The last few months have seen significant movement across a broad array of issues.
APA-Led Activities
APA’s Congressional Advocacy Network Advocates for Psychiatry
Congress’ August recess work period is traditionally a time when members of Congress return to their home districts to reconnect with their constituents about important issues. To capitalize on this important opportunity, members of APA’s Congressional Advocate Network met with members of Congress on two signature issues for mental health. Specifically, Congressional Advocates educated members of Congress on the important role telehealth continues to play in treating individuals with mental health or substance use disorders and to promote the Parity Implementation Assistance Act (H.R. 3753/S. 1962).
Their voice, like your voice, is crucial to our success! You can support these efforts by sending a letter to, or requesting a meeting with, your members of Congress in support of telehealth and the Parity Implementation Assistance Act. You can also learn more about the Congressional Advocacy Network and sign up here . Feel free to email APA staff at [email protected] if you need help requesting a meeting.
APA's Signature Legislation to Expand Access to MH Care Introduced
APA led 18 healthcare organizations in applauding Reps. Lizzie Fletcher (D-TX) and Jaime Herrera Beutler (R-WA), for introducing bipartisan legislation that APA worked closely with them to develop, which would expand the Collaborative Care Model, a care delivery model that integrates behavioral health care within the primary care setting. 
In the Collaborative Care Model, a primary care physician, a psychiatric consultant and care manager work as a team to identify and provide evidence-based treatment for mental health conditions, measure patients’ progress and adjust care when appropriate. The model is supported by more than 90 research studies demonstrating its efficacy in improving patient outcomes and addressing health care disparities. The Collaborate in an Orderly and Cohesive Manner (COCM) Act (H.R. 5218) would create a new grant program for primary care practices to implement the Model, establish technical assistance centers to assist practices implementing the Model and expand research on other promising integrated care models.
Executive Branch Activities
2022 Medicare Physician Fee Schedule and Quality Payment Program
CMS recently released their annual proposed rule on the 2022 Medicare Physician Fee Schedule (PFS) and Quality Payment Program (QPP), which proposes a decrease in the annual conversion factor ($34.89 to $33.58 per RUV). APA will join other physician colleagues in advocating against any reduction in payment. The most significant proposal related to mental health in the PFS section of the rule is CMS’ proposal to pay for audio-only care for mental health services. If adopted, this proposal would be a continuation of coverage currently in place as part of the Public Health Emergency. CMS is seeking feedback with regard to issues related to documentation, range of services to be included and information on any additional guardrails. The proposal includes a requirement for a face-to-face visit every 6 months.
The QPP portion of the rule is focused heavily on policies related to MIPS Value Pathways (MVPs), which is a program CMS is developing within the Merit-Based Incentive Payment System (MIPS) to create coherent, specialty-specific sets of measures across the domains of quality, cost, improvement activities, and promoting interoperability. CMS intends to focus the future of MIPS on MVP development and implementation, and proposes to begin transitioning to MVPs in the 2023 MIPS performance year. No new measures were added to the MIPS Mental/Behavioral Health Specialty Set for 2022. Two measures were removed from the set: (1) Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented; and (2) Closing the Referral Loop: Receipt of Specialist Report. CMS also adjusted the weighting of MIPS performance categories, bringing the cost and quality dimensions into equal weighting at 30 percent each.
APA submitted comments supporting coverage for audio-only care and urging CMS to extend that to include care provided to patients with substance use disorders and to remove any barriers such as requirements for an in-person. We also asked CMS to work with Congress to mitigate the proposed reduction in the 2022 Medicare payment rates to ensure payments for Medicare services are maintained.
FDA Approves Six Month LAI for Adults with Schizophrenia
In early September, the US Food and Drug Administration (FDA) approved the first twice-yearly long-acting injectable treatment for adults with schizophrenia. The paliperidone palmitate is a product of Janssen Pharmaceuticals. A 12-month, randomized, double-blind, non inferiority Phase 3 global study found over 92% of those administered the drug were relapse-free at one year. Learn more.
View a video describing effective communications strategies for clinicians to implement long-acting injectables in their patients’ treatment plans.
HHS Releases Plan to Lower Drug Prices
On September 9, Health and Human Services (HHS) Secretary Xavier Becerra released a comprehensive Plan to lower drug prices. The Drug Pricing Plan is part of a broader initiative stemming from President Joe Biden’s Executive Order on Promoting Competition in the American Economy, which also created the White House Competition Council tasked with coordinating, promoting, and advancing Federal Government efforts to address overconcentration, monopolization, and unfair competition in or directly affecting the American economy. The Plan released by HHS is guided by the Administration’s principles for equitable drug pricing reform through competition, innovation, and transparency.
Changing Clozapine Risk Evaluation and Mitigation Strategy (REMS) Requirements
According to the FDA, all prescribers and pharmacies must be re-certified by November 15, 2021, or they will no longer be able to prescribe/dispense clozapine. Prescribers must re-enroll their patients who will continue clozapine by November 15, 2021. Patients who are not re-enrolled by that day will no longer be able to receive clozapine.
- Pharmacies will no longer be able to use the telecommunication verification (also known as the switch system) to verify safe use conditions. The authorization to dispense will be obtained either through the contact center or online via the REMS website.
- A new Patient Status Form will document absolute neutrophil count (ANC) monitoring for all outpatients. This form must be submitted monthly. Patient monitoring must continue per the Prescribing Information.
APA, along with other organizations, reached out to FDA with concerns about the impact and burden of the changes and requested more time for clinicians and patients to recertify/re-enroll.
APA Supports HHS Proposed Rule
APA responded to HHS’ Proposed Rule, "Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond,” supporting many of the proposed changes, including:
- Emphasizing the applicability of the Mental Health Parity and Addiction Equity Act;
- Lengthening the annual open enrollment period for the individual insurance marketplace and creating monthly special enrollment periods for certain income levels;
- Modifying guidance to 1332 waivers to ensure plans require comprehensive, affordable coverage.
APA’s comments also focused on the need to improve network adequacy as it related compliance with the Mental Health Parity and Addiction Equity Act.
APA Comments on No Surprises Act Regulations
APA provided comments in response to an Interim Final Rule that implements key provisions of the No Surprise Act, which is intended to protect patients from surprise bills and significant out of network cost sharing for emergency services and services provided by out of network providers during an in network facility visit. APA’s comments focused on the need for meaningful compliance with and enforcement of The Mental Health Parity And Addiction Equity Act so that patients who need mental health and substance use disorder care, particularly those suffering from serious mental illness and in need of emergency services, can find an in network clinician/facility to provide that care.
Congressional Activities
US House of Representatives Approves Significant Funding Increase for MH/SUD Programs
In late July, Congress took a critical first step in approving significant funding increases for mental health and substance use disorder programs. The bill boosts funding for the Substance Abuse and Mental Health Services Administration (SAMHSA) by nearly 50% and increases funding for important research at the National Institutes of Health (NIH), including research on health care disparities and addiction. It also invests in enhancing the mental health and substance use treatment workforce and prioritizes enforcement of the Mental Health Parity and Addiction Equity Act by the U.S. Department of Labor. Specifically, the legislation includes:
- $9.16 billion for SAMHSA, an increase of $3.16 billion including:
- An $825 million increase to the Mental Health Services Block Grant, including a 10% set-aside for crisis services funding and an additional $100 million devoted for mobile crisis response and an $89.6 million increase for the Suicide Lifeline and 988 implementation.
- Additional substance use treatment resources of $1.6 billion, including a 33% increase in State Opioid Response Grants.
- $20.3 million for the Minority Fellowship Program, a 20% increase.
- An increase of $341 million for the Health Resources Services Administration to support health workforce development, including $28 million for HRSA’s Loan Repayment Program for Substance Use Disorder Treatment Workforce.
- $37.5 million for the Employee Benefits Security Administration, including a specific focus on improving compliance with the Mental Health Parity and Addiction Equity Act.
- $330 million for the National Institutes of Health research on health disparities, including $250,000 through the National Institute on Minority Health and Health Disparities, as well as a 25% overall increase for the National Institute on Drug Abuse and a roughly 5% increase for the National Institute of Mental Health and the National Institute on Alcohol Abuse and Alcoholism.
- $2.9 billion in additional funding for Veterans mental healthcare, including a $286 million boost for suicide prevention outreach.
Again, this is the first step in a long process to determine funding levels for the U.S. Department of Health and Human Services as well as the Department of Veterans Affairs. The Senate Appropriations Committee must also weigh in on funding levels for these critical programs and then the two chambers will negotiate final figures. However, APA remains pleased that the House proposal recognizes the severity of the mental health and substance use challenges our nation is facing and invests significant new resources to meet them.
APA Applauds Legislation to Support the Conrad-30 Program
APA applauded Senators Amy Klobuchar (D-MN), Susan Collins (R-ME), Jacky Rosen (D-NV) and Joni Ernst (R-IA) as well as Representative Brad Schneider (D-IL) for introducing the Conrad State 30 and Physician Access Reauthorization Act (H.R. /S. 1810 ).
Since 1994, the Conrad State 30 program has brought thousands of foreign physicians who are trained in the United States to medically underserved communities. In return for their service, the U.S. waives a requirement that they return to their home country for two years after their residency and provides them with priority access to the green card system if they serve in the community for five years. The Conrad State 30 and Physician Access Reauthorization Act would reauthorize the Conrad State 30 J-1 visa waiver program for three years. In addition, the legislation seeks to provide additional waivers for states that use at least 90% of their existing waiver capacity, and allows the United States Citizenship and Immigration Services (USCIS) to collect data on the usage of the visas and report that data to HHS and Congress.
MH Community Expresses Widespread Support for the Parity Implementation Assistance Act
46 mental health organizations joined APA in sending a letter applauding the introduction of the Parity Implementation Assistance Act (S. 1962/H.R. 3753), which signals widespread support among the mental health community for the next step in parity implementation. This legislation builds upon APA’s successful advocacy efforts last year to enact the Strengthening Behavioral Health Parity Act by establishing grants that will help states investigate whether insurance plans are covering mental health and substance use disorder treatment as required by law.
House of Medicine Thanks Congress for Protecting Medicare Reimbursement
APA joined over 109 health advocacy organizations in sending a letter to House and Senate leadership thanking them for protecting the Medicare Physician Fee Schedule (MPFS) with a 3.75% Conversion Factor (CF) increase for all services last year and urging Congress to maintain the 3.75% increase to the CF through at least calendar years 2022 and 2023.
APA Encourages the US House of Representatives to Pass Mental Health Legislation
In August, APA encouraged House Speaker Nancy Pelosi (D-CA) and House Minority Leader Kevin McCarthy (R-CA) to support moving several mental health-related bills to the House floor during the Fall. The bills, which have all been marked up and passed by the House Energy and Commerce Committee, pertain to social determinants of health, maternal mortality and severe maternal morbidity, substance use disorders/drug policy and Medicaid.
APA Joins Effort to Increase GME Support
APA joined nearly 70 other health care organizations in requesting House and Senate Health Committee Leadership include additional Medicare supported graduate medical education (GME) training positions in the upcoming budget reconciliation package. In citing the preexisting physician workforce shortages exacerbated by the pandemic, the letter specifically touted the APA endorsed Resident Physician Shortage Reduction Act of 2021 (H.R. 2256/S.834) as a means towards promoting a more robust and diverse physician workforce.
You can help APA advocate for the passage of the Resident Physician Shortage Reduction Act! Use APA’s online advocacy tool to send a pre-written letter to your members of Congress.
State Activities
Scope of Practice: State of the States
So far this year, APA has worked with over 30 District Branches to oppose legislation that would remove physician involvement from patient care in specified circumstances. Psychologist prescribing legislation was introduced in Hawaii, Florida, Illinois, and New York, but did not move through the legislative process. Advanced practice registered nurse (APRN) legislation that would have removed patient safety language was defeated in seven states, while governors signed such legislation into law in three states. Physician assistant legislation that would authorize practice without physician supervision was defeated in four states and was signed into law in three states. APA continues to work with District Branches that are still in legislative session in order to promote and protect patient safety and access to care.
New State Medical Necessity Criteria Laws
Illinois (HB 255) and Oregon (HB 3046) recently signed new medical necessity criteria legislation into law. These new laws, which are similar to California’s 2020 law, require insurers to use generally accepted standards of care when determining medical necessity, and prevent insurers from creating their own internal guidelines for when patients should receive care. APA worked closely with California, Illinois, and Oregon District Branches to support this legislation.