What is CMS regulations?
The Centers for Medicare & Medicaid Services (CMS) today released final regulations that will protect Medicare beneficiaries from deceptive or high-pressure marketing tactics by private insurance companies and their agents during the upcoming 2009 Medicare Advantage and prescription drug open enrollment period. The regulations also include other non-marketing related Medicare Advantage and prescription drug plan (PDP) provisions.
What is CMS in Medicare?
The Centers for Medicare & Medicaid Services (CMS) today released final regulations that will protect Medicare beneficiaries from deceptive or high-pressure marketing tactics by private insurance companies and their agents during the upcoming 2009 Medicare Advantage and prescription drug open enrollment period.
What is a Part D sponsor?
Plans/Part D Sponsors must ensure that materials developed by a third-party providing information on a subset of plan choices that lists, compares, or names available plans, must prominently display the following disclaimer on all materials:
How long does it take to review marketing materials in HPMS?
Based on the material type, and as indicated by HPMS, marketing materials submitted in HPMS for prospective review will have a review timeframe of 10 or 45 days. The marketing review time period begins on the date a material is submitted in HPMS.
What font size is required for footnotes?
All text included on materials, including footnotes, must be printed with a font size equivalent to or larger than Times New Roman twelve (12) -point. The equivalency standard applies to both the height and width of the font.
What is a Part D call center?
Part D Sponsors must operate a toll-free pharmacy technical help call center or make available call support to respond to inquiries from pharmacies and providers regarding the beneficiary’s Medicare prescription drug benefit; inquiries may pertain to operational areas such as claims processing, benefit coverage, claims submission, and claims payment. This requirement can be accommodated through the use of on-call staff pharmacists or by contracting with the organization’s PBM during non-business hours as long as the individual answering the call is able to address the call at that time. The call center must operate or be available during usual business hours, which CMS interprets to mean during the entire period in which the Part D Sponsor’s network pharmacies in its plans’ service areas are open (e.g., Part D Sponsors whose pharmacy networks include twenty-four (24) hour pharmacies must operate their pharmacy technical help call centers twenty-four (24) hours a day as well).
What is the meaning of 1140?
1320b–10, it is forbidden for any person to use words or symbols, including “Medicare,” “Centers for Medicare & Medicaid Services,” “Department of Health and Human Services,” or “Health & Human Services” in a manner that would convey the false impression that the business or product mentioned is approved, endorsed, or authorized by Medicare or any other government agency. This rule extends to Plans, Part D sponsors, and downstream contractors that may be directly or indirectly involved in marketing Medicare plans. Plans/Part D Sponsors should ensure that their subcontractors are not using the Medicare name in a misleading manner.
What is a third party marketing organization?
Third-party marketing organizations are entities such as a Field Marketing Organization (FMO), General Agent (GA), or similar type of organization that has been retained to sell or promote a Plan’s/Part D Sponsor’s Medicare products on the Plan’s/Part D Sponsor’s behalf either directly or through sales agents or a combination of both.
What is a script in Medicare?
Informational scripts are designed to respond to beneficiary questions and requests and provide objective information about a plan or the Medicare program. Sales and enrollment scripts are intended to steer a beneficiary towards a plan or limited number of plans, or to enroll a beneficiary into a plan.
What is Medicare marketing guidelines?
The Medicare Marketing Guidelines (MMG) implement the Centers for Medicare & Medicaid Services’ (CMS) marketing requirements and related provisions of the Medicare Advantage (MA, MA-PD) (also referred to as Plan), Medicare Prescription Drug Plan (PDP) (also referred to as Part D Sponsor), and except where otherwise specified 1876 cost plans (also referred to as Plan) rules, (i.e., Title 42 of the Code of Federal Regulations, Parts 422, 423, and 417). These requirements also apply to Medicare-Medicaid Plans (MMPs), except as modified or clarified in state-specific marketing guidance for each state’s demonstration. State-specific guidance is considered an addendum to the MMG. State-specific marketing guidance
What is a third party marketing organization?
Third-party marketing organizations are entities such as a Field Marketing Organization (FMO), General Agent (GA), or similar type of organization that has been retained to sell or promote a Plan’s/Part D Sponsor’s Medicare products on the Plan’s/Part D Sponsor’s behalf either directly or through sales agents or a combination of both.
How long does it take to review marketing materials in HPMS?
Based on the material type, and as indicated by HPMS, marketing materials submitted in HPMS for prospective review will have a review timeframe of 10 or 45 days. The marketing review time period begins on the date a material is submitted in HPMS.
How much notice do you need to give to a Part D sponsor?
Part D Sponsors must provide at least sixty (60) days’ notice or a 60-day supply with notice to affected enrollees before removing a Part D drug from the Part D Sponsor’s formulary (e.g., adding prior authorization, quantity limits, step therapy or other restrictions on a drug), or moving a drug to a higher cost-sharing tier. A sixty (60) day notice must be provided in writing unless a beneficiary has affirmatively elected to receive electronic notice. Part D Sponsors should refer to Chapter 6 of the Prescription Drug Manual,
What is a Part D call center?
Part D Sponsors must operate a toll-free pharmacy technical help call center or make available call support to respond to inquiries from pharmacies and providers regarding the beneficiary’s Medicare prescription drug benefit; inquiries may pertain to operational areas such as claims processing, benefit coverage, claims submission, and claims payment. This requirement can be accommodated through the use of on-call staff pharmacists or by contracting with the organization’s PBM during non-business hours as long as the individual answering the call is able to address the call at that time. The call center must operate or be available during usual business hours, which CMS interprets to mean during the entire period in which the Part D Sponsor’s network pharmacies in its plans’ service areas are open (e.g., Part D Sponsors whose pharmacy networks include twenty-four (24) hour pharmacies must operate their pharmacy technical help call centers twenty-four (24) hours a day as well).
What is a script in Medicare?
Informational scripts are designed to respond to beneficiary questions and requests and provide objective information about a plan or the Medicare program. Sales and enrollment scripts are intended to steer a beneficiary towards a plan or limited number of plans, or to enroll a beneficiary into a plan.
What is an educational event for Medicare?
Educational events are designed to inform Medicare beneficiaries about Medicare Advantage, Prescription Drug or other Medicare programs and do not include marketing (i.e., the event sponsor does not steer, or attempt to steer, potential enrollees toward a specific plan or limited number of plans).
What is MCMG in Medicare?
The Medicare Communications and Marketing Guidelines (MCMG) interpret and provide guidance on the marketing and communication rules for Medicare Advantage (MA-only, MA- PD) plans (also referred to as “plans”), Medicare Prescription Drug plans (PDP) (also referred to as “Part D sponsors”), and except where otherwise specified, Section 1876 cost plans (also referred to as “plans”) and employer/union-sponsored group MA or Part D plans. These plans are governed under Title 42 of the Code of Federal Regulations (CFR), Parts 422, 423, and 417. These requirements also apply to Medicare-Medicaid Plans (MMPs), except as modified or clarified in state-specific marketing guidance for each state’s demonstration. Such state-specific guidance for MMPs is considered an addendum to the MCMG, and will be posted to:
What is a third party marketing organization?
Third-party marketing organizations are entities such as a Field Marketing Organization (FMO), General Agent (GA), or similar type of organization that has been retained to sell or promote a Plan’s/Part D sponsor’s Medicare products on the Plan’s/Part D sponsor’s behalf either directly or through sales agents or a combination of both.
What is marketing appointment?
Marketing appointments are individual appointments designed to steer or, attempt to steer, enrollees or potential enrollees toward a plan or limited number of plans. All individual appointments between an agent and a beneficiary are considered marketing/sales appointments regardless of the content discussed.
What is enrollment material?
Enrollment materials are materials used to enroll or disenroll a beneficiary from a plan, or materials used to convey information specific to enrollment and disenrollment issues such as enrollment and disenrollment notices.
What is the penalty for misusing Medicare name and marks?
In general, it authorizes the Inspector General of DHHS to impose penalties on any person who misuses the term Medicare or other names associated with DHHS in a manner which the person knows or should know gives the false impression that DHHS has approved, endorsed, or authorized it. Offenders are subject to fines of up to $5,000 per violation or in the case of a broadcast or telecast violation, $25,000.
What is co-branding in Medicare?
Co-branding is defined as a relationship between two or more separate legal entities, one of which is an organization that sponsors a Medicare Plan. Co-branding is when a Plan/Part D sponsor displays the name(s) or brand(s) of the co-branding entity or entities on its materials to signify a business arrangement. Co-branding arrangements allow a Plan/Part D sponsor and its co-branding partner(s) to promote enrollment in the plan. Co-branding relationships are entered into independent of the contract that the Plan/Part D sponsor has with CMS.
How long does Medicare last?
An individual who is aging into Medicare eligibility, typically the seven month period consisting of three months prior to the individual’s birth month, the individual’s birth month, and three months following the individual’s birth month.
When did CMS release 2006 marketing materials?
Organizations that meet the above requirements and comply with CMS Marketing Review Guidelines may begin releasing their 2006 marketing materials on October 1, 2005.
What is MMA in Medicare?
The MMA requires a number of changes to the Medicare program. In order to implement the new Medicare Prescription Drug Benefit and changes to the Medicare Advantage program, CMS defined appropriate regions for PDPs and regional MA Plans as required under the MMA.
What is a Part D plan?
Part D Plans that are licensed by a State as a risk-bearing entity can jointly enter into a single contract with CMS to offer a Regional Preferred Provider Organization (RPPO) or PDP in a multi-state region . The participating organizations would contract with each other to create a single “Joint Enterprise” and would be considered an “entity” for purposes of offering a RPPO or PDP. Joint Enterprises are expected to:
Where to post general operational guidance?
General operational guidance will be posted at http://www.cms.hhs.gov/discountdrugs/ in the document "End of Program and Transition Guidance for Drug Discount Card Sponsors." Questions not answered by this document should be submitted to the MMA Q&A database at http://mmaissuesform.cms.hhs.gov/, and select "drug card" as the topic to ensure that the question is routed to the appropriate CMS subject matter expert.
When did HIPAA become law?
On April 14, 2003, new Federal rules governing the use and disclosure of certain individually identifiable health information by health Plans, health care clearinghouses, certain health care providers (“covered entities”), became enforceable. Medicare Prescription Discount Drug Card Sponsors were added as covered entities by the Medicare Prescription Drug Improvement and Modernization Act of 2003. The regulatory text of the final rule “Standards for Privacy of Individually Identifiable Health Information” (the “HIPAA Privacy Rule”), as modified, can be found at 45 CFR Parts 160 and 164, Subparts A and E. Part D Plans may use or disclose their members’ protected health information as permitted by these regulations and any other applicable privacy laws (for example, more stringent state laws governing the use and disclosure of health information). The HIPAA Privacy Rule generally allows covered entities to use or disclose this information without beneficiary authorization for treatment, payment, or health care operations (as those terms are defined by the rule) and for a number of public interest or benefit purposes, such as public health activities and research subject to certain requirements. Organizations are not required to obtain authorizations prior to using their Medicare beneficiary members' data to provide information to such members regarding their benefit packages. For additional information regarding the HIPAA Privacy Rule, go to the following Department of Health and Human Services, Office for Civil Rights Web Site address: http://www.hhs.gov/ocr/hipaa/.
When can organizations distribute marketing materials?
Organizations may not distribute any marketing materials until they receive notification from CMS.
Can a plan with a state license be a waiver?
Plans with State license(s) may not in their marketing materials or other communications characterize Plans with waivers of state licensure as being subject to less stringent requirements or otherwise less protective of beneficiaries.
How long does it take for a CMS to review a marketing plan?
With respect to shortening the review period to 30 days, the statute requires the submission of marketing materials to CMS for a 45-day period of review. Materials that are not deemed eligible for the 5-day file and use policy must be submitted for a 45-day review period.
What are the sanctions for CMS?
It is important to note that CMS has other enforcement options, such as marketing and enrollment sanctions, for organizations that fail to adhere to marketing requirements. Under these sanctions, CMS may restrict a plan from marketing during marketing season or from accepting new enrollments for a period of time.
What is Section 103?
Section 103 established new statutory prohibitions and limitations for MA plans and Medicare Prescription Drug plans (PDPs) on certain sales and marketing activities. Many of these new statutory marketing provisions were similar (or identical) to provisions that we proposed in our May 16, 2008, proposed rule.
What is the Executive Order 12866?
Executive Order 12866 (as amended) directs agencies to assess all costs and Start Printed Page 54220 benefits of available regulatory alternatives and , if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The provisions of this final rule require plans to submit marketing materials to CMS for review. We estimate the total cost (MA and Part D programs) of these provisions as $197,295. As a result, this final rule does not reach this economic threshold and thus is not considered a major rule.
How long does it take for a marketing material to be reviewed by CMS?
While the statute requires the submission of marketing materials to CMS for a 45 day period of CMS review, based on years of program experience CMS recognized that some MA organizations consistently met all marketing standards, and that their marketing materials warranted less scrutiny.
Which chapter of Medicare and Medicaid amends 42 CFR?
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Can you get Medicare Part A and Medicare Part B?
Under section 1851 (a) (1) of the Act, every individual entitled to Medicare Part A and enrolled under Medicare Part B, except for most individuals with end-stage renal disease (ESRD), could elect to receive benefits either through the Original Medicare program or an M+C plan, if one was offered where he or she lived.
