CMS Implementation Timeline


Affordable Care Act

  • People covered under the Affordable Care Act insurance plans will continue to save on their health insurance coverage during Open Enrollment for 2023 coverage.

Medicare Part B qualifying biosimilars

  • Starting Oct. 1, Medicare will temporarily pay an add-on fee of 8% instead of 6% for qualifying biosimilars.  This increase will encourage competition, lower costs for prescription drugs, and improve patient access to biosimilars.

Medicare Part D drug rebates

  • Oct. 1 is the start of the first 12-month period for which drug manufacturers will be required to pay rebates to Medicare if their prices for certain Part D drugs increase faster than the rate of inflation over the 12-month period.  The Part D inflation rebates for the 12-month periods beginning Oct. 1, 2022 and Oct. 1, 2023 must be invoiced by December 31, 2025.


CMS Press Release 10.18.22

CMS Final Rule Part B and others

October 28, 2022

Contact: CMS Media Relations
CMS Media Inquiries

Biden-Harris Administration Strengthens Medicare with Finalized Policies to Simplify Enrollment and Expand Access to Coverage

Final rule creates Special Enrollment Periods and reduces gaps in Medicare coverage, and improves administration of the Medicare Savings Programs.

Today, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare enrollment and eligibility rules to expand coverage for people with Medicare and advance health equity. The final rule, which implements changes made by the Consolidated Appropriations Act, 2021 (CAA), makes it easier for people to enroll in Medicare and eliminates delays in coverage. Among these changes, individuals will now have Medicare coverage the month immediately after their enrollment, thereby reducing any delays in coverage.  In addition, the rule expands access through Medicare special enrollment periods (SEPs) and allows certain eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty.

The Biden-Harris Administration has made expanding access to health care a top priority, and, under their leadership, more Americans than ever before have health insurance coverage. Today’s final rule builds on this success and supports additional Administration efforts to strengthen Medicare.

“The Biden-Harris Administration has made it clear: we are committed to doing all we can to strengthen Medicare,” said HHS Secretary Xavier Becerra. “Today, we’re making it easier to enroll, expanding access, and eliminating delays in coverage to improve Medicare for the millions of Americans who depend on it. We’re working tirelessly to deliver the health insurance and peace of mind that enrollees deserve.”

“CMS is committed to ensuring that people eligible for Medicare have timely access to this vital coverage,” said CMS Administrator Chiquita Brooks-LaSure. “For the first time, special enrollment periods will be available in traditional Medicare for individuals who were unable to enroll due to exceptional conditions, and individuals who have had a kidney transplant will now be able to receive extended Medicare coverage for immunosuppressive drugs.  Each part of this critical rule advances CMS’ strategic vision of expanding access to quality, affordable health coverage and care.”

A Special Enrollment Period (SEP) lets individuals make changes to their health coverage outside of a typical enrollment period. The SEPs finalized in this rule provide an opportunity for eligible individuals to enroll in Part B if they didn’t enroll in Medicare during their Initial Enrollment Period when they were first eligible, and to do so without a late enrollment penalty. Examples of new SEPs created by this rule are SEPs for eligible individuals who miss an enrollment opportunity because: 1) they were impacted by a disaster or government-declared emergency; 2) their employer or health plan materially misrepresented information related to timely enrollment in Medicare Part B; 3) they were incarcerated; and 4) their Medicaid coverage was terminated after the COVID-19 PHE ends or on or after January 1, 2023 (whichever is earlier).

The final rule also establishes a new immunosuppressive drug benefit that extends vital Medicare immunosuppressive drug coverage to certain individuals who have had a kidney transplant and otherwise would lose Medicare coverage. The changes finalized in this rule go into effect on January 1, 2023.

These changes not only implement important provisions of the Consolidated Appropriations Act, 2021 (CAA), but also support President Biden’s Executive Orders on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government and Continuing to Strengthen Americans’ Access to Affordable, Quality Health Coverage by eliminating confusing coverage waiting periods and allowing CMS and the Social Security Administration to remedy missed enrollment periods by permitting eligible individuals to enroll in Medicare Part B through SEPs for exceptional conditions. Furthermore, these changes support the Administration’s vision for CMS: to serve the public as a trusted partner and steward, dedicated to advancing health equity, expanding access to affordable coverage and care, and improving health outcomes.

“These changes highlight CMS’ efforts to advance health equity and improve access to Medicare,” said Dr. Meena Seshamani, Deputy Administrator of CMS and Director of the Center for Medicare. “Reducing gaps in coverage, allowing for special enrollment periods for individuals in exceptional circumstances, spending money in a smarter way on kidney transplant patients – these are meaningful changes that put people at the center of their care and improve the Medicare program.”

Finally, CMS is making several technical updates to improve administration of the Medicare Savings Programs. These programs help make Medicare affordable for those struggling to afford health care.

CMS encourages people who are approaching Medicare eligibility to research their Medicare coverage options and enrollment deadlines. and 1-800-MEDICARE are both available to help people understand their choices and associated deadlines. In addition, personalized health insurance counseling is available at no cost from State Health Insurance Assistance Programs (SHIPs). Visit or call 1-800-MEDICARE for each SHIP’s phone number.

Medicare Open Enrollment runs from October 15 to December 7, 2022. During this time, people eligible for Medicare can compare 2023 coverage options on provides clear, easy-to-use information, as well as an updated Medicare Plan Finder, to allow people to compare options for health and drug coverage, which may change from year to year.

Medicare Plan Finder was updated with the 2023 Medicare health and prescription drug plan information on October 1, 2022. 1-800-MEDICARE is also available 24 hours a day, seven days a week to provide help in English and Spanish as well as language support in over 200 languages. People who want to keep their current Medicare coverage do not need to re-enroll.

During Open Enrollment, people with Medicare who take insulin are encouraged to call 1-800-MEDICARE or contact their State Health Insurance Assistance Programs ( for help comparing plans and costs this year.

To view a fact sheet on the final rule, visit:

To view the final rule, visit:

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CMS Marketing Best Practices + Agent Broker Marketing FAQ

DEPARTMENT OF HEALTH & HUMAN SERVICES | Centers for Medicare & Medicaid Services | Center for Medicare
DATE: October 19, 2022
TO: All Medicare Advantage Organizations and Prescription Drug Plan Sponsors
FROM: Kathryn A. Coleman Director
SUBJECT: CMS Monitoring Activities and Best Practices during the Annual Election Period

The Centers for Medicare & Medicaid Services (CMS) issues this memorandum informing Medicare Advantage (MA) organizations and Part D sponsors of CMS monitoring activities and sharing plan and sponsor best practices during the 2023 Annual Election Period (AEP), running from October 15, 2022 to December 7, 2023.

CMS is concerned about the marketing practices of all entities, including Third-Party Marketing Organizations. We have reviewed thousands of complaints and hundreds of audio calls and have identified numerous issues with information provided to beneficiaries that is confusing, misleading and/or inaccurate. CMS has conducted so-called “secret shopping” by calling numbers associated with television advertisements, mailings, newspaper advertisements, and internet searches to monitor the experience beneficiaries have engaging these entities. Our secret shopping activities have discovered that some agents were not complying with current regulation and unduly pressuring beneficiaries, as well as failing to provide accurate or enough information to assist a beneficiary in making an informed enrollment decision.  READ THE FULL RELEASE: HPMS Marketing Practices Memo

Contract Year 2023 Medicare Advantage Marketing Policies – Frequently Asked Questions
On May 9, 2022, CMS published its contract year 2023 Medicare Advantage (MA) (Part C) and Prescription Drug Benefit (Part D) final rule (87 FR 27704), wherein CMS established certain marketing and communications requirements for the Part C and Part D programs. These rules were designed to address complaints of inappropriate marketing that CMS received from beneficiaries and their caregivers. In response to a significant increase in marketing-related complaints, CMS staff reviewed numerous recordings of calls from different marketing entities, including individual agents and brokers, as well as larger call centers. The agents failed to provide the beneficiary with the necessary information or provided inaccurate information to make an informed choice for more than 80 percent of the calls reviewed. Examples included beneficiaries being told that if their medication was not on the formulary, the doctor could tell the plan and the plan would simply add it; or incorrectly stating that “nothing would change” when beneficiaries asked if their current health coverage would stay the same.
As 2023 annual open enrollment begins, CMS has received questions regarding these changes, including , the requirement related to recording calls between beneficiaries and Third-Party Marketing Organizations (TPMOs) and the requirements related to the TPMO disclaimer.  READ THE FULL RELEASE: Agent Broker Marketing FAQs_10.19.2022

CMS Won’t Delay New MA Marketing Regs, Despite Broker Requests

By  Amy Lotven / September 21, 2022 at 11:22 AM

Sourced from Inside Health Policy


CMS confirms it has no plans to delay implementation of the 2023 Medicare Advantage and Part D final rule that cracks down on aggressive MA marketing tactics, despite calls to do so from health insurance agents and brokers who object to being included in the definition of a third-party marketing organization (TPMO).

As TPMOs, the brokers and insurance agents would be required to record – and retain – their enrollment calls if the proposed rule is finalized as written.

The National Association of Heath Underwriters (NAHU) have repeatedly asked CMS to either delay the rule or to carve agents from the definition of a TPMO.

From a public policy perspective, it makes no sense to discourage legitimate agents from participating in Medicare Advantage by sweeping them into an effort to curb bad actors, says NAHU Executive Director Janet Trautwein.

NAHU has warned that if CMS doesn’t delay or revise the rule, fewer agents and brokers would participate in Medicare’s forthcoming Annual Enrollment Period (AEP), which the group says would only worsen marketing problems.

Still CMS recently told NAHU that it would not make the changes to the rule that the lobby requested, Trautwein says.  A CMS spokesperson also told IHP that “CMS does not plan to delay implementation of the CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F).”

At issue are the allegedly aggressive marketing tactics used by TPMOs who make unsolicited sales calls to seniors to push Medicare Advantage plans. Trautwein explains that in contrast to agents and brokers who take time to discuss which plan is best for a Medicare beneficiary based on lifestyle, networks and formularies, TPMOs will often push products that might not be appropriate. The marketers also allegedly mislead consumers by telling them they’re calling from Medicare – or a well-known insurer – or use other tactics to lure seniors to enroll in coverage regardless of whether it’s a good fit.

The proliferation of those calls is a huge problem for licensed, certified agents and brokers, Trautwein recently told a panel of health insurance commissioners who have been looking into improper marketing of health plans.

NAHU members tell their clients to ask marketers for their license numbers, but the challenge has become almost insurmountable as many seniors fail to understand that the calls are not legitimate, she says.

CMS stepped up oversight of third-party marketing organizations in its proposed 2023 MA and Part D rule, noting that a significant amount of the 40,000 complaints received in 2021 were about TPMOs. As part of the rule, which was finalized in April, the agency tweaked the definition of a TPMO to include agents and brokers, meaning that NAHU members will also be required to adhere to the new requirements, including the proposed mandate to record all enrollment calls with clients.

NAHU says the requirements will be burdensome to some agents and brokers. Many NAHU members are small, one-person shops and cannot afford the HIPAA-compliant recording equipment needed to record and retain calls, she says. Some agents and brokers might choose not to participate in open enrollment due to the new requirements.

NAHU raised its concerns in comments on the proposed rule, in a separate letter to CMS in July and again in its response to CMS’ request for information on improving MA. 

AHIP also talked about the rule’s potential impact on brokers in its response to the RFI.

“While we appreciate CMS’ goals in protecting against confusing and potentially misleading activities, we have heard questions about the scope of the TPMO requirements and concerns that without further clarifications or modifications, those rules could expand costs and inhibit access to certain agents and brokers,” AHIP says. “We ask CMS to engage with stakeholders to discuss and address concerns related to the TPMO requirements and ensure beneficiaries are protected from inappropriate marketing activities.”

Other stakeholders asked CMS to strengthen oversight over aggressive marketers.

Trautwein says NAHU and CMS have had several discussions about the brokers’ worries, but the agency has refused to bend. 

In addition to declining the delay and the carve out, the agency said it would not offer enforcement relief to parties that attempt to follow the rule in good faith, Trautwein says.

NAHU had asked for guidance on several outstanding questions, including what a broker should do if a client does not want to be recorded. CMS says a broker or agent must terminate the call in those situations, according to Trautwein.

Another source tracking the issue also says some agents and brokers might not participate in MA due to the new rules, but suggests those who bow out might not sell many plans in the first place. The source also says there are reasonably priced options for the phone equipment needed to record and retain calls.

Trautwein also says that some marketing organizations are offering recording solutions to their member agents and brokers, but not all will have access. Brokers and agents also can ask clients to enroll in-person so the requirement would not apply.

She declined to speculate on how many agents and brokers might bow out of the AEP because of the rule, but she says NAHU will survey members once the enrollment period is over to get a better sense of how many agents/brokers opted out.

She says NAHU is still lobbying to get the rule delayed or agents carved out, and adds the group has sent thousands of messages to Capitol Hill about its concerns, but so far there’s been no legislative action.


Trautwein also brought her concerns about the proliferation of aggressive MA marketing, as well as what she views as the problems with CMS’ rule, to the National Association of Insurance Commissioners’ summer meeting in August. During a session of the NAIC’s recently established Improper Marketing Working Group, which was created to address the growing amount of misleading marketing in the individual market, Trautwein explained how agents and brokers selling MA plans have been overwhelmed by the marketing calls. She also raised concerns that CMS’ solution could drive legitimate players out of MA.

State insurance commissioners do not regulate MA marketing, but they are well aware of the problems since they often hear about it from residents or other enrollment assisters.

Congress gave authority over MA marketing to CMS as part of the Medicare Modernization Act. But in May, NAIC asked key lawmakers to consider returning jurisdiction to the states, which it says are better equipped to handle the oversight.

Meanwhile, Senate Finance Chair Ron Wyden (D-OR) in mid-August asked commissioners from 15 states to send information on annual changes in MA marketing complaints from 2019 through 2022, and examples of allegedly false or misleading marketing materials. Wyden asked the states if the marketers are targeting any particular populations like dual-eligible, Black or lower-income beneficiaries.

Responses were due on Friday (Sept. 16), but it’s unclear if they have been received. – Amy Lotven (

Important:  New CMS Review Time fo TV Commercials/Ads


IMPORTANT CHANGE: We have received notification via our carrier partner, Elevance Health/Anthem, that CMS has confirmed to them a change to the review process and timing for TV commercials/advertisments updated in HPMS on 9/16/22.

Verified by the Anthem Compliance Team (9/19/22), CMS stated: We have recently changed the review period for TV advertismenets to 20 days.  We are currently discussing communication strategies.

The new 20 Day Review will require an official review from CMS prior to use.  This differs from the previous submission type of 5 day File and Use, with no immediate review by CMS at time of filing.

As of Wednesday, 9/21, 10 days remain before AEP marketing can occur.  If you have TV commercials/advertisments you are planning to use and have not yet filed with CMS, please be aware of this change, as this can impact when your TV commercial / advertisement can be released.

 We will share additional details as they become available from CMS.


Please take a moment to review the definitions of generic communication and marketing, a subset of communications, that requires material submission for review and approval by CMS. Access the most recent version of our Agent Medicare Compliance Guide here for additional information.

Generic Marketing and Communications

We generally refer to advertising pieces – print, radio, tv, website, etc., as marketing however, CMS uses the terms ‘marketing’ and ‘communication’ to make a distinction  between generic advertising.  


Communications are all activities and materials used to provide information that is targeted to current and prospective enrollees, including their caregivers and other decision makers.  

Generic mailers and advertising materials you create to promote your business and generate leads fall under the definition of “communication” materials (given they are free of carrier names and specific plan informaiton, and do not list benefits, premiums, copays, and cost sharing).


Marketing is a subset of communications and is determined based on both the content and intent of activity or materials.

Marketing includes activities and materials with the intent to draw a beneficiary’s attention to a specific plan or plans and to influence a beneficiary’s decision-making process when selecting a plan for enrollment or deciding to stay enrolled in a plan (retention-based marketing). Additionally, marketing has content with information about the plan’s benefits, cost sharing, measuring, or ranking standards.

Materials that meet the definition of marketing will require submission to CMS through HPMS filing.  The term ‘marketing’ takes on new meaning when we talk compliance. The CMS definition is used to distinguish materials that require review and approval vs. materials that fall under the ‘communication’ definition, which can be used without CMS review/approval.



We’re here to help.  Call if you have questions (614-763-2255).  If you have marketing materials that require filing with CMS for approval or have marketing or communication materials you want reviewed for compliance, please send them via email to:

CMS 2023 Agent Broker Compensation Guidelines

CMS has released the 2023 Agent Broker Compensation Guidelines that govern the maximum allowable first year and renewal compensation for agent level MA and PDP commissions. There is a significant increase in compensation for 2023.



These new rates reflect, roughly, a 4.9% increase in both initial and renewal compensation for MA and Cost Plans. Puerto Rico and the US Virgin Islands have an increase closer to 4.3%.  For PDPs, there is a 5.7% bump on initial and 4.5% bump on renewal commissions.  CMS also reaffirmed the standard referral fee limitations for MA/PDP plans at $100/$25, respectively.


Plan sponsors were reminded that compensation schedules must be submitted by 11:59 pm ET, July 20, 2022.


CMS also reminded plan sponsors of their obligation to ensure agents and brokers selling Medicare products are trained annually on Medicare A, B, C, and D, as well as on plan-specific information.  CMS annually publishes the testing and training requirements, including a sample test each year for guidance.


If you have questions about what these compensation changes mean for you, please reach out to your team at Cornerstone Senior Marketing.

CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F)

CMS FACT SHEET: CMS is issuing a final rule that advances CMS’ strategic vision of expanding access to affordable health care and improving health equity in Medicare Advantage (MA) and Part D through lower out-of-pocket prescription drug costs and improved consumer protections.
An increasing number of Medicare beneficiaries receive services through MA and Part D plans. Over 27 million beneficiaries are enrolled in MA plans (including plans that offer Part D prescription drug coverage), and approximately 24 million beneficiaries are enrolled in standalone Part D plans. Additionally, an increasing number of beneficiaries who are dually eligible for both Medicare and Medicaid are enrolled in MA plans, Medicaid managed care, or both. About 4.1 million dually eligible beneficiaries currently receive their Medicare services through MA dual eligible special needs plans (D-SNPs).
The final rule revises the MA and Part D regulations related to marketing and communications; the criteria used to review applications for new or expanded MA and Part D plans, including compliance with MA provider network adequacy requirements; quality ratings for MA and Part D plans; medical loss ratio reporting; special requirements during disasters or public emergencies; how MA organizations calculate attainment of the maximum out-of-pocket (MOOP) limit for Parts A and B services; and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This final rule also revises regulations for D-SNPs, and in some cases, other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many finalized policies are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.

CMS Marketing Changes

The marketing guidelines for Medicare Advantage and Prescription Drug Plans were updated on May 9, 2022. Among the provisions that apply directly to agents, the two most critical, which are to be in use by October 1, 2022, for Plan Year 2023, are a new required disclaimer and a requirement to record all sales calls with beneficiaries. While not comprehensive, the FAQ’s below will provide details. 

Required Disclaimer 

Disclaimer Language To Use:

“We do not offer every plan available in your area. Any information we provide is limited to those plans we do offer in your area. Please contact or 1-800-MEDICARE to get information on all of your options.” 

Who must use this disclaimer?

Any third-party marketing organization (which includes agents and brokers) must include this disclaimer. 

When and where do I have to have the disclaimer?

  • On all marketing materials: print (if possible, use a 12pt font), electronically, television, and radio
  • Within the first minute of all sales calls
  • Prominently displayed on TPMO websites
  • Verbally, electronically, or in writing, during any sales meeting with a beneficiary

What if I DO offer all plans in my area? 

While the regulation does provide a carve-out for TPMO’s that truly offer all plans in their area, it is exceedingly rare for an agent to truly be able to do this. In most areas, there are one or more plans that are offered only through captive agents, direct to consumer, or certain types of plans that agents and brokers cannot sell. Even if you do offer all plans in one county or service area, it is possible your marketing or referrals may extend to an area where that is not true, so the disclaimer would still be required. 

Requirement to Record Sales Calls

Under these new guidelines, all sales calls with beneficiaries and TPMO’s MUST be recorded and retained for 10 years, including enrollment calls. 

What constitutes a sales call? 

Any call that is related to what CMS calls the “chain of enrollment,” which has been defined as the events from a beneficiary becoming aware of an MA/PDP plan to the end of the enrollment process. This means that calling leads, scheduling appointments, collecting scopes of appointment (telephonically), presenting plans, collecting drug and doctor lists, and phone enrollments would all fall under this guidance. This list is not exhaustive, and other calls that contain marketing content will also need to be recorded and retained. 

How can I record and store calls? 

We recommend reaching out to your current phone provider to see if they offer call recording. If they do not, or it seems cost prohibitive, consider a VOIP phone system that can be used in the office or the field. Some common options are Ring Central, 8×8, and Vonage. For storage, you will need to develop a process for sorting and storing the calls either on a local drive or cloud-based storage. Since these calls contain sensitive data, most free storage accounts will not be HIPAA compliant. We are currently researching the best options for agents to compliantly store this data. 

What about in person appointments? 

In-person marketing and sales appointments do not need to be recorded, however, calls to set appointments or follow-up calls to answer benefit questions would require recording. Servicing questions about current plan business, such as claims, billing, and requesting in force plan documents, are not sales calls and would not require recording. 

I use my cell phone. How can I handle this? 

Most VOIP services have a mobile app version that would allow calls to be recorded from your mobile device. There are also recording apps that would allow for recording calls without VOIP. Be cautioned, however, as a stand-alone recording app will not include any disclaimers that may be required by your jurisdiction before recording, whereas most VOIP systems offer/include these options.

Please reach out with any questions to your team at Cornerstone Senior Marketing.  (614) 763-2255 |  compliance@cornerstoneseniormarketing.comquirement to Record Sales Calls

Medicare weighs premium cut after limiting Alzheimer’s drug

File – The Biogen Inc., headquarters, Wednesday, March 11, 2020, in Cambridge, Mass. Medicare says it’s considering a cut in enrollee premiums, after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs. (AP Photo/Steven Senne, File) (ASSOCIATED PRESS)


Thu, April 7, 2022

WASHINGTON (AP) — Medicare said Thursday it’s considering a cut in enrollee premiums, after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.

The agency “is looking at that, and is still going through the process,” spokeswoman Beth Lynk said of a potential reduction in premiums, as Medicare announced its final coverage decision for Aduhelm, a drug whose benefits have been widely questioned in the medical community.

Officials said Medicare will keep coverage restrictions imposed earlier on the $28,000-a-year medication, paying for Aduhelm only when it’s used in clinical trials approved by the Food and Drug Administration or the National Institutes of Health.

The projected cost of Aduhelm was a major driver behind a $22 increase in Medicare’s Part B premium this year, boosting it to $170.10 a month. That price hike is already being paid by more than 56 million Medicare recipients signed up for the program’s outpatient coverage benefit. Lawmakers have called for a rollback and Health and Human Services Secretary Xavier Becerra already directed Medicare to reassess.

Thursday’s coverage decision illustrates the impact that a single medication can have on the budgets of individuals and taxpayers. It comes as legislation to authorize Medicare to negotiate prescription drug prices remains stuck in the Senate, part of President Joe Biden’s stalled social and climate agenda.

That’s left Democrats with nothing to show on their midterm election-year promises to cut prescription drug costs, unless they can overcome internal disagreements. Most Medicare recipients have their premiums deducted from their monthly Social Security checks. And despite a big cost-of-living increase, they’re feeling the bite of inflation.

Medicare’s determination on Aduhelm included an important caveat. Officials said that if it or any other similar drug in its class were to receive what’s called “traditional” FDA approval, then Medicare would open up broader coverage for patients. Such approval is granted when a medication shows a clear clinical benefit.

That was not the case with Aduhelm. It received what’s known as “accelerated” approval last year because of its potential promise. But manufacturer Biogen is required to conduct a follow-up study to definitively answer whether Aduhelm truly slows the progression of Alzheimer’s. If that study is successful, FDA would grant full approval.

That would also open up Medicare coverage.

Dr. Lee Fleisher, chief medical officer of the Centers for Medicare & Medicaid Services, said “there will be quick access for Medicare beneficiaries” for Alzheimer’s drugs that receive the traditional FDA approval, after demonstrating a clear benefit.

Aduhelm hit the market as the first new Alzheimer’s medication in nearly two decades. Initially priced at $56,000 a year, it was expected to quickly become a blockbuster drug, generating billions for Cambridge, Mass.-based Biogen.

But although the company slashed the price in half — to $28,000 a year — Aduhelm’s rollout has been disastrous.

Pushback from politicians, physicians and insurers left the company with just $3 million in sales from Aduhelm last year. Doctors have been hesitant to prescribe it, given weak evidence that the drug slows the progression of Alzheimer’s. Insurers have blocked or restricted coverage over the drug’s high price tag and uncertain benefit.

The CMS decision means that for Medicare to pay, patients taking Aduhelm will have to be part of clinical trials to assess the drug’s safety and effectiveness in slowing the progression of early-stage dementia.

Tamara Syrek Jensen, head of CMS’s coverage and analysis unit, said “it’s status quo” as far as limitations the agency initially imposed on Aduhelm in January.

The limits stayed on despite a massive lobbying push by the Alzheimer’s Association to change Medicare’s position, including outreach to members of Congress, online advertising and social media campaigns directed at the agency.

The association, the largest group of its kind, has received contributions from drugmakers, including Biogen.

The group’s CEO said he was “very disappointed” after reviewing Medicare’s decision.

“Denying access to FDA-approved Alzheimer’s treatments is wrong,” Harry Johns said in a statement. “At no time in history has CMS imposed such drastic barriers to access FDA-approved treatments for people facing a fatal disease.”

Aduhelm has sparked controversy since the FDA approved it against the recommendation of outside advisers.

The medicine, administered intravenously in a doctor’s office, hasn’t been shown to reverse or significantly slow Alzheimer’s. But the FDA said its ability to reduce clumps of plaque in the brain is likely to slow dementia.

Many experts say there is little evidence to support that claim. And a federal watchdog and congressional investigators are conducting separate probes into how the FDA reviewed the medication.

Alzheimer’s is a progressive neurological disease with no known cure. The vast majority of U.S. patients are old enough to qualify for Medicare, which covers more than 60 million people, including those 65 and older, and disabled people under 65.

The reason Aduhelm falls under Medicare’s outpatient benefit, and not its pharmacy drug program, is that it’s given in a doctor’s office. Beneficiary premiums are set to cover about 25% of the cost of outpatient care.


CMS ALERT February 3, 2022

Biden-Harris Administration Will Cover Free Over-the-Counter COVID-19 Tests Through Medicare

CMS News Alert – February 3, 2022 

CMS Developing Initiative to Enable Access to Eight Free Over-the-Counter COVID-19 Tests for Medicare Beneficiaries in Early Spring

As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in either Original Medicare or Medicare Advantage will be able to get over the-counter COVID-19 tests at no cost starting in early spring. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).

This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries. There are a number of issues that have made it difficult to cover and pay for over the-counter COVID-19 tests. However, given the importance of expanding access to testing, CMS has identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries. This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. CMS anticipates that this option will be available to people with Medicare in the early spring.


Until then, people with Medicare can access free tests through a number of channels established by the Biden-Harris Administration. Medicare beneficiaries can:

  • Request four free over-the-counter tests for home delivery at
  • Access COVID-19 tests through healthcare providers at over 20,000 free testing sites nationwide. A list of community-based testing sites can be found here.
  • Access lab-based PCR tests and antigen tests performed by a laboratory when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional at no cost. In addition to accessing a COVID-19 lab test ordered by a health care professional, people with Medicare can also already access one lab-performed test without an order, also without cost sharing, during the public health emergency.

In addition:

  • Medicare Advantage plans may offer coverage and payment for over-the-counter COVID-19 tests as a supplemental benefit in addition to covering Medicare Part A and Part B benefits, so Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit.
  • All Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

For more information, please see these Frequently Asked Questions,