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In the September 13 Newsletter you will find: NAMD Fall Conference; Issues for Parity Task Force; SIM; MACRA Quality Payment; Emergency Preparedness; EpiPen; Opioid Abuse.

NAMD Update

September 13, 2016
From the NAMD Desk
NAMD Fall Conference – November 6-8
The NAMD Fall Conference is in a new venue this year! The conference will be at the Hyatt Regency Crystal City in Arlington, Virginia. Early-bird registration is available until October 5. Information can be found here. Don’t forget to absentee vote as election day is November 8.
NAMD Staffing Update
NAMD Director of State Policy and Programs, Deidre Gifford, has announced that she will be stepping down from her position on Sept. 16, 2016, and transitioning to a new position as Deputy Director at the Center for Medicaid and CHIP Services (CMCS).
While she was only on staff for a short period of time, Deidre brought to NAMD incredibly valuable insights from her perspectives as a former Medicaid Director and an expert on quality and clinical issues. She helped lead NAMD efforts around the consensus priorities of delivery system and payment reform and helped inform NAMD’s efforts to better serve new Directors. We will all look forward to working closely with Deidre in her new role at CMCS.
After her transition, the team at NAMD will be handling Deidre’s responsibilities until a search is completed for a replacement.
NAMD Welcomes Deb Fournier as Medicaid Director in New Hampshire
On August 29, Deb Fournier was appointed Medicaid Director for the New Hampshire Department of Health and Human Services. For the past two months, she had been serving as the Interim Director and she previously served as the Deputy Medicaid Director.
As the permanent Director, Deb will focus on continuing the effective administration of the Medicaid program, while taking steps to ensure Medicaid is sustainable and is leveraged to address New Hampshire’s mental health and substance use disorder needs. During her time with the Department to date, Deb has worked to implement the New Hampshire Health Protection Program, the Premium Assistance Program and the Building Capacity for Transformation Waiver.
Before joining the Department, Deb led strategic planning and implementation of health care policy and advocacy at the New Hampshire Fiscal Policy Institute.  In this role, she convened and led a Medicaid working group to address developments in New Hampshire Medicaid such as transition to Medicaid Managed Care, Managed Long-Term Care, Medicaid Expansion and the Medicaid Enhancement Tax. Deb previously served as a Senior Policy Analyst for National and Federal Affairs at the Massachusetts Office of Medicaid, Executive Office of Health & Human Services.  Deb holds a J.D. from Northeastern University School of Law, and a
Bachelor of Arts in History from Whitman College.
NAMD Identifies Issues for Administration’s Parity Task Force
On August 30, NAMD provided the perspective of Medicaid Directors on the implementation of the parity rule to the Administration’s Mental Health and Substance Use Disorder Parity Task Force. In the comments, NAMD stressed the need for the Task Force to address the barriers posed by the Medicaid Institutions for Mental Disease (IMD) exclusion to achieving full parity. NAMD calls on the Task Force to set a research agenda to provide more information and a path forward to ameliorate the gaps in care posed by the IMD exclusion.
Secondly, NAMD requests that the Task Force provide additional time for Medicaid programs to comply with the parity rule. The rule’s unique requirements for Medicaid programs, as well as the complexities of the administration of Medicaid behavioral health benefits, require significant analysis by states and Medicaid’s federal partners. This is especially true considering that the structure of Medicaid behavioral health benefits may intersect with managed care programs and long-term services and supports (LTSS), both of which differ significantly from the commercial market and the parity compliance work required on the commercial side.
Read the full NAMD comments here.
In This Issue

NAMD Fall Meeting
Nov. 6-8, 2016
Information and registration here.


Reg Update


CMS Issues RFI on SIM Next Steps
On September 8, the Centers for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) seeking input on the future direction of the State Innovation Model (SIM) initiative within the context of the Medicare Access and CHIP Reauthorization Act (MACRA)’s changes to Medicare physician reimbursement. Specifically, CMS is looking for responses to the following issues:
  1. Partnering with states to implement delivery and payment models across multiple payers in a state that could qualify as Advanced Alternative Payment Models (APMs) or Advanced Other Payer APMs under the proposed Quality Payment Program (QPP) required by MACRA, making it easier for eligible clinicians in a state to become qualifying APM participants and earn the APM incentive;
  2. Implementing financial accountability for health outcomes for an entire state’s population;
  3. Assessing the impact of specific care interventions across multiple states; and
  4. Facilitating alignment of state and federal payment and service delivery reform efforts, and streamlining interactions between the Federal government and states.
The comment period for this RFI closes on October 28, 2016.


Access the RFI here.


CMS Grants Initial Approval to Pennsylvania’s HCBS STP
Recently, the Centers for Medicare and Medicaid Services (CMS) gave Pennsylvania initial approval of its
Statewide Transition Plan (STP), required by the Medicaid home and community-based services (HCBS) final rule. The initial STP describes the state’s systemic assessment of existing HCBS policies, procedures, regulations, and statutes, as well as its strategy for bringing these aspects of its HCBS system into compliance with the rule. The STP also includes public comment on the draft STP and the state’s response to received comments.


In its approval letter, CMS outlines the remaining work to be done before the state receives final approval of its STP. This includes conducting site-specific assessments of HCBS settings, drafting remediation strategies and timelines for bringing settings into compliance by March 2019, developing a plan for identifying settings to submit to CMS for heightened scrutiny review, and establishing monitoring procedures to ensure ongoing compliance.


CMMI Announces Decision Not to Continue IMD Demonstrations
Late last month the Center for Medicare and Medicaid Innovation (CMMI) and the CMS Office of the Actuary (OACT) announced that they will not continue the Medicaid Emergency Psychiatric Demonstration (MEPD), which was extended through legislation enacted in 2015. According to the letter, which was sent to the 11 states that participated in the original demonstration, OACT was unable to certify budget neutrality for continuing the demonstration. The certification of budget neutrality was a requirement in the authorizing legislation. This news comes after states expressed a strong interest in continuing this work under MEPD.
CMS Announces Features of MACRA’s Quality Payment Program
On September 8, the Centers for Medicare and Medicaid Services (CMS) published a blog post detailing aspects of the Medicare Access and CHIP Reauthorization Act (MACRA)’s Quality Payment Program (QPP). By streamlining the existing patchwork of Medicare reporting programs, MACRA provides unprecedented opportunity for clinicians to focus on quality patient care through its Quality Payment Program. Set to begin January 1st of 2017, the Program permits physicians to pick their pace of participation for the first performance period, recognizing the wide diversity of clinician needs and circumstances. During 2017, eligible physicians and other clinicians will have four options of participation (all of which will ensure negative payment adjustments by 2019):
  1. Test the Quality Payment Program: Ensures that systems are working and that clinicians are prepared for broader participation in 2018 and 2019, protecting clinicians from negative payment adjustment;
  2. Participate for part of the calendar year: Allows clinicians to submit Quality Payment Program information for a reduced number of days, meaning their practices can still qualify for a small positive payment adjustment;
  3. Participate for the full calendar year: Allows clinicians to submit Quality Payment Program information for a full calendar year, meaning their practices can qualify for a modest positive payment adjustment;
  4. Participate in an Advanced Alternative Payment Model in 2017: Allows clinicians to participate in the Quality Payment Program by joining an Advanced Alternative Payment Model, meaning that they can receive a 5% incentive payment by 2019.
Read the announcement here.


CMMI Announces Modifications to AHC Model
Last week, CMMI announced modifications to Track 1 of its Accountable Health Communities (AHC) model, intended to support bridge organizations that are working to increase a patient’s awareness of available community services through screening, information dissemination, and referral. In particular, CMS believes two key modifications will make the model more accessible to a broader set of applicants: 1). Reducing the annual number of applicants are required to screen from 75,000 to 53,000; and 2). Increasing the maximum funding amount per award recipient from $1 million to $1.17 million over 5 years.


Read the press release here.


CMS Updates Duals Demo Enrollment and Disenrollment Guidance
On September 2, the Center for Medicare and Medicaid Services (CMS) issued updated enrollment and disenrollment guidance for Medicare-Medicaid Plans (MMPs) in the Financial Alignment Initiative (FAI, otherwise known as the duals demonstration). The new guidance is effective January 1, 2017.
The updated guidance incorporates policy changes and revisions made since June 2013, creates new outreach and beneficiary notification practices to minimize the chances of overwhelming beneficiaries with information, and shares new operational tools to synchronize beneficiary enrollment status across state, CMS, and MMP enrollment systems.


The guidance assumes that states will remain responsible for the MMP enrollment process, including enrollment and disenrollment and opt-outs from passive enrollment. State enrollment brokers must be compliant with the updated guidance, and with CMS approval MMPs may also take on certain enrollment functions.


Access the guidance here.


CMS Finalizes Rule on Emergency Preparedness Requirements for Medicare, Medicaid Providers
On September 8, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on emergency preparedness requirements for providers participating in the Medicare and Medicaid programs. The rule is effective November 15, 2016, and must be implemented by November 15, 2017. The rule applies to 17 provider categories with current Conditions of Participation or Conditions for Coverage under Medicare and Medicaid.
The rule requires providers to meet four best practices for emergency preparedness, with modified standards depending on the provider type:
  1. Emergency plan: Based on a risk assessment, develop an emergency plan using an all-hazards approach focusing on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters specific to the location of a provider or supplier.
  2. Policies and procedures: Develop and implement policies and procedures based on the plan and risk assessment.
  3. Communication plan: Develop and maintain a communication plan that complies with both Federal and State law. Patient care must be well-coordinated within the facility, across health care providers, and with State and local public health departments and emergency systems.
  4. Training and testing program: Develop and maintain training and testing programs, including initial and annual trainings, and conduct drills and exercises or participate in an actual incident that tests the plan.
Access the final rule here. View a fact sheet on the rule


CMS Releases Evaluation of Washington’s FFS Duals Demonstration
Recently, the Centers for Medicare and Medicaid Services (CMS) published an evaluation of Washington’s Financial Alignment Initiative, otherwise referred to as the duals demonstration. The goal of the demonstration is to test integrated care models for dually eligible Medicare-Medicaid beneficiaries. Washington utilized a managed FFS health home model for its demonstration, aiming to coordinate primary care, long-term services and supports, and behavioral health services via development of individual Health Action Plans.


The evaluation provides a qualitative analysis of challenges encountered and lessons learned in several areas of the demonstration, including integration of Medicare and Medicaid, care coordination, eligibility and enrollment, beneficiary experiences, and stakeholder engagement. It also provides a preliminary finding of Medicare savings of $21.6 million (6.1 percent), though Medicaid savings have not yet been estimated.


Read the evaluation here.


HHS Awards $53 Million in Grant Funds to States to Address Opioid Abuse
Recently, the U.S. Department of Health and Human Services (HHS) announced $53 million in funding to 44 States, four tribes and the District of Columbia to improve access to treatment for opioid use disorders, reduce opioid related deaths, and strengthen drug misuse prevention efforts. Funding will also support improved data collection and analysis around opioid misuse and overdose, in addition to better tracking of fatal and nonfatal opioid-involved overdoses. Administered by SAMHSA and the Centers for Disease Control and Prevention (CDC), the funding will support six programs, for example, Strategic Prevention Framework Partnerships for Prescription Drugs Grants, the Prescription Drug Overdose: Prevention for States program, and the Prescription Drug Overdose: Data-Driven Prevention Initiative (DDPI).


CMS Blogs About Updates on SUD Work
In a recent blog commentary, CMS staff from the Innovation Accelerator Program (IAP) briefly described each of its three strategies for sharing Reducing Substance Use Disorder resources: (1) national webinars; (2) webpage resources; and (3) ongoing technical support and tools. In doing so, they articulate what we can expect from each of these strategies in the coming months:
  • Webinars: IAP’s final two webinars will focus on linking and merging data sources and incorporating SUD into managed care contracts.
  • Webpage resources: IAP recently updated the SUD IAP page on to include many of the presentations from its Targeted Learning Opportunities, which connected states to content experts, leading practices and peer state agencies across the country on a number of topics within SUD delivery system reform.
  • Ongoing support: In the coming months, the IAP will share several tools to assist Medicaid agencies with their SUD-related care and payment reforms, including a starting-point resource around developing MAT payment bundles and an SUD provider and service capacity document.

Read the full commentary here.

CMS Issues Guidance on 1557 Non-Discrimination Requirements
On August 8, the Centers for Medicare and Medicaid Services (CMS) issued a memo to a variety of managed care plan programs providing guidance on implementing certain procedural requirements related to the ACA’s Section 1557 non-discrimination requirements. The guidance focuses on requirements around providing beneficiary notice, nondiscrimination statements, and taglines, and provisions related to grievance procedures and compliance coordinators. The guidance generally does not apply to Medicaid managed care plans, except in specific identified contexts, including PACE programs and Medicare-Medicaid plans.


The guidance describes updated Medicare requirements for contract year 2017 impacting the type of information that plans must include in plan notices, as well as the multi-language inserts for regions with applicable populations. It also provides guidance on how plans must structure their grievance procedure process.


Read the guidance here:  Section 1557 Memo 8 8 16.pdf.


HRSA 340B Omnibus Guidance Under OMB Review
The Health Resources and Services Administration (HRSA) has submitted its omnibus guidance impacting several aspects of the 340B drug discount program to the Office of Management and Budget (OMB) for review. The rule was submitted to OMB on September 1. OMB may take 60 days to review rules, with the option to extend its review by 30 days if necessary.

Hill Update


E&C, W&M Leadership Send Bipartisan Letter to HHS on MACRA
On September 6, the Chairmen and Ranking Members of the House Energy and Commerce Committee (E&C) and the Committee on Ways and Means (W&M) sent a letter to U.S. Health and Human Services (HHS) Secretary Sylvia Burwell urging HHS to ensure its implementation of payment reforms under the Medicare Access and CHIP Reauthorization Act (MACRA) be crafted in a manner which allows equal opportunity for success to all providers. The letter specifically calls out the need for MACRA’s Quality Payment Program (QPP) to incorporate flexibilities for small practices.


Read the letter here.

RECAP: House E&C Hearing on Mental Health Parity Oversight
On September 9, the House Energy and Commerce Committee (E&C) Subcommittee on Health held a hearing titled “An Examination of Federal Mental Health Parity Laws and Regulations.” A recording of the hearing, full witness list, and submitted testimony is available on E&C’s website .


The hearing’s objective was to explore implementation of the mental health and substance use disorder parity law’s requirements, which Committee members noted has been challenging. Witnesses highlighted the complex nature of parity analyses undertaken by payers, with one witness calling for a review of the electronic health records Meaningful Use incentives for behavioral health providers and clarification around disclosure of behavioral health records and the application of 42 CFR Part 2, which requires patient consent for such disclosures.


Other witnesses discussed the diffuse nature of parity enforcement across federal agencies, which may also be reflected at the state level. Democrats on the Committee called for the sharing of best practices among states to address these types of implementation challenges. The unique challenges for children with mental illness were also discussed, with witnesses noting long waits for pediatric mental health services even when such services are authorized – an especially acute need in the Medicaid program. Finally, the Committee considered workforce issues and the relationship between Medicaid behavioral health reimbursement and workforce availability.


RECAP: House Budget Committee Hearing on CBO Scoring of CMMI Demonstrations
On September 7, the House Budget Committee held a hearing titled “Center for Medicare and Medicaid Innovation: Scoring Assumptions and Real-World Implications.” During the hearing, Committee members scrutinized the Congressional Budget Office (CBO) scoring methodologies for Center for Medicare and Medicaid Innovation (CMMI) demonstrations, with Republicans indicating the CBO methodology hinders Congressional oversight of CMMI demos and Congress’s ability to alter CMMI demonstration authority based on demonstration performance. Democrats noted that CMMI does require Congressional oversight, though they stated CMMI demonstrations may need several years to potentially meet their objectives.


CBO Deputy Director Mark Headley indicated that CBO’s 10-year cost estimate for CMMI, which projects $34 billion in federal savings, reflects the assumption that CMMI will be successful in identifying and expanding successful demonstrations. The estimate is not tied to any specific demonstrations, which some Committee members took issue with as a departure from CBO’s usual approach. Committee attention focused on CMMI’s Medicare Part B drug payment demonstration, with some objecting that the demonstration’s inclusion of 75% of the Medicare population as not meeting the legislative intent for CMMI projects.


A list of witnesses and their submitted testimony is available on the Budget Committee’s website.


Congress Raises Medicaid Questions on EpiPen Issue
On September 2, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) sent a letter to HHS Secretary Sylvia Burwell raising concerns with the pricing of the EpiPen anti-allergic reaction medication. The letter specifically notes that it appears EpiPen manufacturer Mylan classified the product as a generic under the Medicaid Drug Rebate Program (MDRP), despite its approval by the Food and Drug Administration as a brand drug. Brand drugs receive a higher mandatory rebate in the MDRP than generic products, and to date generics are not subject to inflationary drug price rebates that apply to brand drugs. The letter poses nine questions on this topic for clarification.


Read the letter here.

In the News
WSJ Reports on the Role of PDMPs in Fighting the Opioid Epidemic
The Wall Street Journal recently reported on evidence suggesting that prescription databases can play a role in the battle against the opioid epidemic, helping states to identify various physician practices and reduce harmful prescribing behavior – sometimes through punitive action. Between 2001 and 2010, for example, the use of state databases in 24 states was associated with a 30% drop in the prescribing rate for opioids such as OxyContin; and Kentucky’s prescription monitoring database, accounting for nearly 20,000 doctors, dentists and other prescribers, helped reduce hydrocone (a common painkiller) prescribing by 21% from 2012 to 2015.  The article also discusses the concerns of some stakeholders, which focus on the potential for prescription monitoring databases to jeopardize patient privacy and due-process protection for doctors, violating tenets of the patient-doctor relationship. Cognizant of these concerns, more than a dozen state legislatures have passed laws aimed at improving the databases’ effectiveness since 2015.


Read the article here.


Kaiser Health News Digs in on EpiPen Controversy
Driven by the recent EpiPen controversy, consumers and Congress members pushing for cheaper alternatives to high-priced drugs are seeking answers concerning a four-year backlog of generic drug applications at the Food and Drug Administration (FDA). As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months. Last week, three members of the House Committee on Energy and Commerce wrote a letter to the FDA, seeking clarity around the EpiPen generic applications it has received and subsequently rejected. While the FDA cites “deficiencies in submissions” as the reason for its generic backlog, others blame the FDA’s allegedly imbalanced approval processes: The Generic Pharmaceutical Association (GPhA) argues that the agency has declared applications to be “of ‘poor quality’ because they don’t meet new, more recent standards updated while [the] applications sit in the backlog.”


Read the article  here.


Morning Consult Highlights Elected Officials’ Push Around Drug Innovation Legislation
Morning Consult reports that House Energy and Commerce Chairman Fred Upton (R-Mich.) and the Senate Health, Education, Labor, and Pensions Committee chairman Lamar Alexander (R-Tenn.) plan to make a strong push to pass their 21st Century Cures legislation this September. If a compromise proposal secures sufficient bipartisan support and is passed in the House first, the bill is expected to pass smoothly and quickly in the Senate, requiring only one 60-vote threshold motion before final passage. That being said, outstanding funding issues, a tight calendar, and opposition to mandatory funding for medical research remain serious threats to the bill’s chances of passing before the November elections.


Read the article here.


Pew Charitable Trusts Reports on the Role of Nurses in Boosting Availability of MAT
In 2007, Boston Medical Center developed a program in which registered nurses manage opioid treatment programs, making it easier for physicians to accept more patients and write prescriptions for the medication those patients need. Funded in part by the Massachusetts Bureau of Substance Abuse Services, which has also worked with the state Medicaid program to develop reimbursement rates, the program has been replicated in 30 health centers across the state, contributing to a dramatic increase in the number of doctors in the state who prescribe addiction medication. The program is additionally beneficial in that its patients can receive treatment for their addictions in doctors’ offices and health clinics where various other health needs can also be met. The U.S. Substance Abuse and Mental Health Services Administration recommends other states replicate Boston Medical’s model, and many are considering it, or have already done so (including Washington, California, Connecticut, New York, and Wisconsin).


Read the article  here.

Take Note


September 2016 MACPAC Public Meeting
This Thursday September 15th, MACPAC will host its annual public meeting at the Ronald Reagan Building and International Trade Center. The meeting agenda is posted here.


GAO Analyzes Medicaid Per Capita Cap Proposals
Published September 9, 2016, this report from the Government Accountability Office (GAO) examines key policy and data considerations for designing a per capita cap on federal Medicaid funding. In reviewing its prior reports on Medicaid and a range of federal financing topics, conducting a literature review on Medicaid per capita caps, and interviewing officials from 10 state Medicaid programs, GAO identifies several considerations that could be useful should policymakers elect to pursue a per-enrollee limit on federal Medicaid funding for states, chiefly:
  • What populations would be financed under a Medicaid per-enrollee cap, and whether there would be any flexibility in designing coverage and other program features;
  • The allocation of funds across states over time;
  • Accountability for the receipt of funds and the achievement of health outcomes; and
  • The various effects on other federally financed sources of health care, broader health care costs, states, and Medicaid enrollees.
Read the report here.


GAO, Physician Administered Drugs: Comparison of Payer Payment Methodologies
In this report, GAO compares Medicare’s payments for Part B drugs with those of other payers, providing information on the payment methodologies, drug utilization management strategies, and cost-containment approaches for physician-administered drugs that are used by Medicare, Medicaid, VA, and private payers. It finds that payment methodologies, drug utilization management, and cost-containment approaches for physician-administered drugs varied across the payers, and that compared to Medicare, other federal payers generally paid rates that were the same or lower.


Read the report  here.


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