The WSJ Picks Up NAMSAP Press Release

April 22, 2013

Recently, one of the many but ongoing successes for Tower MSA has occurred. The Wall Street Journal and others covered CEO Rita Ayers’ discussion on pharmacy trends during NAMSAP’s Annual Meeting and Educational Conference on April 25. The Wall Street Journal was just one of many that put out a press release on the discussion. For More information check out the link below.

Tower MSA Partners CEO Rita Ayers Discusses Pharmacy Trends in MSAs at NAMSAP

Effective June 1, 2013 WCMSA Proposals Will Include Benzodiazepines and Barbituates

April 17, 2013

April 8, 2013

On October 2, 2012, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to Part D Sponsors concerning the transition to Part D Coverage of Benzodiazepines and Barbiturates beginning in 2013.

Effective June 1, 2013, all  Workers’ Compensation Medicare Set-Aside (WCMSA) proposals submitted to CMS for a review of the adequacy of the proposal amount are to include the pricing of benzodiazepines and barbiturates, where appropriate.

Please note that WCMSA cases submitted to CMS  before June 1, 2013, closed due to missing, incomplete and/or inadequate supporting documentation (or any  other reason), and subsequently re-opened after June 1, 2013, will also be subject to a review that includes the pricing of benzodiazepines and barbiturates.

To read the memo from CMS to all plans that explains the transition guidance with regards to benzodiazepines and certain barbiturates starting in 2013.

Download

CMS Releases Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide

On March, 29, CMS announced the release of a new Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide. The new guide has been posted and is available in the Downloads section of the CMS Workers’ Compensation Agency Services site at http://www.cms.gov/Medicare/Coordination-of-Benefits/WorkersCompAgencyServices/Downloads/March-29-2013-WCMSA-Reference-Guide-Version-13.pdf.

The WCMSA Reference Guide was created to consolidate information currently found within the Workers’ Compensation Agency Services webpages and CMS Regional Office Program Memorandums, while providing WCMSA information to attorneys, Medicare beneficiaries, claimants, insurance carriers, representative payees, and WCMSA vendors. After reviewing the new guide, I would agree that it is exactly as advertised. There is little new to report for those of us who have researched the CMS website at length and studied each CMS memo released over the past 12 years. For those new to the process, however, the reference guide is an excellent summarization of all requirements, recommendations memos, etc. that have guided us over the years to appropriately protect Medicare’s interests.

While much of the reference guide is technical in nature, providing specific directives for submission, appeals, use of the portal, review expectations, etc., I found three very specific points made to address an area that has historically created confusion. ” If I settle below the CMS threshold amount, does this mitigate the need to prepare an MSA? ”  The short answer is, “No”.  The reasons, specifically explained in the reference guide, are included below:

  • Protecting Medicare’s Interests is ‘The Law
    Any claimant who receives a WC settlement, judgment, or award that includes an amount for future medical expenses must take Medicare’s interest with respect to future medicals into account. If Medicare’s interests are not considered, CMS has a priority right of recovery against any entity that received a portion of a third party payment either directly or indirectly. Medicare may also refuse to pay for future medical expenses related to the WC injury until the entire settlement is exhausted.
  • CMS Submission is Recommended, not Required
    There are no statutory or regulatory provisions requiring that you submit a WCMSA amount proposal to CMS for review. If you choose to use CMS’ WCMSA review process, however,  the Agency requests that you comply with CMS’ established policies and procedures.”
  • CMS Submission Thresholds Are For Workload Management Only
    The thresholds for WCMSA submission to CMS for approval are created based on CMS’ workload, and are not intended to indicate that claimants may settle below the threshold with impunity. Claimants must still consider Medicare’s interests in all WC cases and ensure that Medicare pays secondary to WC in such cases.Also note that both the beneficiary and non-beneficiary workload review thresholds are subject to adjustment. CMS reserves the right to change or remove these thresholds based on Medicare’s interests. Claimants, employers, carriers, and their representatives should regularly monitor the CMS website at http://www.cms.gov/Medicare/Coordination-of-Benefits/Workers-Compensation-Medicare-Set-Aside-Arrangements/Whats-New/Whats-New.html for changes to these thresholds and for other changes in policies and procedures.

I hope the three points above adequately clarify when an MSA is needed as compared to when CMS submission is appropriate.  If questions remain, however, or should you other questions about the guide and its legal implications in settlement, please contact Kristine Wilson, Esq. @ 888-331-4941.

CMS encourages us to continue to visit its website for future updates to the reference guide, including additional details regarding the Workers’ Compensation Review Contractor’s review process

 

The FDA Focuses New Attention on Compounding Pharmacies

According to an article released by NBC News on April 11, 2013, the FDA posted reports on its web site for 28 of 31 compounding pharmacies it inspected between February and April listing a raft of violations ranging from inappropriate clothing for sterile drug processing to insufficient testing for contaminants.

The release of the inspection reports comes five days before a congressional hearing into the meningitis outbreak traced to the Framingham, Massachusetts-based New England Compounding Center (NECC) that killed more than 50 people and sickened hundreds. The hearing, by the House Committee on Energy and Commerce, will be the second held on the matter.

In November, the FDA’s commissioner, Dr. Margaret Hamburg, testified before the same committee that ambiguities in the law had inhibited its ability to take aggressive enforcement action against compounding pharmacies, which are mostly regulated by the states. Republican lawmakers argued that the agency has plenty of authority but failed to use it in a way that could have prevented the meningitis outbreak.

In my post on December 13, 2012, I summarized the first hearing held by the House Committee on Energy and Commerce noting that in follow up the committee sent letters to the board of pharmacy for all 50 states making specific points regarding their responsibility to regulate compounding pharmacies and asking for a response from each by December 7, 2012.  If responses were submitted, they were neither published nor acknowledged by the committee.  Now, it appears that the FDA is back in the hot seat, being challenged on its lack of action.

On Thursday a group of Democratic lawmakers urged the Committee in a letter to invite the head of the International Academy of Compounding Pharmacists (IACP), an industry association, to testify at Tuesday’s hearing.  The letter specifically noted Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding.”

Last month the IACP wrote to members of the Senate Committee on Health, Education, Labor and Pensions in a bid to head off any attempt to allow the FDA to determine whether a firm should be classed as a compounding pharmacy and which pharmaceuticals company. That authority, the letter said, “should and must remain exclusively” with the states.

Both the FDA and the state boards of pharmacy have done a great job of dodging the bullet thus far.  Unfortunately, however, it is the patient who suffers.  And in the case of a workers’ compensation case, the payer as well.   Compounds represent one of the most dangerous and fraudulent forms of medication dispensing. That being said, compounds can also be extremely beneficial when medically necessary, and in the right environment of audits and controls.

Compounds are difficult to analyze value and benefit. As such, they are never indicated for pain management in Evidence Based Medical (EBM) guidelines such as the Official Disabilities Guidelines (ODG).

While there are exceptions, as a general rule compounds should never be authorized and/or covered without consideration of the following intervention strategies:

  1. If Utilization Review (UR) is a part of the state regulatory landscape, compounds should be sent through UR before being authorized for fill the first time.
  2. If the UR reviewer deems the compound to be unnecessary, immediately direct your PBM to exclude it from the patient’s formulary.
  3. If UR isn’t an alternative, escalate the authorization request to a nurse, clinician or physician to request a determination of  necessity and appropriateness based on the state’s designated treatment guidelines.
  4. As an example, for states that follow ODG, compounds would be indicated as necessary and appropriate ONLY in the following situations:
    1. An indicated first line therapy was tried and failed,
    2. The patient has an allergy to an inactive ingredient of a more traditional form of a medication.

At the claim level, we cannot protect our patients against every danger, clinical oversight and scam artist seeking to benefit financially from the workers’ compensation system.  By consistently following the guidelines available, however, and encouraging more states to implement treatment guidelines like ODG, we can better position our companies and our patients to achieve the best in care, cost and compliance.