Wachler & Associates Health Law Blog

Published on: March 20, 2012

CMS Adopts Final Rule for DMEPOS Standards

The Centers for Medicare and Medicaid Services (CMS) has published a final rule for standards regarding Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. The rule, published March 14, 2012 in the Federal Register, revises and specifies the definition of “direct solicitation” as it applies to DMEPOS suppliers. The rule also eliminates the requirement that DMEPOS suppliers comply with local zoning ordinances. In the official comments, CMS indicated that all zoning issues are better left to the states.

The rule limits the contact a DMEPOS supplier can make with a beneficiary. Previously, “direct solicitation” had been broadly defined as telephonic contact. The August 27, 2010 final rule broadened the definition of “direct solicitation” to include not only telephonic contact, but also in-person contact, email, and instant messaging. The new adopted rule, which will be effective April 13, 2012, eliminates the prohibition on “direct solicitation” and only restricts direct contact with the beneficiary by telephone. The new adopted rule further requires that a DMEPOS supplier must have written permission from the beneficiary to contact the beneficiary by telephone.

The new rule also allows DMEPOS suppliers to contract with a third party to provide licensed services, provided the third party is appropriately licensed under applicable state laws. The prior rule prohibited DMEPOS suppliers from contracting licensed services.
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Published on: March 16, 2012

HHS Settles First Breach Notification Case

by Wachler & Associates, P.C.

The first enforcement action from a breach report required by the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule has resulted in an agreement by Blue Cross Blue Shield of Tennessee (BCBST) to pay the Department of Health and Human Services (HHS) $1.5 million.

BCBST reported that unencrypted hard drives had been stolen from a leased storage facility in Tennessee. The hard drives contained personal health information of more than one million people, and included information such as social security numbers and dates of birth. An investigation discovered BCBST failed to ensure the facility had proper security measures in place as required by HIPAA rules. The settlement also requires BCBST to establish a corrective action plan to revise its security policies and conduct training.

The HITECH Breach Notification Rule requires HIPAA covered entities to promptly make notifications in the event of a breach that affects more than 500 individuals. The entity must notify each individual affected, the HHS Secretary, and the media. A breach of information affecting fewer than 500 individuals need only be reported to the HHS Secretary on an annual basis.

More information on the HITECH Breach Notification Rule can be found on the Department of Health and Human Services website.

HIPAA Privacy and Security Rules are enforced by the Health Human Services (HHS) Office for Civil Rights. HIPAA Security Rules establish requirements for how entities must secure and protect electronic health information, and ensure that it remains secure and protected.

More information on the HHS Office for Civil Rights can be found on their website.
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Published on: March 6, 2012

CMS Proposes Regulations to Implement the Law Regarding Reporting and Returning Overpayments

by Wachler & Associates, P.C.

Having compliance plans and procedures in place is becoming increasingly important for Medicare providers and suppliers. On February 16, 2012, CMS released a proposed rule to implement Section 128(d) of the Social Security Act (“Act”) which was added by the Affordable Care Act (“ACA”) and deals with the reporting and returning of overpayments. The proposed rule is significant in that it includes a ten year look back period and proposes a definition for when an overpayment is “identified” which includes a duty for providers and suppliers to make reasonable inquiries when an overpayment is suspected.

The ACA created Section 1128(d) of the Act to detail the requirements for reporting and returning overpayments. Overpayments are defined in Part 4(B) of the law as “any funds that a person receives or retains under title XVIII or XIX [42 USCS Section 1395 et seq. or 1396 et seq.] to which the person, after applicable reconciliation, is not entitled under such title.” Part 2 requires an overpayment be reported and returned by the later of 60 days from the date on which the overpayment is “identified” or the date any corresponding cost report is due. The statute itself does not define “identification” however, the proposed implementing regulation, 401.305(a)(2) defines “identification” as being when “the person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the overpayment.” (77 Fed. Reg. 9179, 9182, February 16, 2012). CMS believes that this will provide an incentive to providers and suppliers to exercise reasonable diligence to determine whether an overpayment exists. CMS goes on in the proposed rule to suggest that without such a definition, a provider or supplier might avoid activities which can be done to determine an overpayment such as “self-audits, compliance checks, and other additional research.”

CMS provides a nonexhaustive list of examples of when an overpayment is identified and the provider or supplier should make a “reasonable inquiry with all deliberate speed” to determine if an overpayment exists, including:

when a provider receives an anonymous compliance hotline telephone complaint about a potential overpayment;
when a provider or supplier reviews billing or payment records and learns it incorrectly coded certain services resulting in increased payment;
when a provider or supplier learns that a patient death occurred prior to the date of service on a claim submitted for service;
when a provider or supplier learns that services were provided by an unlicensed or excluded individual on its behalf;
when a provider or supplier performs an internal audit and discovers overpayments;
when a provider or supplier is informed by a government agency of an audit that discovered a potential overpayment and the provider or supplier fails to make a reasonable inquiry;
when a provider or supplier experiences a significant increase in Medicare revenue with no apparent reason for the increase.

While this list is not exhaustive, it should give providers and suppliers pause and reason to evaluate and update compliance plans. If a provider or supplier acts in reckless disregard or deliberate ignorance of whether it received an overpayment, then it could be found to have knowingly retained an overpayment. And, if an overpayment is retained after the deadline, it becomes an obligation under the False Claims Act, the provider or supplier may have liability under the Civil Monetary Penalties Law, and the provider or supplier could be excluded from participation in Federal Health Care programs.
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Published on: March 6, 2012

CMS Provides List of Providers Sent Notices to Revalidate Their Medicare Enrollment

by Wachler & Associates, P.C.

As part of healthcare reform, Section 6401(a) of the Affordable Care Act requires all providers and suppliers who enrolled in the Medicare program prior to March 25, 2011 to revalidate their provider enrollment under the new screening criteria. Providers and suppliers who enrolled after March 25, 2011 do not need to revalidate at this time as they have already been screened.

Medicare Administrative Contractors (MACs) will be sending revalidation notices to individual providers and suppliers between now and March 23, 2015. Providers and suppliers must complete the enrollment forms within 60 days of receiving the request from the MACs. If a provider fails to submit the provider enrollment forms after receiving the request, it may lead to a suspension of the provider’s Medicare billing privileges.

Providers and suppliers may not revalidate their provider enrollment until they have received a revalidation notice from their MAC. The CMS website provides a list of all the providers and suppliers to whom revalidation notices have been sent (See “download” section). In case a revalidation notice has been sent but never received, every provider is encouraged to check the list to determine whether or not they are currently expected to revalidate. If you are listed, but have not received the request, you should contact your Medicare contractor.
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Published on: February 28, 2012

CMS Releases FY2012 RAC Report

by Wachler & Associates, P.C.

CMS recently released the results of its Medicare Fee-for-Service Recovery Audit Program (RAC) for fiscal year 2012. Once again, improper payment numbers have increased from the year before. For the period from October 2011 – December 2011 the audit program collected $397.8 million in overpayments and returned $24.9 million in underpayments. This is a total of $422.7 million in corrections identified by the audit program, with the vast majority of those improper payments coming from Medicare overpayment to providers. The RAC program has collected $1.27 billion in overpayments since 2010, and has returned $187.7 million during that same timeframe. Not surprisingly, RACs have found far more overpayments to providers than they have found underpayments.

A related CMS Quarterly Newsletter indicates that Regions C and D RACs, Connolly and HealthData Insights (HDI) collected the most in overpayments, while Regions A and B RACs, Diversified Collection Services (DCS) and CGI Federal, collected the least.

The report also identified the top recovery issue by region. All issues were medical necessity issues. The top overpayment issues were:

Region A: Neurological Disorders- Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation for patients with neurological disorders needs to be complete and support all services provided in the setting billed.
Region B: Cardiovascular Procedures- Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation for patients undergoing cardiovascular procedures needs to be complete and support all services provided in the setting billed.
Region C: Neurological Disorders- Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation for patients with neurological disorders needs to be complete and support all services provided in the setting billed.
Region D: Minor Surgery and Other Treatment Billed as an Inpatient Stay- When beneficiaries with known diagnoses enter a hospital for a specific minor surgical procedure or other treatment that is expected to keep them in the hospital for less than 24 hours, they are considered outpatient for coverage purposes regardless of the hour they presented to the hospital, whether a bed was used, and whether they remained in the hospital after midnight.

The yearly report can be found here, while a report on the individual RAC contractors by region can be found here.
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Published on: February 28, 2012

OIG Releases Review MIC Report

by Wachler & Associates, P.C.

Earlier this month (February 2012) the HHS Office of Inspector General (OIG) released its report regarding the assessment of Review Medicaid Integrity Contractors (MICs). The OIG review looked at Review MIC assignments made between January 1 and June 30, 2010. The objectives of the study were to determine to what extent Review MICs were able to complete assignments, recommend audit leads, and identify potential fraud; and to determine what obstacles the Review MICs encountered during the review process.

CMS awarded MIC responsibility to two firms: Thompson Reuters and AdvanceMed. Assignments are given to Review MICs by CMS on a monthly basis. Each assignment specifies the state from which the claims will come, the type of claims, and a range of service dates. Once an assignment is complete, the Review MIC submits its report to CMS where it undergoes a quality assurance review. The assignment must pass this review to be considered complete.

Of the 361 assignments the Review MICs were tasked with during the OIG review period, 81% were completed and 17% were placed on hold by CMS. Rather than recommend specific audit leads as a result of their findings, CMS required the Review MICs to submit lists of providers ranked by the amounts of their potential overpayments. From these lists of 113,378 providers CMS selected 244 audit targets with a total of $39.8 million in potential overpayments from a retrospective 5-year audit period established by CMS.

The OIG review found that not only were the Review MICs unable to accurately complete assignments because of missing or inaccurate data, but states also invalidated more than one third of sampled potential overpayments. States compared the Review MIC findings with information in their state systems and found that 34% were not overpayments.

The OIG reports makes two recommendations, both of which CMS concurs with. The first is to improve the quality of data that Review MICs can access for conducting data analysis. One option the OIG provides is to facilitate Review MIC access to states’ Medicaid data systems. The CMS comments on the OIG report, in which they concur with the OIG recommendations, indicate that CMS has several initiatives underway to improve the quality of the data available to the Review MICs. One CMS long term strategy is to improve the Medicaid Statistical Information System (MSIS). MSIS is currently the only nationwide database of Medicaid claims and beneficiary eligibility information.

The second OIG recommendation is that CMS should require Review MICs to recommend specific audit leads. The OIG report suggests that these audit leads would have the best potential for recoveries and improve the value of the Review MICs contribution to the Medicaid Integrity Program. In their comments, CMS concurs with this recommendation and that the Review MIC assignments will now include specific recommendations for specific audit targets.

The full OIG report can be found on the OIG website.
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Published on: February 27, 2012

Recent RAC Activity

by Wachler & Associates, P.C.

On February 13, 2012 DCS Healthcare added a new CMS approved issue to its approved issues list for DME supplier claims:

• Knee orthosis bundling: Payments for knee orthoses additions, as specified in NHIC’s LCD for knee orthoses, #L27263, are bundled into the payment for specific base knee orthoses, and should be recouped if paid separately.

On February 13 and 15, 2012 Connolly added new CMS approved issues to its approved issues list:

• Therapeutic footwear utilization CMS issue number: C005392010. The LCD and policy article for therapeutic shoes for diabetics limit the use of shoes and inserts as follows: For patients meeting these criteria, coverage is limited to one of the following within one calendar year (January – December): One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and two additional pairs of inserts; or one pair of depth shoes (A5500) and three pairs of inserts.

• Rituximab – Non-covered/non-allowed service-Part B CMS issue number: C001442011. An overpayment exists when a provider bills for a service of J9310/Rituximab with an ICD-9 code that is not included in the list of covered ICD-9 codes for J9310/Rituximab with the applicable local coverage determination document(s).
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Published on: February 27, 2012

Zone Program Integrity Contractor (ZPIC) Audits

by Wachler & Associates, P.C.

Zone Program Integrity Contractors (ZPICs) were created by CMS primarily to investigate suspected fraud, waste, and abuse. ZPICs perform similar audit activities as other Medicare contractors, but with a reactive and proactive focus on the identification of possible Medicare fraud. ZPICs employ “innovative” strategies to engage in the early detection of fraud. The strategies include data analysis, pursuing proactive leads from other Medicare contractors or other sources such as the Fraud Investigation Database (FID), law enforcement, news media or the Internet.

Once a ZPIC initiates an audit, it has the authority to conduct prepayment and postpayment medical review, perform announced and/or unannounced onsite audits, interview staff and beneficiaries, and suspend provider payments pursuant to approval from CMS. While any type of Medicare contractor audit can be disruptive to a provider’s business, it is extremely important for a health care professional to recognize when his or her practice is the focus of a ZPIC audit or investigation. This is because ZPICs also have the authority to refer providers and beneficiaries to law enforcement, refer providers for exclusion from the Medicare program, and utilize statistical sampling and extrapolation to determine overpayment amounts. For this reason, it is imperative that Medicare providers aggressively defend against a ZPIC investigation.

There are seven zones in which ZPICs are assigned, and providers should be aware of the ZPIC assigned to their zone. More information on ZPICs and be found on our website.
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Published on: February 14, 2012

Recent RAC Activity

by Wachler & Associates, P.C.

Connolly Healthcare recently added 17 new issues to its CMS-approved issues list for Region C states. Below is a sampling of the recently approved issues, which fall in multiple categories. For a full list and more information please visit the Connolly website.

Ambulance/transport during a SNF stay to or from a diagnostic or therapeutic site: Ambulance/transport services provided during a SNF stay are not separately paid under the Part B benefit. The cost for these services is considered part of the Part A Prospective Payment made to the SNF Provider. Ambulance transports to or from a diagnostic or therapeutic site other than a hospital or renal dialysis facility (e.g., an independent diagnostic testing facility (IDTF), cancer treatment center, radiation therapy center, wound care center, etc.). The ambulance transport is included in the SNF PPS rate if the first or second character (origin or destination) of any HCPCS code ambulance modifier is “D” (diagnostic or therapeutic site other than “P” or “H”), and the other modifier (origin or destination) is “N” (SNF). The first SNF is responsible for billing the services to the FI.
Inappropriate Payments for Transformational Epidural Injections: Local Coverage Determination policy has indicated specific conditions or diagnoses that are covered for Transformational Epidural Injections. Carrier claims have been identified where the first-listed and/or other diagnosis codes do not match to the covered diagnosis codes in the LCD policies.
Incorrect diagnosis code billed for blood clotting factor: An overpayment exists when a provider bills for a blood clotting factor with an ICD-9 code that is not included in the list of covered ICD-9 codes within the applicable Local Coverage Determination document(s).
Improper payments for Facet Joint Injections: An overpayment exists when a provider bills for an Facet Joint Injection with an ICD-9 code that is not included in the list of covered ICD-9 codes within the applicable Local Coverage Determination document(s).
Incorrect billing of Home Health Partial Episode Payment claims: Incorrect billing of Home Health Partial Episode Payment (PEP) claims identified with a discharge status 06 and another home health claim was not billed within 60 days of the claim from date. Additionally, MCO effective dates are not within 60 days of the PEP claim.

HealthDataInsights recently added new issues to its CMS-approved issues list for Region D states. Below is a sampling of the recently approved issues. For a full list and more information please visit the HealthDataInsights website.

Acute Inpatient Hospitalization – Bowel and Rectal Procedures (DRG 329, 330, 332, 333, 334, 344, 345 and 346): Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation will be reviewed to determine that services were medically necessary.
Acute Inpatient Hospitalization – Hepatobiliary Procedures (DRG 420, 421, 422, 424 and 425): Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation will be reviewed to determine that services were medically necessary.

Published on: February 14, 2012

RAC Posts First Home Health Issue

by Wachler & Associates, P.C.

Connolly Healthcare, RAC for Region C, has recently added its first home health agency issue to its CMS-approved issues list.

The first posted issue targeting home health agencies is an automatic review that will focus on partial episode payments (PEPs). The Medicare Claims Processing Manual defines a PEP as “a reduced episode payment that may be made based on the number of service days in an episode (always less than 60 days, employed in cases of transfers or discharges with readmissions).” The approved home health issue is described below.

Incorrect billing of home health partial episode payment claims. Incorrect billing of home health PEP claims identified with a discharge status 06 and another home health claim was not billed within 60 days of the claim from date. Additionally, MCO effective dates are not within 60 days of the PEP claim.

Home health agencies should be on high alert for RAC audits. In addition, providers may expect additional home health issues to be added for review in the future, including complex reviews.
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