| Government Affairs & Advocacy Find out what’s happening across the country, and how it could affect you and your patients. Learn ASCP's stand on key issues. Make your voice heard. These options and more are available from the links below and on the left. Recent News (click here for archive of past news items) September 29, 2008 Office of Inspector General (OIG) Releases Report: "Trends in Nursing Home Deficiencies and Complaints" This report describes the nature and extent of nursing home deficiencies and complaints in 2007 and identifies trends from 2005 to 2007. From 2005-2007, over 91 percent of nursing homes surveyed were cited for deficiencies. The most common deficiency categories cited were quality of care, resident assessment, and quality of life. "Pharmacy Services" was the 7th most frequently cited category, and it was the one category that experienced the greatest increase in deficiencies from 2005-2007, largely due to the new Interpretive Guidelines that went into effect in December 2006. In 2005, 23.8% of nursing homes were cited for deficient "Pharmacy Services," whereas in 2007, 28.8% of facilities were cited. The report also provides state-specific deficiency statistics. Click here to download the report. September 26, 2008 CMS Extends Deadline for Report Q1 Long-Term Care Pharmacy Rebate Data The Medicare Drug Benefit and C&D Data Group just issued a memo regarding a reporting deadline extension for Q1 2008 long-term care (LTC) pharmacy rebate data. The deadline has been moved back from September 30, 2008 to November 30, 2008. For more details, click here to download the memo. September 24, 2008 ASCP Criticizes DEA's Proposed Rule for Electronic Prescribing of Controlled Substances ASCP has filed comments criticizing the Drug Enforcement Administration's (DEA) proposed rule for e-prescribing for controlled substances. According to ASCP, the proposed rule is not compatible with existing pharmacy workflows and pharmacy practices and imposes considerable new burdens and costs on pharmacies and prescribers without enhancing the ability of DEA to identify and decrease diversion. Further, the proposed rule fails to take into consideration the unique prescribing process that is endemic to long-term care, hospice, home care, and other non-hospital care settings where the prescriber and the patient may not be in physical proximity when the prescription is written. Click here to download ASCP's comments (312 KB PDF) September 24, 2008 FDA Takes Action Against Topical Drug Products Containing Papain FDA intends to take enforcement action against unapproved topical drug products containing papain, as well as those who manufacture or cause the manufacture of such products or their shipment in interstate commerce. In an announcement slated for publication in the Sept. 23 Federal Register, FDA notes that potentially serious adverse events were reported with topical drug products containing papain. Topical drug products containing papain are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently no firm has an approved application to market a topical drug product containing papain. Manufacturers who wish to market topical drug products containing papain must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). Download the FDA's notice by clicking on this link (422 KB PDF). September 22, 2008 CMS Revises Medicare Prescription Drug Benefit Manual; Read ASCP's Summary of the Changes On September 5, 2008, CMS issued revisions to the Medicare Prescription Drug Benefit Manual, Chapter 7 covering Medication Therapy Management, Quality Improvement and related program provisions. A copy of the revised Chapter 7 can be accessed by clicking here. You can download ASCP's summary of the major changes at this link. September 16, 2008 ASCP Submits Comments on Draft Gaps/Extensions to Medication Use Case Management ASCP submitted comments today to the Office of the National Coordinator for Health Information Technology (ONCHIT) on draft gaps and extensions to Use Case Medication Management. Click here to download a copy of the comments. September 15, 2008 ASCP Co-Sponsors National E-Prescribing Conference in Boston, October 6-7 ASCP joins the Center for Medicare & Medicaid Services (CMS) and other industry and association partners in co-sponsoring the upcoming National E-prescribing Conference, to take place in Boston on October 6 - 7. With upcoming policy changes affecting the payments to pharmacists who work with e-prescribing, now is a critical time to stay informed on the issues! Conference registration is currently closed as of 9/25/08. Click here to see the New York Times ad with more details on the conference. September 11, 2008 ASCP Submits Comments on Proposed New Standards for Assisted Living Programs ASCP submitted comments today to the Maryland Department of Health on proposed new standards for pharmacist review of medication regimens of assisted living program residents. For a copy of ASCP's comments, click here. Send your own comments to the Maryland Department of Health by Sept. 15, 2008! Click here for more details. September 10, 2008 OIG releases report titled, "MEDICARE PART D - Some Plan Sponsors Have Not Completely Implemented Fraud and Abuse Programs, and CMS Oversight Has Been Limited." NOTE: Pharmacies are considered "contractors" of Part D plans for the purpose of this GAO report. Therefore, pharmacies with Part D contracts should be aware of any sections of the document mentioning "contractors." Click here to download the report. September 5, 2008 ASCP Submits Comments on Proposed Revisions to CARF Aging Service Standards ASCP submitted comments today on proposed revisions to CARF Aging Service Standards that apply to aging service programs that seek to obtain accreditation. For a copy of ASCP's comments, click here. August 26, 2008 ASCP Submits Comments to CMS Regarding Computer-Generated Fax and NCPDP SCRIPT Exemptions for Long-Term Care Facilities ASCP filed formal comments in response to the Center for Medicare and Medicaid Services' July 7, 2008 Notice of Proposed Rule-making in which CMS proposed revising current Medicare e-prescribing standards to lift the exemption for computer-generated facsimiles. While ASCP opposed eliminating the exemption for computer-generated faxes, ASCP urged CMS to lift the exemption for using the NCPDP SCRIPT standard for e-prescribing in long-term care facilities. Although the exemption was based originally upon valid concerns regarding industry readiness to adopt e-prescribing, the exemption itself is becoming an impediment to adoption. Lifting the exemption will provide needed impetus and help move the industry toward adoption of e-prescribing. It also will help put the LTC industry on equal footing with other health care providers when it comes to participating in incentive and grant programs that support e-prescribing adoption. Click here to download a copy of ASCP's comments. August 21, 2008 Kaiser Family Foundation Issues Report on Medicare Part D Coverage Gap; Finds That Lack of Coverage Affects Patient Use of Medication A new study released by the Kaiser Family Foundation quantifies the number of Medicare Part D plan enrollees in 2007 who reached a gap in their prescription drug coverage known as the "doughnut hole," and also found evidence that 21% of patients caught in that gap changed their use of prescription drugs when forced to pay the full cost of mediations. Click here to download the report. 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. Federal Issues Use these resources to learn more about how current federal issues may directly impact consultant and senior care pharmacy. more >> State Issues Here you will find the latest state legislation and regulations that directly affect consultant and senior care pharmacy. more >> Briefing Rooms Your complete source for information and resources on various issues, including Patient Safety, Repackaging of Medications, HIPAA, etc. more >> Medicare Drug Benefit Resources and links to assist pharmacists and other stakeholders with the Medicare Part D drug benefit program. more >> CMS Resources Centers for Medicare & Medicaid Services (CMS) regulations, guidance documents, links and announcements. more >> ASCP Advocacy Center Take Action! Learn how to communicate your views to decision-makers directly and make a difference for the profession. more >> ASCP-PAC Promote the legislative goals and express the concerns of consultant and senior care pharmacy to members of Congress. (Members Only) more >> Coalitions Listing of various groups and coalitions of which ASCP is a member. more >> Senior Care Advocate eNews ASCP's members-only biweekly electronic newsletter, providing information and updates on federal and state legislative and regulatory issues, and significant clinical developments. more >> Support the Capitol Fund ASCP’s legislative war chest, will increase the ASCP Policy and Advocacy Department’s ability to advance advocacy efforts at the state and federal levels. more >> |

