Articles Posted in Health Law

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The Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Process was mandated by Congress through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which replaced the current fee schedule payment procedure for DMEPOS items with a competitive bidding process. The purpose of the statute is to set DMEPOS payment amounts in a more effective manner, which will result in saving the Medicare program money and reducing beneficiary out-of-pocket expenses.

Bids closed for Round 1 of the DMEPOS competitive bidding program on December 21, 2009. In November of 2010 CMS announced the winners of Round 1 and in January of this year implemented the contracts.

This past summer, the Centers for Medicare and Medicaid Services (CMS) began its pre-bidding supplier awareness program. For this fall, CMS will announce the bidding schedule, begin the bidder education program, and commence the bidder registration period to obtain user ID and passwords. The bidding will begin in winter 2012.

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A new bill was recently introduced in the House of Representative in an effort to amend the Health Care Quality Improvement Act of 1996 (HCQIA) to require greater due process rights for health care professionals before any reports are made to the National Practitioner’s Data Bank (NPDB).

According to the Association of American Physicians and Surgeons, the bill, H.R. 2472, seeks to counter hospitals’ current practice of reporting adverse actions taken against physicians regardless whether the physician had been afforded a hearing or adequate notice about the investigation. According to supporters of the bills, rather than granting physicians an opportunity to defend themselves against these actions, hospitals have been bypassing these due process steps and reporting the actions to the NPBD. Reports to the NPBD have proven to be extremely detrimental to physicians and have resulted in a number of physicians losing their careers.

The bill amends 42 U.S.C. 11133(a) to prohibit a review entity from reporting to the NPDB while the physician is under investigation. Also, the bill would bar a hospital’s ability to submit a report to the NPDB before a physician is afforded a hearing and adequate notice of the adverse actions taken by the hospital. The amendment also seeks to change the current immunity power of a professional review body. The current HCQIA grants the professional review body immunity from actions taken against it even if the reviewer fails to follow the guidelines for adequate notice and hearing procedures described in the Act. The new bill may provide a means for a physician to bring a cause of action against a professional review body when the entity has failed to provide the required notice and hearing prior to filing a report to the NPBD or if the entity has conducted a “sham” peer review.

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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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