Part B Threats

The Medicare Part B program faces threats on a multitude of fronts. From mandatory, far-reaching Center for Medicare & Medicaid Innovation (CMMI) demonstrations, to new guidance that could add additional barriers to care; all of these changes stand to dramatically impact patients’ access to the treatment covered by the Part B program. Learn more below:

Build Back Better Act

On November 19, 2021, the House of Representatives passed the Build Back Better Act, H.R. 5376. The ASP Coalition is deeply concerned that certain drug price setting provisions in the bill affecting Medicare Part B covered drugs will harm beneficiaries with cancer and other serious and complex illnesses, such as rheumatologic, autoimmune, and inflammatory conditions. The legislation requires the Secretary of Health and Human Services to negotiate with drug manufacturers to establish a “maximum fair price” for certain Medicare Part B covered drugs. The bill then ties the government negotiation process to Medicare Part B provider payments – putting physicians and patients in the middle. The legislation would dramatically cut reimbursement to physicians and hospitals, limiting Medicare Part B reimbursement to providers to 106% of the negotiated maximum fair price. These drug pricing provisions in the Build Back Better Act will have a dramatically negative impact on the ability of physicians and other providers to continue to operate and provide essential, often life-saving, Medicare Part B treatments to our patients, severely threatening patient access to care.

The bill could also create incentives for future health care consolidation, which limits choices for beneficiaries and ultimately increases health care costs. We are particularly concerned about the impact of the bill on beneficiaries living in rural areas, who already face barriers to care that impact their health. Furthermore, we are troubled that the drug price setting policies in the Build Back Better Act will create disincentives for biosimilars, which are necessary to offer patients lower cost alternatives. The legislation could harm biosimilar development and follow-on research activities, which lead to additional indications, creating new treatments for patients with serious illnesses who face limited options.

International Pricing Index
On October 25, 2018, the Trump Administration’s Department of Health and Human Services (HHS) proposed major reforms to the Medicare Part B Program. The Administration is looking to implement dramatic changes through a mandatory, far-reaching CMMI demonstration that is essentially a coverage experiment.
One component of this proposed demonstration is the institution of a new International Pricing Index (IPI), which would use the reimbursement rates from foreign countries to set payments in Medicare Part B. Linking our health care policy to other countries who artificially suppress prices through access restrictions and arbitrary controls, does not put patients’ health at the forefront. Instead, this model would tie the hands of providers by narrowing available treatments thanks to market forces outside of the United States’ control. If implemented, patients could face significant new barriers accessing the care they have come to rely on through Medicare Part B, including access to new, innovative therapies.

Competitive Acquisition Programs/Middlemen
Another provision of the proposed CMMI demonstration is the introduction of new middlemen into the Part B program. Competitive Acquisition Program (CAP) vendors would add another layer of bureaucracy between patients and treatment. Patients reliant on Part B treatments often work with their physician to find the drug or drugs that address the nuances of their condition.
Adding middlemen into the negotiations and distribution of medications will create new administrative barriers that may cause harmful delays in treatment. Moreover, the introduction of a third party into the once private and direct patient-doctor relationship may reduce physicians’ flexibility in treating serious chronic illnesses and even preempt the decisions of doctors who understand their patients’ needs best.

Changing Provider Reimbursements
The final component of the CMMI demonstration is significant cuts to payments for providers. Medicare Part B helps provide treatment to some of the most vulnerable populations in our health care system. Dramatically reducing payments may push doctors to limit treatment options, restricting their ability to fight chronic illnesses in the process.
Additionally, cuts to provider payments disproportionally affect small and rural community providers, which may accelerate the already troubling trend of practice closures and mergers, particularly for community health care centers. Fewer practices and fewer treatment options ultimately translate to less choice and individualized care for patients in need of critical treatment. This would particularly affect patients in rural areas who already have limited facility options and restricted access to comprehensive care.

Step Therapy
The Trump Administration implemented a policy to allow Medicare Advantage (MA) plans to implement step therapy for Part B drugs. Step therapy policies, sometimes called “fail-first policies” force patients into a one-size-fits-all model of care that prioritizes potential cost saving over individualized treatment and patient health outcomes. By hindering patients’ access to the most innovative, potentially effective treatment options, this policy may exacerbate health care spending as patients’ conditions continue to be improperly managed through these extra bureaucratic steps. These policies can also add extra administrative burden for providers, taking away critical time they could be spending with patients. They also interfere with the provider-patient relationship by allowing insurance plans to decide which medicine a patient should take first, instead of their provider. Often what drugs are or will be affected by these polices aren’t published, causing needless confusion for both patients and providers.

Moving Medicare Part B Medications to Medicare Part D
In May 2018, the Trump Administration proposed transitioning certain Medicare Part B drugs into the Medicare Part D program. Despite both Part B and Part D falling under the Medicare umbrella, payments, cost-sharing, and reimbursement differ. Arbitrarily shifting Part B medications to Part D may result in additional access issues if these payment considerations are not taken into account. Such a move could potentially increase patients’ out-of-pocket costs, disrupting ongoing treatments and potentially putting once affordable, effective care out-of-reach.
Furthermore, many of the medications covered by Medicare Part B are treatments administered by health care providers, due to their complexities and the need for precision. Moving the administration of these drugs under Part D, means treatments would be provided at local pharmacies and the patients could be largely responsible for the storage and transportation of these medicines. This could open the door to disastrous outcomes as these specialized treatments will not be overseen by the patient’s usual care provider, drugs may not be properly handled, and providers may lose the ability to make on-the-spot dosing decisions based on a patient’s clinical response.