Maine Medicine Weekly Update - Maine Medicine Weekly E-Update, January 18, 2022
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National Public Health Emergency Extended

US Secretary of Health and Human Services Secretary Xavier Becerra late last week renewed the federal public health emergency declaration due to the COVID-19 pandemic.

National Public Health Emergency Declarations

It is the 8th renewal since the initial determination of a public health emergency in January 2020 by former Secretary Alex Azar.

Johns Hopkins Public Health Podcast: COVID-19 Vaccines and Immunocompromised Patients

news clip credit: Portland Press Herald

What do we know now about the number of doses needed for people on immunosuppressant medications to be protected from severe COVID? What about the use of “passive” protection like monoclonal antibodies? Why are negative antibody tests more helpful than positive ones? Why are large agencies like the CDC and FDA not discussing individualized medicine when it comes to vaccine protocols? What’s the next step in researching COVID-19 vaccine protocols for this unique population of patients?(Johns Hopkins)

Download and listen to the latest Public Health on Call podcast from the Johns Hopkins Bloomberg School of Public Health.

Research Suggests Nearly $130 Million Spent Annually on Ivermectin Prescriptions

news clip credit: USA Today

In a newly published study published by the Journal of the American Medical Association Network, researchers from the University of Michigan Medical School and Boston University found private and Medicare Advantage insurance plans spent $2.5 million paying for COVID-related Ivermectin during a single week in August 2021. The research used the most recent week for which dispensing data were available at the time.

Extrapolated to a whole year, the cost of COVID-related Ivermectin would have reached $129.7 million in 2021. They did not look at Medicaid spending.

US Insurer Spending on Ivermectin Prescriptions for COVID-19 | JAMA Network (Jan 13, 2022)

U.S. Supreme Court Blocks Employer Vaccine Mandate; Lets Healthcare Mandate Stand

The U.S. Supreme Court late last week blocked President Biden’s vaccine mandate for large employers but ruled to keep a federal mandate in place for certain health care workers.

In a 6-3 vote, the court granted the applications to stay the OSHA rule mandating that employers with at least 100 employees require covered workers to receive a COVID–19 vaccine or undergo weekly testing.

The Court ruled 5-4 to allow the health care worker mandate for workers at health care facilities that accept Medicare and Medicaid. Chief Justice Roberts and Justice Kavanaugh voting differently than they did on the large employer mandate.

Note: both the federal and state COVID vaccine mandates fir health care do not include private, independent physician practices although many in Maine have implemented their own.

The National Law Review: Split Decision: SCOTUS Stays OSHA ETS, While Upholding CMS Vaccine Mandate

US Sets COVID Hospitalization Record

The United States last week set a new record for COVID-19 hospitalizations, with more than 145,000 people in the hospital with the virus, surpassing the previous high of 142,000 people set in January 2021 before vaccines were widely available.

The hospitalizations are driven in large part by people who are unvaccinated. About a third of the patients with the virus, he said, have tested positive for COVID-19 but are not primarily in the hospital because of the virus.

NEJM Evidence: A New Digital Journal

NEJM Evidence, a new monthly digital journal from NEJM Group, presents innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making.

Aims and Scope

The volume of clinical research continues to grow, yet the standards to establish and validate claims, especially as related to clinical practice, have not followed suit. NEJM Evidence expands the corpus of published research with a focus on providing more context and critical evaluation of the methods and results to support clinical decision-making and does so in a way that respects the time and commitment of the practitioner.

Video link describing the new publication found at https://evidence.nejm.org/about

FDA Warns About Dental Problems with Buprenorphine Dissolved In The Mouth To Treat OUD & Pain

The U.S. Food and Drug Administration (FDA) warns that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.

The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.

FDA Announcement (Website)

Downloadable Version (PDF)

FDA Recall: Metformin HCl Extended- Release Tablets USP, 750 mg by Viona Pharmaceuticals

Viona Pharmaceuticals is recalling twenty-three (23) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg because an Out of Specification (OOS) result observed for one lot of the product (M008132) “N-nitrosodimethylamine (NDMA).

FDA Recall Announcement

The company issued a similar recall for the medicine in June 2021 for the same reason.

Using Data to Improve Opioid Prescribing - new MICIS presentation now available

New education outreach presentation by the Maine Independent Clinical Information Service (MICIS)

To schedule a MICIS presentation for your medical practice, hospital or conference, email skring@mainemed.com or go to https://micismaine.org/contact/.

Using Data to Improve Opioid Prescribing
Available resources to address the Opioid/Substance Use Crisis have been enhanced by the state in the past few years. Pertinent to prescribers, data analytics are being increasingly incorporated into the Prescription Monitoring Program platform. Launched in 2021, the Maine Drug Data Hub provides a centralized repository for substance use-related data and resources. These will be explored in depth and the presentation will conclude with information related to harm reduction. Patient experience will be shared through video.

Learning objectives:
- Use the PMP as a tool to improve prescribing.
- Review data and resources at Maine Drug Data Hub.
- Support and participate in harm reduction.

Visit www.micismaine.org for information on MICIS education outreach and academic detailing.

The Maine Medical Education Trust designates this live internet activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extend of their participation in the activity.

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Maine Medical Education Trust and the Maine Independent Clinical Information Service (MICIS). The Maine Medical Education Trust is accredited by the Maine Medical Association Committee on Continuing Medical Education and Accreditation to provide continuing medical education for physicians.

State Legislature Back in Augusta; MMA Government Affairs Back at It

The 2022 Maine legislative session began on Wednesday, January 5. Because 2021 was the first year in a legislative biennium, or two-year cycle, many health-related bills from that session are active and remain on the calendar for 2022. Democrats continue to hold majorities in both chambers.

While the Capital building is open to the public, all policy committee meeting work (public hearings and work sessions) will initially be held virtually through Zoom and broadcast on YouTube. The House Speaker and Senate President plan to evaluate the operations of the legislature during a pandemic on a regular basis.

Despite a successful legislative year for MMA in 2021, a few very important MMA legislative priority policy issues remain to be settled before the scheduled session adjournment in mid-April.

The MMA’s Legislative Committee, chaired by Jay Mullen, MD MBA FACEP met for the first time Wednesday, January 12 to review continuing priorities for the 2022 session:

LD 1196 – An Act Regarding Targets for Health Plan Investments in Primary Care and Behavioral Health

Summary – The MMA was chosen by the Joint Standing Committee of Health Coverage Insurance, and Financial Affairs to convene a stakeholder group to assist in developing potential recommendations for increased investment in primary care. A final stakeholder report was delivered to the Committee in mid-January.

LD 1550 – An Act To End the Sale of Flavored Tobacco Products

LD 1423 – Raising the Tax on Tobacco Products

Summaries – Two important public health bills to reduce tobacco use and illness – especially for young Mainers – by banning the sale of flavored tobacco products including cigars and e-delivery systems and increasing the tax rates for cigarettes while equalizing tax rates for other tobacco products.

Other Top Legislative Issues

How to spend $800 million in surplus money

Financial relief for Mainers due to the pandemic, inflation, energy costs

Affordable housing

Taxes

Pandemic response policy, including vaccinations policy

Upcoming Public Hearings & Work Sessions

Date	Comm	PH/WS	Bill/Resolve	Bill/Resolve Title	Summary
01/18/22	HHS	PH	LD 1758	An Act Regarding Access to Telehealth Behavioral Health Services during Public Health Emergencies - Representative Colleen Madigan	DHHS would not be allowed to require a licensed mental health facility or licensed substance use disorder treatment facility to obtain written informed consent as the only option from a patient during a federal or state public health emergency. Consent would be allowed verbally, electronically or in writing.
01/18/22	HHS	PH	LD 1841	Resolve, Regarding Legislative Review of Portions of Chapter 283: Newborn Bloodspot Screening Rule, Section 14, a Major Substantive Rule of the Department of Health and Human Services, Maine Center for Disease Control and Prevention	Adds Mucopolysaccharidosis Type I (MPS-1), Pompe, Spinal Muscular Atrophy (SMA), X-linked Adrenoleukpdysrophy (X-ALD) to newborn screening. Clarifies designation of a contact person in each hospital and birthing center, timing of newborn blood specimen collection, parental/guardian refusal of newborn bloodspot screening (NBS) tests, conditions to be screened, types of records to be maintained, responsibilities for follow-up tests and reporting when necessary, storage and use of residual filter paper specimens; and identifies the fee charged for NBS testing.
01/18/22	HHS	PH	LD 1848	An Act To Increase the Availability of Assertive Community Treatment Services - Representative Colleen Madigan	Replaces the term psychiatrist with "prescriber" and defines prescriber for assertive community treatment teams under state law. Adds the option for a licensed practical nurse to be included on an ACT team in lieu of a registered nurse if the prescriber is not a certified nurse practitioner. Defines "Prescriber" as a licensed health care provider with authority to prescribe, including a licensed physician, certified nurse practitioner or licensed physician assistant who has training or experience in psychopharmacology.
01/18/22	HCIFS	Confirmation	Agenda	Office of Affordable Health Care	Nominations
01/20/22	HCIFS	PH	LD 1776	An Act To Allow Pharmacists To Dispense an Emergency Supply of Chronic Maintenance Drugs (Emergency) - Representative Amy Roeder	Allows pharmacists to dispense an emergency supply of a chronic maintenance drug without a prescription if the pharmacist cannot get authorization for a refill AND the pharmacist has a prescription record for the patient, including the amount or unit(s). Does not apply to controlled substances, including opioids. Also requires insurance companies to cover the emergency supply.
01/27/22	HCIFS	PH	LD 1858	An Act Regarding Delegating Authority for Services Performed by Emergency Medical Services Personnel in Health Care Facilities	Authorizes licensed EMS to provide medical services in health care facility settings that are not hospital settings under delegated authority if certain criteria are met. Current law authorizes EMS to provide medical services in hospital settings under delegated authority. The medical service must be in the capacity as an employee or a contracted agent of the hospital or health care facility. Current law provides that the medical service must be rendered in the person's capacity as an employee of the hospital.

New Bills

1747An Act To Require Screening for Cytomegalovirus in Certain Newborn Infants

If a newborn infant fails 2 hearing tests or has other risk factors for cytomegalovirus, a hospital, birthing center or other birthing service shall test the newborn infant, or cause the infant to be tested, for the presence of cytomegalovirus and report aggregate data on the testing to the state. Includes a religious exemption.

The state must provide educational resources to pregnant women and women who may become pregnant on cytomegalovirus.

1758An Act Regarding Access to Telehealth Behavioral Health Services during Public Health Emergencies

A licensed mental health facility may obtain consent from a person receiving mental health services or substance use disorder treatment during a public health emergency. The state may not require only written informed consent.

1771Resolve, To Establish the Advisory Panel To Better Understand and Make Recommendations Regarding the Implications of Genome-editing Technology for the Citizens of the State

The bill is the same as LD 1601 (2021), except for date changes and changing the funding mechanism to a private source. The Maine Community Foundation offered to fund the study. The MMA and Maine, American Academy of Pediatrics formally supported LD 1601.

1776An Act To Allow Pharmacists To Dispense an Emergency Supply of Chronic Maintenance Drugs

"Chronic maintenance drug" means a medication prescribed to treat a chronic, long-term condition and that is taken on a regular, recurring basis.

A person can obtain an emergency supply IF the pharmacy in question has a record of a prescription, AND the pharmacist attempts but is unable to obtain authorization to refill the prescription, AND drug is not a controlled substance, including an opioid medication. Carriers must make emergency supplies of chronic maintenance drugs part of coverage and the pharmacist shall fulfill all documentation and other requirements established by the board.

1781An Act To Align Postpartum MaineCare Coverage with Federal Law

Provide coverage for women (including a non-citizen who is ‘otherwise eligible’) during pregnancy and up to 12 months (from 6) following delivery when the woman's family income is equal to or below 209% (from 200%). Also a date change until August 1, 2022.

1822An Act To Improve Access to Behavioral Health Services by Prohibiting Cost Sharing by Insurers

Carriers cannot apply copayments, deductibles, coinsurance or other cost-sharing requirements other than premiums for behavioral health services. Behavioral health services includes, but is not limited to, mental health care and substance use disorder treatment.

1848An Act To Increase the Availability of Assertive Community Treatment Services

Assertive community treatment teams must include a ~~psychiatrist~~prescriber, registered nurse or licensed practical nurse, certified rehabilitation counselor or certified employment specialist, a peer recovery specialist and a substance use disorder counselor and may include an occupational therapist, community-based mental health rehabilitation technician, psychologist, licensed clinical social worker or licensed clinical professional counselor. A licensed practical nurse may be included on an ACT team in lieu of a registered nurse if the prescriber is not a certified nurse practitioner.

Defines "Prescriber" as a licensed health care provider with authority to prescribe, including a licensed physician, certified nurse practitioner or licensed physician assistant who has training or experience in psychopharmacology.

1858An Act Regarding Delegating Authority for Services Performed by Emergency Medical Services Personnel in Health Care Facilities

This bill authorizes licensed emergency medical services persons to provide medical services in health care facility settings that are not hospital settings under delegated authority if certain criteria are met. Current law authorizes licensed emergency medical services persons to provide medical services in hospital settings under delegated authority.

The bill also provides that the medical service must be rendered in the person's capacity as an employee or a contracted agent of the hospital or health care facility. Current law provides that the medical service must be rendered in the person's capacity as an employee of the hospital.

1860An Act To Address Maine's Suicide and Opioid Crises through the Construction of Affordable Recovery Facilities in Underserved Areas of the State

This bill is a concept draft pursuant to Joint Rule 208.

This bill proposes to direct new federal money to construct affordable recovery facilities in underserved areas in order to better address the State's suicide and opioid crises.

1868An Act To Restore Funding to the State's Tobacco Prevention and Control Program

This bill provides ongoing allocations to the Tobacco Prevention and Control Program to restore the level of funding provided for the program in fiscal year 2020-21.

1877An Act To Prohibit Prior Authorization Requirements and Step Therapy Protocols for Medications Addressing Serious Mental Illness for MaineCare Recipients

Prohibits MaineCare prior authorization or step therapy for prescription drugs used for the assessment or treatment of serious mental illness.

"Serious mental illness" means a mental disorder listed in the edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association that took effect October 1, 2021 that results in serious functional impairment that substantially interferes with or limits one or more major life activities.

"Step therapy protocol" means a protocol that establishes a specific sequence in which prescription drugs for a specified medical condition are medically necessary for a particular enrollee and are covered under a pharmacy or medical benefit by a carrier, including self-administered and physician-administered drugs.

1909An Act To Remove Restrictions on Syringe Service Programs

Exchange programs may not limit the number of hypodermic apparatuses given or require the return of a used hypodermic apparatus as a condition for receiving a hypodermic apparatus.

1910An Act To Improve Children's Mental Health by Requiring Insurance Coverage for Certain Mental Health Treatment

This bill requires health insurance carriers to provide coverage for mental health treatment services that use evidence-based practices that are recommended by a provider for a child 18 years of age or younger. The bill defines "evidence-based practices" as clinically sound and scientifically based policies, practices and programs that reflect expert consensus on the prevention, treatment and recovery science published and disseminated by the United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. The bill’s requirements apply to health plans with an effective date on or after January 1, 2023.

MMA Legislative Committee Meetings

The MMA Legislative Committee has begun meeting again. The Committee meets each Wednesday evening at 7:00 pm while the Maine Legislature is in session.

What: Legislative Committee Meetings

When: Wednesdays - 7:00 PM

The function of the MMA Legislative Committee is to review and advise members of the MMA Board of Directors, MMA Government Affairs staff and the association concerning proposed state and federal legislation associated with public health, health care, and the practice of medicine.

If you would like to receive meeting links, materials, and additional information, email Sarah Lepoff slepoff@mainemed.com or dmorin@mainemed.com. You can also call Sarah at 207.622.3374

If you are unable to attend meetings, but have comments/questions you would like addressed based on any legislation of interest, please feel free to send them to Sarah or Dan.

Committees of MMA can be found here.

Maine AAP, Partnership for Children's Oral Health, Count ME In Survey Request

The Maine Chapter of the American Academy of Pediatrics is working with the Partnership for Children's Oral Health and the Count ME In organization on a pilot to look at how health factors impact student absenteeism, and how schools, medical and dental practices and families could work together for better student outcomes.

To do this, Maine AAP is engaging with schools across several Maine counties, and the primary care and oral health practices in their region. To improve our work, they would really appreciate input from family practice and pediatric clinicians on a short survey. https://www.surveymonkey.com/r/CAProject_2021-22

Maine AAP will share the survey results, along with tools and resources, to each person who completes the survey.

Thank you!

Dee Kerry, Executive Director

Maine AAP: Innovating / Integrating our Way Out of Maine's Oral Health Crisis (Jan 20)

Primary care providers have the greatest access to children when prevention matters most: before the decay process starts! Through innovations in disease prevention and new models of care delivery, dental and medical teams combine to reduce dental disease burden in Maine’s children. Attend this program to learn more!

*Registration is closed for the January 12 program.

AMA Webinar: Implementing the No Surprises Act (Jan 20)

Register to join an AMA webinar on Thurs., Jan. 20 at 1 p.m. Eastern time/Noon Central time, “Implementing the No Surprises Act.”

The No Surprises Act, which aims to protect patients from the financial impact of surprise medical billing, became law on Jan. 1. Learn what physicians need to do immediately to comply with the new law. Experts will also address enforcement challenges and the interaction between state and federal surprise billing requirements.