| Centers for Medicare & Medicaid Services (CMS) Resources Quick Resources - CMS Guidance on Medicare Prescription Drug Benefit - HPMS Memo Library (ASCP Members Only) - ASCP Summary of Part D Changes in New Health Care Reform (ASCP Members Only) Recent News February 20, 2010 CMS Releases Advance 2011 Call Letter, Encourages Part D Sponsors to Curtail Pharmaceutical Waste in Retail Settings The CMS Advance 2011 Call Letter, released February 20, includes a new section entitled, "Encouragement of Sponsor Practices to Curb Waste of Unused Drugs Dispensed in the Retail Setting." In this section, CMS requests that Part D sponsors consider allowing beneficiaries in the community (versus institutional) setting the option to request a trial supply of no more than 7 to 14 days of a Part D covered medication when first prescribed. With this option, Part D sponsors would be expected to prorate cost-share amounts associated with that prescription. According to CMS, current physician prescribing patterns and pharmacy benefit management payment practices result in most prescriptions being dispensed in 30 or 90 day quantities. However, CMS' review of 2007 Prescription Drug Event (PDE) data suggests that up to as many as 30% of first fills for chronic medications are not refilled. Whenever the full amount dispensed is not utilized by the patient due to death, adverse reactions, medication substitution, or other reason for discontinuation, the remaining unused medication becomes waste. It also becomes an environmental hazard when disposed of, and is sometimes a safety hazard in the home or diverted to illegal use. CMS believes that trial fills will be most appreciated by beneficiaries and their physicians when initiating new therapies and for more expensive medications. CMS also believes that the proration of prescriptions ("partial fills") is a practice consistent with state pharmacy law and accommodated by pharmacies and transaction systems today. Thus, only a change in payer practices including negotiation of appropriate dispensing or incentive fees for promotion of these trial fills may be needed to implement this waste reduction strategy at the pharmacy counter. Among other benefits, CMS believes that these trial fills promote savings to the beneficiary, Part D sponsor and Medicare program. September 21, 2009 Understanding the CMS Non-matched NDC List All drugs marketed in the United States are required to be properly listed with the FDA. However, many drugs that are marketed and used have never been listed. Effective January 1, 2010, CMS will not provide payment for drugs that are not properly listed with the FDA. This means that claims submitted for drugs on the non-matched list may be rejected. Further certain multi-source products cold be rejected because registration is manufacturer/distributor specific. As an example, there are several companies that manufacture morphine 20 mg/ml, but the only two that have registered their product are Physician Total Care and Xanodyne Pharmaceuticals. ASCP will be gathering data and investigating this issue further. March 17, 2009 ASCP Submits Comments to CMS Supporting Delay of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Interim Final Rule The interim final rule, published in the Federal Register on January 16, 2009, implements certain MIPPA provisions that: (1) delay implementation of Round I of the competitive bidding program, (2) require CMS to conduct a second Round 1 competition in 2009, and (3) mandate certain changes for the Round 1 rebid and subsequent rounds of the program, including the development of a process for providing feedback to suppliers regarding missing financial documentation and the requirement that contractors disclose to CMS information regarding subcontracting relationships. December 11, 2008 CMS Updates National Drug Codes (NDCs) CMS has implemented a new “NDC Redesign” functionality in its Drug Data Processing System that effects approximately 4,000 NDCs that have previously been accepted and approximately 25 NDCs that have previously been rejected. The list of affected NDCs is available at http://www.csscoperations.com/. CMS expects Part D sponsors to detertmine if any of their enrollees will be affected by these changes and to notify any affected enrollees that their non Part D prescription drug product cannot be paid for under the plan. Download the memo by clicking here. December 9, 2008 CMS issues Guidance Implementing MIPPA Changes to the Definition of “Medically Accepted Indication” Beginning January 1, 2009, Part D sponsors will be required to apply the Part B definition of a medically-accepted indication to those anti-cancer chemotherapy drug claims that are not covered by Part B and are therefore Part D covered drugs. Read the memo by clicking here. December 9, 2008 CMS Issues New Version of Chapter 13 of Drug Benefit Manual Click here to download the new version of the chapter and click here to download the memo issued by CMS to accompany it. June 19, 2008 Advocates Settle BAE Lawsuit Addressing Low-Income Subsidy Eligibility Issues On June 19, 2008, the Centers for Medicare Advocacy and the National Senior Citizens Law Center announced a settlement in Situ, et al. v. Leavitt, a class action lawsuit filed on behalf of full benefit dual eligibles (FBDEs) in Medicare Part D against the Centers for Medicare and Medicaid Services (CMS). Many FBDEs have been unable to fully access their benefits due to enrolment problems that have lead to coverage gaps. FBDEs also have been assessed co-payments that they do not owe due to inaccuracies in CMS’ data base. The settlement agreement is designed to resolve these problems by getting FBDE’s enrolled into Part D plans and by resolving low-income subsidy eligibility issues more quickly without burdening beneficiaries or pharmacies. The settlement does not address payment issues between Part D plans and pharmacies, although it is expected that the settlement terms may help reduced the volume of disputed claims.[1] The settlement covers virtually all full benefit dual eligible beneficiaries who have been unable to access benefits or who have been assessed copayments, incorrectly. Beneficiaries covered by the terms of the settlement include beneficiaries who live in the community as well as those who are institutionalized. Notably, to be considered a member of the class, a beneficiary must contact their plan, CMS or the State Medicaid agency to complain of an auto enrollment or subsidy problem. Click here for a summary of the settlement agreement. Click here for a copy of the settlement. [1] CMS does not have authority to intervene in payment disputes between Part D plans and pharmacies. 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 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. 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 20, 2008 CMS list of poorest-performing nursing facilities nationwide, also known as special focus facilities (SFFs) Updated October 31, 2007 Continuity Assessment Record and Care Evaluation (CARE) Instrument The Medicare Continuity Assessment Record and Evaluation (CARE) is a uniform patient assessment instrument designed to measure differences in patient severity, resource utilization, and outcomes for patients in acute and post-acute care settings. This tool will be used by the Centers for Medicare & Medicaid Services (CMS) to: (1) standardize program information on Medicare beneficiaries' acuity at discharge from acute hospitals, (2) document medical severity, functional status and other factors related to outcomes and resource utilization at admission, discharge, and interim times during post acute treatment, and (3) understand the relationship between severity of illness, functional status, social support factors, and resource utilization. The CARE instrument will be used in the Post-Acute Care (PAC) Payment Reform Demonstration program mandated by Section 5008 of the Deficit Reduction Act of 2005 to develop payment groups that reflect patient severity and related cost and resource use across post acute settings. July 16, 2007 ASCP Letter to CMS About Requirement for Tamper-Resistant Prescriptions for Medicaid Recipients July 2007 CMS Proposes to Remove Exemption of FAX Prescriptions from e-Prescribing Requirements Links to Key CMS Web Pages
|
