June 2, 2021
CMS Adds Administrator, Hits Pause on MCIT
The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is critical for the device industry. However, the agency has also suspended for a second time the Medicare Coverage of Innovative Technology (MCIT) final rule, a development that may not be the last word on this policy.
Brooks-LaSure’s appointment to the CMS post was the result of a May 25 Senate vote that affirmed the Biden administration’s pick with a 55-44 margin, which included five cross-over votes from the Republican Party. In addition to the MCIT question, she faces the prospect of legislation that would put the agency in the crosshairs of a drug pricing debate that is fiercely opposed by industry, but which is the subject of bipartisan support on Capitol Hill.
Brooks-LaSure was a member of the House Ways and Means Committee staff that undertook the drafting of the Affordable Care Act, as well as the 2008 Medicare Improvement for Patients and Providers Act (MIPPA). She takes the CMS position after serving as the director of the health policy practice at Manatt, Phelps & Philips LLC, but her administration might be more relevant to manufacturers of prescription drugs than devices, not just because of the drug pricing debate, but also because of the November 2020 prescription drug rebate rule.
MCIT Rule On Hold Through December
The month of May also saw the second suspension of the MCIT rule, which in this instance is in force through mid-December. This second suspension followed a second comment period during which the agency received hundreds of comments, including from a number of physicians who advocated on behalf of their patients that the rule be reinstated.
The MCIT rule drew support from a wide range of business interests, such as the National Venture Capital Association, which said the rule would pique the interest of investors to the benefit of patients. Former deputy FDA commissioner Anand Shah also lent the rule his support in a May 6 op-ed in which Shah said that Medicare coverage often lags significantly behind FDA approval, including for breakthrough devices. He said many private plans are more apt to cover these advanced technologies, and thus patients may find they have aged out of the ability to access these technologies upon entry into the Medicare program.
One of the hurdles faced by the MCIT rule was the difficulty of redefining the phrase “reasonable and necessary,” which some stakeholders had argued was too ambitious an undertaking. America’s Health Insurance Plans made that and other arguments about the MCIT rule, stating that existing Medicare coverage mechanisms could be refined so as to reduce barriers to access. AHIP also echoed the CMS argument that the initial rule failed to properly appreciate the number of breakthrough devices that would be eligible for the MCIT program.
AHIP criticized the proposed redefinition of reasonable and necessary because any reliance on policies adopted by private payers suggests a reliance on policies that might reflect nothing more than regional variations in the practice of medicine. Another point is that state insurance law may leave private payers with no leeway to not cover a device or service because state law might dictate coverage, even in the absence of compelling clinical evidence.
The concept underlying the MCIT program is not necessarily without congressional support, however, thanks to the legislation that builds on the 21st Century Cures Act. Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) provided a concept paper for Cures 2.0, which includes a number of provisions that take up the question of coverage for novel medical technologies. Even more encouraging for industry was DeGette’s statement earlier this year that Cures 2.0 could be introduced to the House in the first half of 2021.
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