Articles Posted in Compliance

On July, 25, 2011, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) issued a favorable advisory opinion regarding an arrangement under which a company (Requestor), who provides administrative services to the State’s Medicaid program, will disburse pay-for-performance payments to physicians and dentists participating in the state’s Medical Home Program.

The Medical Home Program is the state’s enhanced primary care case management and disease management program for a number of Medicaid beneficiaries. Requestor, through a competitive bidding process, was awarded the contract to administer the disease management program on behalf of the state. The program includes a pay-for-performance program whereby Requestor is required to disburse checks, drawn from Requestor’s own bank account, to physicians and dentists who participate in the program. The payments are funded by the state’s Medicaid program, and Requestor has no discretion to revise the amount of the payments. Furthermore, the state clearly identifies itself as the payment source to the providers, as well as indicates that the Requestor is the administrator of the pay-for-performance program.

The OIG started its analysis by emphasizing that the advisory opinion only addresses the narrow question of whether Requestor’s disbursement of pay-for-performance program payments to physicians and dentists on behalf of the state implicates the anti-kickback statute. The OIG concluded that the arrangement did not implicate the anti-kickback statute and cited four reasons for its conclusion:

The Department of Health and Human Services (HHS) recently issued a report to Congress on a Medicare Ambulatory Surgical Center (ASC) Value-Based Purchasing (VBP) Implementation Plan, as required by the Patient Protection and Affordable Care Act (PPACA).

In this report, HHS sets forth a “roadmap” for ASC VBP implementation which discusses the various issues which must be considered. While the current legislation only gives HHS the authority to impose penalties for failure to report, HHS’ plan presumes that Congress will also grant authority to award better outcomes, value and innovation. The report indicates that the failure to report data could result in a 2% reduction, while, subject to the granting of Congressional authority, ASCs meeting quality targets would see increases in reimbursement. The program may also be structured to reward low performers who demonstrate improvement.

In structuring the ASC VBP, HHS will look to the current quality reporting programs for hospitals and physicians.

On July 14, 2011, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion regarding the use of a preferred hospital network as part of Medicare Supplemental Health insurance (Medigap) policies. Under the proposed arrangement, the requestors who offer Medigap insurance policies, would establish a preferred provider organization (PPO) comprised of certain hospitals. The PPO network would allow the requestors to receive discounts on Medicare inpatient deductibles for policyholders. Also under the proposed arrangement, the requestors would provide a $100 premium credit to policyholders who opt to use a network hospital for an inpatient stay. Any savings realized by the requestors would be filed with the state insurance departments accountable for regulating the premium rates charged by Medigap insurers.

The OIG determined that the proposed arrangement would implicate both the anti-kickback statute and Section 1128A(a)(5) of the Social Security Act which provides for the imposition of civil monetary penalties for providing remuneration to beneficiaries. However, because of several factors, the OIG concluded that the proposed arrangement would present a low risk of fraud and abuse. Although not directly on point, the OIG looked at the safe harbor for waivers of beneficiary coinsurance and deductible amounts, as well as the safe harbor for reduced premium amounts offered by health plans.

The OIG concluded that the discounts offered on inpatient deductibles by the network hospitals would present a low risk of fraud or abuse for the following reasons:

With the rise of the health-related mobile application market, the Food and Drug Administration (FDA) proposed its first-ever regulations on the industry. The regulations target three types of applications that require the FDA’s approval: an application that acts as an accessory to a regulated medical device, turns the mobile technology into a regulated medical device or makes recommendations pertaining to a patient’s treatment or diagnosis. The FDA believes that just because a medical device is used with a cellular phone, it should still face the same regulations as its traditional non-mobile counterpart.

The FDA plans to collect feedback over a 90 day period from manufacturers and other health care providers, and until this happens the regulations will not take effect. According to the Washington Post, some concerns have already surfaced in regards to the proposed regulations, such as the FDA’s ability to monitor the technology when the mobile industry faces such rapid changes. Another concern is the willingness of investors and companies to back these products when facing this sort of regulatory uncertainty. Jeff Shuren, director for the FDA’s Center for Devices and Radiological Health, said that the FDA will likely take a more subtle approach in reviewing the mobile applications due to the speeding change of the industry, such as focusing on the design of the product and eliminating the requirement of clinical trials.

If you have any questions relating to mobile application compliance with FDA regulations or any other compliance issues, please contact a Wachler & Associates attorney at 248-544-0888.

The face-to-face requirements for Medicaid home health services will follow a similar timeframe to that set forth for Medicare. The timeframes were established by the Patient Protections and Affordable Care Act (PPACA), and CMS intends to enforce the regulation. A proposed rule creates the requirement that physicians document the existence of a face-to-face encounter with Medicaid beneficiaries within 90 days prior to the ordering of home health services. However, in circumstances where it is deemed not to be possible to meet the 90 day requirement, the face-to-face encounter would be satisfied by an encounter with the beneficiary occurring within 30 days after the start of home health services. Additionally, states that currently allow use of telehealth or telemedicine when delivering services under Medicaid will remain able to use these techniques to fulfill the face-to-face encounter.

If you have any questions pertaining to the Medicare or Medicaid face-to-face requirement, telemedicine rules or any other regulations under PPACA, please contact a Wachler & Associates attorney at 248-544-0888.

In collaboration with Kaiser Health News, the New York Times recently reported on the concerns over the rising costs associated with hospice care. While Medicare is praised for its reimbursement of providers for hospice services because of the medical and emotional support hospice gives to dying patients, there are concerns that hospice is being misused. According to the article, four in 10 Medicare beneficiaries use hospice services before they die and the cost of hospice care has risen from $2.9 billion in 2000 to $12 billion in 2009.

In response to the growing anxiety that hospice is being abused, the Office of Inspector General of the Department of Health and Human services examined the provision of hospice services in nursing homes. The OIG found that hospices routinely failed to document whether the patients belong in hospice care or that the patients received the care they were entitled to. This discovery prompted the OIG to investigate any unusual patterns in hospice stays.

In light of this recent scrutiny of hospice costs, hospice providers should take extra precautions with regard to compliance programs and should consider conducting self-audits to identify potential risk areas within their organizations.

In contradiction of President Obama’s campaign promises to let states create their own policies regarding medical marijuana use, the Obama administration released a memo approving federal prosecution of anyone in the business of cultivating or supplying marijuana to patients, whether or not they comply with state law. The original guidelines that were set in October 2009 were put in place as a way to spare seriously ill patients and their caregivers from prosecution. However, the memo stated that these guidelines caused an increase in the commercial cultivation, sale, distribution and use of medical marijuana, in which many of these activities casts suspicion on whether it is truly for medical purposes. In the memo, Deputy Attorney General James Cole stated, “persons who are in the business of cultivating, selling, or distributing marijuana, and those who knowingly facilitate such activities, are in violation of the Controlled Substances Act, regardless of state law.”

There have already been raids on suppliers in the 16 states where medical marijuana is legal under state law. Additionally, officials in 10 states have recently received warnings about possible prosecution if they authorized marijuana-selling dispensaries. These warnings have caused states, such as Washington and Rhode Island, to abandon plans that would legalize medical marijuana dispensaries. Other states, including Delaware and Vermont, have decided to continue in their efforts to legalize medical marijuana by approving a number or dispensaries for patients in need of the drug.

If you are a provider with questions regarding participation in the certification of patients for medical marijuana usage and compliance with state or federal law, including compliance with the Michigan Medical Marihuana Act or the Michigan Medical Marihuana Program, please contact at Wachler & Associates attorney at 248-544-0888.

The University of California at Los Angeles Health System (UCLAHS) has agreed to settle potential HIPAA violations stemming from an investigation conducted by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). UCLAHS has agreed to pay $865,500, along with implementing a plan of correction to ensure future compliance with HIPAA.

The investigation was sparked by two separate complaints filed with OCR from two celebrity patients. Allegedly, UCLAHS employees repeatedly viewed the electronic health information of these patients without the necessary authorization. OCR also discovered that the employees looked at the electronic protected health information of a number of other patients over a span of three years.

Under HIPAA, entities must reasonably restrict access to patient information to those employees who have a legitimate work-related reason to view the information. Furthermore, entities are required to sanction employees who have violated these policies. OCR maintains a firm stance that entities should properly train all employees about the current laws protecting patient health information and should have policies in place to ensure compliance with these policies.

The Centers for Medicare and Medicaid Services (CMS) has proposed to rescind the current signature requirement for lab requisitions. Currently, the 2011 Medicare Physician Fee Schedule requires a physician’s or nonphysician provider’s signature on all lab requisitions for tests paid under the clinical lab fee schedule, regardless of whether there is a signed order. This requirement was to become effective at the beginning of 2011. However, CMS decided to postpone this requirement due to commentary by providers, labs and other stakeholders of the health care industry. The signature requirement on lab requisitions was proposed by CMS as a way to reduce fraud and improper payments. Recently, CMS has stated it underestimated the burdens that the rule would have on quality of care due to the amount of time it takes providers to obtain the required signatures, especially for providers who do not use electronic health records.

If you have any questions regarding compliance with the Medicare Physician Fee Schedule, or need help defending against a current or future audit, please contact a Wachler & Associates attorney at 248-544-0888.

On June 14, 2011, the Office of Inspector General (OIG) issued an unfavorable advisory opinion addressing an existing and a proposed arrangement involving contracts between a durable medical equipment (DME) supplier and several independent diagnostic testing facilities (IDTF). The DME supplier (Requestor) provides continuous positive airway pressure supplies (CPAP), which may be prescribed by a physician for patients diagnosed with obstructive sleep apnea. The study may be performed at the IDTFs, and a patient must select a DME supplier to supply the equipment after being prescribed the CPAP.

The existing arrangement involves contracts between Requestor and several IDTFs, some of which have physician investors, where the IDTFs are permitted to display and provide equipment from multiple DME suppliers. The patients are given a list of local DME suppliers, and are advised by IDTFs their right to select which supplier will provide them with the equipment. The contracts only apply to non-federally insured patients. If a non-federally insured patient chooses Requestor’s DME, an IDTF staff member will prepare the CPAP for the patient, along with educating the patient on how to properly use the equipment. For completing these tasks, Requestor pays the IDTF a per-patient fee. Each contract between Requestor and IDTF is non-exclusive and is set for a term of at least one year. Furthermore, Requestor may only terminate the contract for breach or for cause, but the IDTF may terminate the contract at any time.

The proposed arrangement would be similar to the existing arrangements, except for the following three elements: (1) the proposed arrangement would include federally-insured patients; (2) IDTF would be paid a flat monthly/annual fee; and (3) Requestor would have the ability to terminate the contract if it is unsatisfied with the number or patients receiving the services.