Articles Posted in Health Law

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Wachler & Associate’s attorney Amy Fehn, as a member of the ABA’s ACO Task Force, recently participated in the drafting of comments on CMS’ proposed regulations for ACO participation in the Medicare Shared Savings Program. The proposed regulations will govern the way in which ACOs will contract with CMS to become responsible for the delivery of care to an assigned population of Medicare fee for service beneficiaries. The ABA’s ACO Task Force prepared comments to help CMS properly develop ACOs by highlighting some of the problematic areas of the proposed regulations. Click here to view the full version ABA’s comments on the ACO proposed regulations.

For assistance with interpreting the ACO Shared Savings program regulations, or for assistance with creating an infrastructure conducive to ACO participation, please contact a Wachler & Associates attorney at 248-544-0888.

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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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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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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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The Centers for Medicare and Medicaid Services announced last week that in the past year healthcare providers have received $158.3 million in EHR incentives. The incentives have been advocated by the Obama administration to encourage doctors and hospitals to use digital health records that meet federal standards. This encouragement coincides with the Administration’s goal to have half of Americans using digital health records by 2014.

Healthcare providers can receive $63,750 during six years from the Medicaid program and up to $44,000 during five years from the Medicare program. For more information on the meaningful use of electronic health records please contact a Wachler & Associates attorney at 248-544-0888.

Centers for Medicare and Medicaid Services

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Healthcare providers that wish to participate in CMS’ Pioneer ACO Model program must submit a letter of intent to CMS by June 10, 2011. This program is the latest initiative in the development of ACOs. The Pioneer ACO program is an opportunity for groups of providers that are already accustomed to coordinating care and ready to share risk. The Pioneer program will offer greater risks and rewards than ACOs participating under the previously released shared savings program.

Click here to view the letter of intent form. This form must be submitted by email no later than June 10, 2011. 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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