The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would make significant changes to the Medicare Advantage (MA) and Medicare Part D programs (the "Proposed Rule"). The Proposed Rule was published in the January 10, 2014 Federal Register. The Proposed Rule has five primary aims:

1. To implement statutory requirements to establish U.S. citizenship and lawful presence as eligibility requirements for enrollment in an MA plan, Part D plan (PDP), or MA with prescription drugs (MA-PD) plan;
2. Modification and simplification of the agent and broker compensation structure by preserving MA organization (MAO) and PDP sponsor discretion as to whether to pay initial or renewal compensation, but altering the compensation structure to a two-tier model by which initial payment to an agent or broker is no greater than a fair market value (FMV) amount annually established by CMS guidance and limiting renewal compensation to no more than 35 percent of the FMV amount for the second year and subsequent years;
3. Provide guidance interpreting Affordable Care Act (ACA) Section 3307 in the Part D context to permit CMS to identify efficient formulary requirements or other beneficiary protections instead of requiring access to all drugs in a protected class or drug category;
4. To implement ACA Section 6402 requiring MAOs and PDP sponsors to report and return identified Medicare overpayments; and
5. To strengthen MAOs and PDP sponsors' accountability for valid risk adjustment data prior to submission.

Comments on the proposed rule are due by no later than 5 p.m. on March 7, 2014. Summaries of the proposed regulations follow.

Table of Contents [79 Fed. Reg. 1918 – 21]

I. - Executive Summary [79 Fed. Reg. 1922 – 23]

A. Purpose [79 Fed. Reg. 1922]

B. Summary of the Major Provisions [79 Fed. Reg. 1922]

1. Eligibility of Enrollment for Individuals Not Lawfully Present in the United States [79 Fed. Reg. 1922]
2. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation [79 Fed. Reg. 1922]
3. Drug Categories or Classes of Clinical Concern [79 Fed. Reg. 1922]
4. Improving Payment Accuracy [79 Fed. Reg. 1922]
5. Risk Adjustment Data Requirements (§422.310) [79 Fed. Reg. 1922]

C. Summary of Costs and Benefits [79 Fed. Reg. 1922 – 23]

II. - Background [79 Fed. Reg. 1923 – 24]

III. - Provisions of the Proposed Regulations [79 Fed. Reg. 1924 – 2073]

A. Clarifying Various Program Participation Requirements [79 Fed. Reg. 1924 – 95]

1. Closing Cost Contract Plans to New Enrollment (§422.2 and §422.503) [79 Fed. Reg. 1924]

Current CMS regulations prohibit an entity seeking to contract as an MAO from accepting new enrollees under a section 1876 reasonable cost contract in the same area that it wishes to offer an MA plan. Since this requirement only precludes "the entity" contracting as an MAO from having a cost contract open to new enrollment, the prohibition does not apply to another separate legal entity owned by the same parent organization, thereby creating the potential for two legal entities owned by the same parent organization to offer competing cost contract and MA plans. To eliminate the potential for organizations to move enrollees from one of their plans to another based on financial or some other interest, CMS proposes to revise § 422.503(b)(5) so that an entity seeking to contract as an MAO must not accept, or share a corporate parent organization with an entity that accepts new enrollees under a section 1876 reasonable cost contract in any area in which it seeks to offer an MA plan.

CMS also proposes to add the following definition of "parent organization" to § 422.2: "Parent organization means a legal entity that owns one or more other subsidiary legal entities." CMS requests comments on whether a parent organization with less than a 100 percent interest in a subsidiary legal entity should trigger the prohibition.

2. Two-year Limitation on Submitting a New Bid in an Area Where an MAO has been Required to Terminate a Low-enrollment MA Plan (§422.504(a)(19)) [79 Fed. Reg. 1924 – 25]

Current section 422.506(b)(1)(iv) provides for the non-renewal of an MA plan that does not have a sufficient number of enrollees to establish that it is a viable independent plan option. CMS interprets this standard as meaning that the MA plan has fewer than 500 enrollees for non-Special Needs Plans (SNPs) and fewer than 100 enrollees for SNPs over a specified time period of 3 years. Since it would defeat the intent and purpose of this rule if an MAO could simply submit a new bid for the next year in the same area for the same type of plan that failed to attract enrollment over a number of years, CMS proposes to revise § 422.504(a) to require MAOs not to submit a new bid of the same type of plan that has been non-renewed under § 422.506(b)(1)(iv) in the same service area as the non-renewed plan for 2 years after such a non-renewal.

3. Authority to Impose Intermediate Sanctions and Civil Money Penalties (§422.752, §423.752, §422.760 and §423.760) [79 Fed. Reg. 1925]

CMS proposes two changes to its intermediate sanctions and civil monetary penalties (CMPs) authority. First, pursuant to section 6408 of ACA, CMS proposes to provide for sanctions or CMPs if an MAO or Part D sponsor (collectively, "sponsor") (i) enrolls an individual without prior consent (except in certain limited circumstances) or transfers an individual to a new plan without prior consent, or (ii) violates the Part C and D marketing requirements. CMS also clarifies that it is a contract violation to employ or contract with any individual or entity who engages in conduct for which intermediate sanctions are authorized under section 1857(g)(1)(A) through (J).

Second, existing regulations designate the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) as the sole government agency with the authority to impose CMPs for the violations contained in § 422.752 and § 423.752. CMS proposes revisions to clarify that either CMS or the OIG may impose CMPs for the violations listed at § 422.752(a) and § 423.752(a), except that only the OIG may impose CMPs for violations under § 422.752(a)(5) regarding misrepresentation and/or falsification of information furnished to CMS, an individual, or other entity.

4. Contract Termination Notification Requirements and Contract Termination Basis (§422.510 and §423.509) [79 Fed. Reg. 1925 – 26]

CMS proposes several revisions to existing regulations that relate to contract termination. One change would decrease the prior notice requirement for terminating an MA or Part D contract from 90 to 45 days. According to CMS, the 90-day timeframe is not in the best interest of Medicare beneficiaries since CMS terminates contracts in circumstances where a sponsor is significantly out of compliance with Part C or Part D requirements. Also, CMS believes the 90-day timeframe is unnecessarily long given the existing procedural protections and appeal rights afforded sponsors. CMS also proposes to revise the public notification of contract termination requirement to require sponsors to release a press statement to news media serving the affected community or county and posting the press statement prominently on the sponsor's website instead of publishing the notice in applicable newspapers.

5. Reducing the Burden of the Compliance Program Training Requirements (§422.503(b)(4)(vi)(C) and §423.504(b)(4)(vi)(C)) [79 Fed. Reg. 1926 – 27]

Currently, sponsors' compliance plans must include training and education and effective lines of communication between the compliance officer and the sponsor's employees, managers, and directors as well as their first-tier, downstream and related entities (FDRs). In its October 22, 2009 proposed rule,¹ CMS requested public comments on how best to ensure that the training requirement continues to be met while not overly burdening the sponsor or its FDRs that may have their own training programs and contract with multiple MA and/or Part D sponsors. CMS proposes to require all sponsors to accept a certificate of completion of the CMS Standardized General Compliance Program Training and Education Module as satisfaction of the general compliance program training requirement. Sponsors would not be permitted to develop or implement sponsor specific training or provide supplemental training materials to fulfill the general compliance program training requirement; only CMS training would suffice.

Sponsors could develop a one page information sheet containing sponsor specific information (such as compliance officer's contact information, compliance reporting processes and expectations, hotline number or email address for compliance questions, website information for accessing the sponsor's compliance policies and procedures), to be distributed by the sponsor to each of its FDRs.  Alternatively, sponsors could choose to include such information in the contract with the FDR.

6. Changes to Audit and Inspection Authority (§ 422.503(d)(2) and § 423.504(d)(2)) [79 Fed. Reg. 1927 – 28]

CMS proposes several changes to the regulations regarding its right to audit and inspect the facilities and records of each organization. One change is to add authority that will allow CMS to require sponsors to hire an independent auditor to perform full or partial program audits to determine compliance with CMS requirements. CMS would notify the sponsor that it has been selected to perform a full or partial program audit. The sponsor would then be required to engage an independent auditor to perform the audit as directed by CMS using the CMS published protocols, methodologies, and methods of evaluation. At the conclusion of the audit, the independent auditor would provide a copy of its draft findings to CMS and the sponsor. Once the sponsor had an opportunity to rebut any findings, the independent auditor would issue its final audit report to CMS and sponsor.

Each sponsor would be required to undergo an independent program audit at least every three years, but the addition of audits by independent auditors would allow for more sponsors to be audited each year, which, according to CMS, would provide it with more data to evaluate program-wide performance, improve industry performance and protect beneficiaries. CMS also believes that the change would enhance CMS' oversight and provide it with information that would enable the agency to focus time and resources in the areas most needed to ensure compliance with Part C and Part D program requirements.

CMS would continue to perform program audits in limited scenarios, such as when indicated by a risk analysis; and would perform limited "look back" audits to ensure the integrity of the proposed independent audit process.

Finally, CMS proposes to require sponsors with audit results that reveal non-compliance with CMS requirements to hire an independent auditor to validate that correction has occurred. The authority could be invoked for audits conducted by CMS or an independent auditor.

7. Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D (§422.756 and §423.756) [79 Fed. Reg. 1928 – 29]

Under existing regulations, CMS may require a plan under a marketing and/or enrollment sanction to engage in a test period of marketing or accepting enrollments or both. The purpose of the test period is to assist CMS in making a determination as to whether the deficiencies that are the bases for the intermediate sanctions have been corrected and are not likely to recur. CMS proposes to expand the potential applicability of the test period requirement to all types of intermediate sanctions – enrollment, marketing and payment. CMS also seeks to clarify that the test period is not limited to sanctions stemming from marketing or enrollment violations and may relate to any operational area.

Second, CMS proposes to clarify the enrollment parameters for Part D sponsors that are under the benchmark and would normally participate in the annual and monthly auto enrollment process for beneficiaries who receive a low income subsidy (LIS) during a test period. Specifically, CMS proposes to make clear that it may determine that a sanctioned plan may not receive automatically assigned beneficiaries for the entire duration or a portion of the testing period.

8. Timely Access to Mail Order Services (§423.120) [79 Fed. Reg. 1929 – 30]

CMS proposes to amend § 423.120(a)(3) to specify the following mail order fulfillment requirements: 5 business days (from when the pharmacy receives the prescription order to when it is shipped) for those prescriptions requiring intervention beyond filling (such as clarifying illegible orders, resolving third party rejections, and coordinating with multiple providers as part of drug utilization management); and 3 business days (from when the pharmacy receives the prescription order to when it is shipped) for those prescriptions not requiring intervention. CMS indicated its anticipation that more than 99 percent of all mail order prescriptions processed could be filled within the 3- or 5-day standard. CMS believes that the proposed standards are in alignment with existing fulfillment requirements in the market and therefore would not create a new burden or new standard for mail order pharmacies to meet.

Comments as sought on (i) the proposed 3- and 5- day time frames, (ii) whether there are other instances in which the proposed 5-day time frame should apply, (iii) whether CMS should establish additional requirements for beneficiary materials relating to mail order services (e.g., clear definitions of processing time and delivery time; how to access customer support; how to submit a complaint via 1 800 MEDICARE; and beneficiary options for accessing medications when a delivery is lost or delayed), and (iv) any other requirements that CMS should consider for mail order or other home delivery options. 

CMS makes clear in the Proposed Rule its belief that filling initial prescriptions or routine 30-day supplies at mail order is not good practice. Due to the difficulties reported to CMS with consistently and effectively filling short time frame supplies through mail order, CMS does not believe that Medicare beneficiaries in general should be incentivized through lower cost sharing to utilize mail order pharmacies for initial prescriptions or 30-day supplies. CMS recognizes that a small number of beneficiaries depend on mail order due to geographic or mobility issues.

9. Collections of Premiums and Cost Sharing (§423.294) [79 Fed. Reg. 1930 – 31]

CMS proposes to specify that Part D sponsors either directly, or indirectly through related party pharmacies, as defined at § 423.501, are prohibited from reducing or waiving collection of premiums and cost sharing. In contrast, a pharmacy affiliated with one Part D sponsor may waive Part D cost sharing for beneficiaries enrolled in Part D plans offered by other sponsors without violating the Part D uniform benefit requirements.

CMS explains that a sponsor's failure to collect or attempt to collect cost-sharing at the time the service is provided or to bill cost-sharing to the appropriate party (either a beneficiary or another payer) after the fact, is a violation of the uniform benefit requirements at § 423.104(b). The fact that cost sharing is waived by a pharmacy that is related to a Part D sponsor by common ownership, rather than the Part D sponsor itself, and that it may qualify for safe harbor protection under the anti-kickback statute, does not relieve the Part D sponsor of responsibility for the violation of the uniform benefit provisions. According to CMS, the sponsor is not indifferent because the cost-sharing waiver is more likely to be a strategic decision by the sponsor to move market share to the related-party pharmacy and increase profits to the sponsor. Thus, the sponsor is altering the level of cost sharing in the approved bid in violation of § 423.104(b). By contrast, if an unrelated pharmacy waives cost-sharing, the pharmacy is making an independent business decision to which the Part D sponsor is indifferent. 

In addition, CMS proposes to fill a gap in the Part D regulations which do not address Part D sponsors' requirements for refunding incorrect collections of premiums and cost sharing or for retroactively collecting underpayments of cost sharing. Under proposed § 423.294, whenever a sponsor receives information that necessitates a retroactive refund of incorrect collections of premiums and/or cost sharing or collection of underpayments of cost sharing, the sponsor would have 45 days to issue refunds or recovery notices. CMS proposes that, for incorrect collections, Part D sponsors may receive compliance notices from CMS or, depending on the significance of the non-compliance, be the subject of an intermediate sanction.

10. Enrollment Eligibility for Individuals Not Lawfully Present in the United States (§§ 417.2, 417.420, 417.422, 417.460, 422.1, 422.50, 422.74, 423.1, 423.30, and 423.44) [79 Fed. Reg. 1931 – 32]

a. Basic Enrollment Requirements [79 Fed. Reg. 1931]
b. Medicare Eligibility and Lawful Presence [79 Fed. Reg. 1931 – 32]
c. Alignment of MA, PDP, and cost plan eligibility with FFS payment exclusion policy [79 Fed. Reg. 1932]

The Proposed Rule would align MA, Part D, and § 1876 cost plan eligibility with the statutory prohibition to pay federal benefits to individuals who are unlawfully present in the United States. Under 8 U.S.C. § 1611, qualified aliens not lawfully present in the United States, are not eligible to receive any federal benefit, including Social Security Administration (SSA) benefits and Medicare benefits. While aliens not lawfully present in the United States may still be entitled to enroll in Medicare, payment to the beneficiaries is still prohibited under the Medicare Fee-For-Service payment exclusion authority. Yet, currently the MA, Part D, and Medicare cost plan rules have not adopted the same payment exclusion policy. Therefore, aliens not lawfully present in the United States were able to enroll in MA, Part D, and Medicare cost plans and receive benefits in violation of federal law. To remedy this problem, CMS proposes to establish U.S. citizenship and lawful presence requirements for enrollment in all MA, Part D, and Medicare cost plans and for those individuals not lawfully present to disenroll them from these plans based on the date that they lose their lawful presence status.

11. Part D Notice of Changes (§423.128(g)) [79 Fed. Reg. 1932 – 33]

The Proposed Rule provides that if a PDP sponsor intends to change its rules for a PDP, it must do all of the following: (1) submit the changes for CMS review; (2) notify all enrollees at least 15 days before the beginning of the Annual Coordinated Election Period for changes that take effect on January 1; and (3) provide notice of all other changes in accordance with notice requirements specified in the Part D regulations. This proposal is intended to ensure that Medicare Part D beneficiaries currently taking a drug receive timely notice before changes (i.e., modifications to a PDP's formulary) are implemented in order that they have the opportunity to make informed decisions regarding whether to change drugs or request an exception to cover the drug.

12. Separating the Annual Notice of Change (ANOC) from the Evidence of Coverage (EOC) (§ 422.111(a)(3) and §423.128(a)(3)) [79 Fed. Reg. 1933 – 34]

The Proposed Rule would require MAOs to disclose a detailed plan description to each enrollee "at the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period." In addition, all MAOs and PDP sponsors would have to ensure that their current members receive the annual notice of change (ANOC) 15 days prior to the annual enrollment period (AEP), and receive the evidence of coverage (EOC) no later than December 31, for the contract year taking effect January 1 of the next year.

13. Agent/Broker Requirements, Particularly Compensation (§422.2274 and §423.2274) [79 Fed. Reg. 1934 – 36]

Under the current six-year compensation structure for independent agents and brokers, sponsors pay an initial rate for the first year, and then a renewal payment of 50 percent of the initial compensation paid to the agent for years 2 through 6. The initial rate cannot exceed the FMV as published annually by CMS. The initial six year period ended December 31, 2013. In the 2014 Call Letter, CMS notified sponsors that renewal payments could be paid beyond year 6. CMS notes that the compensation structure has proven to be complicated to implement and monitor as it requires MAOs or PDP sponsors to track the compensation paid for every enrollee's initial enrollment, and calculate the renewal rate based on that initial payment. In addition to its complexity, CMS expressed concern that the structure creates an incentive for agents and brokers to move enrollees from a plan of one parent organization to a plan of another parent organization, even for like plan type changes. Currently, in these cases, the new parent organization would pay the agent 50 percent of the current initial rate of the new parent organization, not 50 percent of the original initial rate paid by the other parent organization. Thus, in cases where the FMV has increased, or the other parent organization pays a higher commission, the incentive exists for the agent to move beneficiaries from one parent organization to another. CMS also noted that confusion among sponsors as well as noncompliance has created an unlevel playing field for sponsors in the same geographic area.

As a result, CMS proposes to revise the existing compensation structure for agents and brokers so that, for renewals in Year 2 and beyond, the MAO or PDP sponsor could pay up to 35 percent of current FMV amount for that year, resulting in the renewal year payment changing each year if the sponsor chooses to pay 35 percent of the current FMV. CMS would continue to interpret the FMV threshold in annual guidance to sponsors.

Other proposed changes include: (i) removal of the 6-year cap on the compensation cycle, and (ii) more clearly defining a plan year for compensation and recovery purposes. Under existing regulations, compensation may only be paid for the beneficiary's months of enrollment during the year (January through December). However, according to CMS, some plans have been paying compensation based on an annual cycle, rather than a calendar year cycle.  CMS proposes to clarify that the payment made to an agent must be for January 1 through December 31 of the year and may not cross calendar years.

In addition, CMS proposes to change the timing of payments to require that payments may not be made until January 1 of the compensation year, and must be paid in full by December 31 of the compensation year. CMS believes this proposal is appropriate given the ability of beneficiaries to change plans during AEP, which runs from October 15 through December 7. Under the Proposed Rule, sponsors would not be allowed to pay compensation until the beginning of the calendar year, when the final AEP enrollment becomes effective, simplifying sponsors' compensation processes and enabling them to make more accurate payments.

Existing regulations require sponsors to recover compensation in rapid disenrollment situation (i.e., the beneficiary disenrolls from a plan within the first three months of enrollment). Sub-regulatory guidance identifies several circumstances (e.g., death of the beneficiary, the beneficiary moves out of the service area, the beneficiary becomes eligible to receive LIS, or the beneficiary loses Medicaid benefits) for which plans should not recover compensation even though the beneficiary was enrolled in the plan for less than 3 months. Recovery is not required in these circumstances because the disenrollment decision could not be based on agent or broker behavior.  Recovery would be required for compensation associated with the months after the beneficiary disenrolled. CMS proposes regulatory changes that codify the agency's current policy.

Finally, CMS proposes to codify its existing sub-regulatory guidance regarding referral or finder's fees. Specifically, CMS proposes to limit the amount that can be paid as a referral fee to independent, captive, and employed agents and brokers, regardless of who completes the enrollment, to a reasonable amount specified by CMS. For contract year 2014, that amount is $100. Furthermore, note that, under § 422.2274(a) and § 423.2274(a), CMS requires that referral fees paid to independent agents and brokers must be part of total compensation not to exceed the FMV for that calendar year.

14. Drug Categories or Classes of Clinical Concern and Exceptions (§423.120(b)(2)(v) and (vi)) [79 Fed. Reg. 1936 – 47]

The Proposed Rule would implement ACA's requirements set forth at 42 U.S.C. § 1395w-4(b)(3)(G) by revising § 423.120(b)(2)(v) and (vi) as follows: (1) establishing the criteria the Secretary will use to identify drug categories or classes of clinical concern; and (2) defining the exceptions that permit Part D sponsors to exclude certain Part D drugs from within an identified drug category or class from their formularies (or otherwise limit access to such drugs, including through utilization management or prior authorization restrictions). It also would specify the drug categories or classes that would meet the proposed criteria.

Specifically, the Proposed Rule would modify § 423.120(b)(2)(v) to require that (unless an exception applies) all Part D drugs within a drug category or class be included on the formulary if the drug category or class of drugs for a "typical beneficiary"² with a disease or condition treated by the drugs in the category or class meets both of the following criteria (as determined by CMS):

a. Categories or Classes of Clinical Concern [79 Fed. Reg. 1937 – 41]

Hospitalization, persistent or significant disability or incapacity, or death likely will result if initial administration (including self-administration) of a drug in the category or class does not occur within 7 days of the date the prescription for the drug was presented to the pharmacy to be filled; and

b. Criteria Necessary to Identify Categories and Classes of Clinical Concern [79 Fed. Reg. 1941 – 42]

More specific CMS formulary requirements will not suffice to meet the universe of clinical drug-and-disease-specific applications due to the diversity of disease or condition manifestations and associated specificity or variability of drug therapies necessary to treat such manifestations.

c. Exceptions [79 Fed. Reg. 1942 – 44]

CMS believes it is necessary to identify exceptions to the requirement that a Part D sponsor must include all Part D drugs on its formulary in the drug categories or classes identified by CMS as drug categories or classes of clinical concern to help ensure Part D coverage is limited to Part D drugs, minimize duplicative protections within a drug category or class of clinical concern, and assure beneficiary safety while curbing potential abuse and misuse as a result of the added protection. CMS proposes to retain the existing exception for drug products that are rated as therapeutically equivalent under the Food and Drug Administration's (FDA) Orange Book. In addition, CMS proposes to make the new exceptions: (i) for point-of-sale utilization management safety edits that are based on maximum daily doses and black-box warnings specified on the FDA-approved label, potential drug interactions, or duplication of therapy; (ii) for drug products that are almost always covered under Medicare Parts A or B; (iii) to permit prior authorization for purposes of determining whether a drug is a Part D drug being used for a medically-accepted indication as defined in § 1395w-2(e)(4) or to verify a drug is not covered under Medicare Parts A or B as prescribed and dispensed or administered; (iv) for Part D compounds, although CMS proposes to carve out fixed dose combinations and co-packaged antiretrovirals as discussed in FDA guidance;³ and (v) for certain types of Part D drugs, including multi-source brands of the identical molecular structure, extended-release products when the immediate-release product is included, products that have the same active ingredient or moiety, and dosage forms that do not provide a unique route of administration (for example, tablets and capsules versus tablets and transdermal products).

CMS solicits comments on whether to add an exception to allow Part D sponsors to implement prior authorization, including that used to implement step therapy requirements, to convert beneficiaries to preferred alternatives within these drug categories or classes for enrollees who are initiating therapy (new starts).

d. Analysis and Identification of the Categories or Classes of Clinical Concern [79 Fed. Reg. 1944 – 47]

For coverage year 2015, anticonvulsants, antiretrovirals, and antineoplastics satisfy the Proposed Rule's criteria. The antipsychotic drug class will continue to be treated as a class of clinical concern in 2015 and until CMS determines that it is appropriate to apply the criteria with respect to antipsychotics. These categories and classes will be read narrowly, and do not include every related drug product that an individual who has a disease treated by one of these categories or classes of drugs would need to take. CMS will provide more detailed guidance on the specific formulary checks that will be in place relative to antidepressant and immunosuppressant categories and classes of drugs at a later date.

15. Medication Therapy Management Program (MTMP) under Part D (§423.153(d)) [79 Fed. Reg. 1947 – 53]

a. Multiple Chronic Diseases [79 Fed. Reg. 1949]

CMS proposes to revise its interpretation of "multiple chronic diseases," lowering its previous interpretation of the threshold eligibility criteria such that sponsors must target enrollees having two (instead of three) or more chronic diseases for MTMP services. In addition, at least one of the chronic diseases that a beneficiary has in order to satisfy the eligibility criteria must be one of the list of core chronic diseases. CMS also proposes to redefine the core diseases by combining hypertension and congestive heart failure under the umbrella of "cardiovascular disease," which would also encompass congestive heart failure, acute myocardial infarction, cerebral hemorrhage and effects of stroke, vascular disease, specified heart arrhythmias, and hypertensive heart disease.⁴

b. Multiple Part D Drugs [79 Fed. Reg. 1949 – 50]

CMS proposes to revise its interpretation of "multiple Part D drugs" to require that sponsors target enrollees taking two or more Part D covered drugs for MTMP services. This interpretation would also be construed to mean two or mor