February 27, 2025
4 min learn
Prior authorization reforms, elevated biosimilar entry and the way forward for the Medicare drug value negotiation program are among the many American Faculty of Rheumatology’s prime considerations in a letter not too long ago submitted to CMS.
The advocacy letter was submitted on Jan. 27 in response to proposed rule adjustments to Medicare Benefit and Half D for 2026.
“We imagine most of the provisions within the proposed rule are nicely in step with our advocacy efforts,” the letter said.
A ‘first step’ in prior authorization reform
Among the many prior authorization rule adjustments, CMS has proposed that, as soon as authorised, prior authorizations can’t be reopened throughout an inpatient keep. The principles would additionally require plans to offer detailed explanations of their protection denials and notify of the suitable to attraction.
The time period “inner protection standards” was additionally particularly outlined and clarified to assist guarantee protection choices are clear and evidence-based in circumstances when Medicare protection insurance policies are inadequate, in response to the letter.
The brand new guidelines ought to lead to improved entry to care that advantages sufferers and suppliers alike, Christopher Phillips, MD, chair of the ACR’s Committee on Rheumatologic Care, informed Healio.
“Streamlining and simplifying entry to care is a win for sufferers and suppliers, particularly small suppliers,” he stated. “Reforming the prior authorization course of for Medicare Benefit plans is a optimistic first step, because it helps to reduce delays in affected person care and alleviate administrative burden. In the end, the ACR helps insurance policies that empower care choices made between medical doctors and their sufferers, not insurers.”
Nonetheless, the ACR steered prior authorization delays may very well be additional mitigated with mandated real-time decision-making for emergencies, sturdy enforcement of the brand new necessities, and common publication of information on appeals and overturns.
‘Underwater’ biosimilars
The proposed guidelines additionally embrace an emphasis on the significance of lower-cost medicine, equivalent to generics and biosimilars, being accessible on insurance coverage plan formularies to make sure a “cost-effective drug utilization administration program.” CMS acknowledged that pharmacy profit managers typically favor costlier medicine over extra inexpensive however equally efficient choices, leading to increased out-of-pocket prices for sufferers.
“We all know that record costs rise to permit for increased rebates, which create income for pharmacy profit managers and assist decide which medicine make it on their formulary, however these excessive record costs additionally make drugs prohibitively costly for sufferers,” Phillips stated. “It’s unfair that sufferers are caught in the course of these competing incentives, and it’s our hope {that a} evaluation of the Half D formulary and utilization administration practices will assist enhance entry to equally efficient however extra inexpensive biosimilar therapy choices.”
In its letter, ACR additionally referred to as for CMS and Congress to handle the issue of “underwater biosimilars” in Medicare Half B. Practices can turn out to be “underwater” on a biosimilar when they’re reimbursed for lower than its acquisition value attributable to rebates between producers and pharmacy profit managers driving down the common gross sales value, in response to ACR.
The group steered an modification to the Social Safety Act that will enable using “wholesale acquisition value + 3% to reimburse suppliers till [the average sales price] reaches sustainable ranges.”
An alternative choice favored by some, and first steered by MedPAC, can be to “consolidate billing codes in order that reference merchandise and their biosimilars are reimbursed on the identical fee, based mostly on the volume-weighted common gross sales value,” Amelia Bond, PhD, affiliate professor at Weill Cornell Medical Faculty, informed Healio.
Amelia Bond
“Apparently, this might exacerbate ‘underwater biosimilars,’” she stated. “In a few of my work, and work by my colleague at Dartmouth, Emma Dean, PhD, hospitals and practices want to inventory a restricted variety of molecule sorts — eg, a single biosimilar/reference product quite than all potential merchandise — and business formularies have sturdy affect on which biosimilars/reference merchandise are stocked. This might push practices towards extra white bagging or sending sufferers to costlier facility settings.”
Unsure future for drug value negotiation?
The ACR additionally put in a phrase of assist for the Inflation Discount Act handed below former President Joe Biden, calling for an total “strengthening” of the regulation’s well being care provisions, notably the Medicare Drug Worth Negotiation Program.
“The ACR additionally strongly encourages CMS to proceed strengthening the IRA, notably the Medicare Drug Worth Negotiation Program,” the letter said, including, “We care involved about the way forward for the Medicare Drug Worth Negotiation Program, notably as a result of advantages it has had for sufferers’ entry to rheumatologic remedies.”
Medicare cost cuts
In the meantime, in a separate press launch, the ACR praised a proposed bipartisan invoice that will offset the two.8% reduce to the Medicare doctor price schedule for 2025.
The Medicare Affected person Entry and Observe Stabilization Act, launched by Rep. Gregory Murphy (R-NC) and co-sponsored by 65 different Democrats and Republicans, would add 2% to doctor funds for companies rendered after April 1. The laws was launched on Jan. 31 and has been referred to the Power and Commerce and Methods and Means committees within the Home of Representatives.
“Elevated inflation coupled with chronically low Medicare reimbursement charges threatens affected person entry to care — particularly for rural and underserved populations,” ACR President Carol Langford, MD, MHS, stated within the launch. “If not addressed, the present cuts will destabilize the well being care system and make it tougher for rheumatologists to ship important take care of sufferers nationwide.
Carol Langford
“After years of successive cuts, it’s clear the Medicare cost system can’t perform successfully in its present state and physicians — like rheumatologists — and sufferers are those struggling probably the most,” she added. “We hope congressional management will work to swiftly go this necessary laws to safeguard our well being care system as quickly as potential.”
References:
American Faculty of Rheumatology commends laws to handle dangerous Medicare cost cuts to physicians. https://rheumatology.org/press-releases/american-college-of-rheumatology-commends-legislation-to-address-harmful-medicare-payment-cuts-to-physicians. Printed Jan. 31, 2025. Accessed Feb. 14, 2025.
Contract 12 months 2026 coverage and technical adjustments to the Medicare Benefit program, Medicare prescription drug profit program, Medicare value plan program, and packages of all-inclusive take care of the aged (CMS-4208-P). https://www.cms.gov/newsroom/fact-sheets/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription. Printed Nov. 26, 2024. Accessed Feb. 14, 2025.
