On Jan. 31, HHS released its long-awaited proposed rule on prescription drug rebates. The proposal would make sweeping changes to the way drugs are priced and contracted for by manufacturers, pharmacy benefit managers (PBM) and health plans. In the proposed rule HHS calls for changes to the anti-kickback statute safe harbors for discounts and rebates given by pharmaceutical manufacturers to health plans and PBMs.

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The changes would eliminate the safe harbor protections for such discount arrangements, while creating a new safe harbor for discounts provided to beneficiaries at the point of sale. If finalized rebates would be passed on to patients directly, instead of to the health plan or PBM. The proposal also calls for increased transparency around flat fee arrangements between pharmaceutical manufacturers and PBMs.

The AMA agrees that patients should see the benefit of discounts, rebates and other price concessions on prescription drugs and is very supportive of the administration's calls for increased transparency of arrangements between pharmaceutical manufacturers and PBMs/health plans. However, there are many outstanding questions about the ultimate impact of the administration's proposal, and the AMA is carefully considering the potential effect on items such as Part D plan premiums, drug list prices and the availability and size of future discounts and rebates.

On Feb. 13, the House Judiciary Committee favorably reported HR 8, the Bipartisan Background Checks Act, by a vote of 23-15. The AMA-supported bill would implement near-universal background checks for the purchase of firearms, effectively closing loopholes that allow sales at gun shows or through online sales to evade the current requirement that applies to federally licensed firearms dealers.

Polling shows overwhelming public support for this requirement, including among gun owners. It is one step that can help keep firearms out of the hands of those who are not legally entitled to possess them. The bill is expected to be considered on the House floor in the coming weeks along with another measure, HR 1112, which would extend the time the Federal Bureau of Investigation (FBI) has to complete a background check before a dealer may deliver the firearm to the purchaser. While HR 8 is expected to pass in the House, its fate in the Senate is less certain.

On Feb. 7, the AMA and 103 national medical specialty organizations and state medical societies sent a letter 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, on policies that should be considered as Congress develops legislation designed to provide relief to patients experiencing health care costs not covered by insurance.

Patients, physicians and policymakers are increasingly concerned about the impact that unanticipated out-of-network medical bills are having on patient out-of-pocket costs and the patient-physician relationship. The physician organizations urged Congress to consider:

  • The impact of insurer practices such as narrow networks, inaccurate provider directories and non-adherence to the prudent layperson standard for determining coverage for emergency care
  • The need for transparency in anticipated charges by out-of-network providers for scheduled care
  • The importance of preserving insurers' incentive to negotiate network participation contracts in good faith
  • The need to pair any guidelines for out-of-network payments for providers not chosen by the patient with a payment process that is keyed to the market value of physician services
  • Providing for mediation or an alternative dispute resolution process for circumstances where any minimum benefit standard is insufficient due to factors such as the complexity of the patient's medical condition and other extraordinary factors

Both chambers of Congress and the Trump administration have expressed interest in pursuing policies to address this issue.

The Center for Medicare and Medicaid Innovation (CMMI) has announced a new alternative payment model called Emergency Triage, Treat and Transport, or ET3. Based on action by the AMA House of Delegates, the AMA has been urging Medicare to pay emergency medical service providers for the evaluation and transport of patients to the most appropriate site of care based on the onsite evaluation of the patient's needs, rather than limit payment for transportation to the nearest hospital. The ET3 model will allow ambulance providers to partner with health professionals to treat patients on the scene or through telehealth and to transport them to alternative facilities for care, including their physician's office or an urgent care center, instead of all Medicare patients who call for emergency help being transported to hospital emergency departments. ET3 will start in 2020 and run for five years.

More information about the model is available here.

The Office of the National Coordinator for Health IT (ONC) has released a proposed rule implementing provisions of the 21st Century Cures Act related to electronic health information blocking, interoperability and the ONC Health IT Certification Program. Concurrently, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on patient access to data and interoperability. Provisions in these rules regarding information blocking and application program interfaces (API) will impact interoperability and the way data is exchanged between patients, health providers, payers, technology developers and other health care stakeholders. The proposed rules also promote patient access and price transparency.

ONC and CMS will accept comments until mid-April (the exact date will be updated upon posting on the Federal Register website). The AMA will be drafting comprehensive comments.

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