December 28, 2018
Ms. Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–4185–P
Mail Stop C4–26–05
7500 Security Boulevard
Baltimore, MD 21244–1850
RE: Policy and Technical Changes to Medicare Advantage and Medicare Prescription Drug
Plans for Years 2020 and 2021 (“Proposed Rule”)
Dear Administrator Verma:
America’s Health Insurance Plans (AHIP) appreciates the opportunity to comment on the Proposed
Rule, which would make policy and technical changes to Medicare Advantage (MA) and Medicare
Prescription Drug Plans for plan years 2020 and 2021.
AHIP is the national association whose members provide coverage for health care and related services
for millions of Americans. Through these offerings, including MA and Part D plans covering tens of
millions of Medicare beneficiaries, we improve and protect the health and financial security for
consumers, families, businesses, communities, and the nation. We are committed to market-based
solutions and public-private partnerships that improve affordability, value, access, and well-being for
consumers. The MA and Part D programs are critical to achieving national policy goals for improved
health care, and we share your strong commitment to delivering better health outcomes, value, and
satisfaction to enrollees through MA and Part D.
We strongly support steps CMS has taken to strengthen the MA program, including adding additional
benefit flexibilities and reducing certain unnecessary administrative burdens. We commend CMS for
following a similar approach in the Proposed Rule for implementing important legislative changes
that expand access to telehealth services and enhance integration of Medicare and Medicaid benefits
for individuals in dual-eligible Special Needs Plans (D-SNPs). Below we summarize our comments
on these and several other provisions in the Proposed Rule. We have also attached detailed comments
that discuss these and other issues.
On December 20, 2018, CMS issued new guidance that the agency will delay the original December
31 comment deadline on proposed changes related to the Risk Adjustment Data Validation (RADV)
program until April 30, 2019. At the same time, CMS also indicated that the agency intends to
release data underlying its study relating to the fee-for-service (FFS) adjuster. We understand that
stakeholders have had pending requests for data, assumptions, and methodology disclosures.
Particularly in light of this, we encourage CMS to release this information as soon as possible. A
later release could endanger the public’s ability to adequately analyze the data on a timely basis. We
will review the information and submit extensive and detailed comments on the proposal by the new
deadline.

 December 28, 2018
Page 2
However, based on our review of the information and data already released by CMS, we have
very serious legal and policy objections to the extrapolation and FFS adjuster proposals and
strongly believe the agency should withdraw the RADV provisions in their entirety.
If finalized as proposed by CMS, the RADV provisions would, among other things, reverse course
on the need for an FFS adjuster to meet statutory and actuarial requirements and implement
unprecedented regulatory changes to the MA program on a retroactive basis. These changes would
inject significant uncertainty and risk into the system, undermine the partnership between Medicare
and the private sector, and weaken the MA program for both seniors and taxpayers.
Extending the comment deadline and providing underlying data on the FFS adjuster study will not
cure the proposed fatally-flawed approach. We recommend and urge CMS to: (1) withdraw these
RADV provisions entirely; and (2) engage in direct and meaningful dialogue with MA plans and
other stakeholders to develop a fair, consistent, and appropriate oversight process.
Policy Proposals
As noted above, the Proposed Rule contains a number of other important changes to the MA and Part
D programs, including:
Expanded Telehealth Benefits. CMS proposes to expand the use of telehealth in MA basic benefits,
in accordance with provisions in the Bipartisan Budget Act of 2018 (BBA). We support CMS’
proposed approach, which would provide plans with flexibility to design telehealth benefits to best
meet the needs of Medicare enrollees and improve access to quality care. However, we recommend
that CMS also provide flexibility for plan assessment of capital and infrastructure costs and
investments relating to these benefits.
D-SNP Integration and Integrated Appeals and Grievances. CMS proposes to require certain
levels of integration for D-SNPs and for D-SNPs to have aligned Medicare and Medicaid appeals and
grievances processes where possible. We commend CMS for adhering closely to its statutory
mandate and proposing a thoughtful approach to expand integration while limiting potential for
disruption to beneficiaries and states.
Star Ratings Changes. We appreciate the intent of CMS’ proposal to establish guardrails and use
mean resampling to increase predictability and stability of the cut points for non-CAHPS measures
from year to year. However, sponsors need more data to evaluate the impacts and comment on these
proposed changes. We also reiterate our prior calls for the agency to reinstate predetermined cut
points in advance of measurement periods. This is the best means to ensure transparency,
predictability, stability, and quality improvement.
Preclusion List Policy. We again commend CMS for withdrawing provider and prescriber
enrollment rules for MA and Part D that would have taken effect in 2019 and that would have created
significant disruption and confusion for enrollees. While we generally support CMS’ decision to
create a new preclusion list for certain providers and prescribers, we are concerned that requirements
in the Proposed Rule for 2020 would create unnecessary administrative burdens by adding new
notice requirements and claims denial deadlines that deviate from the well-established approach used
for the OIG exclusion list.

 December 28, 2018
Page 3
Prescription Drug Plan (PDP) Access to Claims Data. CMS proposes to establish a process for
PDP sponsor access to Medicare claims data in accordance with the BBA. While we strongly support
PDP access to data, the lag times proposed for the data (three-months from the last day of the prior
quarter) are much too long for the data to be useful to plans. CMS can do better (e.g., it provides final
claims data monthly in a bundled payment demonstration), and we believe PDPs (which do not need
final claims data) should have even faster access.
The Value of Medicare Advantage
MA plans provide coverage and offer meaningful value to over 20 million seniors and those with
disabilities. Since 2010, Medicare beneficiaries have increasingly chosen to enroll in a MA plan
rather than remain in traditional Medicare. As a result, the MA program has grown by more than 70
percent since 2010, and CMS projects that MA enrollment will represent nearly 37 percent of all
beneficiaries next year. MA plans deliver better care and better value through innovative, patientcentered programs that improve quality and reduce beneficiary costs:
•

•
•

•

1

Greater care coordination and more comprehensive benefits. MA plans work with their
members to prevent, detect, and manage chronic conditions through programs that integrate
and coordinate care. In addition, plans provide more comprehensive benefits than the
traditional Medicare program – such as dental, hearing, and vision coverage. MA plans also
can offer more extensive telehealth services and new types of supplemental benefits (e.g.,
home safety modifications, in-home health aides, and expanded transportation for physician
visits and other medical services) recognizing the social and environmental factors that can
have a profound impact on beneficiary health and outcomes.
More financial security. All MA plans include a cap on beneficiary annual out-of-pocket
costs, and 90 percent of beneficiaries can enroll in a MA plan that offers drug coverage for no
additional premium.
Better health outcomes. Recent peer-reviewed research studies have found that MA plans
have outperformed the traditional Medicare program on clinical quality measures 1, employed
value-based payment arrangements to improve survival rates while lowering costs 2, reduced
hospital readmissions as well as beneficiary days spent in rehabilitation facilities and nursing
homes3,4, and lowered hospital use in the last days of life.5
Cost efficiency for beneficiaries and taxpayers. On average, payments to MA plans are
equivalent to traditional Medicare costs.6 In areas where MA is popular, additional

Timbie, Justin W., Bogart, Andy, Damberg, Cheryl et al. Medicare Advantage and fee-for-service performance on clinical
quality and patient experience measures: Comparisons from three large states. Health Services Research 52(6), Part I: 2038-2060.
December 2017.
2 Mandal, Aloke K., Tagomori, Gene K., Felix, Randell V. et al. Value-based contracting innovated Medicare Advantage
healthcare delivery and improved survival. American Journal of Managed Care 23(2): e41-e49. February 2017.
3 Kumar, Amit, Rahman, Momotazur, Trivedi, Amal N. et al. Comparing post-acute rehabilitation use, length of stay, and
outcomes experienced by Medicare fee-for-service and Medicare Advantage beneficiaries with hip fracture in the United States:
A secondary analysis of administrative data. PLoSMed 15(6): e1002592.
4 Huckfeldt, Peter J., Escarce, Jose J., Rabideau, Brendan, et al. Less intense post-acute care, better outcomes for enrollees in
Medicare Advantage than those in fee-for-service. Health Affairs 36(1): 91-100. January 2017.
5 Teno, Joan M., Gozalo, Pedro, Trivedi, Amal N. et al. Site of death, place of care, and health care transitions among US
Medicare beneficiaries, 2000-2015. JAMA Published online June 25, 2018.
6 Medicare Payment Advisory Commission. Medicare Advantage program: Status report [presentation]. December 7, 2018.

 December 28, 2018
Page 4
enrollment leads to slower traditional Medicare spending growth as providers use MA
practice patterns and care guidelines for their remaining traditional Medicare patients. 7
In addition, a recent survey finds continued high beneficiary satisfaction with the MA program, with
90 percent of MA members reporting satisfaction with their health care coverage and preventive
services, and 84 percent satisfied with their prescription drug coverage.8
Conclusion
We reiterate the industry’s appreciation for CMS’ approach in recent years of expanding flexibility
and reducing administrative burdens for MA plans and commend CMS for continuing that approach
in several parts of the Proposed Rule. However, we have very serious concerns with the RADV
provisions and urge CMS to withdraw the proposal and begin a meaningful dialogue with industry to
develop a fair and appropriate oversight process. We look forward to providing any additional
information you may need and to continuing to work together to improve the health of the
beneficiaries our members serve.
Sincerely,

Matthew Eyles
President and CEO

7

Johnson, Garret, Figuero, Jose F., Zhou, Xiner, et al. Recent growth in Medicare Advantage enrollment associated with
decreased fee-for-service spending in certain US counties. Health Affairs 35(9): 1707-1715. September 2016.
8 Morning Consult National Poll. November 28-29, 2018.

 December 28, 2018
Page 5
Medicare and Medicaid Programs; Policy and Technical Changes to the
Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for
the Elderly (PACE), Medicaid Fee-for-Service, and Medicaid Managed Care Programs for
Years 2020 and 2021
AHIP Detailed Comments
I.

Implementing the Bipartisan Budget Act of 2018 Provisions

A.

Requirements for Medicare Advantage Plans Offering Additional Telehealth Benefits
(§§422.100, 422.135, 422.252, 422.254, and 422.264, Preamble pp. 54987-54992)

CMS proposes rules that implement section 1852(m) of the Social Security Act (SSA), as added by
the Bipartisan Budget Act of 2018 (BBA). Section 1852(m) allows MA plans to provide “additional
telehealth benefits” starting in plan year 2020 and to treat such benefits as basic benefits for purposes
of bid submission and payment by CMS. This provision applies to services that would be covered
under Medicare Part B but for the fact they are provided through electronic information and
telecommunications technology (referred to as “electronic exchange”) rather than in-person.
In general, CMS proposes significant flexibility in defining the types and uses of electronic
exchanges that will qualify as additional telehealth benefits. For example, MA plans could determine
the circumstances under which it is clinically appropriate for a Part B item or service to be furnished
through electronic exchange. CMS also proposes to permit different cost-sharing for Part B services
furnished through electronic exchange compared to in-person visits.
AHIP strongly supports CMS’ approach. It would accommodate a wide variety of telehealth benefits
and services and future technological advancements, consistent with legislative intent. However, we
have the following recommendations to further support the flexibility needed by MA plans to design
telehealth benefits to best meet the needs of Medicare enrollees and improve access to quality care.
i. Capital and infrastructure costs and investments
Consistent with the statutory language, the Proposed Rule excludes capital and infrastructure costs
and investments relating to such benefits from amounts treated as additional telehealth benefits for
bid purposes. In the preamble, CMS states that it is not providing specific definitions for capital and
infrastructure costs or investments given the potential variations among MA plans. However, CMS
also states in its regulatory impact analysis that the agency assumes “15 percent of the additional
telehealth benefits would be considered capital and infrastructure expenses.” CMS indicates it used
the administrative costs permitted under Medical Loss Ratio (MLR) rules as a proxy for the portion
of telehealth benefits it assumes would be treated as capital and infrastructure costs and investments.
We urge CMS to better explain the basis for this assumption. The types of additional telehealth
services that will be offered and used will be wide ranging. We are concerned this 15 percent level
could be viewed by CMS as a de-facto standard that will not provide individual plans the ability to
demonstrate that a different level is appropriate. We recommend that the final rule specify that plans
will have the flexibility to assess their own individual costs of capital and infrastructure expenses

 December 28, 2018
Page 6
based on the types of telehealth service benefits being provided and exclude those costs from their
bids.
ii. Telehealth and network adequacy
CMS requests comments on whether additional telehealth benefit providers should be considered in
the assessment of network adequacy. We strongly support such an approach. Current MA network
adequacy criteria, which rely on time and distance criteria, fail to consider how telemedicine, mobile
medical applications, and other electronic information and telecommunications technologies can
ensure beneficiaries receive the high-quality care they need, when they need it.
We recommend that CMS provide MA plans with more flexibility in meeting network adequacy
requirements through the use of telehealth providers and other high value care and delivery system
innovations and approaches. In addition, CMS’ 2019 MA Network Adequacy Guidance allows plans
to request an exception to use telehealth providers for network adequacy but only in very limited
cases such as in rural counties or areas with extreme access issues. CMS should also consider
allowing more flexibility in the exceptions process. Further, where there is a shortage of providers or
suppliers offering traditional Medicare benefits (e.g., under the Medicare Diabetes Prevention
Program), CMS could permit use of telehealth services to better ensure access to care.
iii. Qualifications for contracted providers of additional telehealth benefits
CMS proposes to require MA plans offering additional telehealth benefits to comply with existing
MA provider selection and credentialing requirements. In addition, plans would have to ensure that
telehealth network providers comply with state licensing requirements and other applicable state laws
where the enrollee is located and receiving the telehealth service.
CMS solicits comments on whether to impose additional qualification requirements for MA
providers of additional telehealth benefits beyond those in the Proposed Rule. We strongly
recommend against such an approach. We believe the proposed requirements are sufficiently
protective. Given the diversity of MA plan and provider network arrangements and telehealth
services, CMS should instead provide plans with the flexibility to apply their own additional network
rules and conditions as they determine necessary to ensure enrollees receive high quality care.
iv. Appeals
CMS indicates in the preamble on p. 54989 that an MA enrollee has the right to request additional
telehealth benefits through the organization determination and appeal processes. CMS further states
that “these rights help ensure access to medically necessary services, including additional telehealth
benefits offered by an MA plan as proposed in this rule.”
For clarity purposes, we recommend that CMS specify in the final rule that such organization
determination and appeals processes apply only to requests for telehealth services included in the
MA plan’s benefit package.

 December 28, 2018
Page 7
Finally, while not specifically addressed in the Proposed Rule, we encourage CMS to provide future
guidance on issues related to additional telehealth services, including encounter data submissions.
We also strongly urge CMS to establish rules under which diagnoses obtained through telehealth
encounters can be considered for risk adjustment purposes, since these services will be incorporated
in the MA basic benefit package starting in 2020.
B.

Dual Eligible Special Needs Plans

i. Integration Requirements for Dual Eligible Special Needs Plans (§§422.2, 422.60, 422.102,
422.107, 422.111, and 422.752, Preamble pp. 54992-54999)
CMS proposes several regulatory changes to implement the BBA’s integration requirements for DSNPs effective 2021. CMS delineates the three types of D-SNPs permitted by the statute and their
respective responsibilities to coordinate or cover Medicare and Medicaid benefits. Furthermore, CMS
proposes additional performance requirements on all D-SNPs to coordinate the delivery of benefits.
States continue to retain authority for determining their Medicare-Medicaid integration environments
and D-SNP options available to their dual eligible residents.
We commend CMS for the approach it has taken in the Proposed Rule, which closely adheres to the
intent of the BBA. We believe the proposals will enhance Medicare-Medicaid integration with
minimal disruption to states and beneficiaries by providing different pathways for states in which
higher levels of integration would be challenging (such as states that exclude dually eligible
individuals from Medicaid managed care).
We also support structural changes in the regulatory language, which include consolidating statutory
and regulatory references and the minimum requirements for each type of D-SNP. We believe these
changes should assist stakeholders, including state Medicaid agencies, in better understanding the
updated SNP definitions, their respective characteristics, and implications for Medicaid program
operations.
However, we believe states, D-SNPs, and other stakeholders would benefit from the following
additional clarifications and examples in the requirements.
a.

Arranging for benefits

Section 1859(f)(3)(D) of the SSA, which pre-dated the BBA, requires D-SNPs to provide benefits, or
arrange for benefits to be provided, to which a person is entitled under Medicaid. CMS notes that it
has not previously issued guidance on this requirement. CMS now proposes to interpret “arrange for
benefits” as requiring that a D-SNP, at a minimum, coordinate the delivery of Medicare and
Medicaid benefits. CMS proposes to include this interpretation in the proposed D-SNP definition.
While the regulatory language itself does not include specifics, the preamble notes that a D-SNP’s
responsibility to coordinate under this provision would encompass a wide range of activities. For
example, CMS indicates that coordination for an individual with functional limitations would include
verification of eligibility for specific Medicaid services like long term services and supports (LTSS),
determination of how they receive services (e.g., through Medicaid FFS or Medicaid managed care),

 December 28, 2018
Page 8
and arrangement for receipt of services from the appropriate payer and/or provider. CMS observes
that under this coordination requirement, it would not be enough for a D-SNP to simply tell an
enrollee to contact a Medicaid managed care plan or the state agency without: providing specific
contact information; coaching the member on the respective roles of the state Medicaid agency, the
Medicaid managed care plan, and the D-SNP; and offering additional support if needed. CMS solicits
comment on whether the proposed definition should be more prescriptive in identifying plan
activities required for coordination or remain broadly defined.
We support the Proposed Rule’s approach of broadly requiring coordination without more specific
standards. This would allow states and their contracting D-SNPs a degree of flexibility in
collaborating to identify specific plan activities that might differ by program or type of service. At
the same time, however, prior to operationalizing this requirement, we believe states and D-SNPs
would find it helpful if CMS provided clearer parameters for demonstrating sufficient coordination
(e.g., through a combination of guiding principles and additional examples).
b.

Notification of admissions for high risk members

CMS proposes in §422.107(d) to require that a D-SNP that is not a FIDE SNP or HIDE SNP notify
the state Medicaid agency or its designee(s) of hospital and skilled nursing facility admissions for at
least one group of high-risk full-benefit dual eligible individuals, as identified by the state Medicaid
agency. The state Medicaid agency would also establish the timeframe(s) and method(s) by which
notice would be provided.
To ensure an efficient implementation of this requirement and minimize potential uncertainty and
confusion among stakeholders, we recommend that CMS provide states with technical assistance and
additional guidance regarding appropriate methods, content, and timeframes for notifications. The
guidance could also address specific items such as formats for data exchanges (including data feeds
and portal access), plan uses of data (e.g., for determining Medicaid eligibility, identifying available
waiver services, or receiving payer/payment information), and processes for designating contacts
who will receive admission information. The guidance would be particularly helpful for state
Medicaid programs with little experience in managed care.
In addition, the preamble to the Proposed Rule gives several examples of how high-risk full-benefit
dual eligible individuals might be identified. CMS indicates processes could include, e.g., targeting
groups based on eligibility for particular waiver services, or through predictive analytics of claims
history. We recommend that CMS encourage states to collaborate closely with their contracted DSNPs and Medicaid MCOs in developing criteria and processes for identifying such high-risk
members.
c.

Enrollment of partial dual eligibles

CMS notes that it considered proposing limits on enrollment of partial duals in D-SNPs. The agency
questioned whether their continued eligibility for D-SNPs was consistent with the new statutory
integration requirements, given that partial duals are eligible only for Medicaid coverage of Medicare
premiums and/or cost sharing, and that there are no Medicaid services for a D-SNP to integrate or

 December 28, 2018
Page 9
coordinate. CMS decided against proposing such limits but continues to consider this issue and
invites comments.
We support the approach in the Proposed Rule and strongly recommend that CMS continue to permit
state Medicaid agencies to determine D-SNP enrollment policies for beneficiaries, including
enrollment of partial dual eligibles. To the extent that a state determines it is in the interests of its
partial dual eligible residents to enroll in D-SNPs, we believe that such individuals can benefit from
an enhanced degree of care coordination, even if the extent of their Medicaid benefits is limited.
ii. Unified Grievance and Appeals Procedures for Dual Eligible Special Needs Plans and Medicaid
Managed Care Plans at the Plan Level (§§422.560 – 562, 422.566, 422.629 – 634, 438.210,
438.400, and 438.402, Preamble pp. 54999-55015)
CMS proposes to implement unified grievance and appeals procedures for D-SNP enrollees pursuant
to SSA section 1859(f)(8)(C), as added by the BBA. The Agency proposals are in two major
categories: (1) assistance that all D-SNPs must provide their members with Medicaid-related
coverage issues and grievances; and (2) integrated appeals and grievances systems for exclusively
aligned HIDE and FIDE SNPs.
We support CMS’ overall approach in the Proposed Rule to implement the new requirements in a
way that will achieve the goals of the statute while minimizing administrative complexity and burden
where possible. We believe the proposals appropriately recognize that the Medicare and Medicaid
statutes and benefit structures conflict too much in some cases to allow a fully unified appeals
process, including post-plan appeals. Furthermore, we agree that targeted application of the rules is
appropriate given the difficulty of implementing these types of procedures for plans that are not
exclusively aligned.
While we support the overall approach, we believe CMS should provide the following additional
clarifications and other guidance to assist stakeholders in implementing these provisions.
a.

Enrollee assistance with appeals and grievances

CMS proposes to require that all D-SNPs assist their enrollees with Medicaid coverage appeals and
grievances. As with the integration requirements discussed above, we believe additional CMS
guidance on several matters would help state Medicaid agencies and MA D-SNPs more efficiently
interpret and apply this requirement. We recommend that CMS consider providing states and DSNPs with technical assistance in several forms.
+ CMS should consider establishing a technical expert panel that would convene
participants with backgrounds in Medicaid and Medicare appeals and grievance
processes. The panel would make recommendations to CMS on appropriate practices
around enrollee assistance, including guidelines for coaching enrollees on self-advocacy.
+ Based on input from the technical expert panel, CMS should develop guidance that
establishes guiding principles for enrollee assistance, provides examples, and identifies
related issues for states and Medicaid plans to consider. CMS should also consider

 December 28, 2018
Page 10
providing incentives to states to further integration. These could prove especially helpful
to state Medicaid programs that have little experience with managed care.
b.

Integrated notice of adverse determination

Per proposed §422.631(d)(1), CMS would require that an applicable integrated plan send an
integrated notice to an enrollee when the plan issues an adverse organization determination. The
proposed notice would include information about the determination, as well as information about the
enrollee’s appeal rights for both Medicare and Medicaid covered benefits. We request that CMS
clarify whether the CMS-10003 Integrated Denial Notice meets the proposed notice requirements.
c.

Interaction with appeals and grievance requirements for MMPs

In the final rule or subsequent sub-regulatory guidance, we request that CMS discuss how regulatory
changes affecting appeals and grievance processes may impact or be implemented in the ongoing
Medicare-Medicaid Plan (MMP) demonstrations.
C. Proposal for Prescription Drug Plan Sponsors’ Access to Medicare Parts A and B Claims Data
Extracts (§423.153, Preamble pp. 55015-55017)
CMS proposes rules to implement section 1860D-4(c)(6) of the SSA, as added by the BBA. This
provision requires the agency to establish a process for a Prescription Drug Plan (PDP) sponsor to
request to receive, beginning in plan year 2020, on a periodic basis and in an electronic format,
standardized extracts of Medicare Part A and B claims data for its enrollees. Section 1860D-4(c)(6)
also instructs the agency to include data “as current as practicable.”
In its proposal, CMS would provide PDPs with Medicare claims data no sooner than on a quarterly
basis with a 3-month lag from the last day of the last month of the prior quarter. We are concerned
that the proposed timeframe would significantly delay access to and impact the utility of the data and
is not consistent with congressional intent for providing actionable information.
We believe it is “practicable” for CMS to provide the information more frequently and promptly. For
example, in the Bundled Payments for Care Improvement (BPCI) Initiative, CMS provides all
participants with FFS claims files across all sites of service (i.e., inpatient and outpatient hospital,
physician office, inpatient rehab, skilled nursing, home health, and durable medical equipment) on a
monthly basis for each beneficiary who qualifies for a bundle under the demonstration. These files
represent adjudicated (i.e., final action) claims, have at most a 1-month lag, and reflect a 14-month
look back period. Participants can download these files from CMS through a unique electronic file
transfer (EFT) site. In fact, we recommend that CMS should provide the data to PDPs even faster
than under the BPCI demonstration, since PDPs do not require final action claims in order to use the
information for care coordination and other clinical purposes.
In addition, CMS proposes to require PDPs to contractually bind contractors and any other data
recipients to the terms and conditions imposed on the PDP sponsor, and to submit an attestation to
the agency regarding permitted and prohibited data uses. We look forward to reviewing and

 December 28, 2018
Page 11
commenting on the related data request and attestation materials for PDP sponsors that CMS released
through the Paperwork Reduction Act comment opportunity collection process.
II. Improving Program Quality and Accessibility
A.

Medicare Advantage and Part D Prescription Drug Plan Quality Rating System (§§422.162(a)
and 423.182(a), §§422.166(a) and 423.186(a), §§422.164 and 423.184, and §§422.166(i)(1)
and 423.186(i)(1), Preamble pp. 55018-55028)

CMS proposes changes to the MA and Part D Star Ratings program affecting the cut point
methodology for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS)
measures, the specifications for several existing measures, and the data integrity policy related to
appeals measures. The Proposed Rule also codifies requirements for calculating Star Ratings in cases
of extreme and uncontrollable circumstances. Our comments and related recommendations regarding
the agency’s proposals are discussed below.
i. Changes to the cut point methodology for non-CAHPS measures
Starting with 2022 Star Ratings, CMS proposes to add mean resampling to reduce the sensitivity of
the clustering algorithm to outliers and reduce the random variation that contributes to fluctuation in
cut points. In addition, CMS proposes to implement a 5 percent bi-directional cap that restricts
movement both above and below the prior year’s cut points. The bi-directional cap would be used for
measures that have been in the Part C and D Star Ratings program for more than 3 years.
We appreciate CMS’ willingness to consider changes to increase predictability and stability of the
cut points from year to year. However, without access to simulation data and detail regarding the
methodology, it is very challenging to assess and comment on the impact of CMS’ proposed changes.
We urge CMS to provide plans with this information as quickly as possible to permit them to conduct
the needed evaluation and analysis and provide the agency with meaningful comments.
Further, AHIP continues to urge CMS to reinstate the policy that will best ensure such predictability
and stability: predetermined cut points in advance of the measurement period. We believe the
elimination of pre-determined thresholds has impeded CMS’ goal of promoting continued quality
improvement. It has undermined the ability of plans and their providers to set markers for
performance activities that are consistent with CMS’ expectations. Moreover, as plans have
transitioned to value-based arrangements with providers, setting goals is essential to help both parties
assess the effectiveness of their efforts to improve quality of care and reduce costs while maintaining
high performance and rating levels. Pre-determined thresholds also provide transparency in the Star
Ratings system, enabling plans and providers to understand the standards and work towards them in a
deliberative process. Moreover, set cut points in advance of the measurement period would help to
simplify the Star Ratings program and reduce burdens on providers contracting with multiple plans,
who otherwise may face varying and conflicting quality performance metrics on the same quality
measures. Predetermined cut points would thus promote a key Administration goal of reducing
unnecessary regulatory burdens.

 December 28, 2018
Page 12
We understand CMS’ concerns that the Star Rating program establish goals using more recent
performance data, including large performance improvements that can be seen in newer measures,
and provide continued incentives for improvement. As noted above, we believe pre-determined
thresholds are the best approach to provide those incentives, and that the other positive elements
(including greater transparency and simplicity and reduced burdens) far outweigh other potential
concerns. Therefore, we urge CMS to issue for public comments the use of pre-determined
thresholds and related methodology as soon as possible.
ii. Medicare Plan Finder (MPF) Price Accuracy measure
CMS is proposing changes to the existing MPF Price Accuracy measure for the 2022 Star Ratings.
As we have indicated in previous comments, due to the frequent fluctuations in drug prices common
to the pharmaceutical marketplace (which may result in changes on a weekly or even daily basis), it
remains challenging for plan sponsors to ensure the MPF is updated immediately to reflect the
market price of a drug. We are concerned that the proposed changes could penalize Part D plans that
are continuing to make substantial investments in the accuracy of their cost reporting.
We continue to recommend that the MPF price accuracy measure be aligned with pricing practices
inherent in the pharmaceutical marketplace. Further, before proposing any additional changes, CMS
should clearly assess the additional value to beneficiaries of the MPF measure based on usage
patterns for price data, etc., and weigh that against the costs to the program (through higher plan
bids) that will arise from additional investments that may be required for Part D plans to comply with
the revised methodology for this measure.
iii. Modification to data integrity policy for appeals measures
CMS proposes to assign a 1-star rating to applicable appeals measure(s) if a contract fails to submit
Appeals Timeliness Monitoring Project (TMP) data for CMS’ review. As we have noted in prior
comments on this subject, AHIP strongly objects to Star Ratings adjustments based on compliance
audit findings. This approach is highly problematic for both policy and methodological reasons. We
support CMS’ use of program audits to monitor plan compliance with regulatory requirements.
However, the purpose and intent of the MA and Part D program audits differ significantly from those
in the Star Ratings system. These audits are qualitative assessments of MA plan and Part D sponsor
processes and protocols. Conversely, the Star Ratings system uses representative statistical samples
from a variety of data sources to measure and compare clinical quality and beneficiary outcomes in
one contract’s beneficiary population with the beneficiary populations of other contracts.
We do not support CMS’ proposal to modify its data integrity policy for appeals measures. CMS
should ensure that the Star Ratings system is focused on improving quality of care received by
beneficiaries instead of incorporating penalties on plans for compliance purposes.
iv. Codification of requirements for calculating Star Ratings in the case of extreme and
uncontrollable circumstances
CMS proposes to codify rules (reflected in the 2019 Call Letter) for calculation of Star Ratings of
certain contracts in certain extreme and uncontrollable circumstances (e.g., natural disasters).

 December 28, 2018
Page 13
AHIP supports CMS’ proposal to codify such rules. At the same time, we recommend that CMS
promote transparency by providing more information about the impacts of such adjustments. This
can include making information publicly available on the identity of affected contracts and
assessing/reporting on the impacts for the Star Ratings program both as a whole and at more granular
levels, including in cases where an adjustment might span more than one measurement period.
We also note that there are important Star Ratings issues that are not addressed in the Proposed Rule
that will be in the 2020 draft Call Letter, such as proposed enhancements to the Categorical
Adjustment Index (CAI) methodology. AHIP supports the continued use of the CAI in the Star
Ratings system while CMS develops a long-term solution to address disparities in MA plan
performance associated with socio-economic status (SES) and other social risk factors. We look
forward to addressing these and other important Star Ratings issues raised in the upcoming Call
Letter.
B.

Improving Clarity of the Exceptions Timeframes for Part D Drugs (§§423.568, 423.570, and
423.572, Preamble pp. 55028-55029)

CMS proposes to change the Part D adjudication timeframes for exception requests when a
prescribing physician’s or other prescriber’s supporting statement has not been received by the plan
sponsor. The current guidance lacks certainty about the timeframe applicable to the exception request
process pending receipt of the prescriber’s supporting statement. In the proposal, CMS would require
the plan to notify the enrollee (and prescribing physician or other prescriber) of its decision no later
than 72 hours (or 24 hours for an expedited decision) after receipt of the prescriber’s supporting
statement or 14 calendar days after receipt of the request, whichever happens first.
We support CMS’ proposal. It provides plans with needed clarity on the exceptions timeframes.
III. Clarifying Program Integrity Policies
A.

Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in MA, Cost
Plans, and PACE (§§422.222 and 423.120, Preamble pp. 55029-55037)

CMS proposes revisions to the preclusion list policy finalized in the CY 2019 MA & Part D final
rule. CMS’ proposal encompasses both substantive changes to the policy and codification of
provisions that were detailed in the preamble of the 2019 final rule. The substantive changes include
CMS’ proposal to require plans, on an ongoing monthly basis, to send a notice to potentially
impacted beneficiaries within 30 days of the date a provider or prescriber is added to the preclusion
list. In addition, plans would be required to deny claims for Part D drugs and MA items or services
that are prescribed or furnished by prescribers and providers on the preclusion list beginning 60 days
after sending the notice to the impacted beneficiary.
We appreciate CMS’ efforts to reduce fraud and abuse in the Medicare program while also reducing
unnecessary administrative burdens. To that end, we reiterate our strong support for CMS’ decision
in the 2019 final rule to remove the prescriber and provider enrollment requirements that raised
serious beneficiary access issues and administrative costs. We also support CMS’ general approach
to implementing the preclusion list, including the agency’s decision to not finalize a proposal that

 December 28, 2018
Page 14
would have required provisional fills for prescriptions written by prescribers on the preclusion list.
However, we are concerned that CMS is now proposing changes to its preclusion list policy that
would create additional complexity while providing limited value to beneficiaries.
As CMS noted in the 2019 final rule, CMS chose to not implement the provisional fill requirement
for several reasons, including: the potential beneficiary confusion in taking an approach different
from the exclusion list; the fact it would enable payments to be made for problematic prescribers for
a long period of time, including those prescribing opioids or other potentially dangerous drugs; and
the complexity and administrative burdens it would add.[1] To address these concerns, CMS indicated
its goal is that “the preclusion list will be operationalized in the same manner as the OIG exclusion
list ….”
We are concerned that the Proposed Rule, particularly separate required beneficiary notices and
claims denial deadlines triggered by the notice, is inconsistent with this goal. We believe the proposal
has the potential for causing beneficiary confusion, could enable a longer period for coverage related
to problematic prescribers and providers, will present operational challenges for plans, and will
increase administrative burdens.
We urge CMS not to implement this proposal. Instead, consistent with CMS’ stated intent, the
preclusion list should be operationalized the same way as the OIG exclusion list. Under the exclusion
list process, CMS makes the exclusion list public, updates the list on a monthly basis, generally posts
it 15 days prior to the exclusion effective date, and expects plans to deny claims as of the effective
date. We note that providers and prescribers are given a chance to appeal before being added to the
agency’s preclusion list; therefore, we believe it would be appropriate for CMS to make the
preclusion list public and implement it in the same manner as the exclusion list.

[1]

83 Fed. Reg. 16660.