The last few months have seen significant movement across a broad array of issues:
Affordable Care Act
On December 14 2018, a federal district judge issued an opinion holding the entirety of the Affordable Care Act unconstitutional in light of Congress’ elimination of the individual mandate penalty in 2017. The district court’s ruling will not be implemented, pending the outcome of the appeals process. APA promptly released a statement calling for a “vigorous appeal” of the district court’s opinion “to protect access to health care for millions of Americans.” APA also joined a statement from America’s Frontline Physicians calling for the district court’s opinion to be overturned on appeal.
Federal Advocacy Conference
Nearly 100 psychiatrists will gather in Washington, D.C. for APA’s 2019 Federal Advocacy Conference to play a critical role in helping to shape health care policy during the 116th Congress. They will lobby members of Congress on issues that affect psychiatry and the patients we serve.
Interested in joining us? APA’s Federal Advocacy Conference will take place March 11-12 at the Washington Marriott Georgetown. Attendees will participate in prep sessions highlighting insights from APA’s leadership and staff on the inner workings of Congress and the legislative process, as well as hands-on advocacy training, so that they are prepared to go on the Hill and advocate. There is a $250 registration fee and attendees will be responsible for their travel and hotel expenses. Space is limited so we encourage you to register before you miss out.
Medicaid Network Adequacy Proposed Rule
APA recently submitted comments on CMS proposed regulations to revise the Medicaid and CHIP managed care regulations. The comments focused on:
- CMS’ proposal to modify the Network Adequacy Standards for these programs.
- the relationship of these network adequacy standard requirements to the MHPAEA parity requirements which also apply to managed care programs.
APA had several recommendations:
- CMS should provide additional guidance on quantitative standards regarding network adequacy and create two categories which distinguish between standards that may be important but are static as to network performance in real time and those which permit assessment of actual performance.
- states be required to utilize a combination of standards and include a standard(s) which measures actual network performance.
APA also recommended, given that network adequacy is a non quantitative treatment limitation, that these regulations specifically cross reference the applicable parity requirements and stipulate that both sets of rules must be satisfied for a plan’s network to be deemed in compliance.
Proposal to Weaken the Part D Protected Classes
APA submitted comments opposing the Administration’s proposal to weaken the Medicare Part D six protected classes (anticonvulsants, antidepressants, antineoplastic, antipsychotics, antiretrovirals, and immunosuppressants) by allowing additional utilization management tools to be applied (i.e., indication-based formulary design and indication-based utilization management). It also codifies an earlier proposal by CMS to allow for Medicare Advantage plans to apply step therapy to Part B drugs. A draft template of the letter was shared with the District Branches to also submit their own comments.
FDA’s Reclassification of ECT
The FDA issued a final order to reclassify ECT from a Class III (high risk) medical device to Class II (moderate risk) for use in treating of catatonia or a severe major depressive episode (MDE) associated with major depressive or bipolar disorder in patients who are treatment resistant or who require a rapid response due to the severity of their psychiatric or medical condition. This is a change that is largely supported by APA, though there are some concerns for the FDA to address to ensure there are not unintended consequences of adopting this proposal. In addition, the FDA lowered the minimum age for whom these ECT devices are considered Class II products to 13 years of, from its originally proposed 18 years of age.
Specifically, APA recommended a class II designation also be given for catatonia, manic episodes (in bipolar disorder), schizophrenia, and schizoaffective disorder and that the patient population in each of these illnesses be limited to individuals with treatment-resistant psychiatric disorders and/or patients with life-threatening conditions related to their underlying psychiatric condition. We also recommended that the class II designation include ECT treatment for children and adolescents meeting the criteria for treatment resistance and in need of a potentially life-saving intervention for the conditions previously indicated and for MDE associated with major depressive disorder or bipolar disorder. A resource document outlining the changes by the FDA will be available next month.
HHS OIG Report on Separation of Immigrant Children from their Families
Recently, the Health and Human Services Office of the Inspector General (HHS OIG) released an issue brief, Separated Children Placed in Office of Refugee Resettlement Care. This report reviews the number and status of children separated from their parent or legal guardian who have entered Office of Refugee Resettlement care. The report stated that children were being separated for a longer period of time than initially reported and that the total number of children separated from their parents are unknown. The report mainly focused on systems changes. However, this is the first in a series of reports that will be published throughout the year. HHS OIG is conducting additional reviews to assess the care and well-being of children and whether the facilities are providing necessary physical and mental health services, including efforts to address trauma. Last summer, the OIG contacted APA during their investigation to provide feedback on appropriate mental health services these children should receive when in their care. If asked, we will continue to provide assistance to them on how to support the emotional well-being of these children and their families.
As you know, APA has been out front about our concerns regarding the trauma children face during these separations, and we have advocated for families to not be separated. We have released public statements and comments to the proposed changes to the Flores rule, called for Congressional hearings, and the Board of Trustees recently passed a position statement. We also reached out to Catholic Charities and Lutheran Services to offer assistance in communities where the children were placed. If you are still interested, please contact your local agency.
New CMS Guidance on Lifting the IMD Exclusion to Treat Mental Health Disorders
In a recent letter to state Medicaid directors, the Centers for Medicare and Medicaid Services (CMS) issued new guidance on how states can design innovative service delivery systems for adults with a serious mental illness (SMI) or children with a serious emotional disturbance (SED) who are Medicaid beneficiaries. Notably, the guidance outlines how states can submit 1115 waivers to fund treatment for patients aged 21 to 64 with an SMI in facilities with more than 16 beds, facilities previously barred from Medicaid funding through the “IMD exclusion.” The guidance notes that while residing in an IMD, patients must have a primary mental health diagnosis. However, beneficiaries should also be screened for co-occurring SUDs, as well as physical health conditions. States have been encouraged to achieve an average length of stay of 30 days in an IMD setting.
CMS also encourages states to use existing Medicaid authority to expand evidence-based treatments, such as telepsychiatry, the Collaborative Care Model, and early intervention for psychosis. This guidance complements last year’s guidance on leveraging Medicaid waivers to expand treatment for substance use disorders, and provides strategies to improve crisis stabilization services, care coordination, and services to address social risk factors, such as housing, education, and employment.
FDA Changes for Prescribers Dispensing Clozapine
The FDA announced a change in the way providers will dispense clozapine. Effective February 28, 2019, prescribers will need to be certified by the Clozapine REMS program and all patients will need to be enrolled by that prescriber. The Center for Drug Evaluation Research’s announcement lays out the specifics of the changes for providers, pharmacists, and patients. The highlights for prescribers are:
Prescribing clozapine for outpatient use must:
- Certify in the Clozapine REMS Program. The certification requires the completion of an enrollment form, a review of educational resources, and an assessment on prescriber knowledge.
- Enroll patients in the Clozapine REMS Program. If the patient is not enrolled in the program, a dispense will not be authorized.
- Obtain an absolute neutrophil count (ANC) for patients in accordance with the clozapine prescribing information and aligned with the patient’s monitoring frequency.
Prescribing clozapine for inpatient use are not required to be certified, however they must enroll the patient in the Clozapine REMS Program prior to receiving their first dose if the patient is initiated on clozapine while in an inpatient setting.
Each of these requirements is expected to be fulfilled by February 28. We will communicate these changes to our members to ensure patients receive continuity of care. APA Administration will also continue engaging FDA to lay out the administrative burden that this will mean for providers treating patients in need.
Congressional Activity Temporarily Slowed by Partial Government Shutdown
The beginning of the new Congress has been significantly colored by the partial government shutdown. The funding lapse, which impacted roughly one third of the government lasted for 35 days and became the longest shutdown in history. While the government was reopened in late January via a temporary funding bill, there is the potential for another partial shutdown if lawmakers fail to reach an agreement on border security, and potentially immigration, by the February 15 deadline. Fortunately, the Labor HHS appropriation bill, which houses many of the APA’s funding priorities including through SAMHSA, HHS and CDC, hasn’t been impacted by the shutdown and has guaranteed funding through September 30.
116th Congress Begins
On January 3, Congress welcomed 110 new members into office. You may also be interested to know:
- There are 3 new doctors and one nurse, including Kim Schrier, MD (WA-8) who will be the first female doctor ever to serve in Congress. This brings the total of healthcare providers in Congress to 22 members.
- Over 1 in 10 new members campaigned with a promise to bring attention to veterans’ health resources, including Tim Burchett (TN-2) who expanded access to mental health services for veterans during his time as Mayor of Knox County.
- Ayanna Pressley (MA-7) campaigned with a specific emphasis on the importance of school-based mental health.
- Many new and returning members of Congress either campaigned on or have expressed interest in issues of significance to APA’s mission.
Calling for Connections to New Members of Congress
Do you have a personal connection to a new member of Congress? Whether a friend, relative, or involved constituent, we want to know! Please email our Grassroots Manager, Sage Bauer at [email protected].
Criminal Justice Reform
Congress passed and President Trump signed the bipartisan criminal justice reform bill, The First Step Act, into law in December. Among its many important provisions, this law will end juvenile solitary confinement, except in cases where the confinement is a temporary response to behavior that poses a serious and immediate risk of physical harm to the individual or others. The law’s new requirements are supported by APA’s position statement on juvenile solitary confinement.
2019 is going to be a very busy year in state capitals, since it is the beginning of a two year legislative session for the vast majority of states. Most states are either already in legislative session. So far this year, legislators in seven states have introduced psychologist prescribing legislation. Additionally, nurse practitioners are seeking to expand their scope of practice in several states, and one state has already introduced independent practice legislation for physician assistants. More legislation regarding scope of practice will be introduced this year and APA will work with District Branches (DBs) and State Associations (SAs) to address all these proposals to the extent the DB/SA wishes. Many DB/SAs have voiced their interest in pursuing APA’s model parity enforcement legislation, with several states imminently expecting introduction of those bills. Positive legislation in support of Collaborative Care, telemedicine, and medication assisted treatment are expected to be introduced in several states, and we are working with states who wish to delink Maintenance of Certification from licensure, credentialing, and reimbursement. For more information about how to get involved in advocacy in your state, please contact Erin Berry Philp at [email protected].
Aetna Settles Legal Action on Access to Mental Health and Substance Use Care
In December, the Massachusetts Attorney General settled allegations that Aetna violated state law by maintaining inaccurate and deceptive provider directories, inadequate provider networks and unfairly denying or impeding member coverage for substance use disorder treatments. Although this settlement was based on state law, it is a wake up call to plans and self-insuring employers that they could be held responsible these violations. If you would like a copy of the agreement, please contact Agathe Farrage at [email protected].
South Carolina Psychiatric Association and APA Oppose Medicaid Work Requirements
South Carolina is among the latest of states applying to impose work or community engagement requirements to its Medicaid enrollees. Along with the South Carolina Psychiatric Association, APA wrote in opposition to this proposal and focused on the impact that the policy would have on low-income parents and individuals struggling with mental health and/or substance use disorders in rural communities.