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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.

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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.

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According to a Boston Globe article, Tufts Medical Center and one of its primary care doctors are being sued by a patient whose privacy rights were allegedly violated when her medical history was sent to a fax machine at her workplace without her consent. The patient, Kimberly White, was recovering from a hysterectomy this past December. While recovering, she asked Dr. Kimberly Schelling to fax a form to White’s employer that was required to receive disability payments. Instead, medical records were allegedly sent to a shared fax machine in the office, which resulted in White’s medical records being viewed by at least two co-workers. White claimed that this disclosure has caused her extreme embarrassment and the inability to show her face at work again. Tufts has not yet filed a response to the complaint, but the hospital maintains that they were in full compliance with the patient’s request to share the medical information.

The HIPAA Privacy Rule allows information to be disclosed pursuant to a patient’s authorization or as otherwise permitted by the HIPAA Privacy Rule. The Office of Civil Rights (OCR) has issued guidance stating that the use of fax machines are permissible so long as reasonable safeguards are taken to protect the information from unauthorized or impermissible disclosure. If you have questions regarding patient privacy or assistance with HIPAA compliance policies and procedures, please contact a Wachler & Associates attorney at 248-544-0888.

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A Miami resident and Detroit clinic owner, Arnaldo Rosario, was recently sentenced to 27 months in prison for his role in recruiting patients to three clinics in the Detroit area. According to the FBI, the Medicare fraud scheme involved remuneration to Medicare beneficiaries for visiting the clinics and fraudulently representing that they had received treatments that were either not provided or not medically necessary. The services were then billed to Medicare and the beneficiaries would receive cash kickbacks for their role in the scheme. Rosario was responsible for obtaining cash from the clinics to pay the kickbacks to the beneficiaries and also to other co-defendants for their role in recruiting and paying Medicare patients. Over a span of one year, Medicare had paid approximately $10.8 million to the clinics based on the fraudulent claims. This case was brought as part of the Medicare Fraud Strike Force, which in its four years of operations, has already discovered more than $2.3 billion worth of allegedly fraudulent Medicare claims. Both Miami and Detroit are cities targeted by the Medicare Fraud Strike Force and providers in these cities should be aware of this heightened scrutiny.

If you have any questions regarding the Anti-Kickback Statute, inappropriate remuneration to beneficiaries, medical necessity issues, or any other compliance issues relating to Medicare fraud or allegations of Medicare fraud, please contact a Wachler & Associates attorney as 248-544-0888.

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The Centers for Medicare and Medicaid Services (CMS) has posted a summary of the Medicare Fee for Service RAC recoveries for the 3rd quarter of fiscal year 2011. The summary displays the amount of each region’s overpayments, underpayments and total corrections, as well as the nationwide totals. In addition to these quantitative findings, CMS has also identified the top issues for each region.

Click here to view the summary posted by CMS.

Review of these issues is helpful for providers wishing to develop a compliance program that will alert them to potential RAC issues prior to a RAC audit. The issues identified by CMS should be a key focus area for providers developing compliance programs to prepare for and hopefully avoid RAC audits. If you need assistance in preparing for, or defending against a RAC audit through the Medicare appeals process, or for assistance implementing a compliance program geared toward identifying and correcting potential risk areas related to RAC audits, please contact a Wachler & Associates attorney at 248-544-0888.

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Health and Human Services (HHS) Office of the Inspector General (OIG) has reported that skilled nursing facilities (SNFs) may be a possible suspect for receiving fraudulent Medicare payments. Auditors for HHS have discovered that many nursing homes are collecting Medicare payments that are much higher than the national average. For example, the average cost for some patients was in excess of $150 per day, whereas the national average is only $3.39 per day. The OIG believes that fraud, waste, and abuse are the likely causes of such payments. These suspicions were highlighted in a report that focused on situations in which Medicare does not cover the patient’s stay in a nursing home but does cover certain procedures during the patient’s stay at the home. The report demonstrated that some nursing homes were paid more than three times the national average for services such as drug treatments and medical equipment.

In light of this recent report, nursing homes can expect increased scrutiny related to the medical necessity of services provided to Medicare beneficiaries. An effective skilled nursing facility (SNF) compliance program, including internal compliance auditing and monitoring, can help SNFs to identify any potential compliance issues prior to a government investigation. If you have compliance questions relating to SNF billing compliance, medical necessity of services provided to SNF beneficiaries or are in need of assistance preparing for or appealing a SNF Medicare audit, please contact a Wachler & Associates attorney at 248-544-0888.

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Despite the large number of Medicare and Medicaid audits and investigations currently being conducted by government contractors, the Government Accountability Office (GAO) recently released a report stating that the federal government’s systems for analyzing Medicare and Medicaid data to detect fraud are “inadequate and underused.”

In 2009, CMS enacted new $150 million systems intended to be a one-stop database accessible to all CMS staff and contractors, law enforcement, and state agencies. However, the report finds that the “share systems data” and other tools to identify and prevent payment of fraudulent claims are still missing. The federal government believes the technology is crucial to curtailing the $60 billion to $90 billion in fraudulent claims paid each year.

The GAO report noted that the current systems don’t even include Medicaid data. Further, only 41 of the 639 analysts charged with using the new detection system have been trained so far. The systems are meant to replace CMS’ “pay and chase” method, which allows criminals to flea before CMS can analyze their claim. The new systems detect fraudulent Medicare and Medicaid claims in real time and deny the claim prior to payment.

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The Centers for Medicare and Medicaid Services (CMS) recently announced it will release a national provider Comparative Billing Report (CBR) this July. CMS will release 5,000 CBRs to physicians ordering spinal orthotic devices billed to Medicare. The CBRs are produced by Safeguard Services under contract with CMS and will provide comparative data to help show how these individual providers compare to other providers within the same field. These comparative studies are designed to help providers review their coding and billing practices and utilization patterns, and take proactive compliance measures. Providers should view CBRs as a tool, rather than a warning, as a way to aid them in properly complying with Medicare billing rules. It is also important to understand that CBRs do not contain patient or case-specific data, but rather only summary billing information as a method of ensuring privacy.

If you are a recipient of a spinal orthotic CBR or are among the other provider types that have been identified to receive CBRs (i.e. physical therapists, chiropractors, ambulance, hospice, podiatry, and sleep studies), please contact a Wachler & Associates attorney at 248-544-0888 to discuss evaluating the CBR analysis and development of an appropriate compliance plan that will reduce audit risks.

Click Here to view a Spinal Orthotic CBR sample

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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.

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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.

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