CMS Updates on Medicare Part D

CMS Update for State and Local Government Officials: Medicare Part D Implementation

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Updated June 21, 2006

Update #28- June 21, 2006: MEDICARE ANNOUNCES SPECIAL ELECTION PERIOD FOR LOW-INCOME BENEFICIARIES AND THOSE AFFECTED BY KATRINA

Today’s Action: The Centers for Medicare & Medicaid Services (CMS) announced a demonstration program allowing certain Medicare beneficiaries to enroll in a Medicare prescription drug plan with no penalty through December 31, 2006. The program is available for seniors and people with a disability who qualify for the extra help for their Medicare prescription drug coverage, or who live in an area affected by Hurricane Katrina. People who qualify for extra help account for the vast majority of Medicare beneficiaries who have not yet enrolled in Medicare Part D or do not have other “creditable” coverage.

Eligible Beneficiaries

Late enrollment penalties will not be collected for certain beneficiaries who enroll in a prescription drug plan under the new Special Enrollment Period:

Individuals who enroll in the low-income subsidy; and

Individuals who were affected by Hurricane Katrina

Individuals who apply and are approved for the low-income subsidy experience a significant change in status, in particular, they become eligible for very comprehensive drug coverage at low or no cost. With this change in status, they have a special enrollment opportunity to enroll in a prescription drug plan anytime throughout 2006. If they do not enroll in a plan on their own, Medicare will facilitate their enrollment into a prescription drug plan with a premium below the low-income benchmark, but they will have the opportunity to change plans before December 31, 2006.

Individuals who are affected by Hurricane Katrina will be considered eligible for this demonstration as if, at the time of the hurricane (August 2005), they resided in any of the parishes or counties declared as meeting the level of “individual assistance” by the Federal Emergency Management Agency (FEMA). FEMA has identified the parishes and counties declared eligible for "individual assistance" as a result of Hurricane Katrina and can be found at www.fema.gov/news/disasters.fema?year=2005.

Timing/Duration

The demonstration program is limited to beneficiaries who enroll beginning in June, 2006 through December, 2006. As long as they stay continuously enrolled in a Part D plan, they will not be assessed a late enrollment penalty. If they disenroll after 2006 and do not have creditable coverage for a continuous period of 63 days or more, they would then incur a late enrollment penalty when they re-enroll in a plan.

For more information, please see: http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1880
Also see download #7 on this page: http://www.cms.hhs.gov/States/03_lowincomesubsidy.asp#TopOfPage

Update #27- May 8, 2006: Part D Enrollment Deadline Nears- May 15th

FOR IMMEDIATE RELEASE CMS Media Affairs Monday, May 8, 2006

TIME IS RUNNING OUT - MAY 15^TH ENROLLMENT DEADLINE NEARS- People With Medicare Urged To Enroll in Drug Benefit Before Deadline Rush

Medicare and its partners will be holding more than 1,000 enrollment events all over the country this week, to help people with Medicare enroll in a prescription drug plan before the May 15^th deadline. In addition to the availability of thousands more volunteers at State Health Insurance Assistance Programs (SHIPs) and many other advocacy and support organizations for seniors and people with a disability, Medicare will have 6,000 customer service representatives and enhanced online support will be available.

“With just a week to go, we are intensifying our local outreach efforts to get more seniors signed up before the May 15^th deadline, and taking every measure possible to ensure that everyone who wants to join a Medicare drug plan can do so,” HHS Secretary Mike Leavitt said. “Signing up is as easy as three simple steps. One: Get your prescriptions together. Two: Get your Medicare card. Three: Call 1-800-MEDICARE or go online at file://www.medicare.gov/.”

The Centers for Medicare & Medicaid Services (CMS) is making available maximum customer service capacity through midnight. The http://www.medicare.gov/ Web site has also been enhanced to improve enrollment support. New features have been added to help users make a plan selection before May 15^th, and server capacity for the Web site has more than quadrupled to better accommodate an increased number of users. Local SHIPs are increasing their staffing levels, and many will stay open until midnight on May 15^th to help people enroll. Thousands of volunteers affiliated with other support organizations are also assisting in enrollment between now and May 15^th.

“Time is running out, and maximum support is available right now if you have questions. Sign up now and avoid any last minute surge,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “Millions of people have already signed up, they are saving money today, and they have peace of mind for tomorrow. To get help, you can call 1-800-MEDICARE, go online and enroll at http://www.medicare.gov/ or attend one of the many sign-up events in your community. If you don't need many drugs now, you can get the lowest cost protection for the future by enrolling now.”

Medicare and tens of thousands of partners will continue to sponsor hundreds of local enrollment events across the country until the May 15^th deadline. Print ads will appear in a number of major local newspapers and USA Today, and radio ads featuring Bill Cosby will get prominent airplay. New public service advertisements have been produced, one featuring First Lady Laura Bush. The Medicare Mobile Enrollment Center buses will be completing their final runs crisscrossing the country this coming week.

Medicare drug plans are also preparing for a possible last-minute surge in enrollment requests. “We have directed plans to prepare for possible increases in enrollment volume, and they must accommodate all beneficiaries who seek to enroll through midnight of May 15^th local time,” said Dr. McClellan. “Over 200,000 beneficiaries are contacting us every day at 1-800-MEDICARE, , and we’ve responded by making available maximum help to keep wait times under about three minutes on average and we expect the drug plans to meet those same goals.”

People with Medicare can join a Medicare drug plan through the mail, phone or Web now through May 15, 2006. All completed applications postmarked on May 15^th must be processed. The initial open enrollment period for Medicare prescription drug coverage ends at midnight local time on May 15^th.

By late April, over 30 million Medicare beneficiaries were getting Medicare-related prescription drug coverage. Almost 6 million Medicare beneficiaries have creditable coverage from other sources, including the Veterans Administration and current employers for beneficiaries who are still working. Tens of thousands of beneficiaries are continuing to enroll online, by phone, and through drug plans daily

Update #26- May 4, 2006: Low Income Subsidy (LIS) Information Documents

The following information is provided by CMS to help determine Low Income Subsidy eligibility.
LIS Fact Sheet
Who Can help you apply fact sheet
If you applied Fact Sheet
LIS Partner Tip Sheet
Homelessness Fact Sheet
Food Stamps Tip Sheet
HUD Tip Sheet
Medicaid Spend Down Tip Sheet
AIDs Tip Sheet
LIS Katrina Fact Sheet

Update #25- April 11, 2006: Status of SPAP Beneficiaries

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850

CENTER FOR BENEFICIARY CHOICES
Memorandum To: All Part D Sponsors
Subject: Status of SPAP Beneficiaries
From: Gary Bailey, Deputy Director, Center for Beneficiary Choices
Date: April 4, 2006

In a letter dated January 18, 2006 from Dr. Mark McClellan, CMS reminded plans to practice reasonable discretion before deciding to initiate disenrollment proceedings for an enrollee’s failure to pay a plan’s monthly premiums. We indicated that, at a minimum, plans must provide for a grace period of at least one month, and must alert the individual of the delinquency and the possible consequences of failure to pay premiums.
This notice is to further clarify that a beneficiary must not be disenrolled from a Part D plan if it has been notified that the premiums are being paid by a State Pharmaceutical Assistance Program (SPAP) or other payer and the plan has not yet coordinated receipt of premium payments with that SPAP or payer. In these cases, Part D plans are required to work directly with the SPAPs or the other payers to systematically coordinate and accept premium payments in accordance with 1860D-23 and 1860D-24 of the Social Security Act, Subpart J of the implementing Federal regulations, and coordination of benefit (COB) guidelines dated July 1, 2005. In other words, plans must bill the SPAP (or the other payer) for the premium and not bill the beneficiary. Until plans can bill the SPAP or other payers directly, plans must not take any action to disenroll the beneficiary for failure to pay premiums.
Plans are currently receiving data from CMS in the COB file indicating which beneficiaries are covered under SPAPs. Field 111 in the Supplemental Records of the COB file (as provided in the 2006 Medicare Advantage and Part D Enrollment and Payment Systems Changes Part IV sent to plans on September 20, 2005) indicates the type of supplemental coverage a beneficiary may have. An indicator of 'Q' identifies when a beneficiary has SPAP coverage. Plans could use this data to withhold systematic release of disenrollment notices to these beneficiaries when an SPAP is paying on behalf of the beneficiary.
For your information, the following states and territories are providing premium assistance in 2006 for all or a portion of the plan’s Part D premiums:
Alaska, Connecticut, Delaware, Indiana, Maine, Maryland, Massachusetts, Montana, New Jersey, Nevada, Texas, USVI, Vermont.
If you have any questions about this issue, please contact your account manager. Thank you for your continued assistance with the implementation of the Part D benefit.

Update #24- April 5, 2006: Helpful Links

HPMS Information
This website contains Medicare prescription drug (Part D) guidance materials distributed to plans by the Health Plan Management System (HPMS) http://new.cms.hhs.gov/PrescriptionDrugCovContra/HPMSGH/list.asp#TopOfPage

This list contains Medicare prescription drug (Part D) systems and other data notices distributed to plans by the Health Plan Management System (HPMS) http://new.cms.hhs.gov/PrescriptionDrugCovContra/HPMSSD/list.asp#TopOfPage 

Formulary Information
The following website contains Part D Formulary Information for physicians, including pharmacy technical support contacts, wxceptions and appeals contacts, the Medicare prescription drug coverage provider communication form, and the Medicare prescription drug coverage determination request form. http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/04_Formulary.asp#TopOfPage

Update #23- March 27, 2006: Next Steps on Formulary Transition Policies*

*(pdf version available at: http://www.medicarerxguide.com/MDRG/2006/200603_HPMS_Transition.pdf)

Department of Health & Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850
CENTER FOR BENEFICIARY CHOICES DATE: March 17, 2006
Memorandum To: All Part D Sponsors
Subject: Next Steps on Formulary Transition Policies
From: Gary Bailey, Deputy Director, Center for Beneficiary Choices

On February 2, CMS issued guidance calling for a one-time, across the board extension of the transition period to March 31 for those individuals who were enrolled with effective coverage dates of January 1 or February 1. According to our guidance, individuals enrolling March 1 or later should generally be provided with the customary 30-day transition period. The transition period has been successful in ensuring that enrollees are provided immediate access to necessary drugs at the point of service. We appreciate your cooperation during this initial implementation.

As the initial transition period ends on March 31 for those early enrollees, I would like to take this opportunity to remind you of the critical importance of aggressively implementing policies and processes that ensure your enrollees have access to appropriate transitions from their previous prescription drug coverage. The purpose of the transition process is not simply to provide a temporary supply of non-formulary drugs during a certain period of time but, rather, to provide your enrollees with sufficient time to work with their health care providers to switch to a therapeutically appropriate formulary alternative or to request a formulary exception on the grounds of medical necessity. At the same time, it is vital that your enrollees be given clear guidance regarding how to proceed after a temporary fill is provided so that an appropriate and meaningful transition can be effectuated before the end of the transition period.

We are asking plans to ensure that they have provided their enrollees who have used a transition benefit with the appropriate assistance and information necessary to enable them to better understand the purpose of the transition. Steps that you should consider to ensure a meaningful transition include:

Analyzing claims data to determine which of your enrollees require information about their transition supply.
Contacting those enrollees to ensure they have the necessary information to enable them to switch to a formulary product or as an alternative to pursue necessary prior authorizations or formulary exceptions.
Increasing staff capacity to respond to an anticipated increase in the volume of formulary exceptions requests.
Increasing call center capacity, including pharmacy help lines, to respond to an anticipated increase in call volume from affected enrollees regarding your transition process.
Making arrangements to continue to provide necessary drugs to an enrollee by extending the transition period, on a case-by-case basis, if the enrollee’s exception request or appeal has not been processed by the end of the minimum transition period. For example, in the event that some of your enrollees were enrolled in two plans at the same time and have been re-enrolled into your plan, we would expect you to provide a new 30 day transition period in cases where the individual is presenting at a contracted pharmacy under your plan for the first time.

We understand that many of you have systems in place to trigger a written notice to a member when a plan provides a transitional first fill of a non-formulary drug, and others still may provide instructions – including instructions to contact the plan for further information – through your contracted pharmacies. While plans have flexibility to provide this information in a variety of forms, the instructions to the enrollee must, at a minimum, explain:

That the transition supply provided is temporary and may not be refilled unless a formulary exception is approved;
That the enrollee will need to work with the plan as well as his or her health care provider to identify appropriate therapeutic alternatives that are on the plan’s formulary and that will likely reduce his or her costs;
That the member has the right to request a formulary exception, the timeframes for processing the exception, and the member's right to request an appeal if the plan issues an unfavorable decision; and
The plan’s procedures for requesting a formulary exception.

Attachment I to this memorandum is a model letter you may use to provide information about your transition processes to affected enrollees. Plans using the model may submit the letter under the file and use certification process. Please note that use of this model letter is not required, but use of an alternative notice will require marketing review and will be subject to a 45-day review process. We will honor transition notices currently in use and previously approved during marketing review prior to the release of this memorandum.

Plans that need to submit new transition notices must submit them under the following marketing material category and code:

Category: Special Materials
Code #: 7004 2006 Transition notice

If enrollees or prescribing physicians request formulary exceptions, the requests must be processed in accordance with Chapter 18, sections 30, 30.1, 30.1.2, 40, and 50 of the Prescription Drug Benefit Manual. I urge you to continue to streamline your exceptions and appeals processes in order to further ensure a smooth transition process for your enrollees. As part of your process, you must make available any exceptions and appeals standard forms to your enrollees, as well as to providers, via U.S. mail upon request, fax, and Internet. Plans also have the option of accepting phone requests for exceptions and appeals and must do so for expedited exceptions requests.

While all of you have committed to provide an initial 30-day supply for new enrollee transitions after March 1, we expect that you will use sound judgment to extend that temporary coverage in certain situations in which a longer transition may be required for valid medical reasons. Applied on a case-by-case basis, such extensions may provide enrollees in special situations with the time they need to effectively transition to a formulary drug or to request a formulary exception.

Attachment II to this memorandum is a document entitled “Important Reminders about Part D Coverage Determinations & Appeals.” This document reiterates established policies on processing coverage determinations and appeals as set out in Chapter 18 of the Medicare Prescription Drug Coverage Manual and provides clarification on several issues that have been raised since the inception of the prescription drug program.

Also attached to this memorandum is a spreadsheet we will be using to track the processes you have put into place for effectuating a meaningful transition for your enrollees. We are also requesting that you report counts of prescriptions that you have provided under your transition policy, the number that have been switched to your formulary, the number under coverage determination and reconsideration, and the status of IRE reconsiderations due to not meeting the timelines. Please submit to CMS by COB March 24 your completed spreadsheet. Please zip the file and send your reply to drugbenefitimpl@cms.hhs.gov and include in the subject line “Transition process spreadsheet: <insert organization name>.”

Please feel free to contact your account manager if you have additional questions.

Attachment I Dear <Beneficiary Full Name>,

Please keep this letter for your records. You are getting this letter because you recently filled a prescription <for insert prescription if known> <that was not on our list of covered drugs (called a formulary)> /<that was subject to a prior authorization requirement that you did not meet>. This last fill of that prescription was a temporary solution. You now need to work with us or your doctor to change your prescription to one that we cover. If that isn’t possible, you must request an exception from us for this prescription.

How do I change my prescription?

You can ask us if we cover another drug used to treat your medical condition. If we cover another drug for your condition, you can ask your doctor if this drug is an option for you. If your doctor tells you that another drug we cover isn’t medically appropriate for treating your condition, you have the right to request an exception from us < to cover your current prescription or insert prescription if known>.

How do I request an exception?

The first step in requesting an exception is for you or your prescribing doctor to contact us. <Provide the necessary address, fax number, and phone number>.

Your doctor must submit a statement supporting your request. The doctor’s statement must demonstrate that the requested drug is medically necessary for treating your condition. Once the physician's statement is submitted, we must notify you of our decision no later than 24 or 72 hours, depending on whether the request is an expedited request or a standard request. Your request will be expedited if we determine, or your doctor tells us, that your life, health, or ability to regain maximum function may be seriously jeopardized by waiting for a standard request.

What if my request is denied?

If your request is denied, you have the right to appeal and ask us to review our decision. You must request this appeal within 60 calendar days from the date of our first decision. <You must file a standard request in writing or we accept standard requests by telephone and in writing. We accept expedited requests by telephone and in writing. Provide the necessary address, fax number, and phone number>.

What if I have questions about this letter?

If you have questions about this letter, please call our customer service number at <insert phone and TTY/TDD number> from <insert customer service hours of operation>.

Sincerely, <Plan Representative> <Material ID number>

Issue: Distribution/Posting of Standardized Pharmacy Notice

Reminder: Plans must arrange with their network pharmacies to distribute or post the standardized Pharmacy Notice (“Medicare Prescription Drug Coverage and Your Rights”). See: 42 CFR §423.562(a)(3). The purpose of the Notice is to provide an enrollee with information about how to contact his or her Part D plan to obtain a written coverage determination when a prescription is not filled as written by the prescribing physician. The notice also reminds enrollees about certain rights and protections related to their Medicare drug benefits.

Resources: The standardized Pharmacy Notice is contained in Appendix 5, Chapter 18 of the Medicare Prescription Drug Benefit Manual, which can be found under “Downloads” at: http://www.cms.hhs.gov/PrescriptionDrugCovContra/06_RxContracting_EnrollmentAppeals.asp#TopOfPage

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Issue: Statutorily Excluded Drugs

Reminder: In general, complaints about statutorily excluded drugs should not be processed as coverage determinations. However, in some cases, an enrollee may use the coverage determination process to argue that a drug is not statutorily excluded, is not statutorily excluded for a specific indication, or is covered by the plan as a supplemental benefit. Conversely, if an enrollee is not disputing that a drug is excluded, but has a question or general complaint about an excluded drug not being covered, plans should process the transaction as an inquiry or a grievance. CMS is developing a model Notice of Inquiry Regarding an Excluded Drug that plans may use when a plan sponsor receives an inquiry for an excluded drug.

Resources: List Serve message of February 28 entitled “Excluded Drugs.”

Section 20.2.4, Chapter 18, Medicare Prescription Drug Benefit Manual. The revised version of Chapter 18 will be posted in early April 2006.

The model Notice of Inquiry Regarding an Excluded Drug will be contained in Appendix 12, Chapter 18 of the Medicare Prescription Drug Benefit Manual.

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Issue: Distinguishing PA Requests from Exception Requests

Reminder: Plans must properly distinguish cases where an enrollee/physician is attempting to demonstrate that they have met prior authorization (PA) requirements associated with a formulary drug from cases where an enrollee/physician is asking for an exception to the PA requirements associated with a formulary drug. The former request should be processed as a coverage determination and the latter request should be processed as a formulary exception since the enrollee/physician is asking for an exception to the application of a cost utilization management tool.

Where an enrollee/physician is attempting to satisfy a PA requirement and the plan has a PA form available for seeking prior authorization for the requested drug, the plan should promptly provide the physician with the necessary PA form(s). Cases where an enrollee/physician is attempting to satisfy a PA requirement should be processed as a coverage determination request. In other words, the plan must notify the enrollee (and the prescribing physician involved, as appropriate) of its decision no later than 24 hours after receiving the request for expedited cases and no later than 72 hours after receiving the request for standard cases.

Where an enrollee/physician is seeking an exception to a PA requirement, the prescribing physician must submit a statement to support the request consistent with the requirements set forth in 42 CFR 423.578(b)(5). As with other exception requests, the plan must notify the enrollee

(and the prescribing physician involved, as appropriate) of its decision no later than 24 hours after receiving the physician’s supporting statement for expedited cases and no later than 72 hours after receiving the physician’s supporting statement for standard cases.

Finally, if an enrollee/physician asks for coverage for a non-formulary drug, the plan should contact the enrollee/physician and explain the need for a supporting statement in order to process the request. The request should be properly processed as a formulary exception request and not as a PA request since PA requirements do not apply to non-formulary drugs.

Resource: Section 30.1, Chapter 18, Medicare Prescription Drug Benefit Manual

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Issue: Timely Processing of PA requests

Reminder: If a physician is requesting prior authorization of a drug and is attempting to show that the PA requirements have been satisfied (as opposed to requesting an exception to the PA requirements), the plan must process the request within the same timeframes that apply to all coverage determination requests (as expeditiously as the enrollee’s health requires, but no later than 24 hours for expedited cases and 72 hours for standard cases).

Resource: Section 30.1, Chapter 18, Medicare Prescription Drug Benefit Manual

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Issue: Timeframes for Processing Coverage Determinations

Reminder: In all cases, plans must notify enrollees of initial coverage determinations as expeditiously as the enrollee’s health condition requires. In expedited cases where applying the standard timeframe may seriously jeopardize the life or health of the enrollee, the plan must notify the enrollee of its decision no later than 24 hours after receiving the request or, for cases involving exception requests, no later than 24 hours after receiving the prescribing physician’s supporting statement. In cases where the standard timeframe is applied, the plan must notify the enrollee of its decision no later than 72 hours after receiving the request or, for cases involving exception requests, no later than 72 hours after receiving the prescribing physician’s supporting statement. If a plan fails to meet these timeframes, it must forward the case to the Part D QIC within 24 hours of the expiration of the timeframe. Plans should not auto-forward cases to the Part D QIC if the timeframe has not expired or if the plan has already issued a decision.

Note: If a coverage determination request involves an exception, the plan’s timeframe begins when the plan receives the prescribing physician’s supporting statement. The physician may provide either a written or an oral supporting statement. If the physician provides an oral supporting statement, the plan may require the physician to subsequently provide a written supporting statement demonstrating the medical necessity of the drug. The plan must be explicit about the supporting statement requirements and, if the plan requires additional supporting medical documentation, it must clearly identify the type of information that must be submitted.

Resource: Sections 30.2.1, 30.2.2, 40.2, 40.4, 50.4, and 50.6, Chapter 18, Medicare Prescription Drug Benefit Manual

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Issue: Timeframes for Processing Redeterminations

Reminder: In all cases, plans must notify enrollees of redetermination decisions as expeditiously as the enrollee’s health condition requires. In expedited cases where applying the standard timeframe may seriously jeopardize the life or health of the enrollee, the plan must notify the enrollee of its decision no later than 72 hours after receiving the request. In cases where the standard timeframe is applied, the plan must notify the enrollee of its decision no later than 7 days after receiving the request. If a plan fails to meet these timeframes, it must forward the case to the Part D QIC within 24 hours of the expiration of the timeframe. Plans should not auto-forward cases to the Part D QIC if the timeframe has not expired or if the plan has already issued a decision.

Resource: Sections 70.7, 70.7.1, 70.8.1, and 70.8.2, Chapter 18, Medicare Prescription Drug Benefit Manual

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Issue: Auto-forwarding Cases to the Part D QIC

Reminder: When a plan fails to notify an enrollee of a coverage determination or redetermination within the applicable timeframe, the plan must auto-forward the case to the Part D QIC, Maximus, within 24 hours of the expiration of the timeframe. In all cases, enrollees must be notified of decisions as expeditiously as their health requires, but no later than 24 hours for expedited coverage determinations and 72 hours for standard coverage determinations. Enrollees must be notified of redetermination decisions no later than 72 hours for standard cases and no later than 7 days for standard cases. If a coverage determination request involves an exception, the plan’s timeframe is tolled until the plan receives the prescribing physician’s supporting statement. Plans should not auto-forward cases to the Part D QIC if the timeframe has not expired or if the plan has already issued a decision. Cases that are improperly auto-forwarded to the Part D QIC because the plan’s adjudication timeframe has not expired will be remanded to the plan for proper processing.

Resources: Sections 40.4 and 70.10, Chapter 18, Medicare Prescription Drug Benefit Manual

Section 5, Part D QIC Reconsideration Procedures Manual, http://www.medicarepartdappeals.com/

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Issue: Prompt Submission of Case Files to the Part D QIC

Reminder: When a Part D plan receives a request for a case file from the Part D QIC, the plan must forward the complete case file to the Part D QIC within 24 hours of the request for expedited cases and within 48 hours of the request for standard cases. Failure to promptly forward the complete case file to the Part D QIC may result in unnecessary delays in the Part D QIC’s ability to begin processing the reconsideration request. The Part D QIC is also subject to short adjudication timeframes and must notify enrollees of decisions within 72 hours (expedited cases) or 7 days (standard cases).

Part D plans must use the Reconsideration Case File Transmittal Form developed by the Part D QIC and be certain to include the plan’s contract number, plan ID number, and formulary ID number.

Resources: The Reconsideration Case File Transmittal Form can be downloaded from: http://www.medicarepartdappeals.com/

Section 70.20, Chapter 18, Medicare Prescription Drug Benefit Manual

Section 5, Part D QIC Reconsideration Procedures Manual

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Issue: Part D QIC Information on Redetermination Notices

Reminder: Plans must include the Part D QIC filing information on the Redetermination Notice/Denial of Medicare Prescription Drug Coverage, including the Part D QIC’s fax number. Including the fax number will facilitate an enrollee’s ability to quickly request a reconsideration. CMS has developed a model Request for Reconsideration form that plans must include with each adverse Redetermination Notice. This model Request for Reconsideration will be included in the revised Chapter 18 of the Medicare Prescription Drug Benefit Manual. In addition, the model Redetermination Notice is being revised and will also be included in the revised Chapter 18 of the Medicare Prescription Drug Benefit Manual.

Resource: Maximus contact information, including filing locations (address/fax), is set forth on page one of the Part D QIC Reconsideration Procedures Manual at http://www.medicarepartdappeals.com/

The model Request for Reconsideration form and revised model Redetermination Notice will be contained in Appendix 13, Chapter 18 of the Medicare Prescription Drug Benefit Manual. The revised version of Chapter 18 will be posted in early April 2006.

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Issue: Availability/Accessibility of Plan Prior Authorization Forms

Reminder: Where an enrollee/physician is attempting to satisfy a PA requirement and the plan has a PA form applicable to the requested drug, the plan should promptly provide the physician with the necessary PA form(s). Plans should make every reasonable effort to provide prescribing physicians with clear instructions on what information is needed to make timely coverage determinations and should provide physicians with any applicable forms that the plans have available. Plans should make these forms readily available, such as by posting all such forms on a webpage dedicated to PA/exceptions/appeals issues. CMS will work with plans to provide links to these web pages.

Update #22- March 23, 2006: Medicare takes steps to help people with limited incomes and resources enroll in Part D.

FOR IMMEDIATE RELEASE CONTACT: CMS Media Affairs (202) 690-6145 March 19, 2006
MEDICARE TAKES STEPS TO HELP PEOPLE WITH LIMITED INCOMES AND RESOURCES TAKE ADVANTAGE OF COMPREHENSIVE MEDICARE DRUG COVERAGE

Everyone in Medicare now has access to prescription drug coverage, regardless of their income or how they get their Medicare. For those with limited incomes, there is extra help providing comprehensive coverage with no or low premiums and low or no deductible.

To ensure that beneficiaries receive the benefit of the extra help, CMS is facilitating the enrollment of certain beneficiaries into prescription drug plans. This week, CMS will begin mailing letters to approximately 1.2 million people with Medicare who have applied for and been approved for the extra help and those who are enrolled in other federal assistance programs such as Supplemental Security Income (SSI) and Medicare Savings Programs.

The letters let the beneficiary know in which Medicare prescription drug plan they will be enrolled if they take no action before April 30. Unless they enroll on their own during March, these beneficiaries will have their prescription drug coverage begin on May 1. CMS is enrolling these beneficiaries earlier to make sure that they receive the benefit of the extra help immediately, and without having to pay a penalty. These beneficiaries can still decline the enrollment before it becomes effective, and would not be charged a premium.

A copy of the letter will be available online at http://www.cms.hhs.gov/. The letter will be printed on green paper so that it can be readily identified by beneficiaries, their family members, and other organizations that counsel beneficiaries about their Medicare Choices.

Many of these individuals will not be charged a premium for this drug coverage. However, some of these individuals qualify for sliding-scale premium assistance. But if those beneficiaries don’t enroll in a plan by May 15, 2006, and don’t have prescription drug coverage that is as good as Medicare’s, they will have to pay more for this coverage if they want to enroll later.

Beneficiaries whose employer or union plan sponsor is claiming the retiree drug subsidy on their behalf will not be included in this facilitated enrollment process. However, it is possible that a beneficiary with other drug coverage that is as good as or better than Medicare prescription drug coverage will still be enrolled by CMS because he or she qualifies for extra help. These beneficiaries may want to keep their current coverage and decline enrollment from Medicare.

These beneficiaries should read the letter they received from their employer or union (or the plan that administers their drug coverage), because employers and unions can work with Medicare prescription drug coverage in different ways. If they have questions, they should call their plan or benefits administrator or the office that answers questions about their benefits. They may want to keep their current coverage and decline enrollment from Medicare by calling 1-800-MEDICARE.

CMS also worked with State Pharmacy Assistance Programs in New York, New Jersey, Connecticut, Pennsylvania, and Illinois to make sure that any of their members that the State plans to enroll in a Medicare Prescription Drug Plan are not also facilitated enrolled by CMS.

All of the plans that qualify for the automatic enrollment must meet Medicare’s standards for access to medically necessary drugs at a convenient local pharmacy. Beneficiaries also have the option to change plans if they are unhappy with the plan into which CMS facilitated them. The letters will also help ensure that these beneficiaries are aware that they can choose a different approved plan in their area, and that they can call 1-800-MEDICARE to find out more about these plans.

The letters make it clear to beneficiaries that they can choose a different approved plan in their area. The green facilitated enrollment letter will list all the prescription drug plans available in their region with premiums at or below the low-income premium subsidy amount. It also recommends calling 1-800-MEDICARE to find out more about these plans.

Beneficiaries can get personalized information about their prescription drug plan options. 1-800-MEDICARE is available at anytime with little or no waiting. People can also go to http://www.medicare.gov/, or get face-to-face help from one of the many partner organizations, such as the State Health Insurance Programs or attend one of the many enrollment events being held around the country to get additional information about their drug coverage options. # # #

Update #21- March 23, 2006: Toolkit for Transitional Coverage

For the first time in its 40 year history, Medicare began offering prescription drug coverage. Millions of people have been getting their prescription drugs at significant savings since the program began on January 1.

The Centers for Medicare & Medicaid Services (CMS) has been working closely with the Medicare prescription drug plans to ensure that people with Medicare enrolled in the plans, including those also enrolled in Medicaid, have access to needed medicines even if the drugs they had been taking were not included on the plans’ drug lists. The original policy required “transition” coverage of a beneficiary’s brand name drug for the first 30 days in which the beneficiary was enrolled in the drug plan, and in the case of beneficiaries in long-term-care facilities, a 90-day supply.

A few weeks after the program began, CMS worked with plans to extend the original transition policy to 90 days for any beneficiary that had enrolled effective January 1, and 60 days for beneficiaries who enrolled effective February 1. The extended period ends on March 31, but for beneficiaries enrolling after these dates; the 30 day transition policy continues to apply.

To help counselors, health care providers and others who care for people with Medicare, CMS has developed training and educational materials about the transition period. These materials will help you provide assistance to clients, patients and members of the community. Partners can access the toolkit at http://www.cms.hhs.gov/partnerships/18_transition.asp. In order to ensure a smooth transition, Medicare beneficiaries should remember to:

Contact their plan to make sure all medications are covered by the plan.
Talk with their pharmacist to learn what covered drugs can be used in place of a current drug, if the drug is not covered by a plan, and work with their doctor to change their prescription to a drug on the plan’s formulary.
Talk with their doctor about switching to a covered drug or request an exception from the plan before the transition supply is gone.

Update #20- March 23, 2006: Medicare Enrolled Update

More Than 27 Million Medicare Beneficiaries are Enrolled in Prescription Drug Coverage Medicare beneficiaries signing up at a rate of 380,000 per week
Medicare announced today that 1.9 million additional beneficiaries have signed up for prescription drug coverage since mid-February. This represents a 25 percent increase over last month in the number of people who have selected a plan and brings the total of those who have signed up individually over the past four months to approximately 7.2 million.

Attached, please find the HHS link for more information http://www.hhs.gov/news/press/2006pres/20060323.html
For enrollment data by county, visit http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/cedata032006.zip.
You may also find this information at the CMS website http://www.cms.hhs.gov/ within CMS Highlights.

Update #19- March 21, 2006: Updated Guidance – Changes to Effective Date and PDP Notice Requirements for Auto-Enrollment and Facilitated Enrollment

Links to facilitated enrollment notice
Links to the English and Spanish versions of the facilitated enrolment notice are now available on the CMS website.

English versions
http://www.cms.hhs.gov/partnerships/Downloads/11186.Full.pdf
http://www.cms.hhs.gov/partnerships/Downloads/11191.PARTIAL.pdf

Spanish versions
http://www.cms.hhs.gov/partnerships/Downloads/11186S.Full.pdf
http://www.cms.hhs.gov/partnerships/Downloads/11191S.PARTIAL.pdf

These links are available on the MMA Outreach Publications list:
http://www.cms.hhs.gov/partnerships/mmaop/list.asp

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850

CENTER FOR BENEFICIARY CHOICES
To: Medicare Prescription Drug Plans (PDPs)
From: Anthony J. Culotta, Acting Director /s/ Medicare Enrollment and Appeals Group
Subject: Updated Guidance – Changes to Effective Date and PDP Notice Requirements for Auto-Enrollment and Facilitated Enrollment

Date: March 17, 2006
The purpose of this memo is to provide information and guidance about the following:
• The first round of facilitated enrollment, effective May 1, 2006
• Effective dates for future auto-enrollment actions
• Retroactive enrollments for full-dual beneficiaries who have voluntarily enrolled in a PDP

Earlier this week, CMS released two transaction files to PDPs that contain information about beneficiaries to be facilitated or auto-enrolled into Part D. This memo outlines requirements associated with both the facilitated enrollment and auto-enrollment processes, and provides updated guidance. The first file, released on March 13, includes those beneficiaries who have been auto-enrolled or facilitated enrolled. The second, released on March 15, was a special Transaction Reply Report that includes only the facilitated enrollment population.

CMS is changing the effective date of auto-enrollment for certain subsets of full-benefit dual eligibles. In addition, CMS is modifying previous guidance provided on November 10, 2005 as to when PDPs must provide a confirmation notice to new auto-enrollees, and is extending this requirement to facilitated enrollees. CMS is also changing the effective date of the initial round of facilitated enrollment for non-full benefit dual eligibles who are eligible for the low-income subsidy from June 1, 2006 to May 1, 2006.

Facilitated Enrollment Effective May 1, 2006
The effective date of facilitated enrollment for beneficiaries included in the special March 15 Transaction Reply Report will be May 1, 2006. Facilitated enrollments can be distinguished by looking for the following: Field 21 – Enrollment Source = C (facilitated enrollment); and Transaction Reply Code = 118 (facilitated enrollment).

Thus, the effective date of facilitated enrollment of non-full benefit dual eligibles who are eligible for the low-income subsidy remains prospective, i.e. the first day of the second month after the beneficiary is included in a monthly facilitated enrollment run, as outlined in section 30.1.5.B of CMS’ PDP Eligibility, Enrollment and Disenrollment Guidance).

New Guidance on Auto-Enrollment Effective Date
Under our existing PDP Eligibility, Enrollment and Disenrollment Guidance (Section 30.1.4.B.), the auto-enrollment effective date for full-benefit dual eligibles who are first Medicare eligible and subsequently become Medicaid eligible, is the first day of the second month after the person is identified by CMS (i.e., included in our monthly auto-enrollment process. However, this policy may result in a gap in prescription drug coverage for these individuals. Likewise, full-benefit dual eligibles who voluntarily enroll in a Part D may experience a gap in prescription drug coverage, since that enrollment is effective prospectively.

Therefore, effective immediately, the effective date of auto-enrollment for full-benefit dual eligibles who are Medicare eligible and subsequently become Medicaid eligible will be the first day of the month of Medicaid eligibility or January 1, 2006, whichever is later. This includes those individuals who become eligible for both Medicare and Medicaid in the same month. This updated guidance supersedes instructions in Section 30.1.4.B of CMS’ PDP Eligibility, Enrollment and Disenrollment Guidance as applicable to this subset of auto-enrollees. CMS will continue to calculate the effective date of auto-enrollments and provide this information on the Transaction Reply Report (TRR) and the PDP notification file.

Revised Guidance on Auto-Enrollment Effective Date for Full-Benefit Dual Eligibles With Previous Enrollment in a Part D Plan
Also, effective immediately, the auto-enrollment effective date for full-benefit dual eligibles who had previously been enrolled in a Part D plan, but disenrolled and failed to enroll in a new Part D plan, is the first day of the month after the disenrollment effective date from the previous Part D plan. This updated guidance supersedes Section 30.1.4.B of CMS’ PDP Eligibility, Enrollment and Disenrollment Guidance as applicable to this subset of auto-enrollees.

Thus, all auto-enrollments will now have a retroactive effective date, as follows:
• New full-benefit dual eligibles who are Medicare eligible first will be auto-enrolled retroactive to the start of Medicaid eligibility;
• New full-benefit dual eligibles who are Medicaid eligible first will be auto-enrolled retroactive to the start of Medicare Part D eligibility as outlined in Section 30.1.4.D. (which remains unchanged for the population who is Medicaid first and then becomes Medicare eligible);
• Full-benefit dual eligibles with previous Part D plan enrollment will be auto-enrolled retroactive to the day after the end of that previous coverage.

Revised Guidance on Effective Date of Voluntary Enrollment by Full-Benefit Dual Eligibles with Out-of-Pocket Costs in Previous Uncovered Months
In limited instances, a full-benefit dual eligible voluntarily enrolls in a Part D plan in the month(s) before the individual would otherwise have been auto-enrolled. Individuals with active elections are not included in our auto-enrollment process. However, since an individual’s elected enrollment normally would not be effective until the first day of the following month, this would mean that the individual would have a coverage gap before the effective date of the election and thus would likely incur out-of-pocket prescription drug costs.
To remedy this situation, we are establishing a Special Enrollment Period (SEP) that will permit such individuals to have their voluntary enrollment be retroactive to the first day of the previous un-covered month(s). The effective date is retroactive only to the beginning of the month in which there were out-of-pocket costs, not necessarily all months in which there was no Part D plan enrollment. Please note that the beneficiary must have been a full-benefit dual eligible during each of the uncovered month(s), and incurred out-of-pocket costs during this time. Where these cases originate with CMS, caseworkers in CMS’ Regional Offices will take the appropriate action and notify the PDP. If a full-benefit dual eligible member requests this retroactive coverage directly from the PDP, the PDP must develop the retroactive request and submit it to CMS Division of Payment Operations.

Revised Guidance on Deadline for PDP Confirmation Notice to New Auto- and Facilitated Enrollees
Beginning in June 2006, PDPs must provide the confirmation notice to new auto- and facilitated enrollees within seven (7) business days of receiving the weekly TRR with confirmation of auto- or facilitated enrollment, or the PDP notification file (monthly file listing assignments, that also includes address data), whichever is later. This requirement must be met for new autoand facilitated enrollees beginning in June 2006, and replaces guidance issued on November 10, 2005 (see Q&A #5) for auto-enrollees, and section 30.1.5.D of the PDP Guidance.

Further Information
We appreciate PDPs’ continued cooperation in ensuring full-benefit dual eligibles do not experience coverage gaps, and that all auto- and facilitated enrollees are notified in a timely manner that their enrollment is confirmed. If you have any questions, please contact Sharon Donovan at (410) 786-2561, or sharon.donovan@cms.hhs.gov

Update #18- March 21, 2006: Updated Guidance- Changes to Effective Date of Medicare Advantage

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850

CENTER FOR BENEFICIARY CHOICES
To: Medicare Advantage Organizations and 1876 Cost Plans
From: Anthony J. Culotta, Acting Director /s/ Medicare Enrollment and Appeals Group
Subject: Updated Guidance – Changes to Effective Date of Medicare Advantage (MA) and 1876 Cost Plan Auto-Enrollments and Notice to Begin Facilitated

Enrollment of Other LIS Beneficiaries
Date: March 17, 2006
The purpose of this memo is to provide information and guidance about the following:
• The first round of facilitated enrollment, effective May 1, 2006
• Effective dates for future auto-enrollment actions
• The monthly file of full benefit duals enrolled in MA plans

Facilitated Enrollment Effective May 1, 2006
MA organizations and 1876 Cost Plans must facilitate enrollment of their non-full benefit dual members who are also eligible for the low-income subsidy (LIS) effective May 1, 2006, instead of June 1, 2006, as stated in previous guidance. Affected beneficiaries must receive notice from the organization about such enrollment no later than April 10, 2006, so that they have sufficient time to opt-out or change plans prior to May 1. (See Chapter 2, Exhibit 28 of the Medicare Managed Care Manual (MMCM) for the model notice to be used for this purpose.) The following data elements will enable organizations to distinguish these non-full dual members (“Other LIS Eligibles”) from full-benefit dual eligibles:
• LIS premium subsidy amount is 025, 050, or 075
• LIS copayment level = 4 (15%)
• LIS copayment level =1 ($2/5) and the individual is not on the MA full dual file

1876 cost plans must follow the same process to auto- or facilitate enroll those beneficiaries who do not have a Part D optional supplemental benefit, even though they may have elected astand-alone PDP on their own. Since cost plans will not necessarily know which of their members are enrolled in a stand-alone PDP, they must still include them in the auto- or facilitated enrollment process, and provide timely notification to the beneficiary in advance of submitting the enrollment transaction to CMS. (Please see Guidance issued on February 8, 2006 for more information about the timeframes for notifying beneficiaries and submitting enrollment transactions to CMS.) If the beneficiary subsequently informs the plan that s/he has elected a PDP, the cost plan must accept this “opt-out” from auto- or facilitated enrollment and cannot submit an enrollment transaction on behalf of this individual.

CMS has safeguards in place to prevent existing MA and cost plan enrollees from being facilitated enrolled into a PDP. However, there may be instances in which a beneficiary election will not have been processed at the point in time when facilitated enrollment occurs. In these cases, the beneficiary will receive a notice from CMS informing him/her that s/he has been enrolled into a PDP. However, once the beneficiary election is processed, it will prevail over the facilitated enrollment made by CMS.

New Guidance on Auto-Enrollment Effective Date
Our existing guidance in Chapter 2 of the MMCM (Section 20.4.6) currently requires that fullbenefit dual eligibles enrolled in an MA plan without Medicare prescription drug benefits be enrolled into an MA-PD plan in the same organization. The effective date of this enrollment for those who are Medicare eligible and subsequently become Medicaid eligible is the first day of the second calendar month following the month of auto-enrollment. However, this policy may result in a gap in prescription drug coverage for these individuals.

Therefore, effective immediately, the effective date of auto-enrollment for full-benefit dual eligibles who are Medicare eligible and subsequently become Medicaid eligible will be the first day of the month of Medicaid eligibility, the first day of enrollment in an MA-only plan or 1876 Cost Plan Benefit Package without Part D optional supplemental benefit, or January 1, 2006, whichever is later. This also applies to those individuals who become Medicare and Medicaid eligible in the same month. As a result, all auto-enrollments will now be retroactive, as shown below:
• New full benefit duals who are Medicare eligible first will be enrolled retroactive to the start of Medicaid eligibility (i.e., the first day of month they appear on the MA full dual file)
• New full duals who are Medicaid eligible first will be enrolled retroactive to the start of Medicare Part D eligibility (i.e., the effective date of their enrollment in the MA-only plan, which should also coincide with first day of the month they appear on the MA full dual file. Please also see Guidance issued on February 8, 2006).

However, in no case will the effective date of auto-enrollment precede the date that the individual became an enrollee of the MA organization or 1876 Cost Plan. This updated guidance supersedes instructions in Section 40.1.6 of Chapter 2 of the MMCM as applicable to this subset of auto-enrollees.

Continuation of MA Full Dual File

CMS will continue to provide the monthly MA Full Dual File as a means for MA organizations and 1876 Cost Plans to identify their current full-benefit dual eligibles enrollees who need to be enrolled into the organization’s Part D benefit. The March MA full dual file was released to plans on March 13, 2006. The file will still be limited to existing full-benefit dual eligible enrollees in an organization. (See information above about identifying “Other LIS Eligibles.”) The organization must continue to determine whether any of those individuals require autoenrollment, and if so, auto-enroll them.

Beginning this month, the MA full dual file will only be sent to MA organizations and 1876 cost plans that need to conduct auto-enrollment, specifically:
• MA-organizations with at least one MA-only plan
• 1876 Cost Plans that offer a Part D optional supplemental benefit
• MA-PFFS that offer a Part D benefit.
The MA full dual file will no longer be sent to the following organizations:
• MA organizations that only offer MA-PD plans, since all enrollees have Part D benefits and do not need to be auto-enrolled
• 1876 Cost Plans that do not offer a Part D optional supplemental benefit in any of its Plan Benefit Packages (PBPs)
• 1833 Cost Plans
• MA Private Fee-For-Service (MA-PFFS) plans that do not offer a Part D benefit in any of its Plan Benefit Packages (PBPs)
• MA organizations or 1876 Cost Plans in the territories

Further Information
We appreciate MA organizations and 1876 Cost Plans’ continued cooperation in ensuring fullbenefit dual eligibles and other LIS eligibles are enrolled in a timely manner so as to avoid coverage gaps. If you have any questions, please contact Sharon Donovan at (410) 786-2561, or sharon.donovan@cms.hhs.gov

Update #17- March 17, 2006: Home Infusion Therapy

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services -7500 Security Boulevard -Baltimore, Maryland 21244-1850
CENTER FOR BENEFICIARY CHOICES

March 10, 2006
Memorandum To: All Part D Sponsors
Subject: Home Infusion Therapy
From: Gary Bailey, Deputy Director, Center for Beneficiary Choices

As we move into the third month of implementing the Medicare Drug Benefit, we want to clarify for prescription drug plan sponsors the Part D benefit for home infusion therapy as we are hearing numerous complaints in this area. We believe that your review of this letter and attachments will assist us in making this benefit more effective for your members.

As you are aware, we require coverage of home infusion drugs under Part D that are not currently covered under Parts A and B of Medicare. Although the Medicare Part D benefit does not cover equipment, supplies, and professional services associated with home infusion therapy, it does cover the ingredient costs and dispensing fees associated with infused covered Part D drugs. Please refer to Attachment I to this letter which describes the payment obligations under Medicare for home infusion therapy.

Clear Directions to Access Home Infusion Pharmacy
We have been hearing complaints about the inability of beneficiaries and their providers to identify and access in-network systems capable of delivering home infusion drugs covered under Medicare Part D. We remind plan sponsors that they need to have in place through their customer and provider service lines clear directions on how to contact an in-network pharmacy for appropriate coverage of Part D home infused drugs.

Home Infusion Drugs Must be Provided In a Usable Form
We have been hearing complaints about beneficiaries receiving drugs to be used for their home infusion therapy in an unmixed, unusable form. It is important to emphasize that, while we do not expect the Part D plans to provide or pay for supplies, equipment, or the professional services needed for home infusion therapy, we do expect the plan sponsor’s contracted pharmacy to deliver home infused drugs in a form that can be administered in a clinically appropriate fashion.

In addition, home infusion networks must have contracted pharmacies capable of providing infusible Part D drugs for both short term acute care (e.g. IV antibiotics) and long term chronic care (e.g. alpha¹ protease inhibitor) therapies. While the same network pharmacy does not necessarily need to be capable of providing the full range of home infusion Part D drugs, the home infusion network, in aggregate, must have a sufficient number of pharmacies capable of providing the full range of home infusion Part D drugs to ensure enrollees have adequate access to medically necessary home infusion therapies when needed.

Assurances that Ancillary Services Will be Provided
Generally, facility discharge planners, in collaboration with a patient’s physician, are responsible for ensuring that the components needed to safely administer a drug at home are present upon a patient’s discharge. However, we also expect the Part D plan’s in-network contracted pharmacy vendors -- particularly those that do not supply the necessary ancillary services (which are not a Medicare Part D benefit) -- to receive assurances that another entity can arrange for the provision of these services, such as a home health agency. In other words, Part D plans must require their contracted network pharmacies that deliver home infusion drugs to ensure that the professional services and ancillary supplies are in place before dispensing home infusion drugs. We would consider this action of obtaining assurances a minimum quality assurance requirement on Part D plans under 423.153(c). Please refer to Attachment II to this letter which describes the overall decision tree with respect to the coordination of home infusion therapy.

Time Sensitive Nature of Home Infusion Therapy
Home infusion therapy may serve as a vehicle to promote early hospital discharge. We understand that there have been unexpected delays in the approval of off-formulary requests for infusion drugs. This has resulted in some beneficiaries remaining in an inpatient setting before the home infusion therapy can be initiated while an exceptions request is submitted and resolved. Because the need for home infusion therapy is often of an urgent nature, physicians dealing with home infusion therapy situations may determine that an expedited coverage determination or redetermination is necessary for their patients and communicate this information to the Part D plans. Plan sponsors should resolve these requests as quickly as possible.

Thank you for your help in ensuring that Part D enrollees have timely access to medically necessary home infusion therapy.

Update #16- March 9, 2006: What drugs do Medicare Drug Plans Cover (CMS Pub. No. 11194)

What drugs do Medicare Drug Plans Cover?

Medicare drug plans must cover prescription drugs in all prescribed categories and classes but Medicare drug plans don’t have to cover every drug. Certain drugs may be excluded*. Although your drug plan may not have a specific drug on their list of covered drugs (formulary), a similar drug that is safe and effective should be available. This may be in the form of a therapeutic alternative or generic drug (see below). This makes sure that people with different medical conditions can get the treatment they need. All Medicare drug plans have negotiated to get lower prices for the drugs on their lists of covered drugs. This means using drugs on your plan’s list will save you money. You will pay these lower prices for your prescriptions even before you meet the deductible. In addition, choosing a generic alternative instead of a brand-name drug can save you money with each refill.

My drug plan covers generic drugs. Are they as good as brand-name drugs?

Yes. Today, almost half of all prescriptions in the United States are filled with generic drugs. The U.S. Food and Drug Administration ensures that a generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. Generic drugs use the same active ingredients as brand-name drugs and work the same way. This means they have the same risks and benefits as the brand-name drugs. Creating a drug costs a lot of money. Since generic drug makers don’t develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug.

My drug plan says I need prior authorization for a medicine that is on the plan’s list of covered drugs. What does prior authorization mean?

Medicare drug plans may have rules that require prior authorization. Prior authorization means before a plan will cover certain prescriptions, your doctor must first contact the plan. Your doctor has to show there is a medical reason why you must use that particular drug to treat your condition. Plans do this to be sure certain drugs are used correctly and only when necessary.

What is Step Therapy?

One form of prior authorization is step therapy. With step therapy, in most cases, you must first try certain less expensive drugs that have been proven effective for most people with your condition. For instance, some plans may require you to try a generic drug (if available), then a less expensive brand-name drug that is on their drug list, before you can get a similar, more expensive brand-name drug covered. However, if you have already tried the similar, less expensive drugs and they didn’t work, or if your doctor believes that because of your medical condition you must take the more expensive drug, he or she can contact your drug plan to request an exception. If your doctor’s request is approved, the plan will cover the more expensive drug.

What if I’m taking a drug that’s not on my plan’s list (or is a step-therapy drug) when my drug plan coverage takes effect?

Medicare requires drug plans to fill your prescriptions through March 31, 2006, even if the prescription is for a drug that’s not on the plan’s drug list (or is a step-therapy drug). This “transition plan” gives you and your doctor time to find another drug on the plan’s drug list that would work as well. However, if you have already tried similar drugs and they didn’t work, or if your doctor believes that because of your medical condition it is necessary for you to take a certain drug, he or she can contact your plan to request an exception. If your doctor’s request is approved, the plan will cover the drug.

What are Quantity Limits?

For safety and cost reasons, plans may limit the quantity of drugs that they cover over a certain period of time. For example, you may be prescribed a drug with the instruction to take one tablet per day. In this instance, a plan may cover only a 30-day supply at a time (up to 90-day supply if filled through a plan’s mail order program). If you disagree with the quantity of drugs your plan will cover over a certain period of time, you may ask your plan for an exception.

What if I choose a drug plan and then my doctor changes my prescription?

If your doctor needs to change your prescription or prescribe a new drug, your plan’s list of covered drugs will include drugs to treat your new medical needs. This list and the prices for drugs can change. To get information about the specific drugs your plan covers and their cost, look at the company’s website or call the drug plan’s customer service number. Your doctor can also get information about the drug list for your plan. Medicare drug plans cover both generic and brand-name prescription drugs in all prescribed categories and classes. Certain drugs may be excluded*. Medicare requires drug plans to cover medically necessary drugs, so in general there will be a drug on the plan’s list that is safe and effective to treat your condition.

What if I don’t want to switch to another drug?

If your doctor needs to prescribe a drug that isn’t on your Medicare drug plan’s drug list, and you don’t have any other health insurance that covers outpatient prescription drugs, you can request an exception (see below) from your plan. If your plan still won’t cover a specific drug you want to use, you may appeal the decision. Urgent appeals take only a few days.

How do I get an exception?

The first step in requesting an exception is to contact your drug plan. Your plan will tell you how to submit the information they need to make a decision. The plan may request the information in writing. They also can choose to accept the information over the phone. Your doctor must submit a statement supporting your request. The doctor’s statement must say that the requested drug is “medically necessary” for treating your condition. Once this information is submitted, your drug plan must notify you of its decision no later than 24 or 72 hours.

What if the plan decides not to give me an exception?

If your request is denied, you can appeal your drug plan’s denial. There are several levels of appeal available to you. Appeal through your plan. You must request this appeal within 60 calendar days from the date of the plan’s first decision. You or your appointed representative must file a standard request in writing unless your plan accepts requests by telephone.

What if the plan decides not to give me an exception?

Review by an independent review entity. If the plan again decides against you, you can request a review by an independent review entity. You or your appointed representative must make a standard or expedited request within 60 days from the date of the decision. If the independent review entity agrees with your plan’s decision, you can still appeal through other levels. These include possible reviews by administrative law judges, a Medicare Appeals Council, and Federal court. Time and dollar limits may apply. More information about these appeals is available on www.medicare.gov on the web. Or, contact your drug plan for information on their exception and appeals process.

Someone told me I should switch to another drug plan that covers the prescription I need. Should I?

Medicare drug plans must continue their transition plan through March 31, 2006. The purpose of the 90-day transition period is that if you enrolled in the first few months of the program, you have time to work with your doctor and find a drug that would work as well for you on your plan’s drug list. And, if you have already tried similar drugs and they didn’t work, or if your doctor believes that because of your medical condition it’s necessary for you to take a certain drug, he or she can contact your plan to request an exception. If your doctor’s request is approved, the plan will cover the drug. If you enroll in a Medicare drug plan after March 31, 2006, Medicare requires drug plans to fill your prescriptions once, within the first 30 days your coverage is in effect, even if the prescription is for a drug that’s not on the plan’s drug list (or is a step-therapy drug). This gives you and your doctor time to find another drug on the plan’s drug list that would work as well or time for your doctor to request an exception due to any special medical needs you have for a specific drug. If your doctor’s request is approved, the plan will cover the drug.

For more information

• Talk to your doctor about getting safe and effective alternative drugs that may also save you money, or to request an exception if necessary for your condition.
• Contact your drug plan with questions about what is covered by your plan.
• Call your State Health Insurance Assistance Program for help with an appeal or choosing Medicare prescription drug coverage that meets your needs.
Call 1-800-MEDICARE (1-800-633-4227) for their telephone number.
TTY users should call 1-877-486-2048.
* Certain drugs may be excluded by law, such as benzodiazepines, barbiturates, drugs for weight loss or gain, and drugs for relief of colds. Medicare may not pay for these drugs.

Update #15- March 7, 2006: Medicare Consumer Alert

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services Room 303-D 200 Independence Avenue, SW Washington, DC 20201

Office of External Affairs MEDICARE CONSUMER ALERT FOR IMMEDIATE RELEASE CONTACT: CMS Media Affairs March 7, 2006 (202) 690-6145

Medicare Beneficiaries Urged to be on the Look-out for Phone Scams

The Centers for Medicare & Medicaid Services (CMS) warns seniors and people with disabilities to be aware of a scheme that asks Medicare beneficiaries for money and checking account information to help them enroll in a Medicare Prescription Drug Plan.

This scheme is called the “$299 Ring” for the typical amount of money Medicare beneficiaries are talked into withdrawing from their checking accounts to pay for a non-existent prescription drug plan. Consumers can report these cases to their local law enforcement agencies or 1-877-7SAFERX (1-877-772-3379).

Medicare has received complaints from Indiana, Michigan, Pennsylvania, Massachusetts New Jersey and Georgia. Complaints have been made against a number of different companies, but authorities believe that the companies are the same and are typically based outside the U. S. As soon as CMS receives these complaints, they are investigated and referred to federal law enforcement authorities.

No Medicare drug plan can ask a person with Medicare for bank account or other personal information over the telephone. No beneficiary should ever provide that kind of information to a caller. They should contact their local police department if they believe someone is trying to take money or information from them illegally.

People with Medicare should also remember that they should be on the lookout for anyone trying to take advantage of them and take steps to protect themselves by remembering:

• No one can come into your home uninvited.
• No one can ask you for personal information during their marketing activities.
• Always keep all personal information, such as your Medicare number, safe, just as you would a credit card or a bank account number.
• Whenever you have a question or concern about any activity regarding Medicare, call 1-800-MEDICARE.

In addition, legitimate Medicare drug plans will not ask for payment over the telephone or the Internet. They must bill the beneficiary for the monthly premium. Typically, that amount is set up as an automatic withdrawal from the beneficiary’s monthly Social Security check. Beneficiaries may also opt to pay the monthly premiums in other ways such as writing a check or setting up automatic payments from their checking accounts.

Update #14- State Status of Medicare Low Income Subsidy Applications Received by the Social Security Administration as of 1/27/06

Click here to see the SSA Completed Decisions by State.

Update #13- Secretary Levitt's Progress Report II on the Medicare Prescription Benefit, Feb. 22, 2006 Download PDF Version

[EXCERPT]
"We are now at the 53rd day since implementation of Medicare prescription drug coverage. After reviewing the numbers and experiences to date, I can report that we are seeing solid progress. But we are not done. We continue to work aggressively to solve the problems that inevitably occur in transitions this size. Enrollment is going up; Costs are going down.
More than 25 million enrollees are now receiving prescription drug benefits and we are adding on average of 250,000/week. The marketplace is working. ...
"The reimbursement program for administrative payments and limited drug payments will continue as needed for the coming weeks."

Update #12- February 10, 2006 More Time to Fill the Prescriptions You Need

Medicare and your drug plan are working together to make sure you have coverage for the prescriptions you need.

All Medicare drug plans must make sure that the people in their plan can get medically-necessary drugs to treat their conditions. Medicare drug plans cover both generic and brand-name prescription drugs. The drug lists must include a range of drugs in the prescribed categories and classes. This makes sure that people with different medical conditions can get the treatment they need.

Most plans have a list of drugs covered by the plan called a formulary. Your plan may have a different brand-name drug for your condition on its list than the prescription you currently take. You can work with your doctor to change to this drug or to a generic drug if one is on the list. If your doctor thinks you need a drug that isn’t on the list, your doctor can apply for an exception to try to continue your current prescription. If the plan denies the request, you can appeal their decision.

When your Medicare prescription drug coverage starts and you go to the pharmacy for the first time to fill a prescription, you may not have had time to work with your doctor. You may still be taking a prescription that isn’t covered by your Medicare drug plan, or a prescription that requires a prior authorization by your doctor before your Medicare drug plan would cover it.

So that you are able to leave the pharmacy with a prescription, your plan will cover a 30-day supply of your current prescription. You need to contact your doctor so you can change your prescription to one that is covered by your plan or if necessary, work on requesting an exception.

Medicare and your plan are now providing you more time to work with your doctor on a solution in these cases. If your Medicare drug plan coverage was effective on January 1 or February 1, 2006, you will now have until March 31, 2006, to work with your doctor to switch to a prescription on your plan’s list. Until then, your plan will allow your pharmacist to fill your current prescription through March 31, 2006.

If you join a Medicare drug plan and your coverage starts on March 1, 2006, or later, your plan will still allow you to fill a one-time, 30-day supply of your prescription in these cases. Then, you will have 30 days to talk with your doctor about a change that works for you.

CMS Pub. No. 11193 February 2006 CENTERS FOR MEDICARE & MEDICAID SERVICES

Update #11- February 10, 2006 A Memo to All Part D Plans that Address 30-day Billing Limit for Pharmacists and Beneficiaries (click for PDF version)

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

MEMORANDUM
TO: All Part D Plan Sponsors
FROM: Gary Bailey, Deputy Director for Plan Policy and Operations
RE: 30 Day Billing Limit for Pharmacists and Beneficiaries
DATE: February 7, 2006

We want to again thank all the Part D plans for their willingness to work with CMS over the past month as we implement the Medicare prescription drug benefits for our beneficiaries. Through your work, we have provided prescription drugs to millions of Medicare beneficiaries.

We are working on various issues that we hope will continue to provide for smooth implementation of the benefit. Over the past week, pharmacists have begun to bill or to resubmit bills to Part D plans for claims that were lacking correct billing information. As they attempt this rebilling, pharmacists are encountering a 30 day billing limit placed by the Part D plan. That is, the Part D plan is again rejecting the drug claim as "too old" because it exceeds the 30 day limit.

There may also be beneficiaries who will need to request reimbursement from the plan for incorrect co-payment amounts or other payments they made that were incorrect.

Because of systems issues being encountered at CMS and at plans, we are requesting that plans not implement 30-day billing limits placed on pharmacists and beneficiaries. Instead, these edits should be relaxed to allow pharmacists to bill Part D plans for claims that are as old as 90 days. In addition, beneficiaries should have 90 days in which to provide documentation to the plan for any incorrect payments they may have made.

If you have any questions about this issue, please contact your account manager.

Thank you for your continued assistance with the implementation of the Part D benefit.

Update #10- February 10, 2006 A Press Release Providing Tips for Beneficiaries Enrolling in the Medicare Rx Program (click for PDF version)

For Immediate Release: Contact:

Thursday, February 09, 2006 CMS Office of Public Affairs
202-690-6145

For questions about Medicare please call 1-800-MEDICARE or visit http://www.medicare.gov/.

MEDICARE OFFERS TIPS WHEN ENROLLING IN PRESCRIPTION DRUG PLANS

PEOPLE WITH MEDICARE REMINDED TO ENROLL EARLY IN THE MONTH

Millions of people with Medicare enrolled in prescription drug plans are leaving pharmacy counters with their prescription drugs, and at a significant savings since the drug coverage began on Jan. 1.

“Medicare’s new prescription drug coverage is working for millions of seniors and people with disabilities. At the same time, we are making progress in fixing problems that some may be experiencing at the pharmacy counter,” said Health and Human Services Secretary Mike Leavitt. “One way to reduce problems is for beneficiaries to earlier in the month to ensure they will be able to get their medicines the first of the next month.”

If a person enrolls or changes plans before the 15th day of any month, it is much more likely that things will go smoothly at the pharmacy counter than if they enroll later in the month. A beneficiary who enrolls after the 15th of the month, may need to spend extra time at the counter working details out.

CMS expects the percentages of those who have to spend extra time at the pharmacy counter will decline as more and more people get and use their new prescription drug cards.

People with Medicare should remember:

After your prescription drug plan has processed your enrollment application, you should get an acknowledgement letter or confirmation letter from the plan you joined. This may take several days, so if you enrolled towards the end of January, you will get your letter sometime the first week of February.
If you need to fill a prescription

Take your acknowledgement or confirmation letter with you to the pharmacy until you get a membership card.
If you haven’t gotten a letter yet, you might have one or more of the following to bring with you to the pharmacy: a welcome letter from the plan, an enrollment confirmation number, or a copy of an enrollment application signed by a plan representative.
If you have both Medicare and Medicaid or have been approved for the low-income subsidy (extra help paying for prescriptions), bring a copy of your yellow automatic enrollment letter from Medicare, a Medicaid card, your approval letter from the Social Security Administration, or other proof that you qualify for extra help.
If you need to get a prescription before you get your letter or membership card, let your pharmacist know your plan name and bring one of the items above to get your prescriptions – it just may take some extra time.
As a last resort, if you pay out-of-pocket for your prescription, save your receipts and work with your plan to be reimbursed.

“If you have any questions about your prescription drug coverage, you can call 1-800-MEDICARE or your plan’s toll-free phone line,” said Secretary Leavitt.

CMS has posted a tipsheet for Medicare partners about enrolling early in the month at http://www.cms.hhs.gov/partnerships/downloads/earlyinmonthtipsheet.pdf

Update #9- February 8, 2006 Encouraging Early-in-Month Enrollments Tip Sheet (click here for PDF version)

As of February 2006- New Medicare Prescription Drug Coverage

As you help people with Medicare compare Medicare drug plans and make a choice that works for them, it is also important to consider the timing of each enrollment.

Generally, if a person with Medicare enrolls in a Medicare drug plan at the beginning of the month, they will be able to get the most out of their coverage, from the first day it is effective. Enrollments early in the month give Medicare and drug plans time to update their systems, and mail important information like a membership card, acknowledgement letter, and welcome package to enrollees before their coverage becomes effective. In these cases, even if a person with Medicare goes to the pharmacy on the first day of coverage, they can get their prescriptions quickly and accurately.

Enrollments later in the month make it far less likely that all of the information needed to file the claim correctly will be available at the pharmacy or the plan. For enrollments being processed later in the month, it is important to provide the enrollee with some extra information to help manage expectations and help the person successfully fill prescriptions. This information is especially important because a person who enrolls late in the month might not receive an acknowledgement or confirmation letter, or a membership card by the day the coverage starts.

In these cases, if the enrollee needs to fill a prescription, he or she should know:

• Take the acknowledgement or confirmation letter to the pharmacy until they receive a membership card.

• If they haven’t gotten a letter yet, they might have one or more of the following to bring to the pharmacy: a welcome letter from the plan, or an enrollment confirmation number.

• If the person has both Medicare and Medicaid or has been approved for the low-income subsidy (extra help paying for prescriptions), they should bring a copy of the yellow automatic enrollment letter from Medicare, a Medicaid card, an approval letter from the Social Security Administration, or other proof that they qualify for extra help.

• If they need to get a prescription before receiving a letter or membership card, they should let the pharmacist know the Medicare drug plan name and bring

one of the items above to get prescriptions filled, and be aware that it may take some extra time.

• As a last resort, if a person must pay out-of-pocket for the prescription, they should save the receipts and work with their Medicare drug plan to be reimbursed.

Update #8- February 2, 2006 Medicare Demonstration Project to Reimburse the States for Part D Efforts

CMS is making available a new Medicare demonstration project which will allow states that have assisted their dual eligible and low-income subsidy entitled populations in obtaining and accessing Medicare Part D coverage to be reimbursed for their efforts. This demonstration permits Medicare payments to be made to States for amounts they have paid for a dual eligible's Part D drugs, or a low-income subsidy entitled Part D Plan enrollee's Part D drugs, to the extent that those costs are not otherwise recoverable from a Part D plan and are not Medicare required cost sharing on the part of the beneficiary. The demonstration would also provide payments for certain administrative costs incurred by the States. NOTE: The reimbursement plan applies to others receiving low-income subsidies, such as SPAP beneficiaries, as well as duals.

For further information regarding this program, please refer to the Dear State Medicaid Director Letter attached below. In addition, an electronic copy of the Demonstration Template is also attached.

Click HERE for the CMS Repayments to States webpage

Click HERE for the Dear State Medicaid Director Letter

Click HERE for the Demonstration Template

Update #7- January 24, 2006 Fact Sheet on State Reimbursement for Medicare Part D Transition

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

FACT SHEET State Reimbursement for Medicare Part D Transition

January 24, 2006

Summary

This state reimbursement plan enables States to be fully reimbursed for their efforts to help ensure that their beneficiaries eligible for Medicare and Medicaid have access to their covered Medicare drugs as they move to their new Medicare Part D drug coverage. The plan also supports limiting the need for State reimbursement by supporting the use of Medicare payment systems whenever possible, and promotes the effective transition of dually eligible Medicare beneficiaries into their new Medicare coverage.

Background

The Centers for Medicare & Medicaid Services (CMS) has taken numerous actions to ensure that full benefit dual eligibles, those eligible for both Medicare and Medicaid, continue to receive needed medications as they make the transition from Medicaid coverage of their drugs to coverage under the new Medicare Part D drug benefit. CMS is committed to working with States to make the transition as seamless as possible for all dually eligible beneficiaries.

To ensure that the Medicare and Medicaid programs can respond expeditiously to the needs of the dual eligible beneficiaries, this state reimbursement plan will allow States that have assisted their dual eligible populations in obtaining and accessing Medicare Part D drug coverage to be reimbursed for their efforts.

In particular, the demonstration plan will permit Medicare payment to be made to States for amounts they have paid for a dual eligible’s Part D covered drugs, to the extent that those costs are not otherwise recoverable under Part D. In addition to providing Medicare funds to reimburse amounts paid by States for Part D covered drugs, the demonstration would also provide payments for administrative costs incurred in the coordination of the drug benefit by State Medicaid programs. CMS will establish a staff team to provide expedited review of applications of States applying for this demonstration.

Purpose

To promote smooth transition to Part D for the subset of Medicare-Medicaid beneficiaries who have had difficulty and who are currently receiving assistance from a State, to minimize State costs, and to fully reimburse States for their costs.

This demonstration, to be administered under Section 402 Demonstration Authority, will evaluate whether timely and effective collaboration between a State and CMS can reduce overall Medicare expenditures by 1) promoting faster inclusion of affected dual eligible beneficiaries in their Part D plan, leading to more effective use of prescription drugs; and 2) promoting high-quality care for dual eligible beneficiaries, due to more effective coordination between Medicare and Medicaid coverage. These steps are expected to lead to lower total Part D costs and lower Medicare and Medicaid expenditures.

With input from the States through a workgroup that has been established, CMS will provide a template for use by those States which re-instituted some coverage through their Medicaid system for dual eligibles. The template is expected to be available shortly and will be posted on the CMS Website. Based on this process, CMS and affected states will develop a process for reconciling payments involving beneficiaries in State Pharmacy Assistance Programs (SPAPs) who were enrolled in Medicare Part D.

Key Features

• State Reimbursement: States that meet the conditions of the waiver will have their full drug benefit costs reimbursed through (1) CMS assurance of payment reconciliation with the prescription drug plans and (2) Medicare payment of any net drug cost differential after reconciliation. In addition, CMS will provide funding for administrative costs incurred by states.

• Payer of Last Resort: States will use payment approaches that support pharmacist efforts to primarily bill the Medicare Part D plan, and that promote the use of Medicare point-of-sale billing, before relying on State payment. States will provide input to CMS and plans on ways to enhance plan and program performance for the state’s dual eligible beneficiaries and pharmacists, to help reduce State billing.

• Timely Data Sharing: States that participate will provide timely summary information on claims incurred, including summary amount and beneficiary identification information, to facilitate reconciliation and beneficiary transition to Part D plans. States will also work with CMS to provide valid data on any set of beneficiaries who may not have been included properly in the State’s previous dual eligible files.

• Claims Identification: States will separate claims for the transition period from claims the States would have otherwise paid through a separate state program. In some States, the State has elected to pay all cost sharing, for example, on behalf of some beneficiaries who would otherwise have paid a copayment.

• End Date: This temporary demonstration program would have an anticipated end date of February 15, 2006. Participating States would discontinue payments through their Medicaid systems on or before this date. The Secretary may provide a short-term extension of the demonstration program.

• Retroactive Effective Date: The demonstration would be retroactive to the first date the state paid claims.

Update #6- January 18, 2006 Memo to All Part D Sponsors- Collaborative Next Steps with CMS

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

January 18, 2006
Memorandum To: All Part D Sponsors
Subject: Collaborative Next Steps
From: Mark B. McClellan, M.D., Ph.D., Administrator

As we move into the third week of implementing the Medicare Drug Benefit, I would like to thank you for your efforts in serving many millions of beneficiaries through the new prescription drug plans. As a result of your efforts, stand-alone prescription drug plans are now filling more than a million prescriptions a day, and hundreds of thousands of beneficiaries, especially dual-eligible beneficiaries, are starting to use their new coverage every day. We know you share our concern about ensuring that all beneficiaries in the program, especially our dual eligible beneficiaries, can use this coverage effectively. Consequently, we would like to recap some of the things we are doing together so we can continue to serve all beneficiaries effectively and continue to remain particularly sensitive to the needs of our most vulnerable beneficiaries.

Additional User Calls Scheduled

We are increasing the number of user calls to three a week until the end of February. The primary focus of these calls will be systems issues, and we anticipate that you and we will have the appropriate people participate. We are particularly interested in confirming that dual eligible beneficiaries are identified at the correct copayment level. We will send out a specific schedule of the calls via HPMS and the Part C and D listserv. However, please note that the first call will be this Friday (January 21^st) from 3:30 to 5:00 PM EST, which may be accessed by using the same dial-in information used for our regular Wednesday calls. During the Friday call, we are particularly interested in specific analysis of the first data file on dual eligibles we sent to some of you on January 12^th, as well as any initial reactions to the second file providing LIS status for all eligible individuals that we expect to provide you later today.

Updated Contact Information

Please confirm that we have complete and up-to-date details on casework contact information for your plan. As you know, this information is helping us better manage casework and ensure faster resolution. In addition to a CMS casework communication email address, this information should include your organization's designated emergency and pharmacy technical support contacts to assist CMS caseworkers in urgent situations. These contacts need to be available 24 hours a day, seven days a week. It is also critical that your pharmacy hot line be a toll-free number. Finally, in terms of plan contact information, we need you to assure that your existing phone number for physicians to contact you to request an exception or appeal is up to date. We remind you that providers need both a toll-free phone number and a copy of your exception form so they have real and immediate access to your exceptions and appeals process. Establishing all of these contact points will enable us and you to respond quickly and effectively to the various situations that are coming to our attention during this initial phase of program implementation.

Transition Guidance

We want to remind you of recent communications on transition and copayment issues. We sent you letters on January 6^thand 13^themphasizing the critical importance of plans upholding and further strengthening their transition policies and supporting timely responses for pharmacists. As we have noted in these communications, it is important that you have expedited systems in place to handle utilization management edits in a timely manner by ensuring pharmacists have adequate access to plan representatives who can resolve transition issues appropriately in real time so that undue burdens are not placed on beneficiaries.

It is important to recognize that the provision of a temporary supply of medications is intended to facilitate the transition process. In that regard, while all of you have committed to provide an initial 30 day supply that will be adequate in most cases, we appreciate that you will use sound judgment to extend that coverage in the special situations where a longer transition may be required for sound medical reasons. And to ensure that the 30 day period will be adequate in the vast majority of cases, it is important that the member be given clear guidance on how to proceed so that they are in the right place at the end of the 30 day period. We understand that you have systems in place that trigger a written notice to the member when you provide a transitional first fill of their prescription. The notice should explain that the supply is temporary, instruct the member to work with you and his or her physician to identify appropriate drug substitutions, explain the member's right to request a formulary exception, and describe the procedures for requesting such an exception. It is critical that the notice go to the beneficiary as soon as the prescription is filled so they have adequate time to reach resolution before they need a refill.

LIS Copayments

We also communicated with you about establishing expedited procedures for approval of low-income subsidy (LIS) cost sharing at the point of service when appropriate. We continue to be engaged with you in an intensive effort to ensure that all Medicare Prescription drug plans have accurate information about the correct cost sharing levels for dual eligible and other low-income subsidy beneficiaries in their plans. To that end, on January 12^th, we sent a file to many of you containing information on dual eligible and other low income subsidy beneficiaries to support an initial phase of validating your membership/enrollment files so that a LIS enrollee eligible for a full subsidy is appropriately set up for a benefit that would adjudicate at the pharmacy for no more than the $2/$5 copay and institutionalized dual eligible beneficiaries with no copays.

The special TRR file we anticipate sending you today contains the premium subsidy levels and the LIS copay categories for dual eligibles and other low income subsidy beneficiaries. As with the previous file, you should use this information to validate your membership/enrollment files so that claims for LIS enrollees will adjudicate at the pharmacy at the appropriate cost sharing levels. More information regarding these files is contained in the attachments to this letter.

Disenrollments for Failure to Pay Premiums

We also want to remind you of our guidance on disenrollments for failure to pay premiums. As you know, our regulations and guidance provide PDPs and MA-PDs with reasonable discretion with respect to decisions concerning when to initiate disenrollment proceedings for an enrollee’s failure to pay a plan’s monthly premiums. At a minimum, plans must provide for a grace period of at least one month, and alert the individual of the delinquency and the possible consequences of failure to pay premiums. For new enrollees, plans must wait until notified by CMS of the actual premium for which the beneficiary is responsible before sending them a bill.

We recognize that plans need to collect premiums due in a timely manner, but we urge you to exercise appropriate judgment and discretion in initiating billing and disenrollment actions in any case where there may be doubt about the enrollee’s subsidy status. It’s important to keep in mind that incorrect premium billing may not only concern beneficiaries who have no premium obligations but also result in unnecessary administrative burden associated with refunding premiums that are collected in error.

In conclusion, I want to thank you for the important work you have already done to address start up issues as we continue together to implement the biggest change in Medicare in 40 years. While we have focused together on problems that need to be resolved, we can also share the satisfaction of knowing that we are serving millions of people successfully. I am confident that working together, we will continue to achieve noticeable progress solving outstanding issues and meeting beneficiary needs.

Attachment I

Special Marx LIS Transaction Reply Report

The record layout we will use is the current Marx Weekly/Monthly TRR, but only with the following fields populated. Other fields not listed will be filled with spaces. Please refer to the attached record layout titled, “Marx Special LIS Transaction Reply Report Record Layout.”

Claim Number (HICN)
Surname
First Name
Middle Name
Sex Code
Date of Birth
Contract Number
State Code
County Code
Transaction Reply Code (for this file all Tics will = 167)
Transaction Type Code (for this file all Transaction Types = 01)
Effective Date
Part D Low-Income Premium Subsidy Level
Low-Income Co-pay Category
The definition of Transaction Reply Code 167 is “NEW LIS PREMIUM,” but we are using this single code as a broad indicator for this special TRR for your plan to read both the Part D Low-Income Premium Subsidy Level and the Low-Income Co-pay Category fields for information that may be missing or needed in order to properly set the correct benefit level for the dual eligible or the LIS beneficiary.

It is expected this Special TRR will be sent to the plans sometime today. Please be on the lookout for this file since this is a Special TRR that is not the result of any transactions that your plan has submitted, is not linked to a Batch Completion Status Summary Report, and does not contain the normal entire set of data other than the minimum set of data to assist your plan in processing the critical LIS information.

If you have any questions, please contact the MMA Help Desk at 1-800-927-8069 or mmahelp@cms.hhs.gov

Attachment II

Marx Special LIS Transaction Reply Report Record Layout.

Field

Size

Position

Description

1. Claim Number

12

1 – 12

Claim Account Number

2. Surname

12

13 – 24

Beneficiary Surname

3. First Name

7

25 – 31

Beneficiary Given Name

4. Middle Name

1

32 - 32

Beneficiary Middle Initial

5. Sex Code

1

33 - 33

Beneficiary Sex Identification Code
0 = Unknown
1 = Male
2 = Female

6. Date of Birth

8

34 – 41

YYYYMMDD Format

7. Filler

1

42

Space

8. Contract Number

5

43 – 47

Plan Contract Number

9. State Code

2

48 – 49

Beneficiary Residence State Code

10. County Code

3

50 – 52

Beneficiary Residence County Code

11. Filler

1

53

Space

12. Filler
</