| Government Affairs & Advocacy ASCP Members -- Are you reading ASCP Insider?Read ASCP Insider to catch the latest exclusive updates on legislative developments, ASCP's advocacy work, and other issues affecting pharmacists! Archives available here (members only). All ASCP members are eligible to receive the weekly Insider enewsletter free! If you're not already receiving it, please email us to request it!Recent NewsCheck out our archive of past news items.May 24, 2010 ASCP Files Comments on DEA Interim Final Rule on E-Prescribing of Controlled Substances In March, the Drug Enforcement Administration (DEA) released an interim final rule for the electronic prescribing of controlled substances. The rule provides practitioners with the option of writing prescriptions for controlled substances electronically and also permits pharmacies to receive, dispense, and archive these electronic prescriptions. However, the system and process requirements are unclear for the unique pharmaceutical care management requirements and workflows pertinent to long-term care and other post acute providers (collectively referred to as “LTPAC” providers) such as nursing facilities, hospice, home health care and assisted living communities. Although the interim final rule went into effect June 1, 2010, the DEA did accept public comments on the rule. ASCP sent an individual comment letter (PDF) in addition to a joint letter with the American Society of Health-System Pharmacists, American Pharmacists Association, and National Community Pharmacists Association (PDF). Our individual letter focused on four major issue areas:
May 10, 2010 ASCP Sends Comments to The Joint Commission on Proposed Revisions to Medication Reconciliation Goal ASCP recently submitted comments to The Joint Commission on proposed changes to their National Patient Safety Goal (NPSG) on Medication Reconciliation, which is applicable to nearly all of their accreditation programs including Long-Term Care and Home Care (which includes accreditation of long-term care pharmacies). ASCP requested that The Joint Commission encourage accredited facilities and organizations to utilize and recognize pharmacists as leaders and key personnel for medication reconciliation initiatives. While recognizing that not all organizations/facilities use a pharmacist to perform the medication comparison process for every single patient, we recommended that a pharmacist at least be involved in the development of organization/facility policies, procedures, and forms (as applicable) for conducting and documenting reconciliation activities and be available for further consultation when/if questions or concerns arise. ASCP also recommended that the patient or family be provided with both written and verbal information regarding the medications the patient should be taking once he/she leaves the organization/facility due to low health literacy, visual impairments, and cognitive deficiencies that limit seniors' ability to read and comprehend medical information. Additionally, ASCP encouraged The Joint Commission to recognize electronic health records as a possible source and recipient of medication information.
May 6, 2010 House Launches Seniors Task Force On May 6, House Democrats announced the creation of a Seniors Task Force and introduced their "Seniors Bill of Rights." The Seniors Bill of Rights declares that Congress should unwaveringly uphold the dignity and independence of older Americans by supporting efforts that guarantee for them financial security; quality and affordable health and long-term care; protection from abuse, scams, and exploitation; a strong economy now and for future generations; and safe and livable communities with adequate housing and transportation options. Rep. Jan Schakowsky (D-Ill) is the primary sponsor of this resolution. Other founding members of the Seniors Task Force are Rep. Doris Matsui (D-Calif.); Rep. Dina Titus (D-Nev.) and Rep. Mark Schauer (D-Mich). April 13, 2010 LTC Pharmacists: Take ASCP's Survey on the New Medicare Part D Requirement to Reduce Pharmaceutical Waste in Long Term Care! With passage of the health care reform legislation, federal law now mandates that PDP sponsors must utilize specific, uniform dispensing techniques such as weekly, daily, or automated dose dispensing when dispensing covered part D drugs to part D enrollees in nursing facilities. The law will take effect on or after January 1, 2012. This means the Centers for Medicare and Medicaid Services (CMS) has less than a year before it must issue the 2012 "Call Letter" notifying Part D sponsors exactly what is expected and how this is to be implemented. According to the Congressional Budget Office (CBO), requiring short cycle dispensing is expected to generate savings of nearly $6 billion over ten years. We believe that the estimated savings is highly inflated and likely based on faulty assumptions. While we applaud efforts by Congress to address pharmaceutical waste, mandating shorter cycle fills in Part D is the wrong approach and likely will be very costly to long-term care pharmacies, Part D plans and even beneficiaries. On March 19, 2010, the National Council for Prescription Drug Plans (NCPDP) held a listening session in Baltimore, Maryland where industry representatives provided comments based upon a set of questions that had been prepared in advance. Now, it's your turn! ASCP needs to hear directly from you about how short cycle dispensing will affect your pharmacy's operations and your ability to provide high-quality, cost-effective pharmaceutical services to your customers. As your voice in Washington, we also want to know from you how we should be directing our advocacy resources on this issue. We estimate it will take 15-20 minutes to complete this survey. We hope that you will take the time to share your views on this critical issue. The survey is now closed. March 9, 2010 Senate Special Aging Committee to Hold Hearing on DEA and Patients in Pain ASCP has confirmed that the Senate Special Aging Committee will hold a hearing later this month on the impact of DEA rules on frail, elderly and dying patients in long-term care. The hearing is open to the public but space may be limited. The time and place of the hearing have not yet been finalized. Please watch the ASCP Web site for further details, or join the QCCPP mailing list for the most up-to-date news! March 9, 2010 ASCP leads QCCPP delegation to meet with Attorney General Eric Holder's Office On March 9, ASCP Director of Policy and Advocacy Claudia Schlosberg led a delegation representing the Quality Care Coalition for Patients in Pain (QCCPP) to meet with Attorney General Holder's office. The purpose of the meeting was to educate the Attorney General's key advisors regarding the impact of the DEA policies on patient care. The meeting was cordial and the AG's staff asked several questions particularly about the role and presence of physicians in long-term care. Other members of the delegation included Rebecca Elon, MD, a geriatrician with Greater Geriatrics at the Greater Baltimore Medical Center, Ross Brickley, RPh, the President of CCRX of North Carolina, Ron Buzzeo RPh and Ralph Breitfeller. March 1, 2010 GAO Report: Specialty-tier Eligible Drugs a Factor in Medicare Beneficiaries Reaching the "Catastrophic Coverage Threshold" The Government Accountability Office (GAO) published on March 1 a report of its findings based on a request to research information regarding the high cost of drugs eligible for a specialty tier under Medicare Part D plans. The report looks at Medicare Part D spending in 2007 and how different cost structures affect out-of-pocket expenses for beneficiaries. It also looks at Part D plan sponsors' ability to negotiate price concessions and manage utilization. The study found that:
January 26, 2010 FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain ASCP learned today that the U.S. Food and Drug Administration (FDA) has approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. This is the only FDA-approved morphine sulfate oral solution available at this concentration. The manufacturer is Roxane Laboratories. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now. Today's action is part of the FDA's unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product to ensure that there is enough supply of the drug available for patients. The FDA will also be working with organizations such as ASCP and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability. During a telephone call today with FDA's Douglas Throckmorton, M.D., Deputy Director, Center for Drug Evaluation and Research (CDER), ASCP learned that:
For more FDA information on this issue: 1. March 31, 2009 Warning Letters, companies, and affected products 2. List of FDA-approved drug products January 15, 2010 ASCP, Other Groups Urge Congress to Fix Pharmaceutical Waste Provisions for Long-Term Care As Congressional leaders wrap up their negotiations on health care reform, ASCP, in conjunction with over a dozen other interests, sent letters to leaders within the House of Representatives urging them to support our previously proposed revisions to Section 1187 of the Affordable Health Care for America Act. This provision requires the Secretary to mandate that pharmacies under contract to Medicare Part D plans utilize specified dispensing techniques in order to reduce pharmaceutical waste in long-term care. Specifically, the letter used House leaders to: 1. Require the Secretary to collaborate and consult with relevant stakeholders to develop proposed standards and techniques that promote patient safety, minimize administrative burden and do not impose uncompensated costs on plans, pharmacies or facilities. 2. Ensure the workability of any proposed standards and techniques by requiring the Secretary to conduct pilot testing as appropriate. 3. Formalize the uniform adoption of the standards and techniques through rulemaking.
Senate Passes Historic Health Care Reform Legislation On December 24, 2009, the U.S. Senate voted 60-39 to pass historic health care reform legislation. Now the Senate and the House must work to reconcile the differences in the two separate bills. Some observers believe the process could be complete before the State of the Union speech. However, others believe that it will be difficult to bridge the differences between the two bills quickly. One major issue remains the fate of the House's "public plan" option. Alternative language in the Senate Bill gives the Office of Personal Management (OPM) authority to establish and oversee a minimum of two, multi-state plans. Other issues that must be reconciled include: 1. The breadth and scope of the individual and employer mandates: Both Bills require all Americans to obtain health insurance or pay penalties. The House bill imposes a tax of 2.5 percent of adjusted gross income up to the average national premium for self or family plans offered in the exchange. The Senate penalty is a $750 tax per person (capped at $2,250 per household) or 2 percent of income,whichever is greater. The House bill requires that all employers provide coverage but the Senate Bill exempts employers with 50 or fewer employees. 2. Revenue Generators: The Senate bill places a tax on so-called "Cadillac" or high-cost insurance plans.The House Bill taxes high earners. The House legislation reduces payments to Medicare Advantage plans to 100 percent of fee for services realizing more than $160 billion in savings. The Senate version reduces payments by about $119 by creating a competitive bidding program. 3. State vs. Federally-operated Health Insurance Exchanges: Both Senate and House bills establish health insurance exchanges. However, in the House bill, the Federal government oversees the exchanges. In the Senate bill, health insurance exchanges are operated by individual states. 4. Subsidies: In the House bill, government subsidies are provided to people earning from 133 to 400 percent of the Federal poverty level (FPL) and premiums are capped at 1.5% for the lowest income earners and 12% for high earners. The Senate bill provides subsidies for people earning 100 to 400 percent FPL, while premiums are capped at 2.8% and 9.8% depending on income. 5. Medicaid Expansion: Both bills expand Medicaid. In the House, Medicaid is expanded to 150 percent of FPL, while the Senate expands it to 133 percent. 6. Age rating: In the Senate bill, age rating is restricted to 3:1. In the House bill age rating is more restrictive at 2:1. December 22, 2009 Senate Healthcare Reform Legislation Moves Closer to Passage Democrats continue to move sweeping health care reform legislation closer to passage, with successful passage of Senator Harry Reid's (D-NV) Manager's Amendment on December 19 followed by several procedural votes. The final vote in the Senate is scheduled to take place on December 24. Once passed, the Senate bill will have to be reconciled with the House bill (H.R. 3962), which passed November 7. Democrats are hoping to produce a final bill that can be signed by President Obama in late January. Senator Reid's Manager's Amendment contains a number of important changes including tightened restrictions on health insurance companies, some expanded delivery and payment reforms and new language to restrict the use of federal funds for elective abortions. It also does away with the public option, replacing it with a provision that would authorize the Office of Personnel Management (OPM), which currently administers the Federal Employees Health Benefits Program, to contract with insurers to offer at least two nationwide plans, one of which must be nonprofit, through the new health insurance exchanges. OPM would be responsible for negotiating with insurers and ensuring the plans meet minimum standards, as it does for FEHBP. Senator Barbara Boxer's (D-CA) amendment to provide loan repayment assistance for pharmacists and other health care professionals who specialize in geriatrics was not included in the final bill. Republicans continue to criticize the bill, particularly a number of state-specific provisions that were designed to secure support from several holdout Senators, including conservative Democratic Senator Ben Nelson of Nebraska. Under the Manager's Amendment, the federal government will fully and permanently fund 100% of Nebraska's Medicaid expansion. Vermont and Massachusetts, which were ineligible for any increase in federal Medicaid funding, will receive temporary increases. December 16, 2009 House Members Advocate for Higher Reimbursement to Community Pharmacies for Generic Drugs Last week, a bipartisan group of sixteen House Members sent a letter to Speaker Nancy Pelosi (D-8 CA) asking her to push for a higher Medicaid pharmacy reimbursement rate if the health care reform measure is sent to a conference committee, but they stopped short of asking for a specific figure. Both the House and Senate health care reform bills include provisions that would increase the federal upper limits that Medicaid reimburses community pharmacies for generic drugs -– the House version is 130 percent of the weighted average of the average manufacturer price (AMP) and the Senate is 175 percent. Signers of the letter include Reps. Anthony D. Weiner (D-9 NY), Joe Barton (R-6 TX), Michael A. Arcuri (D-24 NY), Marion Berry (D-1 AR), Sanford D. Bishop Jr. (D-2 GA), Leonard L. Boswell (D-3 IA), Rick Boucher (D-9 VA), Christopher P. Carney (D-10 PA), Joe Courtney (D-2 CT), Lloyd Doggett (D-25 TX), Stephanie Herseth Sandlin (D-AL SD), Walter B. Jones (R-3 NC), Cathy McMorris Rodgers (R-5 WA), Jerry Moran (R-1 KS), Timothy J. Walz (D-1 MN), and Peter Welch (D-AL VT).
ASCP Sends Boxer Amendment Sign-on to Senate Last week, ASCP circulated a sign-on letter to other pharmacy associations and members in support of Senator Boxer's Amendment to establish a loan repayment program for health care professionals (including pharmacists) who specialize in geriatrics. Nine organizations and more than 250 individuals signed onto the letter that was sent to all 100 Senators. If you support Senator Boxer's Amendment, please consider calling your Senator today and ask them to co-sponsor Amendment No. 2944--Geriatric Health Care Workforce. It's easy, simply dial the US Capitol Switchboard and ask to be connected to your Senators' offices. The number is 202-224-3121. December 11, 2009 DEA Responds to Sen. Kohl and Sen. Whitehouse's Letter--and QCCPP Writes Back! The DEA has responded to Senator Kohl and Senator Whitehouse's letter, which had raised concerns about the inability of nursing home and hospice patients to receive timely, adequate access to pain medication and other controlled drugs. DEA did not address the Senators' concerns; instead, DEA's response states that it has discovered that some pharmacies affiliated with long-term care facilities are violating the Controlled Substances Act and its implementing regulations. Among practices cited are reliance on chart orders and hospital discharge summaries. The Quality Care Coalition for Patients in Pain wasted no time in responding to the Drug Enforcement Administration's letter to Senators Kohl and Whitehouse (PDF). In its letter (PDF) to Attorney General Eric Holder, dated December 10, 2009, QCCPP points out the differences between what DEA allows in hospitals and in nursing homes, and the resulting impact on patients. The letter explains how strict compliance with DEA rules and policies adds additional steps that can significantly delay treatment. The letter goes on to state: "While we respect and support DEA's mission to ensure that controlled drugs are not being diverted and are only used for legitimate medical purposes, the needless suffering that patients are now enduring demands that a balance be achieved that addresses these legitimate law enforcement concerns without causing harm to patients."
Senator Dorgan Lashes Out at FDA Commissioner Over Drug Reimportation Amendment FDA Commissioner Margaret A. Hamburg has sent a letter to Sen. Byron Dorgan (D-ND) commenting on his legislation to allow imports of pharmaceuticals. Hamburg said the legislation as currently written would be logistically challenging to implement and "resource intensive." She also cited "significant safety concerns related to allowing the importation of non-bioequivalent products," as well as issues related to confusion in distribution and labeling "that remain to be fully addressed in the amendment." Senator Dorgan responded by calling Commissioner Hamburg's concerns "completely bogus." December 8, 2009 ASCP Opposes CMS's Proposed Changes to Part D Formulary Policies Designed to Protect Beneficiaries' Access to Medically Necessary Medications ASCP has filed comments in response to CMS' proposed policy and technical changes to Medicare Part D. Although ASCP supports a number of proposed changes, ASCP expressed strong opposition to changes that would weaken the criteria used to define protected drug classes and limit the ability of long-term care residents to secure access to non-formulary drugs during care transitions.
Federal IssuesUse these resources to learn more about how current federal issues may directly affect consultant and senior care pharmacy.State IssuesHere you will find the latest state legislation and regulations that directly affect consultant and senior care pharmacy.Briefing RoomsYour complete source for information and resources on various issues, including Patient Safety, Repackaging of Medications, HIPAA, etc.Medicare Drug Benefit Briefing RoomHere are resources and links to assist pharmacists and other stakeholders with the Medicare Part D drug benefit program.Medicare & Medicaid ResourcesCheck out the resources for the Centers for Medicare & Medicaid Services (CMS). These resources include regulations, guidance documents, links and announcements.ASCP Advocacy CenterTake Action! Learn how to communicate your views to decision-makers directly and make a difference for the profession.ASCP-PACPromote the legislative goals and express the concerns of consultant and senior care pharmacy to members of Congress. (Members Only)CoalitionsCheck out the various groups and coalitions of which ASCP is a member.Support the ASCP Advocacy/Campaign 2011 FundHelp support the ASCP’s advocacy efforts at the state and federal levels. |
