CopyCited 22 times | Published | Court of Appeals for the Eleventh Circuit | 2002 U.S. App. LEXIS 18487, 2002 WL 31000006
...The central issue is whether there is a conflict
between the recently enacted Florida law and the governing federal Medicaid
statute, 42 U.S.C. § 1396r-8. The state of Florida argues that the new Florida law,
ch. 2001-104, codified at Fla. Stat. §
409.91195,
409.912, provides for a “prior
authorization program” within the meaning of 42 U.S.C....
...See § 1396r-8(d)(4)(C).
B.
In the spring of 2001, the Florida legislature passed the law that forms the
basis of the present controversy. See Laws of Florida, ch. 2001-104 (“the 2001
amendments”), amending Fla. Stat. §§
409.91195,
409.912.1 After Governor Bush
signed the bill, the Florida law went into effect on July 1, 2001....
...ces under which a state
Medicaid plan can restrict coverage of Medicaid-eligible outpatient drugs.
Unfortunately, the terminology adopted by the Florida law has at least two
ambiguities that have produced the current controversy. First, section
409.91195
mandates the creation of a “preferred drug formulary,” which seems to be an
imprecise parallel to a “formulary” within the meaning of § 1396r-8(d)(1)(B)(iv),
(d)(4). Second, the term “preferred drug formulary” is used interchangeably
1
The text of §§
409.91195,
409.912(37) are reproduced in an appendix to this opinion.
10
throughout section
409.91195 with the term “preferred drug list.”2 The reference
to a “preferred” drug list or “preferred” drug formulary appears to be unique to the
Florida statute, since the term “formulary” in § 1396r-8 is not modified by...
...usly represents an attempt by the
Florida legislature to conform a “preferred drug formulary” to at least some of the
requirements of a “formulary” as defined by the federal Medicaid statutes. For
example, the first sentence of Fla. Stat. § 409.91195 reads as follows: “There is
created a Medicaid Pharmaceutical and Therapeutics Committee within the Agency
for Health Care Administration for the purpose of developing a preferred drug
2
The Report and Recommendation of the federal...
...e judge, which was subsequently adopted
by the district court, makes the following rather succinct observation:
The Florida statutes use the phases “preferred drug formulary” and “preferred drug list”
interchangably. E.g., Fla. Stat. § 409.91195(1), (4), (6), (7), (8), (9), (11)....
...develop a formulary within the meaning of § 1396r-8(d)(4). Compare § 1396r-
8(d)(4)(A) (“The formulary is developed by a committee consisting of physicians,
pharmacists, and other appropriate individuals appointed by the Governor of the
State ... .”), with Fla. Stat. § 409.91195(1) (“The Medicaid Pharmaceutical and
Therapeutics Committee [charged with the development of a preferred drug
formulary] shall be comprised as specified in 42 U.S.C....
...terms of safety,
effectiveness, or clinical outcome of such treatment for such population over other
drugs included in the formulary and there is a written explanation (available to the
public) of the basis for the exclusion.”), with Fla. Stat. § 409.91195(9) (“The
Medicaid Pharmaceutical and Therapeutics Committee shall develop its preferred
drug list recommendations by considering the clinical efficacy, safety, and cost-
effectiveness of a product.” (emphasis added)), and Fla. Stat. § 409.91195(4) (“To
the extent feasible, the committee shall review all drug classes included in the
formulary at least every 12 months, and may recommend additions to and deletions
from the formulary, such that the formulary provides for medic...
...e submitted to the CMS
proposed revisions to the State’s Medicaid Plan, including deletion of the phrase
“preferred drug formulary,” replacing it with “preferred drug list.”5 The new
sentence reads, “In accordance with Florida Statute 409.91195 and pursuant to 42
U.S.C....
...If the Florida law created a Medicaid
20
“formulary,” we would agree with the PhRMA that Florida officials developing the
preferred drug list could not consider a drug’s “cost-effectiveness,” as required
under Fla. Stat. § 409.91195(9), when the governing federal statute clearly limits
such decisions to clinical issues of safety and drug effectiveness....
...ith
comparable therapeutic properties that are also more cost-effective for the state. Presumably, some
doctors will learn to avoid the prior authorization program by routinely looking for a suitable drug
on the “preferred drug list,” Fla. Stat. § 409.91195(4); hence, the shifts in market share following
the enactment of the Florida law....
...By stretching its Medicaid
dollars, the Florida law has the potential for providing more and better medical
services to the target population. Finally, because Florida’s preferred drug list is
based on both clinical and cost-related factors, see Fla. Stat. § 409.91195(9)
(requiring that preferred drug list recommendations be based on “clinical efficacy,
safety, and cost-effectiveness of a product”), the Florida law leaves open the
possibility that a medically superior drug will be included on t...
...Instead, the Florida law merely conditions
coverage for non-preferred drugs on whether the prescribing physician has
followed the prior authorization procedure.
If this case presents us with difficult issues of statutory interpretation, this
difficulty arises from the confusing phraseology of the Florida law. Section
409.91195 begins with the sentence, “There is created a Medicaid Pharmaceutical
and Therapeutics Committee within the Agency for Health Care Administration
[AHCA] for the purpose of developing a preferred drug formulary pursuant to 42
U.S.C....
...However, the term “preferred drug
formulary” does not appear in the governing Medicaid statute, and the reference to
§ 1396r-8 resolves nothing; a prior authorization program is defined in subsections
(d)(1)(A) and (d)(5), while a “formulary” is defined in subsections (d)(1)(B) and
(d)(4). Further, section 409.91195 of the Florida law uses the term “preferred drug
30
formulary” interchangeably with “preferred drug list”: subsections (1) and (6) refer
to “preferred drug formulary”; subse...
...ulary, as required by § 1396r-
8(d)(4)(C). The AHCA insists that the Florida law permits the state to implement a
conforming Medicaid formulary at a later date, and that the Medicaid
Pharmaceutical and Therapeutics Committee, created pursuant to section
409.91195, would already be in place to assume this additional duty....
...The AHCA has adopted a reasonable construction of the Florida
law that comports with the requirements of the governing federal Medicaid statute.
The judgment of the district court is therefore AFFIRMED.
32
33
Appendix
The following is the text of Fla. Stat. § 409.91195:
There is created a Medicaid Pharmaceutical and Therapeutics
Committee within the Agency for Health Care Administration for the
purpose of developing a preferred drug formulary pursuant to 42
U.S.C....
CopyCited 1 times | Published | District Court, N.D. Florida | 2001 U.S. Dist. LEXIS 22606, 2001 WL 1694101
...Again for the reasons stated by the magistrate judge, this court concludes that the plaintiff's motion for summary judgment and permanent injunctive relief must be denied. The plaintiff asks this court to enjoin enforcement of two recently amended Florida laws: sections
409.91195 and
409.912(37) of the Florida Statutes....
...According to the plaintiff, these laws authorize the creation of a state Medicaid formulary in violation of subsection (d)(4) of section 1927 of the Social Security Act (the "federal Medicaid law"). The magistrate judge determined and this court agrees that sections
409.91195 and
409.912(a)(37), as amended in 2001, do not authorize the creation of a "formulary" as that term is used in the federal Medicaid law but, instead, allow the establishment of a "preferred drug list" and a "prior authorization program" expressly permitted by the federal Medicaid law....
...he dispensing of at least 72-hour supply of a covered outpatient prescription drug in any emergency situation (as defined by the Secretary). 42 U.S.C. § 1396r-8(d)(5)(A) and (B). The Florida law which is challenged in this suit consists of sections
409.91195 and
409.912, Florida Statutes, as amended by Chapter 2001-104, Laws of Florida. The new law took effect on July 1, 2001. A copy of the enactment is attachment A to doc. 8. Section
409.91195 has been amended to create a Medicaid Pharmaceutical and Therapeutics Committee within the Agency for Health Care Administration "for the purpose of developing a preferred drug formulary pursuant to 42 U.S.C. § 1396r-8." Id., § 8, amending FLA. STAT. §
409.91195. Upon recommendation of the Committee, the Agency is to "adopt a preferred drug list." Id., amending FLA. STAT. §
409.91195(4)....
...The approval was retroactively effective nunc pro tunc July 1, 2001. Id., ex. F, p. 5. Except for mental health drugs, antiretroviral drugs, and drugs for institutional residents, "reimbursement for drugs not included in the formulary is subject to prior authorization." Id., amending FLA. STAT. § 409.91195(5)....
...The temporary list was adopted in June, 2001, by the existing Medicaid Pharmaceutical and Therapeutics Committee, which had appointees by not only the Governor, but by the presiding officers of the Florida House of Representatives and the Senate. FLA. STAT. § 409.91195(1) (2000) (prior to amendment)....
...Plaintiff argues that the Florida Statutes reflect an intent to create a drug formulary as intended by § 1396r-8(d)(4) because the amended statutes use the word "formulary." The Florida statutes use the phrases "preferred drug formulary" and "preferred drug list" interchangeably. [4] E.g., FLA. STAT. § 409.91195(1), (4), (5), (6), (7), (8), (9), (11)....
...to provide drugs to Medicaid beneficiaries at the lowest cost possible. [5] Plaintiff had argued that the Florida law establishes a Medicaid Pharmaceutical and Therapeutics Committee to be "comprised as specified in 42 U.S.C. § 1396r-8." FLA. STAT. § 409.91195(1)....
...ject. Id. (citation omitted). Dietrich v. Key Bank, N.A.,
72 F.3d at 1514. [4] The title to Committee Substitute for Committee Substitute for Senate Bill 792, which became Chapter 2001-104, Laws of Florida, announces that the amendment to FLA. STAT. §
409.91195 will require the establishment of a "preferred drug formulary." Doc....
