Articles Posted in Compliance

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On September 26, 2012 The Department of Health and Human Services Office of Inspector General (OIG) issued a report on Schedule II drugs inappropriately billed to Medicare Part D. The report found that Medicare Part D inappropriately paid for $24.6 million in Schedule II drugs billed as refills, despite federal law prohibiting refills of Schedule II drugs.

OIG Report on Schedule II Drug Refills.pdf

Schedule II drugs are the second most controlled drugs under the Controlled Substances Act. They are classified as drugs which have a medical use, but have a high potential for abuse and may lead to severe psychological or physical dependence. Schedule II drugs with the highest number of refills billed to Medicare in 2009 include fentanyl, oxycodone-acetaminophen, morphine sulphate, and methadone HCI.

According to the report, 12,356 pharmacies billed for refills of Schedule II drugs, of which six percent were long-term-care pharmacies. Despite consisting of only six percent of the pharmacies that billed for refills of Schedule II drugs, long-term-care pharmacies were responsible for seventy-five percent of the refills. The report raises the possibility that some of these pharmacies actually incorrectly billed partial fills as refills. Partial fills are permitted for Schedule II drugs because of prohibitions on the amount a pharmacy can keep on hand at any one time. As a result, pharmacies will do partial fills of a prescription over a period of time, rather than filling the whole thing at once. In the CMS response to the report, CMS urged that it was likely that a majority of the refills were actually partial fills that were incorrectly billed. In turn, the OIG responded that even if that were the case it is still illegal to bill a refill of a Schedule II drug, regardless of the circumstances.

The OIG report further found that more than 25,000 refills of Schedule II drugs that were billed had invalid prescriber information. Prescriptions for Schedule II drugs require the name, address, and signature of the prescriber. Refills without proper prescriber information accounted for $1.4 million paid by Medicare Part D in 2009.

In 2009, the report concluded, 75% of all Medicare Part D sponsors paid for Schedule II drugs billed as refills, which indicates there are not appropriate safeguards in place to stop refills. The OIG made the following recommendations to CMS:

1. Issue guidance to sponsors to prevent billing of Schedule II refills and to ensure accurate billing of partial refills.

2. Exclude Schedule II refills when calculating payments to sponsors.

3. Monitor sponsors to ensure that they validate prescriber numbers for Schedule II drugs.

4. Follow up on sponsors and pharmacies with high numbers of refills of Schedule II drugs.

In response to these recommendations, CMS indicated that it will not work with sponsors and pharmacies to determine why there are not controls in place to prevent Schedule II refills. CMS will instead explore the use of PDE edits to prevent billing. CMS also did not agree to exclude Schedule II drugs billed as refills from payments to sponsors, and indicated that it will instead examine PDE edits to alert sponsors to inappropriate refills.
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The Obama administration, through a strongly worded letter signed by Attorney General Eric H. Holder Jr. and Secretary of Health and Human Services Kathleen Sebelius, warned healthcare providers of “troubling indications” that hospitals are using electronic health records to game the Medicare and Medicaid reimbursement system. The letter was sent to five major hospital trade associations, and follows a New York Times report that the use of electronic records might be contributing to a rise in Medicare billing, particularly in hospital emergency rooms. The administration claims that the use of electronic records, which were introduced to reduce costs and improve care, have lead to false documentation and inappropriate coding.

Throughout the letter, the government vowed to vigorously prosecute doctors and hospitals that are implicated in fraud. Regulators will examine the significant increase in billing for the most expensive evaluation services. The federal government obtained $2.4 billion from health care fraud settlements and judgments last year, and prosecutions against fraud are up 75% since 2008.

Specifically, the letter claims that hospitals are “cloning” electronic medical records, where information of one patient is repeated in other records, and also using electronic records to “facilitate upcoding of the intensity of care or severity of a patient’s condition as a means to profit with no commensurate improvement in the quality of care.” As evidence, the letter cites that hospitals received $1 billion more in Medicare reimbursements in 2010 compared to 2005, and attributes that increase to billing codes that classify more patients as sicker and needing more care.

Conversely, healthcare providers contend that “the new systems allow them to more accurately record information about their patients, leading to higher payments for the services they provide.” The hospital trade associations agree that the alleged practices are unacceptable and cannot be tolerated. However, experts criticize the government for not providing more guidance to both healthcare providers and the software companies developing the electronic records.

The concerns of Regulators, including the Office of Inspector General for Health and Human Services, demonstrate the government’s intention to “ensure payment accuracy and to prevent and prosecute healthcare fraud” and a continuing trend by the government to carefully scrutinize services billed by hospitals and physicians.
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The U.S. Department of Health and Human Services (HHS) recently agreed to a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.

The HIPAA Security Rule protects electronic health information by requiring HIPAA-covered entities to use various safeguards to ensure that electronic protected health information remains private and secure. The Privacy Rule, by contrast, grants individuals rights over protected health information, and sets rules for who may view that information.

MEEI submitted a HIPAA breach report, as required by HIPAA’s Breach Notification Rule, following the theft of an unencrypted personal laptop. The laptop contained electronic protected health information (ePHI), including patient prescriptions and clinical information.

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On September 11, 2012 the United States Court of Appeals for the Ninth Circuit held that a Recovery Audit Contractor’s (RAC’s) initial decision to reopen a claim is not subject to judicial review. The case, Palomar Medical Center v. Sebelius, involved Palomar Medical Center arguing that a RAC has to establish good cause for an initial reopening decision. The Court of Appeals affirmed the ruling of the United States District Court for the Southern District of California, which held that the issue of good cause for reopening a claim cannot be raised after the audit’s conclusion and the revision of a paid claim.

Palomar v Sebelius.pdf

In 2007, the RAC notified Palomar that a claim from 2005 totaling $7,992.92 was under review and that records were requested to support medical necessity. Subsequently, after it submitted the requested documentation, Palomar was notified that an overpayment had been identified and the overpayment must be repaid. The overpayment was affirmed at the redetermination and reconsideration levels. Palomar then requested a hearing with an Administrative Law Judge (ALJ).

The ALJ affirmed that the services were not medically necessary, but found that the RAC did not make a showing of good cause for the late reopening. Finally, the Medicare Appeals Council (MAC) decided that:

1. Neither the ALJ nor the MAC had jurisdiction to assess whether good cause existed for reopening because the RAC’s decision to reopen was not subject to the administrative appeals process, and
2. The services were not medically reasonable and necessary.

Palomar appealed to the District Court and then the Court of Appeals on the issue of reviewability of the reopening, but not on the issue of medical necessity of the services.

The Court of Appeals for the Ninth Circuit held that because Congress established the RAC program, and expressly stated that reopenings were allowed under regulations promulgated by the Secretary, the regulations would control. Since the regulations explicitly state that there may be no appeal of a reopening decision because reopening decisions are final, the question of good cause to reopen a claim cannot be litigated after a RAC has revised a claim determination.

Although the court determined that the issue of good cause for reopening is not appealable, the court conceded that it was not an easy question to answer because of two competing principles: (1) Congress wanted an effective recovery audit program to reduce Medicare payments with resulting benefits for Medicare beneficiaries and taxpayers, under procedures set by the Secretary and (2) the provider has a legitimate interest in finality of determinations on its revenue for medical services. Despite the competing principles, the court ultimately concluded that to allow a provider to challenge the good cause for reopening during the appeals process could lead to the waste of resources and administrative inefficiency if the good cause was later rejected during the appeals process.
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On September 4, 2012 the Department of Health and Human Services Office of Inspector General (OIG) issued a report in which it found that during calendar years 2009 and 2010 Medicare made overpayments to Inpatient Rehabilitation Facilities (IRFs) totaling an estimated $8.4 million.

The Centers for Medicare and Medicaid Services (CMS) establish a prospective payment rate for specific case-mix groups to which each beneficiary is assigned based on their expected clinical resource needs. IRF patient data is transmitted through Patient Assessment Instruments (PAIs) which contain the data on each beneficiary that is necessary to assign each to a case-mix group. IRF claims are processed and paid through Medicare Administrative Contractors (MACs). The IRF must submit the PAI data to the MAC within 27 days from the beneficiary’s discharge date. If PAI data is submitted after the 27 day window, a 25% late assessment penalty is applied to the case-mix group.

In the report, the OIG published the results of an audit conducted over calendar years 2009 and 2010 which examined whether IRFs received the reduced case-mix group payments for claims with PAIs that were submitted after the 27 day window. During the audit timeframe, 2,414 claims were transmitted after the 27 day window which totaled $41.6 million. The audit examined a 108 claim sample, of which 88 did not receive the 25% case-mix reduction. From this sample the OIG estimated that $8.4 million in overpayments were made to IRFs.

The OIG made recommendations to CMS which included the following:

1. Adjust the 88 sampled claims for overpayments of $696,371 to the extent allowed under the law.
2. Work with the OIG to resolve the remaining 2,306 nonsampled claims with potential overpayments estimated at $7.7 million and recover overpayments.
3. Continue to provide specific education to IRFs on the importance of reporting the correct PAI transmission dates on their claims.
4. Support the MACs’ and RACs’ efforts to conduct periodic postpayment reviews of IRF claims.

In response to the report, CMS concurred with the findings of the OIG and outlined implementation possibilities for the recommendations.
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On September 12, 2012, the Centers for Medicare and Medicaid Services (CMS) released a national provider Comparative Billing Report (CBR) targeting podiatry services. The CBRs will be released to a maximum of 5,000 podiatry service providers. This is the second time in which podiatry services have been the focal point of a CBR.

The CBRs are produced by Safeguard Services under contract with CMS and will provide comparative data to help show how these individual providers compare to other providers within the same field. These comparative studies are designed to assist providers in reviewing their coding and billing practices and utilization patterns, and take proactive compliance measures by conducting self-audits through meaningful comparisons to other podiatry providers billing similar codes. It is also important to understand that CBRs do not contain patient or case-specific data, but rather only summary billing information as a method of ensuring privacy. CMS suggests that providers should view CBRs as an educational tool, rather than a warning, to help aid them in properly complying with Medicare billing rules. However, based upon our experience, it is clearly an indication that individuals receiving CBRs are prospective audit targets because their utilization of these codes exceeds their peers.

The recently released podiatry services CBRs are to serve as a follow up to the CBRs previously received by providers in April 2011. This repeat study is intended to serve the same educational and compliance goals as the prior study; however the newly issued CBRs provide more recent billing data–billed Medicare Part B claims data with service dates from May 1, 2011 through April 30, 2012 that were processed by July 27, 2012. Furthermore, the POS and CPT codes addressed in the recently released CBRs are identical to the codes utilized in the prior study; which include POS codes 11 (office) and 31 (skilled nursing facility), and the following CPT codes:

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On September 4, 2011, the Office of Inspector General (“OIG”) issued an unfavorable advisory opinion (Advisory Opinion No. 12-11), which addressed an ambulance supplier’s proposed agreement with a municipality to waive cost-sharing amounts for emergency medical services (“EMS”). The requestor of the opinion, a for-profit provider of basic life support ambulance services (“BLS Supplier”), proposed to provide part-time EMS services for a municipality that currently enlists volunteer first aid squads as its majority provider of ambulance services. These volunteer providers generally do not charge residents cost-sharing amounts for the services rendered. In instances where volunteer squads are incapable of responding to emergency calls, other ambulance suppliers, such as BLS Supplier, may provide the services. Some of these instances are attributable to a volunteer squad’s inability to respond to a particular call, while other situations are due to volunteer squads dispatching in that they are unavailable to cover a service area during certain blocks of time.

The proposed arrangement in question involves BLS Supplier entering into agreements with municipalities to provide EMS on a part-time basis for the aforementioned situations. BLS Supplier would use insurance-only billing, in which it would bill Medicare and other third-party payors, but would agree to allow the municipality to waive all cost-sharing amounts.

In issuing its opinion, the OIG determined that the proposed agreement could potentially violate the anti-kickback statute because such waivers of Medicare cost-sharing amounts may constitute prohibited remuneration to induce referrals. The OIG went on to state that municipalities must pay the owed amounts to an independent ambulance supplier if municipalities seek to assume the cost-sharing obligations. The anti-kickback statute is implicated in the proposed arrangement if the municipalities either fail to make the payments to BLS Supplier or fail to permit BLS Supplier to directly bill the residents for the services provided. The OIG emphasized that this is especially true when a municipality enters into an agreement with an independent ambulance provider, such as BLS Supplier, to be its primary supplier of emergency ambulance services during designated time slots, even when only provided part-time. This opinion was distinguished with a prior OIG opinion (Advisory Opinion 99-1) where an independent ambulance supplier merely provided services during isolated and unanticipated circumstances in which the volunteer squad was currently preoccupied with another emergency response.

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The Centers for Medicare and Medicaid Services (CMS) recently released Comparative Billing Reports (CBRs) to Skilled Nursing Facility (SNF) providers. The CBRs are released to a maximum of 5,000 providers. CBRs can be an effective way to identify potential audit weaknesses and take corrective action before an audit.

SNFs that receive CBRs will see their rehabilitation plus extensive services category RUG code billings broken down by therapy level grouping and compared to regional and national averages. The CBRs are a response to increases in ultra high therapy RUG billings nationwide. Providers with higher than average ultra high therapy RUG billings are encouraged to examine their procedures and compliance plans to determine that therapy level RUG codes are billed appropriately.

The CBRs are produced by SafeGuard Services under contract with CMS and will provide comparative data to help show how these individual providers compare to other providers within the same field. These comparative studies are designed to help providers review their coding and billing practices and utilization patterns, and take proactive compliance measures. Providers should view CBRs as a tool to aid them evaluating their practices to ensure that they are properly complying with Medicare billing rules. Furthermore, providers should carefully analyze the data in CBRs to evaluate whether the CBR adequately reflects the provider’s billing practices. It is also important to understand that CBRs do not contain patient or case-specific data, but rather only summary billing information as a method of ensuring privacy.

In addition to skilled nursing facilities, provider types that have been identified to receive, or have already received, CBRs include: podiatry services, home oxygen services, evaluation and pain management services, cardiology services, advanced diagnostic imaging, electrodiagnostic studies, sleep study, hospice, ambulance services, chiropractic services, physical therapy, and durable medical equipment.
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On August 22, 2012 the American Hospital Association (AHA) published the results of a survey which indicates that Recovery Audit Contractor (RAC) claim denials were up in the second quarter of 2012 from the first quarter. The results of the survey include data collected from more than 2,000 hospitals nationwide.

The survey reveals that hospitals saw an increase in RAC denials in the second quarter of 2012 of 24%. Additionally, medical record requests rose 22% and the dollar value of claims denied increased 21%. Hospitals reported Short Stay Medically Unnecessary as the most common reason for denial. According to the survey 70% of denials were listed as Short Stay Medically Unnecessary, which is a rise of 1% from the first quarter of 2012.

Hospitals are spending an increasing amount on RAC issues. In the second quarter of 2012, 55% of the hospitals in the survey indicated they spent more than $10,000 on RAC issues. Hospitals also spent an average of $24,064 on external legal counsel in the same quarter.
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The Department of Justice (DOJ) reportedly set an email to hospitals nationwide on August 30, 2012 instructing them to examine implantable defibrillator surgeries covered by Medicare to determine if they were improperly billed to Medicare. The email, as reported by modernhealthcare.com, included a “resolution model” with instructions for hospitals to self-audit, and estimate monetary penalties under the False Claims Act.

The DOJ has been conducting an investigation into improperly billed implantable defibrillator surgeries for more than two years, and the resolution model sent to hospitals is the first attempt by the DOJ to come to a settlement resolution for these instances.

The investigation centers around a National Coverage Determination (NCD) set by the Centers for Medicare and Medicaid Services (CMS) which establishes the instances in which an implantable defibrillator is covered by Medicare.
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