ACA Now

Implementation Status

2012

Prior to January 2013, CMS issued informational program releases to states and drug manufacturers participating in the Medicaid drug rebate program, including Release No. 82 (which addresses the monthly AMP reporting requirement) and Release No. 83 (on the amended FUL provision and the AMP smoothing process).  To view these CMS releases, which are available in zipped files, please visit here and click on the applicable years.

Also, CMS in early 2012 issued a proposed rule regarding this section’s provisions. CMS has yet to finalize the rule; however, per the OMB/OIRA website, final action on the rule is “targeted” for August 2013.

Note also that in the fall of 2012, the OIG examined in a report the extent of states’ collection of rebates for drugs paid through Medicaid MCOs pursuant to the ACA requirements (per section 2501 of the ACA, though there are some parallel implications to this provision in the report).  To view the most up-to-date information on the draft monthly AMP-based FUL files (including the three-month rolling average FULs) and the updated draft Methodology and Data Elements Guide, view CMS’ webpage that contains a consolidated listing.

2013

On May 2, CMS issued Release #86, which pertains to reporting Average Manufacturer Price (AMP) units. See here under the “2013 Drug Manufacturer Release #86 [ZIP]” file.

On July 23, 2013, HHS posted its updated semiannual regulatory agenda.  Per the updated agenda, consistent with the ACA requirements (at sections 2501, 2503, and 3301, as well as section 1206 of the reconciliation “side car”), CMS tentatively anticipates issuing a final rule on Medicaid reimbursement of outpatient drugs (CMS-2345-F) in January 2014.   Per the agenda listing, “this final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs…[and] also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.”

In a related event, on July 18, CMS announced that updates had been made to the CMS webpage housing Medicaid drug programs data to reflect, among other data, certain drug rebate program information for Medicaid Managed Care Organizations (MCOs).  See here.

Also, in a related event, on July 22, CMS announced via a provider listserv message that, effective as of July 1, 2013, Part I of the nationwide retail pharmacy survey (under which the subsequent National Average Retail Prices (NARP) file is produced and which provides information about consumer purchase prices) has been suspended due to “pending funding decisions.”  Details posted here.

On Aug. 30, the OIG released a report titled “Medicaid Drug Pricing in State Maximum Allowable Cost Programs.” States may use  MAC programs in lieu of Federal upper limit (FUL) rates in setting prescription drug prices. Pursuant to the OIG’s analysis, it recommended that CMS finalize implementation of post-ACA FUL rates and that the agency encourage states to examine their MAC programs to identify areas of additional cost savings.

On Oct. 31 CMS posted draft August 2013 average manufacturer price-based FULs, as well as draft 3-month rolling average FULs.

On Nov. 27, CMS posted an informational bulletin that announced it would finalize AMP-based FULs in July 2014. The Agency also posted final National Average Drug Acquisition Cost (NADAC) files.

On Nov. 27, CMS announced via the issuance of an informational bulletin that, following ongoing consultation with the states, CMS is providing this “advanced notice” to announce its intention to finalize the AMP-based FULs in July 2014.  Coinciding with this announcement, CMS pointed to new information pertaining to the availability of final National Average Drug Acquisition Cost (NADAC) files (available here).

On Dec. 30,  CMS updated its website here to add the October 2013 AMP-based and 3-month rolling average (3MRA) FUL files. On January 22, 2014, the GAO released a report (overview) recommending that CMS “expeditiously implement the ACA-based FUL formula” for Medicaid outpatient prescription drugs and regularly monitor ACA-based FULs’ relationship with [NADACs], tabulated by CMS as a “national benchmark for retail pharmacy acquisition costs of Medicaid covered outpatient prescription drugs.”

2014

On Feb. 6, 2014, the GAO issued a revised copy of its January 2014 report on Medicaid prescription drugs and FULs (GAO-14-68) to include the previously-omitted HHS comments on the draft report. Note also that CMS posted several updates to its Medicaid prescription drug webpage in February 2014 including: (1) updates to the the Federal Upper Limits (FUL) page to account for the December 2013 AMP-based and 3MRA FUL files (posted February 26); (2) updated information on the Medicaid Drug Rebate (MDR) Program Data page regarding the list of products that are in the MDR program but are not listed with FDA (posted February 14); (3) updated 4Q2013 quarterly files available on the MDR Program Data page (posted February 10); and updated Medicaid Prescription Reimbursement Information by State and the State Supplemental Drug Rebate Agreements as of December 2013 updated on the State Prescription Drug Resources page (posted February 5).

On a related note, in early March 2014, CMS issued technical guidance to states and participating drug manufacturers (see here and here, respectively) enumerating 2012 state utilization data for branded prescription drug (BPD) fees, as well as denoting other changes applicable to the Medicaid Drug Rebate (MDR) program. Also on a related note, on March 17, CMS issued the list of products that are in the MDR program but that are not listed with the FDA; see here under the section entitled “Products In The Medicaid Drug Rebate Program That Are Not Listed With FDA.”

On April 15, 2014, CMS posted the list of products in the Medicaid Drug Rebate program that are not listed with the FDA. In late April, CMS posted February 2014 ACA AMP-based draft FULs, as well as 3-month rolling average FULs; available here.

On a related note, on May 2, CMS posted updated NADAC weekly files and weekly comparison files on its Survey of Retail Prices page.

On June 2, CMS announced that it will not finalize ACA FULs for multiple-source prescription drugs in July 2014, as it had indicated it would in November 2013 guidance (available here). The agency says that “in the November 2013 Informational Bulletin, we stated that further detailed guidance would be provided for states to implement the Affordable Care Act FULs, and we remain committed to ensuring that this guidance is provided to states with sufficient time to implement the FULs.” A new finalization date for the FULs is expected when CMS releases additional guidance to states, with ongoing analysis of draft ACA FULs – compared with National Average Drug Acquisition Cost pricing – in the interim.

In early June, CMS posted the draft March 2014 AMP-based ACA Federal Upper Limits (ZIP file) for Medicaid drugs, as well as the draft March 3-month rolling average FULs (ZIP file).

On July 31, CMS posted the May 2014 AM-based and 3MRA FUL files.

On Sept. 12, CMS issued a memorandum to participating Medicaid Drug Rebate program manufacturers. Among other things, the memo addresses issues regarding timely reporting of AMP and Best Price (BP) pricing data, as well as the recent appointment of Dr. John Coster to serve as the Director of the Division of Pharmacy within CMCS. CMS also issued a memo to state technical contacts addressing rebate obligations for terminated manufacturers and terminated products, among other things.

On Sept. 29, CMS updated its FUL page to reflect the July 2014 AMP-based and the three-month rolling average (3MRA) FUL files.

In early Oct., CMS posted the draft July 2014 AMP-based FULs for Medicaid drugs, as well as the draft July 3-month rolling average FULs.

On Nov. 20, CMS announced its plan to release finalized ACA FULs for multiple-source Medicaid prescription drugs at or about the same time that it publishes the Medicaid Covered Outpatient Drug final rule (CMS-2345-F). CMS said at that time – which it did not specifically delineate – it anticipates releasing “formal detailed guidance” to states on implementing the ACA FULs. The guidance will include “information that the states will need to include in their Medicaid state plan amendments, including detailed timelines for compliance.” In the interim, the agency will continue its analysis of monthly draft ACA FULs here, including FULs’ relationship to the National Average Drug Acquisition Cost. Previously, CMS postponed finalization of the ACA FULs – which had been expected in July 2014 – in an announcement this summer. See also: August Draft AMP-based FULs and three-month rolling average FULs posted in early Nov. here.

2015

In Jan. 2015, CMS posted here updated monthly (Nov. 2014) AMP data for drugs in the Medicaid Drug Rebate Program reported or not reported.

On Feb. 26, CMS posted the Dec. 2014 AMP-based and three-month rolling average (3MRA) FUL files.

On Mar. 31, CMS posted the Feb. 2015 monthly AMP reported or not reported file for drugs in the Medicaid Drug Rebate program.

On Apr. 30, CMS updated its landing page pertaining to Medicaid FULs to provide Mar. 2015 monthly AMP data for drugs in the Medicaid drug rebate program (reported or not reported).

On May 12, CMS posted 1^st quarter 2015 Drug Product Data file data (available here).

In June CMS updated its Medicaid Federal Upper Limits (FULs) landing page to reflect the posting of draft April 2015 AMP based FULs, as well as draft April 2015 three-month rolling average (3MRA) FULs.

In September, CMS updated its Medicaid Federal Upper Limits (FULs) landing page to reflect the posting of draft July 2015 AMP based FULs, as well as draft July 2015 three-month rolling average (3MRA) FULs.

In December, CMS updated its Medicaid FUL landing page to reflect the posting of draft October 2015 AMP based FULs, as well as draft October 2015 three-month rolling average (3MRA) FULs.

On Dec. 31, CMS issued Medicaid Drug Rebate guidance to participating drug manufacturers (Release No. 95), delineating information regarding labeler request for claims level data (CLD) from states, reminders regarding the dispute resolution prevention process, among others topics.

2016

On Jan. 21, CMS released its final rule (fact sheet; press release) on Medicaid reimbursement for covered outpatient drugs, including key dimensions of the Medicaid Drug Rebate Program. The rule primarily implements statutory changes specified at sections 2501 and 2503 of the ACA and finalizes provisions that the agency proposed in February 2012. The rule takes effect on Apr. 1, 2016. States will have one year following this effective date to submit State Plan Amendments (SPAs) incorporating the final rule’s requirements, with CMS sub-regulatory guidance anticipated that will address this process. Certain provisions of the final rule are open for public comment; submissions are due by April 1.

On Jan. 22, following the release of the Medicaid outpatient drug final rule, CMS provided an update on its planned timeline for publication and implementation of finalized ACA FULs for multi-source Medicaid drugs. Specifically, CMS plans to publish draft ACA FULs for two months beginning in January 2016 before finalizing the FULs. The final ACA FULs will be published in late March 2016 and will be effective on April 1, 2016, which coincides with the effective date of the aforementioned final rule.  CMS notes that “[s]tates will have up to 30 days from the April 1, 2016, effective date to implement the FULs.”

On Jan. 28, CMS posted the draft Jan. 2016 Medicaid FULs for multi-source prescription drugs here. The draft AMP-based ACA FULs are calculated pursuant to last the latest AMP rule. CMS also posted a Methodology and Data Elements Guide discussing the FULs.

On Feb. 11, CMS issued a SMD letter providing more detailed guidance to states on implementing its recently finalized regulation on Medicaid reimbursement of covered outpatient drugs. The letter addresses specific options that states have for effectuating changes to Medicaid drug reimbursement under the final rule and submitting any necessary SPAs (due by Apr. 1, 2017) to CMS.

On Feb. 25, CMS posted draft Feb. 2016 Medicaid FULs for multi-source prescription drugs here. The draft AMP-based ACA FULs are calculated pursuant to last the latest AMP rule. CMS also posted a revised Methodology and Data Elements Guide discussing the FULs.

On Apr. 27, CMS posted here updated ACA FULs for multi-source prescription drugs pursuant to the Medicaid covered outpatient drug final rule issued in Jan. 2016. CMS states that “[s]tates will have up to 30 days from the May 1, 2016 effective date to implement these updated FULs.” See also here.

On May 27, CMS released the latest Federal Upper Limits (FULs) for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid outpatient drug rule. States have 30 days from the June 1 effective date of these FULs to implement them.

On June 30, CMS released the latest Federal Upper Limits (FULs) for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid outpatient drug rule. States have 30 days from the July 1 effective date of these FULs to implement them.

On July 6, CMS released an FAQ responding to questions raised by various stakeholders regarding the Covered Outpatient Drug Final Rule with Comment that was published in the Federal Register on Feb. 1, 2016 as well as the State Medicaid Director Letter (#16-001) that was issued on Feb. 11, 2016. Several answers provide guidance on Federal Upper Limits (FULs) and Average Manufacturer Price (AMP) calculations.

On July 14, CMS released parallel guidances for Manufacturers (see here) and States (here) regarding value based purchasing (VBP) arrangements for drugs in state Medicaid programs. The main issue addressed by the guidance is whether VBP arrangements impact a manufacturer’s “best price,” an amount used to calculate statutory rebates for drugs used by the Medicaid program.

On July 28, CMS released the latest FULs for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid outpatient drug rule. States have 30 days from the Aug. 1 effective date of these FULs to implement them.

On Aug. 26, CMS released the latest FULs for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid outpatient drug rule. States have 30 days from the September 1 effective date of these FULs to implement them.

On Sept. 29, CMS released the latest FULs for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid outpatient drug rule. CMS continues to also post National Average Drug Acquisition Cost (NADAC) weekly and the weekly comparison data.

On Oct. 17, CMS announced the release of the 2016 State Drug Utilization Data on Medicaid.gov. The data is available in individual state-by-state reports, or can be viewed as a whole in the 2016 Entire Dataset. In accordance with the Medicaid Drug Rebate Program, states report this drug utilization data for covered outpatient drugs that are paid for by state Medicaid agencies. The data includes state, drug name, National Drug Code, number of prescriptions, and dollars reimbursed.

2017

On Mar. 9, CMS issued guidance to states (State Release #179) reiterating certain limitations on Medicaid Federal Financial Participation (FFP) and manufacturer rebates under the Medicaid Drug Rebate Program (MDRP) for drugs used for cosmetic purposes or hair growth, or drugs to treat sexual dysfunction or erectile dysfunction.

On Mar. 29, CMS issued updated ACA-based FULs. States have up to 30 days from the Apr. 1, 2017 effective date to implement the updated FULs, CMS states.

In early July, CMS issued two guidance documents (State Release #181 and Manufacturer Release #105) for states and manufacturers, respectively, addressing certain operational issues related to the Medicaid Drug Rebate Program.

In early July, CMS released the latest FULs here for multi-source Medicaid drugs, which are calculated according to the methodology finalized in the Medicaid Covered Outpatient Drug rule. States have 30 days from the July 1, 2017 effective date of these FULs to implement them.

2018

On Apr. 30, CMS updated the ACA FULs pursuant to the 2016 Medicaid Covered Outpatient Drug final rule with comment. CMS notes that states “…have up to 30 days from the May 1, 2018 effective date to implement these updated FULs.”

CMS posted updated ACA FULs for June and July 2018 here and here, respectively.

2019

Updated FULs are released on a monthly basis here. States have up to 30 days from the effective date to implement the FULs. Details here.