on things such as cosmetic surgery, cafeteria plans, health insurance providers, production and importation of drugs and medical devices, medical information providing, hospitals and the adjusted gross income floor of medical expenses.
  • Doctors and hospitals will receive less compensation than they do now to control revenue streams.
  • The Medicare program will see $500 billion in cuts to its program along with the Medicare tax being raised, but these cuts are not empty dismissals as the new plan can cover what these cuts lose.
  • The pharmaceutical industry has pledged lavish spending to the government through advertisements in helping to pass the bill.
  • A sweeping federal student loan legislation as a part of the bill eliminates banks as the middleman, thus eliminating millions in bank fees paid by the government.
  • "Cadillac Plans" or plans that exceed $10,200 a year for individuals or $27,500 for families will see a 40 percent tax rate attached to them for the insurers to pay.

Other concerns of the new health care reform bill:Many people are also concerned about longer waits to visit their doctor with this new increased, centralized government health insurance bill, such as what happened in Massachusetts. This will very likely not be the case because in Massachusetts, they made all their changes at once and it wasn't feasible to overload the pre-existing system with those changes. The new national bill phases in these changes over time so that the system can adapt. 

Wait times are also expected to go down at emergency rooms at hospitals, where wait times have been steadily increasing over the last decade. Patients who are covered under the new bill who were not before are expected to go to a primary care physician instead of directly to the emergency room for one-time treatments.

Also built into the bill is millions of dollars for community health centers that are expected to be able to take on tens of millions of patients so that your primary care physician isn't held up by the increase in patients covered.

A not-so-well-known part of the bill:Sweeping changes in the student loan program, an administration priority that has been stalled in the Senate for months, will now be in effect. They will have the government originate all student loans, denying banks and other private lenders of a lucrative business they have long had through government paid fees. Much of the savings would go into increased Pell Grants for needy college students, but black and Hispanic colleges would also benefit.

Of course this is only the beginning of the reform as many of the provisions set for 2014 could be changed by amendments and other legislation before then, but when they do, we'll be on your side with what those changes mean.

Do you think this is a good bill for America? For you? For your neighbors? Let us know in the comments section below and vote in our poll.

Some of the information used in this report came from the Joint Committee On Taxation, the CBO, The New York Times, CNN.com and ABCNews.com.

AAO-HNS Addresses Coding for Implantation of a Hypoglossal Nerve Stimulator

In a new "CPT for ENT" article, the American Academy of Otolaryngology — Head and Neck Surgery (AAO-HNS) addresses a question on coding for implantation of a hypoglossal nerve stimulator.

CPT for ENT articles are a collaborative effort between AAO-HNS's team of CPT advisors, members of the Physician Payment Policy workgroup and health policy staff.

The question tackled in this latest CPT for ENT article is as follows:

Q: How do I code for implantation of a hypoglossal nerve stimulation system that includes placement of a chest wall sensor(s)?

To view the answer on the AAO-HNS website, click here.

Have questions about ENT billing? Contact PGM Billing, one of the nation's leading medical billing agencies, to find out what they can do for your practice.

Free Chiropractic Billing Resource: American Chiropractic Association Webinar on ICD-10 Implementation

The American Chiropractic Association provides a free, valuable coding and billing resource you can access regardless of whether you are a member of ACA.

"ICD-10 Implementation for the Chiropractic Clinic" is a previously recorded webinar presented on behalf of ACA by Nicholas Payne, DC, an ACA insurance liaison from Kentucky.

The webinar's objectives are identified as follows:

Understanding ICD-10

  • Difference from ICD-9
  • Need for change
  • ICD-10 benefits

Implementing ICD-10

  • Structure
  • Impact
  • Documentation and billing
  • Transition
  • Testing
  • Best resources

To access this free resource on YouTube, click here. If you are responsible for providing chiropractic coding and/or chiropractic medical billing, this is a program worth watching.

Note: Oct. 1, 2015, was recently confirmed as the new compliance date for healthcare providers to make the transition to ICD-10.

Federal Regulators Paying Close Attention to Laboratory Billing

Laboratory billing is under great scrutiny by federal regulators as indicated by a series of developments this year.

OIG Special Fraud Alert

In June, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert regarding laboratory payments to referring physicians (pdf). According to OIG, this Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices for blood specimen collection, processing and packaging, and for submitting patient data to a registry or database.

The Alert describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti-kickback statute.

The first involves blood specimen collection, processing and packaging arrangements under which clinical laboratories are providing remuneration to physicians to collect, process and package patients’ specimens. While Medicare allows the person who collects a specimen to bill Medicare for a nominal specimen collection fee in certain circumstances, there are a number of arrangements that may be problematic. According to OIG, these include when:

  • payment exceeds fair market value for services actually rendered by the party receiving the payment;
  • payment is for services for which payment is also made by a third party, such as Medicare;
  • payment is made directly to the ordering physician rather than to the ordering physician’s group practice, which may bear the cost of collecting and processing the specimen;
  • payment is made on a per-specimen basis for more than one specimen collected during a single patient encounter or on a per-test, per-patient or other basis that takes into account the volume or value of referrals;
  • payment is offered on the condition that the physician order either a specified volume or type of tests or test panel, especially if the panel includes duplicative tests (e.g., two or more tests performed using different methodologies that are intended to provide the same clinical information) or tests that otherwise are not reasonable and necessary or reimbursable; and
  • payment is made to the physician or the physician’s group practice, despite the fact that the specimen processing is actually being performed by a phlebotomist placed in the physician’s office by the laboratory or a third party.

The second OIG trend concerns registry payments. OIG indicated it had become aware of arrangements under which clinical laboratories are establishing, coordinating or maintaining databases, either directly or through an agent, purportedly to collect data on the demographics, presentation, diagnosis, treatment, outcomes or other attributes of patients who have undergone, or who may undergo, certain tests performed by the offering laboratories.

While registry arrangements may take various forms, OIG notes they typically involve payments from laboratories to physicians for certain specified duties, such as submitting patient data to be incorporated into the registry, answering patient questions about the registry and reviewing registry reports. Registry arrangements may induce physicians to order medically unnecessary or duplicative tests, including duplicative tests performed for the purpose of obtaining comparative data, and to order those tests from laboratories that offer registry arrangements in lieu of other, potentially clinically superior, laboratories.

OIG notes that whether any particular registry arrangement violates the anti-kickback statute depends on the intent of the parties to the arrangement. Payments from a laboratory to a physician to compensate the physician for services related to data collection and reporting may be reasonable in certain limited circumstances. However, the anti-kickback statute prohibits the knowing and willful payment of such compensation if even one purpose of the payments is to induce or reward referrals of federal healthcare program business.

Some possible arrangements identified by OIG that may be evidence of unlawful purposes include the following:

  • The laboratory requires, encourages, or recommends that physicians who enter into registry arrangements perform the tests with a stated frequency to be eligible to receive compensation or avoid a reduction in compensation.
  • The laboratory collects comparative data for the registry from, and bills for, multiple tests that may be duplicative or that otherwise are not reasonable and necessary.
  • Compensation paid to physicians pursuant to registry arrangements is on a per-patient or other basis that takes into account the value or volume of referrals.
  • Compensation paid to physicians pursuant to registry arrangements is not fair market value for the physicians’ efforts in collecting and reporting patient data.
  • Compensation paid to physicians pursuant to registry arrangements is not supported by documentation, submitted by the physicians in a timely manner, memorializing the physicians’ efforts.
  • The laboratory offers registry arrangements only for tests (or disease states associated with tests) for which it has obtained patents or that it exclusively performs.
  • When a test is performed by multiple laboratories, the laboratory collects data only from the tests it performs.
  • The tests associated with the registry arrangement are presented on the offering laboratory’s requisition in a manner that makes it more difficult for the ordering physician to make an independent medical necessity decision with regard to each test for which the laboratory will bill (e.g., disease-related panels).

Study: Questionable Billing for Medicare Part B Clinical Laboratory Services

In early July, OIG issued its study, "Questionable Billing for Medicare Part B Clinical Laboratory Services (pdf)" (which was later corrected and reissued in mid-August) The objective was to identify questionable billing for Part B clinical laboratory (lab) services in 2010.

The study analyzed Part B claims for lab services with dates of service in 2010. When labs submit claims for each lab service provided for Medicare beneficiaries, each claim contains information about the lab provider, the ordering physician, the beneficiary and the lab service. Researchers developed 13 measures to describe labs' billing patterns and identify labs with questionable billing patterns. They then calculated and analyzed the distribution of the measures for each lab, and then calculated a statistical threshold for the 13 measures and determined whether a lab's billing was unusually high for each measure. Additionally, they calculated the total number of claims and total allowed amount associated with certain measures of questionable billing.

Researchers found that in 2010, more than 1,000 labs exceeded the thresholds (i.e., had unusually high billing) for five or more measures of questionable billing for Medicare lab services. For example, a lab might have an unusually high percentage of claims with ineligible and/or invalid ordering-physician numbers, or an unusually high allowed amount per ordering physician. Some labs that exceeded the thresholds for fewer than five measures also exhibited billing that may warrant further review. Medicare allowed $1.5 billion across all labs for claims associated with questionable billing.

The OIG notes that while there may be some labs that have legitimate reasons for exceeding certain thresholds, collectively, these findings call for stronger oversight of labs and identification of specific issues with Medicare payments for lab services that need to be addressed to more effectively safeguard Medicare.

OIG recommended that CMS:

  1. review the labs identified as having questionable billing and take appropriate action;
  2. review existing program integrity strategies to determine whether these strategies are effectively identifying program vulnerabilities associated with lab services; and
  3. ensure that existing edits prevent claims with invalid and ineligible ordering-physician numbers from being paid.

CMS concurred with all recommendations.

Laboratories Under Investigation

In September, it became apparent that the feds were serious about cracking down on illegal payments by labs to physicians.

As the Wall Street Journal reports, Virginia's Health Diagnostic Laboratory is being investigated by the Justice Department for its payments of blood-sample fees to doctors. The company's CEO has resigned amid the investigation.

The Pittsburgh Post-Gazette reports Universal Oral Laboratories of Pennsylvania is also subject of a federal investigation, with prosecutors alleging that the lab's owner built the business by giving kickbacks to doctors for sending patients' saliva samples for prescription drug adherence testing.

Boston Heart Diagnostics Corp. in Boston is another lab under investigation, according to a Boston Globe report. Federal investigators are examining whether diagnostic firms, including Boston Heart, has improperly paid doctors who send them patients' blood specimens to test their risk for cardiovascular disease.

Looking for help with your laboratory billing?

For more than 30 years, PGM Billing, a leading physician billing company, has worked with reference and clinical labs. PGM has developed one of the most effective lab billing, coding and financial management services on the market. To learn about what PGM and its team of expert lab billers and coders can do for you, contact us today.

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