April 18, 2019: National Advocacy Update

On April 16, the AMA sent a letter (PDF) to the House Committees on Ways and Means, Energy and Commerce, and Education and Labor, as well as the Senate Health, Education, Labor and Pensions Committee and Finance Committee, urging the committees and Congress to protect patients from unanticipated, or "surprise," medical bills by examining the full range of situations that cause patients to receive medical bills that their health insurance plan will not cover. These situations include health insurance market concentration and narrow provider networks that increase the likelihood patients may receive care from an out-of-network provider, particularly in emergency situations. The letter also discusses the consequences when health insurance plans shift costs to patients by denying care through utilization management (including prior authorization), mental and substance abuse payment disparities, retroactive denials, and formulary changes.

The AMA emphasized that remedies must protect patients from costs that should have been covered by their health insurer, and instead focus on creating a process that relies on unbiased claims data where providers and insurers can reach a fair payment amount for out-of-network care in situations where a patient cannot choose the provider. The letter cites a survey that a clear majority of patients who have experienced a surprise bill place responsibility on their health care insurance plan rather than on physicians.

The AMA has joined other health organizations in supporting legislation (PDF) to address the troubling rates of maternal mortality, morbidity and infant mortality in the United States. The Mothers and Offspring Mortality and Morbidity Awareness Act or "MOMMA Act," (S. 916/H.R. 1897) was reintroduced by Senators Richard Durbin (D-IL), Tammy Duckworth (D-IL) and Representative Robin Kelly (D-IL). More women die from pregnancy-related complications in the United States than in any other developed country, and the rate of maternal deaths continues to rise. Major disparities in maternal mortality exist, with black women being three to four times more likely than white women to die during pregnancy or shortly after birth. Moreover, for every maternal death that occurs, an estimated 100 other women suffer severe complications of pregnancy or childbirth.

The MOMMA Act seeks to lower the country's rising maternal and infant mortality rates and reduce racial disparities in health outcomes by:

• Expanding coverage under Medicaid and the Children's Health Insurance Program, as well as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), through a longer post-partum period for women
• Improving coverage and access to doulas
• Improving and scaling best practices for maternity care
• Improving implicit bias and cultural competency training among health care providers

The legislation also would bolster federal efforts to support states in collecting, standardizing and sharing maternal mortality and morbidity data.

In response to a 2018 joint request (PDF) from the AMA and the American Heart Association (AHA), the Centers for Medicare & Medicaid Services (CMS) agreed to review its national coverage policy for ambulatory blood pressure monitoring (ABPM). It has now proposed to expand the covered indications for ABPM to include use in diagnosing patients with suspected masked hypertension and informing their treatment plans.

Masked hypertension occurs when office blood pressure measurement is normal but ABPM is elevated. The proposed coverage decision notes CMS has now concluded that ABPM has benefits beyond only ruling out white-coat hypertension—it is an essential tool in managing hypertension to reduce mortality and improving other health outcomes for Medicare patients. The AMA and AHA are encouraged by the proposal to expand coverage to additional indications. AMA is reviewing the details of the proposed coverage decision and will submit comments to CMS.

Click here to review the proposed coverage decision memo. Public comments will be accepted until May 9.

On April 8, the AMA submitted comments on a proposed rule seeking changes to the current safe harbors for prescription drug rebates. With the proposed rule, the administration seeks to eliminate safe harbor protections for prescription drug price reductions (including rebates and other discounts) paid by drug manufacturers to health plans and/or pharmacy benefit managers (PBM) contracting with health plans administering Medicare Part D plans or with Medicaid managed care organizations (MCO).

The administration is also proposing to create a new safe harbor for prescription drug price reductions paid directly to beneficiaries at the point of sale. This proposal would essentially eliminate the current system of PBM-negotiated rebates and ensure that patients taking drugs for which discounts are available are able to directly benefit from those discounts. The proposed rule also includes some additional transparency requirements for PBMs in the Part D/Medicaid MCO space, proposing that certain fees included in contracts with manufacturers are clearly disclosed.

The AMA supports changes to the prescription drug rebate system that would allow patients to directly benefit from any price reductions negotiated with manufacturers. However, the AMA also urged the U.S. Department of Health and Human Services (HHS) to consider the potential of unintended consequences for all beneficiaries, including the potential for increased premiums in Part D plans, no meaningful reductions in drug list prices, a decrease in amount of price reductions offered and increased drug spending by Medicaid programs.

The prescription drug rebate proposal is the latest of several proposals put forth by the Trump administration looking at prescription drug spending and prices. The AMA continues to work closely with the administration to ensure policy changes have a meaningful impact on patient out-of-pocket costs and maintain access to critical treatments.

The FDA released its first discussion paper (PDF) and request for feedback on a proposed regulatory framework for artificial intelligence/machine learning-based software (AI/ML) as a medical device. The proposal builds on the FDA's ongoing work to modernize the regulatory framework for software as a medical device (SaMD), including non-AI/ML-based software.

For SaMD, the FDA is proposing a precertification program for software manufacturers that could ultimately result in streamlined review of software products created by manufacturers gaining precertification status, similar to the TSA Pre-Check program for travelers. The AI/ML-based software discussion paper proposes to utilize the precertification program as the regulatory pathway for certain types of continuously learning artificial intelligence-based products, but with additional considerations for this type of software product.

Much like the precertification proposals, this discussion paper does not represent guidance or binding regulatory changes from the FDA. The AI/ML-based software discussion paper represents only the FDA's current thinking and seeks feedback from interested stakeholders to help further develop the framework. The AMA is carefully evaluating this discussion paper and the potential considerations for physicians in any new regulatory framework for software products of this type. The FDA is seeking comment by June 3.

• April 18, 2019: Advocacy spotlight on FDA and CDC issue clarifications on opioid prescribing guidelines 
• April 18, 2019: State Advocacy Update