Legislative Priorities

Prior Authorization

The Alliance of Specialty Medicine supports opportunities to improve the prior authorization process to ensure safe, timely, and affordable access to care for patients. The current prior authorization process can be burdensome for patients, providers, and insurance plans, and we seek to improve the process. The lack of industry-wide standards for the use of electronic prior authorization further complicates this process.

The Medicare program requires Medicare Advantage (MA) plans to provide coverage equivalent to traditional fee-for-service (FFS) in Medicare Part A and Part B. Furthermore, the Centers for Medicare & Medicaid Services (CMS) instructions to plans preclude them from using prior authorization and other utilization control tools in a manner that imposes inappropriate barriers to access. Despite these requirements, MA plans are overusing and misusing these practices because CMS has not provided adequate guidance on what constitutes appropriate prior authorization, nor does the agency in its oversight role collect adequate data to assess the utility of these programs and their impact on patient access to care. In April of 2022, the Office of the Inspector General of the Department of Health and Human Services issued a report finding persistent and inappropriate details of services and payments by MA plans in the prior authorization process.   The House Energy and Commerce’s Subcommittee on Oversight and Investigations followed up the report with a hearing on Medicare Advantage plans including inappropriate denials of care.  

In the 117th Congress, the Alliance supported the Improving Seniors’ Timely Access to Care Act (H.R. 3173/S. 3018) which would streamline prior authorization in the Medicare Advantage (MA) program. Although H.R. 3173 garnered 380 combined bipartisan co-sponsors and passed the House of Representatives unanimously by voice vote, the Senate did not take up the bill.

In January 2023, The Alliance of Specialty Medicine participated in an in-person roundtable discussion on reforming prior authorization in federally-sponsored healthcare programs. The panel was convened by Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, and U.S. Surgeon General Vice Admiral Vivek H. Murthy, MD, as the Biden Administration looks to remedy abuses in the prior authorization program and ensure patients’ timely access to medically necessary care.  The Alliance also released a  survey of its physician members about prior authorization and other utilization review practices. Respondents overwhelmingly indicated that the use of prior authorization (PA) has increased in the last five years across all categories of services and treatments.

The Alliance also submitted comments to CMS generally supporting its Advancing Interoperability and Improving Prior Authorization proposed rule. The rule, which largely pertains to Medicare Advantage plans, Medicaid/CHIP Fee-for-Service (FFS) and managed care plans, and qualified health plans on the Federally-Facilitated Exchanges aims to improve the electronic exchange of data between payers, patients, and clinicians, and to streamline prior authorization processes through electronic data exchange requirements. The Alliance reiterated concerns about current prior authorization practices and expressed support for policies that aim to speed up prior authorization decision timeframes and increase the transparency of payer prior authorization requirements and patterns. However, the Alliance also included recommendations on ways for CMS to strengthen its proposals, such as extending its proposals to drugs, adopting shorter prior authorization decision timeframes than proposed, and opposing a proposal to measure and hold physicians accountable for their use of electronic prior authorization processes.

• Alliance Issue Brief: Prior Authorization 2023
• OpEd on Prior Authorization, Dr. John Ratliff
• Alliance Comments on the Advancing Interoperability and Improving Prior Authorization Proposed Rule

Step Therapy

In step therapy, insurers require patients, sometimes even those stable on a certain medication, to try and fail medications before agreeing to cover the initial therapy prescribed by the health care provider. This practice jeopardizes the health of patients and the physician-patient relationship. A 2018 article in the Food and Drug Law Journal discusses that such policy has been shown not to save money in the long run due to patient complications. Appealing step therapy protocols can be very timely and burdensome for physicians and patients and can take months to resolve — all while the disease is progressing.

In 2018, the Alliance was troubled to hear of CMS’ recent decision to allow Medicare Advantage plans to institute step therapy for Part B drugs starting in 2019. The Administration proposed this significant change via a memo that has no formal commenting opportunity and leaves many implementation questions unanswered, including questions about how patient access will be protected.  The Alliance wrote to CMS Administrator Seema Verma, expressing its opposition to this policy change because of its lack of protections for vulnerable patients who need access to Part B medications.

The Alliance supports federal legislation to address this issue, including H.R. 2163 and S. 464,  the Safe Step Act.

• Issue Brief: Prior Auth and Step Therapy 2022

Medical Liability Reform

The Alliance supports comprehensive, meaningful medical liability reform that reduces growth in health care costs, stabilizes professional liability insurance premiums, preserves access to specialty care, and encourages physician engagement in meaningful quality improvement activities. We support legislation that will help achieve health system savings by reducing the incentives for defensive medicine and protect physicians from unaffordable liability premiums. Congress should enact medical liability reform based on the California or Texas models, which include reasonable limits on non‐economic damages. In addition to these health care cost savings, such reforms will also improve patient access to specialty care — particularly high-risk specialties.

• Issue Brief: Medical Liability Reform 2022

Off-Label Use

The Alliance of Specialty Medicine maintains that a specialty physician may prescribe or administer any legally marketed product for an off-label use within the authorized practice of medicine where the physician exercises appropriate medical judgment and it is in the best interests of the patient. If specialty physicians use a product for an indication not in the approved or cleared labeling, they have the responsibility: (1) to be well informed about the product; (2) to base its use on a firm scientific rationale and sound medical evidence; and (3) to maintain awareness of the product’s use and effects. Specialty physicians should appropriately counsel patients about the benefits and risks of the proposed treatment, and whether alternative treatments might be available. Specialty physicians are encouraged to notify the relevant agency or institution of adverse events related to the use of medical products. The following documents represent the Alliance’s position on the issue of off-label use:

• Physician-Directed Applications Position Statement
• FDA Public Hearing Testimony – Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

Network Adequacy

Patients face access to care barriers due to narrow health plan networks. Many times, unknown to patients, entire specialties are excluded from health plans or the number and mix of specialists and subspecialists are not adequate to meet the needs of the insured population. Networks should be sufficiently robust to ensure that an appropriate number of specialists and subspecialists per enrollee are available. Additionally, network directories should be updated in real-time and provide patients with clear, concise, and accurate information. Finally, decisions to remove a physician from the network without cause should not be made in the middle of a contract year. Congress and the Administration should ensure appropriate oversight to hold insurers accountable to ensure patients have timely access to the right care, in the right setting, by the most appropriate health care provider. The following documents represent the Alliance’s position on issues related to narrow networks:

• Alliance Survey Highlights 2017
• OpEd on Network Adequacy and Surprise Billing

Private Contracting

The current structure of Medicare restricts the ability of seniors to see the physician of their choice by limiting beneficiary access to all physicians. One way patients can overcome this hurdle is to “privately contract” for services directly with their physicians. Unfortunately, under current law, beneficiaries who wish to enter into these private contracts must pay for the service entirely out of their own pocket, despite having paid into Medicare for many years. Furthermore, if a physician has “opted out” of Medicare to contract privately — with even one patient — the physician is ineligible for Medicare reimbursement for two years. Congress should eliminate the two‐year Medicare exclusion for physicians who privately contract and allow patients who privately contract to recoup the amount Medicare would otherwise pay for the service. The following documents represent the Alliance’s position on the issue of private contracting:

• Letter in Support of the Medicare Patient Empowerment Act of 2019 (S.2812)

Fair Medicare Physician Reimbursement

Americans should have a range of coverage options whether they get their health care in the private market, through an exchange plan, or under the Medicaid or Medicare programs. The Alliance of Specialty Medicine urges Congress to maintain a viable fee-for-service (FFS) option in Part B, along with the Merit-based Incentive Payment System (MIPS) program and reject the Medicare Payment Advisory Commission’s (MedPAC) recommendation to replace MIPS with a program not relevant to specialists. Maintaining a viable fee-for-service option in Medicare Part B is necessary, as it is the most appropriate reimbursement structure for many specialists and will help to preserve patient access to the unique services offered by specialists. Furthermore, MIPS is the only meaningful and viable pathway for many specialists to engage in the Quality Payment Program established under MACRA.

The Alliance of Specialty Medicine also believes that the physician self-referral (a.k.a. “Stark”) law must be modernized, to permit physicians to participate and succeed with the intent behind the Medicare Access and CHIP Reauthorization Act (MACRA) – to collaborate within and across specialties to improve patient care, lower costs, and improve efficiencies within the health care system.

The following documents represent the Alliance’s position on the issue of fair Medicare physician reimbursement:

• Issue Brief: Physician Reimbursement 2022
• Issue Brief: MACRA 2022
• Testimony of Dr. Parag Parekh, “MACRA and MIPS: An Update on the Merit-based Incentive Payment System
• Testimony for the Record, Implementation of MACRA’s Physician Payment Policies