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The Department of Health and Human Services (HHS) has issued a letter to health care providers to ensure that they are aware of their ability under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to take action, consistent with their ethical standards or other legal obligations, to disclose necessary information about a patient to law enforcement, family members of the patient, or other persons, when they believe the patient presents a serious danger to himself or other people.

In the letter, HHS describes the HIPPA Privacy Rule as requiring a careful balance between protecting the patients’ privacy and ensuring the safety of the patient and others. In general, the Privacy Rule requires providers to protect the privacy of the patients’ health information. However, an exception is created when a health care provider believes in good faith that a warning is necessary to prevent or lessen a serious and imminent threat to the health or safety of the patient or others. A provider is presumed to have a good faith belief if his or her belief is based on the provider’s actual knowledge, such as through the provider’s interactions with the patient, or when the provider is relying on a credible representation by a person with apparent knowledge or authority, such as a credible family member of the patient.

If a health care provider does believe in good faith that a warning is necessary to prevent a serious and imminent threat to the health or safety of the patient or others, then the Privacy Rule allows the provider to alert those persons whom the provider believes are reasonably able to prevent or lessen the threat. In alerting such persons, the provider may disclose patient information, including information from mental health records, if necessary. Furthermore, persons “reasonably able to prevent or lessen the threat” may include police officers, the patient’s family members, or even campus security or administration.
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The American Taxpayer Relief Act of 2012, which became law on January 3, 2013, and is more widely known for addressing the fiscal cliff, also included a less publicized provision which changes the lookback period in the “Provider Without Fault” provisions of the Social Security Act from three years to five years. This provision is important for providers who are defending a Medicare audit. This provision previously provided that, absent evidence to the contrary, providers would be deemed to be “without fault” if an overpayment is discovered more than three years after it was paid. Thus, this provision could often be used as a defense in Medicare audits where the claims at issue were discovered more than three years prior to the audit results letter (although the “absent evidence to the contrary” language was sometimes difficult to overcome). The American Taxpayer Relief Act of 2012 in Section 638 amends section 1870 of the Social Security to allow CMS a five year reopening period.

This provision appears to have been included in the Act in response to the Office of Inspector General’s (OIG) assertions that the three year lookback period was an obstacle to overpayment recovery.

Providers should note that other provisions of the “Provider Without Fault” language in section 1870 of the Social Security Act may still present a viable defense to the extent that the provider complied with all pertinent regulations, made full disclosure of all material facts, and on the basis of the information available, had a reasonable basis for assuming that the payment was correct.
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According to the latest figures released by the Centers for Medicare and Medicaid Services (CMS), Recovery Audit Contractors (RACs) corrected a total of $2.4 billion in improper payments in fiscal year (FY) 2012, of which $2.29 billion was attributable to overpayments collected and $109.4 million was from underpayments returned. The amount of total corrections in FY 2012 was an enormous increase from the $939.3 million in total corrections reported in FY 2011. Since October 2009, the RACs have corrected a total of $3.43 billion, of which roughly 92% has been attributable to overpayments collected.

Medical necessity of cardiovascular procedures was reported to be the top issue for overpayments in RAC regions A, B and C. In RAC region D, the top issue for overpayments was found to be minor surgery and other treatments billed as inpatient. The top RAC issues for underpayments were not provided by CMS.

If you need assistance in preparing for, or defending against RAC audits, or implementing a compliance program geared toward identifying and correcting potential risk areas related to RAC audits, please contact an experienced health care attorney at Wachler & Associates attorney at 248-544-0888.

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Recently, CGI Federal, the RAC for Region B, added two new home health issues to its CMS-approved issues list. In the past, RACs have primarily focused their attention on hospitals due to the high bounty they receive for correcting improper claims. However, as displayed in the 2011 RAC statement of work, CMS has directed RACs to begin pursuing other provider types beyond hospitals. The newly approved home health issues for Region B include:

  • No skilled service: To qualify for the home health benefit, a patient must need a skilled service. When a skilled service is needed, dependent services may also be covered. Dependent services are not covered for a patient who no longer needs a skilled service. Claims with no skilled service billed will be reviewed to determine whether the qualifying criteria of having an ongoing skilled service has been met.
  • Skilled nurse length of stay: Late episodes (third and later) receive increased payments, therefore payment incentives exist for extended home health care. Medicare covers skilled nursing services when they are reasonable and necessary. Extended nursing care for observation and assessment may not be covered. Claims for nursing services into the third episode and after will be reviewed to determine if all Medicare coverage criteria is met.

In addition to the new home health issues, CGI Federal also added two new issues targeting physicians in Region B, which include:

  • Incorrect Billing of Diagnosis Codes for Colonoscopy and Sigmoidoscopy: This is an automated review to ensure correct reporting of diagnosis codes for colonoscopy and sigmoidoscopy services.
  • Professional Trastuzumab Off-Label Uses: The purpose for this automated edit is to identify claims for Traztuzumab (Herceptin®) being used for off-label indications

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On November 8, 2012, the Centers for Medicare and Medicaid Services (CMS) released its final rule updating the home health prospective payment system for calendar year 2013. In particular, the final rule provides CMS with new options for surveying and sanctioning home health agencies (HHAs). According to the final rule, HHAs will be subject to a standard survey at least once every 36 months, which will be unannounced and performed by the state agency or an accrediting organization. The standard survey’s objective is to review the HHA’s compliance with a select number of conditions of participation (CoP). In addition to the standard survey, HHAs will be subject to a variety of other surveys, which include:

  • Abbreviated standard survey: similar to the standard survey, but concentrates on a smaller number of CoPs determined to be an area of concern; conducted within two months of a specific concern, receipt of complaints, or change in ownership.
  • Extended survey: used to ensure compliance with additional CoPs that were not surveyed in the standard survey, or to review certain policies and procedures in which the surveyors determined the HHA provided substandard care.
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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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