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Recent News

July 20, 2008
Electronic Prescriptions for Controlled Substances – Will DEA’s Proposed Rule Work for Long-term Care?
The Drug Enforcement Administration (DEA) has proposed new regulations that would permit controlled substances to be prescribed and dispensed electronically.  The new rules reflect DEA’s concerns that if not properly implemented, electronic prescribing could provide additional means of diverting controlled substances for illegal purposes.  Thus, the proposed rules outline detailed requirements for the creation, transmission and acceptance of electronic prescriptions, as well as detailed requirements for practitioners, service providers and pharmacies.  Notably, these new requirements are in addition to, and not a replacement of, existing requirements for written and oral prescriptions for controlled substances.  The proposed rules reflect DEA’s paramount law enforcement concerns.  But, will they work for the health care community broadly? And are they flexible enough to meet the unique needs of practitioners and pharmacies in long- term care? Practitioners, pharmacists, pharmacies, standard-setting organizations, HIT companies and many others are taking a hard look at the proposed rules in an attempt to come up with answers. 

June 9, 2008
CMS Discontinues the original E1 eligibility query.
Effective April 1, 2009, CMS will discontinue support for the original E1 eligibility query and continue to support only the “enhanced E!” moving forward.  The Enhanced E1 was implemented in December 2006 to provide enhanced search capability, additional data elements in the response, and more explicit messaging when the TrOOP facilitator is unable to identify the plan enrollment.  Pharmacists may need to work with their software vendors to upgrade/reprogram the pharmacy’s software or amend existing contractual arrangements to request and receive the enhanced version of E1.  CMS recommends implementing the enhanced E1 by November 15, the beginning of the Medicare Part D open enrollment period for 2009. 
For a copy of CMS’ Announcement, click here.

June 9, 2008
CMS increases frequency of accepting and processing State Medicaid eligibility files.
Beginning on or about June 15, 2008, State Medicaid Agencies will be able to submit multiple dual eligible files throughout the month and on any day of the month and CMS will process files submitted by the State Medicaid Agencies and perform LIS deeming and auto-/facilitated enrollment on a daily basis, absent any unforeseen circumstances.  Part D sponsors will receive information about the results of LIS deeming on the weekly Transaction Reply Reports (TRRs) released throughout the month, not just on the first weekly TRR of the month, as is currently the case.  In addition, PDPs that qualify for auto-/facilitated enrollment will receive the PDP notification File for Auto-and Facilitated Enrollments on a flow basis throughout the month beginning on or about June 15, 2008.
For a copy of CMS’ Memorandum for Part D Plans, click here.

June 6, 2008
The OIG Issues Report on the Availability of Medicare Part D Drugs to Dual-Eligible Nursing Home Patients. 
The Department of Health and Human Services (HHS), Office of the Inspector General (OIG) has published a report, "Availability of Medicare Part D Drugs to Dual-eligible Nursing Home Residents," that reports findings from a survey of nursing home administrators, nursing home medical  directors and long-term care pharmacy directors regarding dual-eligible nursing home residents access to Medicare Part D drugs. Click here for the full details.

June 5, 2008
New CMS Hospice Regulations
The Centers for Medicare & Medicaid Services (CMS) released revised Conditions of Participation (CoP) for hospice programs that participate in the Medicare and Medicaid programs.  In the revised CoPs, new medication-related services are required, above and beyond what was required in the previous (current until December) regulations.   Consultant pharmacist services were previously required only for inpatient hospice facilities.  The new requirements are broadened to include all hospice programs, which presents a new opportunity for consultant pharmacists to market their services and skills to hospices.   Dispensing pharmacies who provide medications and/or durable medical equipment to hospice patients, should also be aware of the new requirements.

Click here for the CMS Final Rule that outlines the new Hospice Regulations.

Click here for ASCP's Summary of the Medication Management Requirements in the New Hospice Regulations.

June 2, 2008
One June 2, 2008, ASCP filed comments on the OIG's draft CPG for nursing homes.  While supporting most of hte OIG's recommendations, ASCP's comments raise concerns that the draft CPG does not accurately reflect the critical role of pharmacists in promoting appropriate medication use, does not reflect the impact of Medicare Part D on formularies and drug access, and does not reflect CMS' most current guidance on enrollment assistance.  Click here to access a copy of ASCP's comments.

May 30, 2008
USP's Medicare Part D Model Formulary Guidelines Move to Three Year Revision Cycle.
In response to a request from the Centers for Medicare and Medicaid Services (CMS), the United States Pharmacopeia (USP) announced on May 20, 2008, it will no longer revise the Medicare Model Guidelines on an annual basis. Instead, “based on the success and stabilization of recent versions of the Model Guidelines, the Centers for Medicare and Medicaid Services (CMS) and USP have agreed to move from an annual timeline for revision to a three-year cycle.”
 
The MMA designates USP to develop the Medicare Model Guidelines and to revise the Guidelines from time to time to reflect changes in therapeutic uses of covered Part D drugs and additions of new covered Part D drugs.  Plans that design to conform to the categories and classes in the Model Guidelines may not be found “likely to substantially discourage enrollment” by certain Medicare beneficiaries. (MMA, Section 1860D-11(e)(2)(D)(i) and (ii)).
 
USP’s press release states that CMS will use the current Medicare Model Guidelines Version 4.0, without changes, through plan year 2011.  In 2010, USP intends to begin work on Version 5.0, which will be utilized during the Part D formulary review process for plan year 2012. Version 4.0 and related information are available on USP’s Web site.

May 30, 2008
District Court upholds Co-payment Award to Omnicare
A Federal District Court has ruled that an arbitrator did not exceed his authority when he ruled that Prime Therapeutics, a pharmacy benefit manager under contract to various part D plans, must pay Omnicare, Inc., a long term care pharmacy, over $500,000, for unpaid co-payments on prescriptions drugs dispensed under the Medicare Part D Program.  Based upon the terms of the parties' contract, the arbitrator ruled that Omnicare has the responsibility not to collect the co-pays from a beneficiary if Omnicare knows that the enrollee is or may be eligible for subsidy payments, even if Prime denies that the individual is eligible.  He also found that Omnicare was not required to provide "Best Available Evidence,"  or "BAE "to Prime in order for Omnicare to be entitled to reimbursement of the co-payments.  Instead, he determined that Part D Plan Sponsors are responsible for providing BAE to CMS.

May 20, 2008
Announcing the ASCP/NABP LTC Model Rules Took Kit and List Server! ASCP members throughout the country are working to promote State adoption of the NABP/ASCP LTC Model Rules. To help support these efforts, ASCP has created a Tool Kit and a new LTC Model Rules Group list server. We are also prepared to offer technical assistance.  If you are already working to promote adoption of the LTC Model Rules or are interested in learning more about the issues, please click here to access the Tool Kit and to join the LTC Model Rules Group.

May 3, 2008
Arbitrator Rules that LTC Pharmacy has No BAE Obligation;  Awards $554,281 for Unpaid Co-pay Claims
An arbitrator has ruled that Prime Therapeutics, a Pharmacy Benefit Manager under contract to several Part D plans must pay Omnicare $554,281 for improperly adjudicated co-payments.  The arbitration found that Omnicare had properly submitted the co-payment claims to Prime and had not collected the co-payments from low-income beneficiaries.  The arbitrator rejected Prime Therapeutics defense that Omnicare had not submitted “Best Available Evidence” (BAE) and therefore was not entitled to payment.  The arbitrator ruled, that under the terms of the contract between the parties, Omnicare had no obligation to collect BAE in order to be paid. Prime Therapeutics has asked a Federal Court to vacate the arbitrator’s ruling.  A decision on Prime Therapeutics Motion to Vacate is expected in about one month.

April 17, 2008
The Institute of Medicine's Health Care Workforce Report portents a health care crisis due to the severe shortage of health care professionals trained in the field of geriatrics.  IOM recognizes that there are severe deficiencies in the numbers of pharmacists certified in geriatrics.

April 10, 2008
CMS finalizes Medicare Part D ePrescribing Standards

April 8, 2008
ASCP Medicare Part D Legislation in the 110th Congress

March 25, 2008
CMS requires all Part D plans to identify an individual(s) responsible for "best available evidence." 

March 3, 2008
ASCP Comments on Option for Prescription Drug Plans to Lower Their Premiums for Low-Income Subsidy Beneficiaries, Proposed Rule, CMS-4133-P

February 12, 2008
CMS releases an updated list of the poorest-performing nursing facilities on surveys nationwide, which CMS refers to as "special focus facilities (SFFs)".

January 18, 2008
CMS issues Survey & Certification Memo #08-10, reminding surveyors to cite all deficiencies based on a violation of statutory and/or regulatory requirements.  “Permissive duties( mentioned in the Interpretive Guidelines) are not requirements, and the lack of use of any particular tool does not, by itself, constitute sufficient grounds for the citation of a deficiency.”

February 1, 2008
National Council for Prescription Drug Programs (NCPDP) Sends Letter to State Medicaid Directors Suggesting Recommendations on Tamper-Resistant Prescription Requirements

January 8, 2008
Claudia Schlosberg joins ASCP as Director, Policy and Advocacy


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