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Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.
Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.
The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.
The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.
The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.
CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”
Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.
Other changes in the rule eliminate requirements that sponsors eliminate plan offerings unless they “meaningfully differ” from one another, allowing plans to offer more choices to beneficiaries, and potentially more cost-saving options to meet their needs. It also clarifies rules regarding the “any willing provider” requirement to allow for more pharmacy options available to Part D enrollees and allow them to shop for best deals for their pharmaceuticals.
In combination with the final 2019 call letter that provides Medicare Advantage and Part D sponsors with the guidelines for submitting their plan designs for the coming coverage year, the rule also finalizes policies related to stemming the opioid crisis, including providing tools to help prevent opioid overprescribing and abuse. The rule implements provisions of the Comprehensive Addiction and Recovery Act of 2016 that require CMS to supply a framework that allows Part D sponsors to implement drug management programs to limit at-risk beneficiaries’ access to coverage for frequently abused drugs.
For example, plans will be allowed to limit at-risk beneficiaries to selected physicians and/or pharmacies to receive their prescriptions, although it will exempt patients who are being treated for cancer-related pain, are receiving palliative or end-of-life care, or are in hospice or long-term care from these drug management programs.
CMS also is limiting the availability of special enrollment periods for beneficiaries dually eligible for Medicare and Medicaid or eligible for the low-income subsidy who are identified as at-risk or potentially at-risk for prescription drug abuse.