July 12, 2019: National Advocacy Update

This week the AMA called on (PDF) the U.S. Department of Homeland Security (DHS) and U.S. Customs and Border Protection (CBP) to address the condition of their facilities at the southern border, which are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. The AMA also issued a letter (PDF) to the House Committee on Oversight and Reform in advance of the upcoming hearings entitled, "Kids in Cages: Inhumane Treatment at the Border," and "The Trump Administration's Child Separation Policy: Substantiated Allegations of Mistreatment."

"Conditions in CBP facilities, including open toilets, constant light exposure, insufficient food and water, extreme temperatures, and forcing pregnant women and children to sleep on cement floors, are traumatizing. These facilities are simply not appropriate places for children or for pregnant women. We strongly urge the Administration and Congress to work with the medical community to develop policies that ensure the health of children and families is protected throughout the immigration process," wrote AMA CEO and EVP James L. Madara, MD.

On June 18, the AMA signed on to a letter (PDF) of support for H.R. 3239, the "Humanitarian Standards for Individuals in Customs and Border Protection Custody Act," along with 13 other health care organizations. H.R. 3239 takes important steps toward ensuring that appropriate medical and mental health screening and care is provided to all individuals, including immigrant children and pregnant women, in CBP custody.

In September the administration released a proposed rule expanding the long-term detention of migrating families. Consistent with AMA policy adopted during A-18, the AMA submitted a comment letter (PDF) opposing the proposed rule and its impact on the health and well-being of migrating families. The AMA has been, and will continue to be, aggressive (PDF) in demanding oversight of these detention facilities and will continue to voice its concern (PDF) and advocate for the health and safety of migrating children and families.

Responding to a joint request from the AMA and the American Heart Association (AHA), the Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination expanding covered indications for the use of ambulatory blood pressure monitoring (ABPM) in diagnosing hypertension to include suspected masked hypertension, where in-office blood pressure readings may be lower than those taken elsewhere. Previously, Medicare covered ABPM for suspected white coat hypertension, when in-office blood pressure is higher than when measured at home, but not for masked hypertension, such as for patients whose blood pressure is normal in the clinic but above normal out of the clinic or at night.

As the AMA and AHA urged in a joint comment letter (PDF) on the proposed coverage decision, CMS made important modifications to the final ABPM policy:

• Updated systolic and diastolic blood pressure readings that qualify for ABPM coverage to reflect the 2017 AHA/American College of Cardiology guidelines
• Removed the requirement for lifestyle interventions prior to ABPM use
• Specified detection of nocturnal hypertension as a covered indication for ABPM use

Expanded Medicare coverage of ABPM is consistent with recommendations of the U.S. Preventive Services Task Force and represents a major advance in physicians' ability to appropriately diagnose hypertension, which can have serious consequences for patients' health without appropriate diagnosis and management.

More information on AMA and AHA tools for controlling hypertension is available here.

One of the four key pillars of the administration's plan to end the HIV epidemic within 10 years is preventing at-risk individuals from acquiring HIV infection, especially through increased use of pre-exposure prophylaxis (PrEP). The U.S. Food and Drug Administration (FDA) has taken an important step to improve patient access to PrEP by removing risk evaluation and mitigation strategy (REMS) requirements that have been in place for the PrEP medication, Truvada, and its generics since the medication's approval in 2012. The FDA requires a REMS for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, the FDA indicates that only a few medications require a REMS. By removing the REMS requirement, the FDA has removed one barrier to accessing PrEP.

The FDA action, effective July 1, is consistent with AMA policy, which supports effective use of PrEP for HIV and removal of barriers that are not clinically relevant. Also of note, the US Preventive Services Task Force recently issued an "A" recommendation for PrEP after an evidence review found that PrEP is of substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV acquisition. The FDA action to remove the REMS follows a recent decision by the drug's manufacturer to donate up to 2.4 million bottles of Truvada annually to the Centers for Disease Control and Prevention (CDC) for uninsured Americans at risk for HIV.

On April 23, CMS released its proposed rule describing federal fiscal year 2020 policies and rates for Medicare's prospective payment systems for acute care inpatient hospitals and the long-term care hospital prospective payment system. In response, the AMA submitted comments (PDF) on June 24 and was encouraged by CMS' efforts in the proposed rule to reduce administrative burden, such as the Promoting Interoperability program focusing on interoperability and improved patient access to health information.

The AMA was also encouraged that CMS plans to seek specialty and stakeholder input prior to implementation of reimbursement and policy changes related to Medicare Severity Diagnosis-Related Groups that could have the potential to negatively impact patient access to care. However, the AMA believes the proposals related to the inpatient and long-term care quality programs need to be refined. To date, CMS' approach to addressing the opioid crisis through quality measurement has been too narrowly focused on preventing and/or reducing opioid use in the absence of addressing the larger clinical issue—ensuring adequate pain control while minimizing the risk toward opioid addiction. Quality measurement must focus on how well patients' pain is controlled, whether functional improvement goals are met and what therapies are being used to manage pain.

The bipartisan Cannabidiol and Marihuana Research Expansion Act, S. 2032, has been introduced in the Senate and aims to improve the process for conducting scientific and clinical research on cannabidiol (CBD) and marijuana, and streamline the development of safe and effective cannabinoid-based drugs approved by the FDA.

The AMA strongly supports this legislation sponsored by Senators Feinstein (D-CA), Grassley (R-IA) and Schatz (D-HI) to enable legitimate research evaluating the potential efficacy and safety of medicines derived from cannabis. The AMA is very concerned with the growing public support and legislative efforts at all levels of government to legalize the use of cannabis. These efforts have resulted in many individuals using marijuana-derived products that have not been approved by the FDA.

The AMA believes that scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use. However, legal and regulatory barriers to cannabis and cannabinoid research have left physicians and patients without the evidence needed to understand the health effects of these products and make sound clinical decisions regarding their use.

• July 12, 2019: Advocacy spotlight on Congressional efforts to address surprise billing continue 
• July 12, 2019: State Advocacy Update 
• July 12, 2019: Judicial Advocacy Update