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Recently, the Centers for Medicare and Medicaid Services (CMS) released an MLN Matters article stressing the importance of providers preparing and maintaining legible medical record documentation. CMS contractors are required to deny a provider’s claim for repayment if the item or service is not reasonable and medically necessary. Submitting legible medical documentation is critical because CMS review contractors are required to rely on the submitted documentation when determining the medical necessity of the billed item or service.

When submitting medical record documentation to support a claim for payment, providers should ensure that the medical records are complete and legible. In addition, the medical records should include the legible identity of the provider and the date of service. In connection with submitting documents that contain amendments, corrections or delayed entries, CMS specified that providers must comply with the following principles: (1) any amendments, corrections or addenda must be clearly and permanently identified; (2) the author and date must be clearly indicated; and (3) all original content must be clearly identified.

Medicare also requires that providers properly authenticate any service ordered or provided. Such authentication is achieved by including the author’s signature, which can be handwritten or electronic. Contractors will disregard any order in which a signature is missing and will continue their review of the medical record as if the order was never received. When reviewing medical documentation that is not an order, the contractor will consider evidence in a signature log or attestation statement to determine the author’s identity when the original documentation is missing or illegible. However, contractors will not take into consideration a signature attestation for orders.

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Recently, the Office of Inspector General (OIG) released a report focusing on various areas of concerns pertaining to Medicare appeals at the Administrative Law Judge (ALJ) level. In 2005, the responsibility for conducting ALJ appeals was transferred from the Social Security Administration to the Department of Health and Human Services (HHS). Upon this transfer, HHS established the Office of Medicare Hearings and Appeals (OMHA) which formed a group of ALJs committed to deciding Medicare appeals. In addition, ALJs were required to follow new regulations that addressed the application of Medicare policies, acceptance of new evidence, and the participation of the Centers for Medicare and Medicaid Services (CMS) in the appeals. In its report, the OIG assessed the impact of these changes on ALJ appeals by gathering and analyzing appeals data from fiscal year (FY) 2010.

The report contains several findings in which the OIG determined to be significant. For instance, the OIG found that 85 percent of all appeals decided by ALJs in FY 2010 were filed by providers, compared to 11 percent filed by beneficiaries and 3 percent filed by State Medicaid agencies. Moreover, the OIG found that a small subset of these providers were frequent filers, accounting for nearly one-third of all appeals.

The OIG also found that ALJs reversed prior-level appeals and granted fully favorable decisions to appellants 56 percent of the time. Meanwhile, Qualified Independent Contractors (QICs) decided fully in favor of appellants in only 20 percent of appeals. The OIG determined that these differences in fully favorable decisions were due to a number of key factors. One factor was the tendency of ALJs to interpret Medicare policies less strictly than QICs, finding that ALJs often granted fully favorable decisions when the intent of a Medicare policy was met, rather than the strict letter of the policy, whereas QICs strived to follow Medicare policies more strictly. Another reason stated in the OIG’s report for the favorable outcome disparity was due to the difference in the degree of specialization in Medicare program areas between ALJs and QICs. Each of the QICs specialize in a particular Medicare program area (e.g. Part A, Part B and DMEOPS appeals), while ALJs receive randomly assigned appeals that involve all Medicare program areas.

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On November 1, 2012, the Centers for Medicare and Medicaid Services (CMS) published its final rule detailing the durable medical equipment (DME) face-to-face encounter requirements. In response to the various comments submitted, CMS made several key revisions to the proposed rule that was released on July 6, 2012.

The DME face-to-face encounter final rule requires that a physician, physician assistant, nurse practitioner or clinical nurse specialist perform a face-to-face encounter as a condition of payment for certain DME items. Even though the face-to-face encounter may be performed by any of these practitioners, the encounter must be documented by the physician in order for the supplier to receive payment.

In its final rule, CMS states that the requirements contained in the final rule will only apply to new orders written on or after the effective date (i.e. the rule will not be applied retroactively to orders already written). The effective date for this provision is July 1, 2013, which CMS believes will give suppliers sufficient time to implement the new policy.
In addition, the final rule also made changes to the face-to-face timing requirements, which include: (1) the face-to-face encounter must occur within the 6 months preceding the written order, which is an expansion from the original requirement of 3 months; and (2) the option to perform the face-to-face encounter 30 days after the written order has been removed from the rule. Furthermore, Medicare beneficiaries discharged from a hospital do not need to receive a separate face-to-face encounter, so long as the physician or treating practitioner issues the DME order within 6 months after the date in which beneficiary was discharged from the hospital.

The final rule also states that for DME items that do not require written orders before delivery, verbal orders are sufficient for the supplier to dispense DME; however, the supplier must obtain written orders prior to submitting a claim for payment. In contrast, for DME items that do require written orders before delivery, the supplier must have the written order, including the face-to-face documentation, prior to delivery when submitting a claim for payment.

Finally, CMS removed the proposed requirement that DME orders include “necessary and proper usage instructions” and the diagnosis. However, CMS still expects to see related diagnoses included in the beneficiary’s medical records and expects suppliers to continue to provide instructions to the beneficiary or care giver for proper usage of the DME item.
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On November 1, 2012, the American Hospital Association (AHA), along with four hospitals, filed a lawsuit against the U.S. Department of Health and Human Services (HHS) in the U.S. District Court for the District of Columbia. The lawsuit, which names as the defendant Kathleen Sebelius in her official capacity as the Secretary of HHS, alleges that the Medicare program has engaged in an unlawful government practice in its refusal to reimburse hospitals for full Part B reimbursement where an Part A inpatient admission is denied by a Recovery Audit Contractor because the inpatient services were provided in the wrong setting, i.e. the services should have been provided in an outpatient setting.

Since the Recovery Audit Contractor Demonstration Program, Wachler & Associates has worked with the AHA to play an active role in the efforts to obtain full Part B reimbursement for hospitals with Part A inpatient admissions denied as not medically necessary by Recovery Audit Contractors (RACs). From our own experience, we have obtained success on behalf of our hospital clients through the administrative law judge hearing stage of appeal. Many administrative law judges have recognized that hospitals are entitled to full Part B reimbursement where inpatient admissions are denied as not medically necessary. As such, administrative law judges specifically order full Part B reimbursement for hospitals. The roadblock following ALJs orders, however, was that Medicare Administrative Contractors (MACs) would refuse to effectuate payment. In an almost ironic turn of events, in a July 13, 2012 memorandum that our firm obtained from a MAC, the Centers for Medicare & Medicaid Services (CMS), while professing that it still believed that hospitals were not entitled to full Part B reimbursement in these situations, directed all MACs and other fiscal intermediary contractors to effectuate ALJ orders for full Part B reimbursement. Although CMS’s July 13 memorandum was promising for hospitals with ALJ orders for full Part B reimbursement, the fact remains that to obtain an ALJ order for full Part B reimbursement a hospital must proceed through the arduous Medicare appeals process. Therefore, the lawsuit recently filed by the AHA is an important step towards challenging the core of CMS’s policy that hospitals are not entitled to full Part B reimbursement where an impatient admission is denied because the services were provided in the wrong setting.

The lawsuit filed by the AHA alleges that CMS’s policy against full Part B reimbursement, or as coined in the complaint CMS’s “Payment Denial Policy”, violates requirements of the Federal Administrative Procedures Act as well as the requirement in the Medicare Act to pay for medically necessary hospital services. The complaint, released today by the AHA, articulately outlines CMS’s refusal to provide hospitals with full Part B reimbursement and the effect CMS’ refusal has on hospitals and patient care. The complaint states, “CMS simply refuses to pay hospitals for services that it acknowledges are covered under Medicare Part B and that it acknowledges were reasonable and necessary in the particular case.” The complaint continues, “[b]oth the uncertainty and the actual loss of Medicare funds ultimately may adversely affect patient care.” Furthermore, AHA’s complaint also accurately explains the uncertainty of CMS’s exact justification for its “Payment Denial Policy.” The complaint states that CMS has made no effort to articulate a statutory justification or any justification for its policy.

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A proposed settlement agreement was filed in the federal District Court of Vermont on October 16, 2012 which, if approved, would clarify Medicare coverage for beneficiaries of skilled nursing facilities (SNFs), home health services (HH), and outpatient therapy services (OPT).

Jimmo v Sebelius.pdf

The settlement proposal is the result of Jimmo v. Sebelius, a class action lawsuit brought by a class of Medicare beneficiaries that challenges Medicare contractors’ consistent denials of home health services provided to Medicare beneficiaries because a beneficiary’s condition failed to improve or did not have the possibility for improvement. The home health provider community and Medicare beneficiary supporters have consistently advocated that Medicare contractors’ denial of home health services based on the alleged “improvement standard” was inconsistent with Medicare policy and regulations. The class action lawsuit challenged the “improvement standard” arguing that medically necessary home health services may be provided to Medicare beneficiaries with chronic conditions because although their conditions may not “improve,” the home health services will prevent the beneficiaries from deteriorating further. The proposed settlement, filed in October, includes provisions that would require the Centers for Medicare & Medicaid Services (CMS) to not only revise portions of the Medicare Manuals to clarify that an “improvement” requirement does not exist for medically necessary home health services, but to also educate Medicare contractors and other reviewers on the appropriate standards to apply when reviewing home health services.

Among the provisions of the settlement proposal are revisions to the Medicare Benefit Policy Manual. Revisions would be made to chapters 7, 8, and 15 of the manual, and would clarify coverage standards for SNF, HH, and OPT care to cover patients that have no improvement potential, but still need maintenance care in their current state of health. The clarified standards would allow for coverage of skilled SNF, HH, and OPT services for maintenance of a patient’s condition even if there is no restoration or improvement potential. Currently, most Medicare contractors consistently deny coverage for home health services that are provided to beneficiaries with no restoration or improvement potential. In addition to the revisions to the Medicare manuals, the proposed settlement would include two review periods for the plaintiffs to review changes to the Medicare Benefit Policy Manual before any of the terms are implemented as rules in the Medicare manuals. During the two review periods, 21 and 14 days respectively, Plaintiffs would be allowed to provide comments and suggestions which the Centers for Medicare and Medicaid Services (CMS) must make a good faith effort to utilize.

CMS would also be required under the settlement agreement to engage in an educational campaign about the revisions for providers, suppliers, and contractors. The campaign would include written materials communicated via MLN Matters articles and program transmittals, as well as changes to CMS call center customer service scripts.

In addition to the educational materials, the settlement would also require CMS to hold an open door forum on the manual revisions, as well as hold two national calls. The two national calls, one for providers & suppliers and one for contractors & adjudicators, would communicate the policy clarifications related to the revisions.

The proposed settlement, if approved, would have a major impact on home health providers and Medicare beneficiaries. Consistently during the Medicare appeals process, on behalf of our clients we have advocated against Medicare contractors’ improper denial of home health services because the beneficiary did not “improve” during the certification period. Although we have experienced some success on behalf of our clients, particularly at the Administrative Law Judge hearing stage of appeal, the inconsistent standards applied by lower level Medicare contractors meant that our clients were forced to spend their time and resources appealing improper claim denials. If approved, the proposed settlement could eliminate inconsistent decisions and help facilitate home health care providers’ reimbursement for medically necessary services.
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The American Hospital Association (AHA) sent a letter to the Department of Health and Human Services Inspector General Daniel Levinson on October 24, 2012, urging the Office of Inspector General (OIG) to focus on inappropriate claim denials by Recovery Audit Contractors (RACs). The letter stresses that RAC effectiveness needs to be evaluated and integrity programs need to be streamlined.

According to the AHA’s RACTrac survey data, seventy-five percent of appealed RAC denials are reversed. The AHA asserts that because the RACs are paid on a contingency fee basis, there is a strong financial incentive to deny more claims and increase contingency payments. The implication is that RACs are not monitored effectively and are thus allowed to inappropriately deny claims to increase contingency payments. The letter explicitly states that, “[d]enying payment for an entire inpatient stay is far more lucrative for the contractors than identifying an incorrect payment amount or an unnecessary medical service.”

The AHA further urges that more provider education is needed to improve the rates of payment errors. According to the RACTrac survey, more than half of the respondents indicated that they have received no education from the Centers for Medicare and Medicaid Services (CMS) on avoiding payment errors. The letter stresses that program integrity could be strengthened with provider education.
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Representatives Sam Graves (R-MO), Todd Akin (R-MO), Billy Long (R-MO), and Adam Schiff (D-CA) introduced a bill to Congress on October 16, 2012 which proposes to reduce the Medicare contractor audit burden on hospitals. The bill, called the Medicare Audit Improvement Act of 2012 (Act), proposes changes to the ways contractors may conduct audits and imposes additional requirements on contractors.

Medicare Audit Improvement Act of 2012.pdf

Among the requirements introduced in the Act are limits to the amount of additional documentation a Medicare contractor may request for complex pre-payment audits and complex post-payment audits. The Act would limit the additional documentation requests for hospitals’ Part A claims to the lesser of 2 percent of those claims for the year, or 500 additional documentation requests during any 45 day period.

The Act also proposes penalties for contractors that fail to maintain compliance with Medicare program requirements. Specifically, the Act calls for financial penalties when a contractor fails to complete an audit determination within the applicable timeframes, and when a contractor fails to provide communication in a timely manner regarding claim denials and appeals. Further, the Act proposes to impose financial penalties for appeals which are overturned. When a party successfully appeals a claim denial, the Act would require the contractor to pay a monetary penalty to the party that prevailed in the appeal. This aspect of the Act is notable given the number of claim denials, particularly in the area of short-stay inpatient admissions, that are overturned at the ALJ level of appeal.

Medical necessity audits are also addressed by the Act. Under the Act, pre-payment and post-payment medical necessity audits would only be allowed if it addresses a widespread payment error rate. A widespread payment error rate is defined in the Act as a 40 percent payment error rate as determined by a significant sampling of claims submitted, adjusted to take into account claim denials overturned on appeal. Also, the Act calls for a restoration of due process rights under the AB Rebilling Demonstration Program. This mean that the Centers for Medicare and Medicaid Services (CMS) could not require providers in the demonstration project to waive their right to the appeals process for inpatient claim denials which, under the demonstration, could then be re-billed under Medicare Part B for 90 percent of the Part B payment.

Contractors would also be required to publish performance data under the Act. Contractors would be required to publish data each year on:

• the aggregate number of audits conducted,

• the aggregate number of denials for each audit type,

• denial rates,

• the aggregate number of appeals filed by providers,

• the aggregate rate of appeals, and

• the appeal outcomes at each stage of appeal.

Additionally, publication of performance evaluations of contractors performed by independent entities, including error rates, would be required.
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The Region D Recovery Audit Contractor (RAC), HealthDataInsights (HDI), has posted a new issue which states that it will begin pre-payment review of medical necessity for MS-DRG 312 (syncope and collapse). The issue is part of the pre-payment review demonstration program, and is the first approved issue posted as part of the program.

HDI posted the issue for all Region D states, but the pre-payment review program has only been approved by the Centers for Medicare and Medicaid Services (CMS) for 11 states: California, Florida, Illinois, Louisiana, Michigan, Missouri, New York, North Carolina, Ohio, Pennsylvania, and Texas.

CMS intends the pre-payment review demonstration program to prevent improper payments and lower the payment error rate. The program will focus on claims with high improper payment rates. The program will be concurrent with MAC pre-payment review programs, but CMS has advised that the contractors will make efforts to coordinate in order to prevent duplicate review of the same claims.
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Each year, the Department of Health and Human Services Office of Inspector General (OIG) releases a Work Plan for the upcoming fiscal year. The Work Plan outlines reviews and activities that the OIG plans to conduct in the upcoming fiscal year, and shows the current OIG areas of focus. On October 3, 2012, the OIG released its Work Plan for fiscal year 2013.

According to the 2013 OIG Work Plan, the OIG will continue to look into physician-owned distributorships (PODs). The Work Plan states that the OIG will review the high utilization of orthopedic spinal implants, and to what extent physician-owned distributors provide the implants to hospitals associated with high utilization. The review will also address potential conflicts of interest and patient safety concerns posed by the physician-owned distributors.

This continued focus on PODs is consistent with the OIG’s response to the Senate Finance Committee’s Letter setting forth its concerns regarding the risk of Medicare program abuse associated with PODs, which we previously blogged about here.

In light of this increased scrutiny, PODs should carefully review the legality of their structure, as well as the impact on utilization by physicians associated with the POD, with the understanding that a high utilization will cause the POD to undergo increased scrutiny by the OIG.
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Editor’s Note: This is part of a week long series exploring the impact of the OIG 2013 Work Plan on different types of providers and organizations.

On October 3, 2012 the Department of Health and Human Services Office of Inspector General (OIG) released its Work Plan for fiscal year 2013. Among the new issues the Work Plan outlines are issues that will affect Durable Medical Equipment (DME) suppliers. The Work Plan states that the OIG will examine:

Quality Standards–Accreditation of Medical Equipment Suppliers:
The OIG will review accreditation organizations’ procedures for the accreditation of medical equipment suppliers. Medicare has a series of quality standards to which medical equipment suppliers must comply. Accreditation organization procedures must ensure that all medical equipment suppliers they accredit meet the Medicare quality standards. The OIG review will also examine CMS validation surveys which are intended to monitor accreditation organization procedures.

Lower Limb Prostheses–Supplier Compliance with Payment Requirements:
The OIG will examine Medicare payments to medical equipment suppliers for lower limb prosthetics to ensure that Medicare requirements were met. Providers must furnish, upon request, information to determine amounts due. This can include documentation showing that the order was reasonable and necessary. In past reviews, the OIG has found claims submitted by suppliers with deficiencies in documentation, including claims for beneficiaries with no orders from a referring physician.

DME suppliers should also be aware of other issues that appear in the Work Plan. These include:

• Power Mobility Devices–Supplier Compliance With Payment Requirements • Vacuum Erection Systems–Reasonableness of Medicare’s Fee Schedule Amounts Compared to Amounts Paid by Other Payers • Continuous Positive Airway Pressure Supplies–Reasonableness of Medicare’s Replacement of Supplies Compared to That of Other Federal Programs • Diabetes Testing Supplies–Improper Supplier Billing for Test Strips in Competitive Bidding Areas • Diabetes Testing Supplies–Supplier Compliance With Requirements for Non-Mail-Order Claims • Medical Equipment and Supplies–Potential Savings From the Competitive Bidding Program • Medical Equipment and Supplies–Opportunities To Reduce Medicaid Payment Rates for Selected Items

DME suppliers should be prepared that the identification and review of these issues may lead to additional focus by CMS and its contractors. Compliance plans can be effective measures to help DME suppliers to proactively prepare for increased scrutiny from CMS contractors.
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