OIG: Physician/Lab Arrangement Could Implicate Health Care Fraud and Abuse Laws
The OIG voiced additional concern over potentially improper and abusive marketing activities that may occur under the arrangement in that the laboratory company would have access to the physician's patients' information, and would thereby have the opportunity to encourage the physician to order medically unnecessary tests. The OIG stated that this would be considered suspect marketing activity.
For more information on this article or the OIG Advisory Opinion, please contact Leigh Ann O'Neill at 317-238-6346.
Indiana DCS Publishes Residential Provider Manual
- Errors have been made in the cost report submitted to the department, calculation of the rate, or the determination by the department of the reasonableness of any cost; or,
- The determination of the rate by the department has an adverse impact on child welfare in Indiana and no other residential provider in the State of Indiana, or other licensed provider, can adequately address the adverse impact to child welfare in the State of Indiana.
- Identification of the current rate and approved new rate, as applicable to a specific program or service offered by the residential provider;
- An updated or revised cost report for the applicable program or service, including an itemized statement of administrative and indirect costs that the residential provider considers allowable under the provisions of this rule;
- A clear, concise statement of the reasons for the requested change; and
- A detailed statement of related information in support of the change.
The administrative appeal request must be submitted on the DCS form, Residential Treatment Services Provider and Child Placing Agency Rates Administrative Appeal Request (available here). An administrative appeal against DCS will be conducted under applicable provisions of the Administrative Orders and Procedures Act. The residential provider will have the burden of proving that, by a preponderance of the evidence, DCS’ decision following the administrative review was erroneous. Two (2) or more separate appeals with the same or substantially the same facts may be consolidated by the administrative law judge into one appeal. During the period of a review or an appeal, DCS will pay the rate stated in the most recent letter mailed to the provider. If a new rate is established during the review or appeal, the new rate will be applied retroactively to the effective date stated in the original rate notification letter. Any rates already paid will be adjusted up or down.
If you have questions regarding the Manual, or would like assistance with requesting a review of your DCS residential rate, please contact Leigh Ann Lauth O'Neill at 317-238-6346.
Accountable Care Organizations Final Rule Released
The official version of the final rule will be published in the Federal Register on November 2, 2011, at which time it is expected that the Innovation Center will officially launch its Advance Payment Model program, which is aimed at determining if pre-payment of a portion of future shared savings might spur ACO participation. Information on the Advances Payment Model program can be found here.
For more information on the Final Rule, please contact one of our health care reform lawyers, Leigh Ann O'Neill or Tom Neal.
ASC Notice Rule Eased
If you have questions about this article, or about other ASC compliance requirements, please contact Leigh Ann Lauth O'Neill at 317-238-6346.
IOM Publishes Criteria for Essential Benefits Development
• Ambulatory patient services
• Emergency services
• Hospitalization
• Maternity and newborn care
• Mental health and substance use disorder services, including behavioral health treatment
• Prescription drugs
• Rehabilitative and habilitative services and devices
• Laboratory services
• Preventive and wellness services and chronic disease management.
• Pediatric services, including oral and vision care.
However, when it comes to specific items and services that will be included in the definition of "essential health benefits," the Department of Health and Human Services is required to promulgate a rule. As one might imagine, this particular rule includes highly political issues, and it is speculated that a proposed rule may not be published until after the 2012 election.
Until then, HHS has requested the Institute of Medicine (IOM) to assist in this rulemaking process by proposing a set of criteria and methods that should be used in deciding what benefits are most important for coverage as essential health benefits. The IOM Released its report on Oct. 6, 2011: Essential Health Benefits: Balancing Coverage and Costs. In this report, the IOM recommended the following criteria to guide essential health benefit content on specific components:
• Be safe—expected benefits should be greater than expected harms.
• Be medically effective and supported by a sufficient evidence base, or in the absence of evidence on effectiveness, a credible standard of care is used.
• Demonstrate meaningful improvement in outcomes over current effective services/treatments.
• Be a medical service, not serving primarily a social or educational function.
• Be cost effective, so that the health gain for individual and population health is sufficient to justify the additional cost to taxpayers and consumers.
The IOM also suggested the following caveats:
• Failure to meet any of the criteria should result in exclusion or significant limits on coverage.
• Each component would still be subject to the criteria for assembling the aggregate EHB package.
• Inclusion does not mean that it is appropriate for every person to receive every component.
While the IOM's report does not shed enormous light on which items and services might ultimately be included as "essential health benefits," the direction the IOM has provided to HHS is useful. If you have questions regarding the IOM report, or other health reform issues, please contact one of our health reform lawyers, Leigh Ann O'Neill at 317-238-6346.
Increased FMAP Available for Non-Institutional Long Term Services
Increased payments to states under this program will run from October 1, 2011 through September 30, 2015, and the total expenditures cannot exceed $3 billion. In order to obtain the increased FMAP rates, a State must apply for this program.
Medicaid RAC Rule Finalized
On September 16, 2001, the Centers for Medicare and Medicaid Services finalized the rule that will implement the health care fraud and abuse program. The Final Rule "provides guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs) and the payment methodology for State payments to Medicaid RACs." While the framework for the Medicaid RAC program was established in the corresponding proposed rule, the Final Rule sets forth the following important points:
- States may exclude Medicaid managed care claims from review by Medicaid RACs
- States must coordinate the recovery audit efforts of their Medicaid RACs with other auditing entities
- States must set limits on the number and frequency of medical records to be reviewed by the Medicaid RACs subject to requests for exceptions made by the RACs
- RACs must not review claims that are older than 3 years from the date of the claim, unless it receives approval from the State
- RACs should not audit claims that have already been audited or that are currently being audited by another entity
- If a provider appeals a Medicaid RAC overpayment determination and the determination is reversed, at any level, then the Medicaid RAC must return its contingency within a reasonable timeframe as prescribed by the State
- States must adequately incentivize the detection of underpayments and States must notify providers of underpayments that are identified by the Medicaid RACs
- States must provide appeal rights under State law or administrative procedures to Medicaid providers that seek review of an adverse Medicaid RAC determination
For more information regarding the Medicaid RAC program and the Final Rule, please contact Leigh Ann O'Neill.
Obama Proposes Deficit Cuts: Includes Medicare and Medicaid Savings
On September 19, 2011 the President proposed a plan that would include $320 billion in health care spending cuts. As part of the plan, the President proposes to cut Medicare spending by $248 billion and Medicaid spending by $72 billion over the next 10 years. While the President pledges not to cut benefits for individuals receiving Medicare and Medicaid assistance, the plan would affect the payments for drug companies, hospitals, nursing home facilities, and home health agencies. The plan would heighten efforts to curb fraud and abuse expenses, and the White House claims such efforts would be partially responsible for $224 billion in savings from reducing overpayments. Additionally, the plan would increase costs for new Medicare beneficiaries by imposing higher Part B deductibles and introducing cost-sharing for home health services.
HHS Announces $700 Million in Health Center Grants
- One makes $600 million available to "existing health centers across the country for longer-term projects to expand their facilities, hire more employees and serve more patients."
- The other makes $100 million available and "emphasizes shorter-term projects and will provide [funding] to existing health centers to address immediate facility needs."
PPACA Payment Bundling Program Announced
HHS is seeking applications for payment bundling programs, giving the applicants flexibility in determining which episodes of care and which services will be covered by the bundled payment. In order to apply, providers should start by visiting the Center for Medicare and Medicaid Innovation.
If you have questions about this article, or about the payment bundling program, please contact one of our health care reform lawyers, Leigh Ann O'Neill at 317-238-6346.
Final Rule to Impact Hospice and Long Term Care Payments
On August 5, 2011, the Department of Health and Human Services published its Final Rule implementing section 3004 of the Patient Protection and Affordable Care Act ("PPACA"). The Final Rule will impact long term care rates. Specifically, this Section requires Long Term Care Hospitals (LTCHs), Inpatient Rehabilitation Hospitals (IRHs), and Hospice programs to submit certain quality measures information for rate year 2014 and subsequent rate years. Failure to submit the required information will result in a reduction, by 2%, of the annual update to a standard Federal Medicare rate for discharges applicable to LTCHs and IRHs, and an update to the annual Medicare market basket applicable to Hospice programs.
The Final Rule adopts the first of two quality measures that must be reported beginning in 2014:
(1) Urinary Catheter-Associated Urinary Tract Infections (CAUTI); and
(2) Pressure Ulcers that are New or Have Worsened.
Additionally, the Final Rule also discusses a third measure that HHS is currently developing and intends to propose to adopt for FY 2014 in future rulemaking. That measure will be the 30-day Comprehensive All-Cause Risk-Standardized Readmission Measure.
If you have questions about the Final Rule or other health care payment reform issues, please contact one of our health care reform lawyers, Leigh Ann O'Neill, or visit us at Health Reform Connect.
An Update on Reporting of Crimes in Long Term Care Facilities
Further guidance to be published
CMS is expected issue additional guidance in the form of FAQs that will address some often asked questions about the implementation of the Memorandum. CMS is also expected to release a sample poster that LTCs may use for purposes of notifying individuals of their reporting obligations under the new requirements. Unfortunately, the CMS guidance is not expected to clarify certain grey areas of the reporting requirement such as what constitutes "reasonable suspicion" or who qualifies as a "contractor" of a LTC, which in turn requires that person (the contractor) to make a report if he or she forms a reasonable suspicion of a crime.
Indiana’s long term care trade associations, including the Indiana Health Care Association ("IHCA"), met the ISDH in mid-July to discuss the department’s implementation of the Memorandum. Due to the variety of questions that have been asked of the ISDH regarding implementation, the department intends to issue guidance regarding their enforcement of the new requirements. The ISDH is working on revisions to the Facility Incident Reporting Form in order to allow individuals (or facilities if making a group report; see Krieg DeVault Health Care Alert or the Memorandum regarding group reporting) to use that form when reporting reasonable suspicions of crimes to the ISDH.
Since the trade association with the ISDH in mid-July, the IHCA has followed-up with the ISDH to request specific items to be addressed in ISDH issued guidance. Such items include clarifying the definition of "crime" and "reasonable suspicion," clarifying when and on what basis LTCs can rely upon local law enforcement definitions/interpretations of "crime" and "reasonable suspicion," clarifying what documentation the ISDH will require LTCs to maintain in order to verify reports of crimes to local law enforcement, and an explanation on ISDH enforcement of alleged violations of the reporting requirement. While further guidance from the ISDH is expected, a timetable for such guidance has not yet been set.
The ISDH also recently had a meeting with the Indiana Attorney General’s ("AG") office to discuss in an attempt to gain the AG’s interest in clarifying ambiguities in the reporting requirement for Indiana’s providers. Attorneys General in other states have been interested in helping define ambiguities in the reporting requirement and assist with education of local law enforcement partners.
Lastly, both the IHCA and ISDH have reached out to the Indiana Sherriff’s Association and the Indiana Association of Chiefs of Police to alert their members to the new reporting requirement. Early communication with each of these law enforcement associations should help with the local understanding of the new reporting requirements. On August 1, 2011 the ISDH sent a letter to the above named law enforcement associations regarding the new reporting requirement (click here for a copy of the ISDH letter).
Recommendations
LTC facilities should immediately develop policies and procedures implementing the crimes reporting requirements. Though enforcement of the requirements is not expected to begin immediately, necessary drafting of policies, and training of covered individuals will take time.
Training of covered individuals (owners, operators, employees, managers, agents or contractors of the facility) regarding their individual duty under the requirement is critical. Each facility will want to be sure that each covered individual understands his/her responsibility, how to make a report, how to join a group report if a group report is being made, that the individual is are not to be retaliated against for making a report to the ISDH or local law enforcement and if retaliation occurs how the individual can make a report regarding such retaliation.
LTC facilities are encouraged to reach out to their local law enforcement agency, either the county sheriff or city/town police, as applicable, regarding communication of reports. Facilities should also consider engaging local law enforcement agencies further to request their assistance in helping training facility staff about what constitutes a "crime" and the concept of "reasonable suspicion."
If you have any questions about the crime reporting requirements, please contact Zach Cattell at 317-636-4341 or Leigh Ann O’Neill at 317-238-6346.
PT Billing for Medicare Home Health Patients
A couple of exceptions must be noted: the following services, although they may be included in the home health plan of care, are to be billed separately:
- Osteoporosis drugs (although the cost of administration is within the PPS rate); and
- Durable medical equipment, including prosthetics, orthotics, and oxygen
PPACA CO-OP Proposed Rule Published
On July 20th, the Department of Health and Human Services published its proposed rule under section 1132 of the Patient Protection and Affordable Care Act ("PPACA") regarding the "Establishment of Consumer Operated and Oriented Plan (CO–OP) Program." It is the purpose of the CO-OP program to foster the creation of qualified nonprofit health insurance issuers to offer qualified health plans in the individual and small group markets in the States in which the issuers are licensed to offer such plans. Under this section the Secretary of the Department of Health and Human Services will provide loans and grants to persons wanting to establish a qualified nonprofit health insurance company that would offer qualified health plans. In awarding such grants and loans, the Secretary must: 2) take into account the recommendations of the advisory board established under this section; 2) give priority to applicants that will offer qualified health plans on a Statewide basis, will utilize integrated care models, and have significant private support; and 3) ensure that there is sufficient funding to establish at least 1 qualified nonprofit health insurance issuer in each State, except that this requirement shall prohibit the Secretary from funding the establishment of multiple qualified nonprofit health insurance issuers in any State if the funding is sufficient to do so.
For more information on the proposed rule, or anything relate to health care reform, please visit us at Health Reform Connect, or contact one of our health care reform lawyers, Leigh Ann O'Neill at 317-238-6346.Nursing Home Facilities Demonstration on the Horizon
"Starting this fall, CMS will competitively select independent organizations to partner with and implement evidence-based interventions at interested nursing facilities. These interventions could include using nurse practitioners in nursing facilities, supporting transitions between hospitals and nursing facilities, and implementing best practices to prevent falls, pressure ulcers, urinary tract infections, or other events that lead to poor health outcomes and expensive hospitalizations."
To learn more about the upcoming demonstration project, click here or contact one of our health care reform lawyers, Leigh Ann O'Neill at 317-238-6346.First of Multiple Exchange Rules Published
- How States are to go about establishing their Exchange (if they elect to do so, rather than defer to the Federal government to operate an Exchange on their behalf);
- Minimum requirements that health insurers must meet to participate in the Exchange and to offer qualified health plans (QHPs);
- Basic standards that employers must meet to participate in the Small Business Health Options Program.
6th Circuit Upholds Individual Mandate
"By regulating the practice of self-insuring for the cost of health care delivery, the minimum coverage provision is facially constitutional under the Commerce Clause for two independent reasons. First, the provision regulates economic activity that Congress had a rational basis to believe has substantial effects on interstate commerce. In addition, Congress had a rational basis to believe that the provision was essential to its larger economic scheme reforming the interstate markets in health care and health insurance."
The 6th Circuit's decision is only one of many more to come- at least three other circuit cases are pending- one each in the 3rd, 4th, and 11th Circuits.
If you would like more information on this decision or on health reform in general, contact one of our health care reform lawyers, Leigh Ann O'Neill, at 317-238-6346.
Reporting of Crimes in Long Term Care Facilities
On June 17th, 2011, the Centers for Medicare and Medicaid Services (“CMS”) released Survey and Certification Memorandum 11-30-NH (the “Memorandum”) (for a copy click: S&C 11-30-NH) that provides guidance to State Survey Agencies (“SSA") regarding the reporting of reasonable suspicions of crimes in long term care facilities (“LTC”), also known as the “Section 1150B requirements.” The requirement for covered individuals to report suspicions of crimes in LTCs to the SSA and at least one law enforcement agency, as well as requirements on LTCs to notify covered individuals of their duty to report, all stem from the Elder Justice Act that was part of the Patient Protection and Affordable Care Act ("PPACA").
The Memorandum has been long expected by the LTC industry and by SSAs and serves as the only official guidance from CMS on the suspicion of crimes reporting requirement. CMS acknowledges that there are “no CMS regulations that apply specifically to section 1150B [the "reporting requirements]” and the Memorandum serves to explain the requirements of the new law so that it is implemented without any delay that may be caused due to the rule-making process. CMS notes further guidance will be released that addresses implementation of the Civil Monetary Penalty component of the Section 1150B requirements.
The reporting law applies to all LTC facilities that received at least $10,000 in annual federal funds during the preceding year. The Memorandum specifies that the reporting obligation applies to Nursing Facilities, Skilled Nursing Facilities, hospices that provide services in long-term care facilities and ICFs/MR. Based on the Memorandum it does not appear that CMS has interpreted Section 1150B to apply to assisted living facilities receiving Medicaid waiver funds. Under the new law, a covered long term care facility must:
1. Determine each year whether it received at least $10,000 in Federal funds in the preceding year;
2. Annually notify all covered individuals of the individual’s reporting obligation (covered individuals are owners, operators, employees, managers, agents or contractors of the facility);
3. Post a notice in appropriate and conspicuous locations for employees that details employees’ rights, including information on how to file a complaint with the SSA if an employee is retaliated against for making a report to the SSA pursuant to the reporting requirement;
4. Not retaliate against a covered individual who lawfully reports a reasonable suspicion of a crime under Section 1150B.
The Memorandum then goes on to discuss functions that will be executed by “[a] facility that effectively implements section 1150B,” which are:
1. Coordination with State and local law enforcement to determine what actions are considered crimes;
2. Review existing facility policies and procedures to ensure compliance with existing CMS and State requirements for reporting incidents and complaints (i.e. policies and procedures in place for reporting of abuse, neglect or misappropriation of resident property); and
3. Develop and maintain policies and procedures to ensure compliance with Section 1150B.
Civil Monetary Penalty and exclusion sanctions may apply to individuals who fail to comply with the reporting requirements, to LTC facilities that retaliate against an employee who makes a lawful report, and LTC facilities are ineligible to receive Federal funds for any period they employ an excluded individual due to certain violations of the new law.
Covered individuals (owners, operators, employees, managers, agents or contractors of the facility) are required to report reasonable suspicions of crimes to the SSA and at least one local law enforcement agency. The required reporting time period depends on whether the reasonable suspicion was based on events that result in serious bodily injury; these suspicions must be reported immediately and no later than 2 hours after the suspicion was formed. All other events giving rise to a reasonable suspicion of a crime must be reported no later than 24 hours after the suspicion was formed.
While each covered individual has the right and duty to report to the SSA and at least one local law enforcement agency, multiple covered individuals may file a single report that includes information about the suspected crime from each covered individual. Each covered individual that joins a multiple-person report should be specifically identified. A multiple-person report may be further supplemented with additional information should additional covered individuals become aware of the incident or events giving rise to a reasonable suspicion of a crime. Thought the multiple-person reporting mechanism may be instituted by a facility, a facility may not prohibit an individual from directly reporting to the SSA or a local law enforcement agency.
The Memorandum also provides SSAs with guidance on distinguishing between types of allegations that it may receive from covered individual reports. The allegation categories specified by CMS are (1) Events Giving Rise to a Suspected Crime; (2) Allegations of Individual Failure to Report; and (3) Allegations of Facility Failure to Comply with Section 1150B. In each case, if an SSA receives a report that falls into any of the above three categories, the SSA must assess the reported information and investigate based upon existing CMS policies and procedures for addressing complaints or incidents. Any deficiency citations issued will be ones that are currently specified in existing CMS regulations and guidance.
For example, the Memorandum states that an allegation that a covered individual did not report or were not informed of their duty to report could lead to a F226 tag (failure to develop and/or implement policies and procedures for reporting abuse/neglect) or an F493 tag (failure to develop and/or implement policies and procedures regarding management and operation of the facility).
The Memorandum expressly states that SSAs are to focus on “(a) the events giving rise to the reports made under this [Section 1150B] requirement and (b) the LTC facility’s responsibilities under existing CMS conditions and requirements to report incidents, prevent abuse or neglect, provide quality care and a safe environment, train staff, and similar duties of direct relevance to safety and quality of care.”
Bed-Hold Policies: What is required of Indiana’s Long Term Care Facilities?
Questions remain frequent among long term care providers in Indiana regarding facility-level impacts of the decision by the Indiana Office of Medicaid Policy and Planning (“OMPP”) to eliminate reimbursement for bed-hold days. The elimination of reimbursement for bed-holds was effective February 1, 2011 (For a copy of this bulletin, click here), and the Indiana Medicaid State Plan will be amended in the coming months to finalize elimination of reimbursement. OMPP has also posted, and periodically updated, a news summary on www.IndianaMedicaid.com that discusses the impact of the reimbursement changes on Indiana’s long term care facilities and their residents (Click here for the news summary).
More recently, requirements for long term care facilities to maintain updated bed-hold policies were discussed during a panel presentation at the 2011 Indiana Health Care Association's ("IHCA") Convention & Expo in May. In addition to the above OMPP-issued materials, the IHCA offers the following points for long term care facilities when developing bed-hold policies.
· Facilities must have a bed-hold policy that states whether or not the facility allows a resident to pay to hold a bed during a leave of absence
o Though facilities are not required to allow a resident to pay to hold a bed, facilities must still have a policy that states whether or not payment for holding a bed is permitted by the facility
· The duration of the bed-hold period must be clearly stated in the facility policy
· Bed-hold policies should state that Indiana Medicaid does not reimburse for bed-holds
· Payment by residents for bed-holds must follow applicable Medicare and Medicaid guidelines regarding billing for non-covered services
· Charges for bed-holds should be set at fair market value and must be equally applied to all residents regardless of payor source
o Facilities may be at risk for Anti-Kickback violations related to improper inducements to government program beneficiaries if charges for bed-holds are not fair market value and equal application of those charges are not maintained. However, an exception to the Anti-Kickback statute may apply in certain circumstances for bed-hold charges that are unable to be collected. This exception depends on certain elements regarding facility advertisements, other relevant services and financial need of the resident.
· If a resident on leave is expected to return to the facility, regardless of whether they have paid to hold a bed, the facility is not required to discharge the resident
· If a resident is discharged from a facility, however, the facility must permit the resident to return to the first available semi-private bed when (i) the resident continues to qualify for Medicaid, (ii) the resident requires nursing-level care and (iii) the facility is able to provide appropriate care for the resident.
o A resident may be discharged from the facility for many reasons including, but not limited to, the resident’s failure to pay for a bed-hold or when the bed-hold period expires. Facilities must follow applicable regulations and procedures when discharging a resident.
If you have questions about this article or about bed hold policies, please contact Zach Cattell at zcattell@ihca.org or 317-616-9001 or Leigh Ann O'Neill at 317-238-6346. .



