A bill to require the Secretary of Health and Human Services to provide an individual who seeks to have a particular item or service to be covered benefit under the Medicare program the option to meet with the Secretary in advance to develop a written agr

6 Pages·1999·0.22 MB·English

by  United States. Congress. House

I
106t1shtcSoenssgiroenss H. R. 2338
To require the Secretary- of Healtli and Human Sennees to proAide an
indhddual who seeks to have a particular type of item or service to
be covered benefit under the Medicare Program the option to meet
withtheSecretary-inadvancetodevelopawTittenagreementspecifying
theinformationnecessary-fortheSecretary-tomakeanationalcoverage
determinationunderthe^MedicareProgram.
IN THE HOUSE OF REPRESENTATIVES
JUXE24,1999
Mr.Ramstadintroducedthefollowingbill;whichwasreferredtotheCom-
mitteeonWaysand^Nleans.andinadditiontotheCommitteeonCom-
merce, for a period to be subsequentlydetermined bythe Speaker, in
eachcaseforconsiderationofsuchprovisionsasfallwithinthejurisdic-
tionofthecommitteeconcerned
A
BILL
To require the Secretary of Health and Human Services
to provide an individual who seeks to have a particular
type ofitem or service to be covered benefit under the
MedicareProgramtheoptionto meetwiththe Secretary
in advance to develop a written agreement specifying
the information necessary for the Secretary to make a
nationalcoveragedeterminationundertheMedicarePro-
gram.
1 BeitenactedhytheSenateandHouseofRepresenta-
2 tivesoftheUnitedStatesofAmericainCongressassembled,
—
.
2
1 SECTION1.SHORTTITLE.
2 ThisActmaybecitedasthe"MedicareCoverageIn-
3 formationDecisionActof1999"
4 SEC.2.MEETINGSREGARDINGCOVERAGEDECISIONS.
—
5 (a)Meetings\vltutheSecretaey.
6 (1) GENERAL.
—
7 (A) Deadline for :meeting. In the
8 case ofa person who submits to the Secretary
9 of Health and Human Services written notice
10 that the person intends to seek a national cov-
11 erage determination by the Secretary with re-
12' spect to whether a particular type or class of
13 items or services shall be covered under the
14 medicare programundertitleXVIII ofthe So-
15 cial SecurityAct (42 U.S.C. 1395 et seq.), the
16 Secretaryshallmeetwith suchpersonnotlater
17 than30daysafterreceivingtherequest.
—
18 (B) Purpose of meeting. Subject to
19 paragraph (3), thepurposeofanymeetingpur-
20 suantto paragraph (1) shallbeto enterinto a
21 writtenagreementthatdescribesthespecificin-
22 formation the Secretary requires in order to
23 make a national coverage determination with
24 respect to the particular type or class ofitems
25 orservicesundersuchtitle.
>HR2338IH
|3'
1 (2) Context of notice.—A notice under
2 paragraph (1) shall include the following descrip-
3 tions: '
4 (A) Adescription oftheparticulartype or
5 classofitemsorservicesproposedtobecovered
6 undersuchtitle.
7 (B) Adescription ofthe conditions forthe
8 use ofthe particular type or class of items or
9 services.
|
10 (C) Adescription ofthe benefit categories
11 forwhich the particular type or class ofitems
12 orservicesisintendedtobeused.
—
13 (3) Exception. If the Secretary determines
t4 that a national coverage policydetermination is not
15 appropriate or is premature forthe particular class
16 ofitems or services that is the subject ofthe meet-
17 ing, the Secretary may dechne to enter into an
18 agreement.
—
19 (b)ProvisioxsRegardixgAgreemexts.
—
20 (1) Ix GEXERAL. Inthecase ofanagreement
,21 enteredintobythe Secretaryandsuchpersonunder
22 subsection (a), notlaterthan 30 days afterthedate
23 the agreement is entered into, the Secretary shall
24 transmitthewritten agreementto suchperson. The
25 writtenagreementshallbepartoftheadministrative
•HR2338ra
—
4
1 record with respect to the national coverage deter-
2 mination ofthe particular type or class ofitems or
3 services proposed by such person to be covered
4 undersuchtitle.
—
5 (2)Modifications.
—
6 (A) Ix GENERAL. Subject to subpara-
7 graphs(B)and(C),anyagreemententeredinto
8 undersubsection(a)maynotbemodified.
—
9 (B) Exceptions. ^Any such agreement
10 maybe modified in anyofthe follow manners:
11 (i)Inthecaseofaproposedmodifica-
12 tion to the personbythe Secretary, other
13 than adeterminationunderclause (ii), the
14 ' person submits to the Secretary written
15 notice that the person agrees to the modi-
16 fication.
17 (ii) Subject to subparagraph (C), the
18 Secretary determines that a substantial
19 scientific issue essential to determining
20 whether the particular type of class of
21 items or services is reasonable and nec-
22 essaiyhasbeenidentified.
23 (C) SUBSTANTL^L SCIENTIFIC ISSUE.
24 modificationtoanagreementbyreasonofade-
25 terminationundersubparagraph (B)(ii) shallbe
«HR2338IH
1 inwriting, andmayonlybemadeaftertheSec-
2 retary has provided to such person an oppor-
3 tunitytomeetwiththe Secretarytodiscussthe
4 scientificissueinvolved.
—
5 (c)TradeSecrets. Subjecttoparagraph(2),any
6 informationreportedtoorotherwiseobtainedbythe Sec-
7 retarypursuanttothis sectionwhichisexemptfromdis-
8 closure pursuant to subsection (a) ofsection 552 oftitle
9 5, United States Code, byreason ofsubsection (b)(4) of
10 suchsection,shaUbeconsideredconfidentialandmaynot
11 be disclosed, except that such information may be dis-
12 closed to officers or employees of the Department of
13 HealthandHumanServicesintheircapacityasemployees
14 inadministeringthemedicareprogramundertitleXVIH
15 oftheSocialSecurityAct.
•HR2338IH
ensLIBRflRV
aOIS 0QD1LT71