Legislation in Pennsylvania
Pennsylvania is now prepared to dispense interchangeable biologics, although the FDA has not deemed any biosimilar to be interchangeable. With the passage of SB 514, a Pennsylvania pharmacist will now be able to dispense a cheaper biologic that the FDA has deemed “interchangeable.” If this substitution is made, Pennsylvania law will require the pharmacist to notify the prescriber that a substitution has occurred. ACR policy states that if a biosimilar is substituted, notification should be given prior to substitution or within 24 hours.
SB 514 is actually a win for providers and patients across the country. The national trend for notification for these laws is 5 business days. SB 514 was amended with support from the Pennsylvania Pharmacy Association to have notification "within a reasonable amount of time." This language was not further defined and many stakeholders were concerned that prescriber notification would not occur in appropriate amount of time. The Pennsylvania Medical Society and other stakeholders were able to successfully amend SB 514 to require 72 hour notification.
Pennsylvania’s victory on notification language has national significance. If SB 514 passed without reasonable notification time, it would reverse the trend for provider notification. Because this is one of the most recent biosimilar substitution bills to be signed into law, other states notification period will trend toward ACR policy.
Substitution of Interchangeable Biologics
Biosimilar legislation was a major issue in many states. Letters on pending legislation
were sent to multiple states. Legislation passed in the following states:
ACR policy states that if a biosimilar is substituted, notification should be given prior to substitution or within 24 hours.
Step Therapy/Step Edits
Step therapy initiatives made progress this year allowing patients bypass already failed therapies. In addition, these laws also allow a provider to shorten the length of a step. The following states have signed step therapy into law:
ACR policy does not support step therapy and care directed by insurance formularies. ACR supports care that is patient specific and policy that allows providers to determine best course of care.
Prior Authorization Reform
Pennsylvania Update- HB 1657 has been introduced to reform the prior authorization process in Pennsylvania.
National Update- Prior authorization legislation was successful in the states of Delaware, Florida, and Ohio so far these bills were crafted from AMA model language and would require insurers:
ACR policy seeks to reduce the administrative burdens of Prior Authorizations and supports simplifying PAs to increase patients’ access to care.
ACR has been working with the American Medical Association to strengthen their model legislation. Prior Authorization will likely be a key focus for state medical societies and specialty organizations in 2017. ACR is participating in an ongoing workgroup with the AMA and 40 other stakeholders to discuss best practices for Prior Authorization reform.
Specialty Tier Medication Reform
Limiting the costs of specialty tier medications is still a priority for the ACR and its coalition partners but this policy is met with strong opposition in all legislatures.
ACR policy supports limiting the cost of coinsurance and believes access to biologics should be affordable to plans and patients.
ACR in the states:
Staff worked with collaborative initiatives on step therapy, specialty tier and prior
Authorization with advocacy partners including the Arthritis Foundation, National
Psoriasis Foundation and Lupus and Allied Diseases Association.
The Affiliate Society Council has increased its membership to 35 states with Nevada joining. Five additional states are on track to join the ASC by the ACR’s annual meeting in November which will raise the total number to 40 states.
Staff continues to provide updates and support to state societies including attending meetings in seven states since January. It is anticipated that fifteen states will be covered in 2016. In addition, staff has been helping state societies promote their annual meetings by emailing ACR/ARHP members in their respective states.
State societies continue to engage in ACR issues including providing comments on AMA
Resolutions and federal call to action initiatives.
Other legislation monitored:
States with Biosimilar legislation filed:
States with Step Therapy legislation filed:
States with Prior Authorization legislation filed:
States with Specialty Tiers legislation filed:
SB 514 is actually a win for providers and patients across the country. The national trend for notification for these laws is 5 business days. SB 514 was amended with support from the Pennsylvania Pharmacy Association to have notification "within a reasonable amount of time." This language was not further defined and many stakeholders were concerned that prescriber notification would not occur in appropriate amount of time. The Pennsylvania Medical Society and other stakeholders were able to successfully amend SB 514 to require 72 hour notification.
Pennsylvania’s victory on notification language has national significance. If SB 514 passed without reasonable notification time, it would reverse the trend for provider notification. Because this is one of the most recent biosimilar substitution bills to be signed into law, other states notification period will trend toward ACR policy.
Substitution of Interchangeable Biologics
Biosimilar legislation was a major issue in many states. Letters on pending legislation
were sent to multiple states. Legislation passed in the following states:
- Arizona – notification within 5 business days.
- Hawaii – notification within 5 business days.
- Idaho – notification within 5 business days.
- Kentucky – notification within 5 business days.
- Oregon – notification within 5 calendar days.
- Pennsylvania –Notification within 72 hours.
ACR policy states that if a biosimilar is substituted, notification should be given prior to substitution or within 24 hours.
Step Therapy/Step Edits
Step therapy initiatives made progress this year allowing patients bypass already failed therapies. In addition, these laws also allow a provider to shorten the length of a step. The following states have signed step therapy into law:
- Indiana
- West Virginia
ACR policy does not support step therapy and care directed by insurance formularies. ACR supports care that is patient specific and policy that allows providers to determine best course of care.
Prior Authorization Reform
Pennsylvania Update- HB 1657 has been introduced to reform the prior authorization process in Pennsylvania.
National Update- Prior authorization legislation was successful in the states of Delaware, Florida, and Ohio so far these bills were crafted from AMA model language and would require insurers:
- To have a web-based system to receive PA requests.
- To disclose all PA rules to providers.
- Enrollees of the health plan must receive basic information about which drugs and services will require prior authorization.
- Have faster timeframes for prior authorization decisions for urgent/non-urgent situations.
- To allow a provider to request a “retrospective review” for unanticipated procedures those were performed during an authorized procedure, with some limitations.
- Place a prohibition on retroactive denials regarding coverage or medical necessity, as long as the procedure was performed within 60 days of receiving an authorization.
ACR policy seeks to reduce the administrative burdens of Prior Authorizations and supports simplifying PAs to increase patients’ access to care.
ACR has been working with the American Medical Association to strengthen their model legislation. Prior Authorization will likely be a key focus for state medical societies and specialty organizations in 2017. ACR is participating in an ongoing workgroup with the AMA and 40 other stakeholders to discuss best practices for Prior Authorization reform.
Specialty Tier Medication Reform
Limiting the costs of specialty tier medications is still a priority for the ACR and its coalition partners but this policy is met with strong opposition in all legislatures.
ACR policy supports limiting the cost of coinsurance and believes access to biologics should be affordable to plans and patients.
ACR in the states:
Staff worked with collaborative initiatives on step therapy, specialty tier and prior
Authorization with advocacy partners including the Arthritis Foundation, National
Psoriasis Foundation and Lupus and Allied Diseases Association.
The Affiliate Society Council has increased its membership to 35 states with Nevada joining. Five additional states are on track to join the ASC by the ACR’s annual meeting in November which will raise the total number to 40 states.
Staff continues to provide updates and support to state societies including attending meetings in seven states since January. It is anticipated that fifteen states will be covered in 2016. In addition, staff has been helping state societies promote their annual meetings by emailing ACR/ARHP members in their respective states.
State societies continue to engage in ACR issues including providing comments on AMA
Resolutions and federal call to action initiatives.
Other legislation monitored:
States with Biosimilar legislation filed:
- Connecticut: SB 313 - notification within 5 business days.
- Michigan: HB 4812 - notification not required.
- Missouri: HB 1366/SB 875 - notification within 5 business days.
- Nebraska: LB 979 - notification within 5 business days.
- New York: S06311/A08648 - notification within 5 business days.
- Ohio: HB 505 - notification within 5 business days.
- Pennsylvania: SB 514 - "within a reasonable amount of time."
- Rhode Island: H7816 - notification within 5 business days.
States with Step Therapy legislation filed:
- Illinois: HB 3549
- Missouri: HB2029 (awaiting governor signature)
- New York: AB: 2834C/S3419B (awaiting signature)
- North Carolina: HB 1048
- Ohio: SB 243
States with Prior Authorization legislation filed:
- Minnesota: HF 1060/SF 934
- West Virginia: SB 273
States with Specialty Tiers legislation filed:
- DC: B21 32
- Georgia: HB 875
- Illinois: HB 3605
- New York: AB 4273
- Washington: HB 2871
