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The Center for Medicare and Medicaid Services (CMS) has extended the deadline for the submission of the Pioneer ACO Model program letters of intent to June 30, 2011. Additionally, the Application deadline has been extended to August 19, 2011. Applications received from organizations that have not submitted a letter of intent will not be considered.

Click the following links to complete the Pioneer ACO letter of intent and application. If you wish to participate in CMS’ Pioneer ACO Model program and need assistance in doing so, please contact a Wachler & Associates attorney at 248-544-0888.

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The U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion for a Requestor regarding a vaccine reminder program. In February 2011, the Requestor, a manufacturer of pneumococcal bacteria vaccines for immunization of infants and toddlers, expanded a vaccine reminder program to entities that insure and treat patients covered by federal healthcare programs. Prior to February the reminder program was only to the parents or guardians of children who may have needed one or more doses of the vaccine.

Under the expansion, the Requestor offers the reminder program to entities regardless of the number of children that have been or will be vaccinated. The Requestor also pays for the reminders, either through telephone calls or postcards and there is no other charge to the entities that wish to participate. The reminder postcards or telephone calls do not refer to a specific product and do not recommend a specific avenue for vaccination. They merely suggest that the child’s parent or guardian contact a clinic to determine if a vaccine is required.

The OIG analyzed the program under the beneficiary inducement statute and the anti-kickback statute. The OIG first concluded that the reminder messages to the parents from the Requestor were not inducements since they only inform the parents about the potential need to have a vaccination. Further, the OIG determined that the relationship between the Requestor and the healthcare entities did not violate the anti-kickback statute. Although there is some independent value to the entities from the program, there is a low risk of fraud and abuse because of several factors, including: the arrangement was narrowly tailored and transparent, available to all health insurers and entities regardless of their use of the Requestor’s vaccines and the reminder messages do not recommend a specific vaccine or course of vaccination, thus they still encourage patient’s freedom of choice.

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In February, the Centers for Medicare & Medicaid Services published its Final rule implementing changes in the provider enrollment processes. Effective March 25, 2011, providers participating in Medicare, Medicaid and Children’s Health Insurance Program will undergo an initial screening process prior to enrollment. In addition, providers are now required to revalidate their compliance with CMS enrollment requirements every five years. Suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) must revalidate every three years. As a catch all, CMS may demand that any provider revalidate and undergo screening at any time.

The new rule, found in Medicare Program Integrity Manual Chapter 15, sections 19 though 19.4, finalized provisions related to the (1) establishment of provider enrollment screening categories, (2) submission of application fees as part of the provider enrollment process, (3) suspensions of payment based on credible allegations of fraud, and (4) authority to impose a temporary moratorium on the enrollment of new Medicare providers and suppliers of a particular type (or the establishment of new practice locations of a particular type) in a geographic area.

The screening process establishes 3 levels of risk – limited, moderate, or high – and each provider will be assigned to a risk category. The rule also addresses application fees. Providers initially enrolling in Medicare will pay an initial application fee, and current provides will pay the fee when they revalidate.

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The Office of the National Coordinator for Health Information Technology (ONC) announced a new program on Wednesday to encourage the innovation of health information technology through prizes and challenges. The program, called Investing in Innovations (i2) Initiative, was created under the America Compete Reauthorization Act of 2010 and has already awarded the first $5 million to two projects.

For more information on health care law developments, please visit www.wachler.com.

Investing in Innovations (i2) Initiative http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=3635&in_hi_userid=11673

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AARP recently unveiled an online tool aimed at helping senior citizen beneficiaries fully understand their quarterly health care statements. This tool will aid in fully informing seniors of all charges the Medicare program has paid, along with dates, billing codes and a description of the medical service. The AARP website urges senior citizens to use this tool to identify errors on their bill as well as to spot fraud.

CMS has made numerous efforts over the years to enlist the help of Medicare beneficiaries to detect and report Medicare Fraud.

An effective compliance program is the best defense against billing errors that can lead to complaints or allegations of Medicare fraud by beneficiaries. If you have any questions regarding Medicare billing or development of a compliance program, please contact a Wachler & Associates attorney at 248-544-0888.

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The Office of Inspector General (OIG) recently reported that it believes Medicaid is being inappropriately billed for certain nonmedical services (e.g. bathing, dressing and light housework). As a result of two recent audits, OIG has requested that North Carolina and Washington refund the federal government more $61 million resulting from improper Medicaid claims. It was discovered that these claims lacked the necessary documentation. Additionally, it was determined that the claims weren’t included in the states’ plan of care, were provided without medical supervision and the qualifications for the in-home providers could not be verified.

If you have any questions relating to home health compliance or Medicaid/Medicare billing requirements, please contact a Wachler & Associates attorney at 248-544-0888.

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Through a proposed rule, the Centers for Medicare and Medicaid Services have answered the call by organized medicine to extend the deadline for qualifying physicians to meet electronic prescribing requirements and add additional hardship exemptions. With the current rules, eligible physicians must use an e-prescribing system to complete at least 10 paperless drug orders between January 1, 2011 and June 30, 2011 to avoid a 1% Medicare pay cut in 2012. However, the proposed rule gives the physicians another opportunity to avoid the cut and add more hardship exemptions that a physician could meet. Whereas under the current rule physicians have to apply for hardship exemptions by June 30, 2011 and only have two possible exemptions, the proposed rule extends the deadline to October 1, 2011 and adds more hardship claims, including:

• The physician has limited prescribing activity during the six-month time frame.

• The physician has delayed purchasing an e-prescribing system because he or she intends to participate in Medicare’s electronic medical records incentive program from 2011.

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A sleep medicine and durable medical equipment company, Areté Sleep LLC, Areté Sleep Therapy LLC, and Areté Holdings LLC will pay a $650,000 settlement pursuant to federal authorities discovering the company to have submitted false claims to Medicare over a seven year span.

According to federal prosecutors, the false claims were for diagnostic tests performed by unlicensed/uncertified technicians. These licenses/certifications are required by Medicare rules and regulations. Areté filed for Chapter 11 bankruptcy in early 2011 and has agreed to pay the settlement with the proceeds from its asset sales.

If you have any questions or concerns regarding compliance with Medicare rules and regulations, or if you have questions regarding compliance issues associated with billing for sleep studies and related DME, please contact a Wachler and Associates attorney at 248-544-0888.

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On June 1, 2011, the Office of Inspector General (OIG) announced that it expects to recover an estimated $3.4 billion in connection with its Medicare and Medicaid investigations, audits, and reviews. The amount was accrued between October 2010 and March 2011 in the form of penalties, fines, and settlements. Of the estimated $3.4 billion in recoveries, $222 million stems from audits while $3.2 billion arose from 349 criminal and 197 civil actions. The OIG featured the following items in its Semiannual Report to Congress:

•· 100 healthcare professionals were arrested for their participation in various healthcare-related crimes (e.g. violating the anti-kickback statute and money laundering) which resulted in $225 million in false billing.

•· Two drug companies, GlaxoSmithKline and Allergan USA, agreed to pay $750 million and $600 million, respectively, to resolve various charges.

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The Centers for Medicare & Medicaid Services (CMS) intends to roll out its Part D RAC program during the third quarter of 2011. In implementing the program, CMS has contracted with ACLR Strategic Business Solutions to be the Part D recovery audit contractor. This company has already recovered tens of millions of dollars through its auditing process for government contractors. John Spiegel, director of the Medicare Program Integrity Group, stated that “CMS is working on business planning, technology requirements, staffing and communications initiatives to achieve the program goals.” He also mentioned that CMS intends to implement a website that will provide additional Medicare Parts C and D RAC information.

Medicare Part D plans and sponsors should consider conducting internal audits and implementing compliance programs at this time in order to be in the best position to avoid or defend against a RAC audit.

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

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