If drug plan denies request for exception, there are five additional levels of appeal.
For more extensive information on the Medicare Part D Exceptions and Appeals process, see Medicare Rights Center’s Medicare Part D Appeals Manual (March 2009) at http://www.medicarerights.org/appealsmanual.html.
Contact Legal Resources ...if your client has lost an exception request.
Endnotes
1 42 C.F.R. § 423.30(a)(1)(i) and (ii)
2 The Medicare Part B premium for 2011 is actually $115.40/mo. However, Social Security recipients will not be getting a cost-of-living increase in their checks in 2011 (nor did they in 2010). As a result, SSA is not allowed to deduct the higher premium in 2011, because this would cause everyone’s checks to be reduced. This is known as the “hold harmless” provision of the Social Security Act. See 42 U.S.C. §1395r(f). Therefore, most Medicare beneficiaries will continue to pay $96.40/mo., the premium in effect in 2009. Those who first enrolled in Part B in 2010 will continue to pay $110.50/mo. Those who enroll in Part B in 2011 will have to pay the higher $115.40/mo. premium.
3 Based on a list provided by CMS dated 9/8/11, available at
http://www.cms.gov/PrescriptionDrugCovGenIn/Downloads/PDP_Source2012.zip. 4 Based on a list provided by CMS dated 9/8/11, available at
http://www.cms.gov/PrescriptionDrugCovGenIn/Downloads/MA_SNP_Source2012.zip.
5 CMS, Medicare Medical Savings Account Plans, Pub. No. 11206, available at
http://www.medicare.gov/Publications/Pubs/pdf/11206.pdf (February 2008).
6 CMS, Medicare Private Fee-For-Service Plans, Pub. No. 10144, available at
http://www.medicare.gov/Publications/Pubs/pdf/10144.pdf (September 2007).
7 Center for Medicare Advocacy, Medicare Advantage Private Fee-For-Service (PFFS) Plans: A Primer For Advocates (June 16, 2009) available at
http://medicareadvocacy.org/InfoByTopic/MedicareAdvantageAndHMOs/MA_P
FFSPrimerForAdvocates.pdf.
8 Center for Medicare Advocacy, Next Steps for Some Beneficiaries In Medicare Special Needs Plans (September 15, 2011), available at
http://www.medicareadvocacy.org/2011/09/next-steps-for-some-beneficiaries-in-
medicare-special-needs-plans/.
9 42 C.F.R.§ 423.104(f)(2). 10 42 C.F.R.§ 423.104(f)(1).
11 Social Security Administration, Medicare Premiums: Rules For Higher-Income Beneficiaries, Pub. No. 05-10536, available at
http://www.socialsecurity.gov/pubs/10536.pdf (January 2011).
12 Patient Protection and Affordable Care Act, Pub. L. No. 111-148.
13 CMS, Closing the Prescription Drug Coverage Gap, Pub. No. 11464, available at
http://www.medicare.gov/Publications/Pubs/pdf/11464.pdf (May 2010).
14 CMS, Medicare Coverage Gap Discount Program beginning in 2011, available at
http://www.cms.gov/PrescriptionDrugCovContra/Downloads/2011CoverageGap
Medicare Prescription Drugs Are Becoming More Affordable, available at
http://www.medicare.gov/Publications/Pubs/pdf/11493.pdf (November 2010).
15 CMS, Prescription Drug Benefit Manual, Chapter 5: Benefits and Beneficiary Protections, 20.5, available at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/PDMChap5Be
neProtections.pdf(July 3, 2008)
16 42 C.F.R. § 423.120 (b)(2)(i); United States Pharmacopeial Convention, Inc., Medicare Model Guidelines Version 4.0, at
http://www.usp.org/pdf/EN/mmg/modelGuidelinesV4.0WithFKDTs.pdf
(February 4, 2008). See also http://www.usp.org/hqi/mmg/revisions.html
17 CMS, Prescription Drug Benefit Manual, Chapter 6: Part D Drugs and Formulary Requirements, 30.2.5, available at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/R2PDB.pdf
(July 18, 2008).
18 Plans may exclude drugs from these six classes of clinical concern under the following circumstances:
– “multi-source brands of the identical molecular structure;
– extended release products when the immediate-release product is included; – products that have the same active ingredient or moiety; and
– dosage forms that do not provide a unique route of administration (e.g., tablets and capsules versus tablets and transdermals)”
See note 17. 19 See note 17. 20 42 C.F.R. § 423.153(b)
21 CMS, Prescription Drug Benefit Manual, Chapter 7: Medication Therapy Management and Quality Improvement Program, 60.4 & 60.5, at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/R3PDB.pdf,
(September 15, 2008).
22 CMS, Prescription Drug Benefit Manual, Chapter 6: Formulary, 30.3.3.3. See note 17.
23 42 C.F.R. § 423.120(b)(5); CMS, Prescription Drug Benefit Manual, Chapter 6: Formulary, 30.3.4.1.
24 See definition of “Part D Drug” at 42 C.F.R. § 423.100 25 42 C.F.R. § 423.104(f)(1)(ii)(A)
26 Id. at 20.1. See note 17. See also 42 C.F.R. § 423.100; MMA 1860-2(e)(2) and 1927(d)(2); 42 U.S.C. § 1395w-102(e)(2)(A).
For a list of excluded drugs with additional comments, see CMS, Part D Drugs/Part D Excluded Drugs, at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/PartDDrugsP
27 Id. at 20.2. See note 17.
28 Id. at 10.6. See note 17. Note that beginning in 2009, Medicare began considering certain off-label anticancer chemotherapeutic regimens to be Part D covered drugs, if supported by compendia other than the three usually accepted by Medicare, and/or peer-reviewed medical literature. In addition, the decision in the Layzer v. Leavitt federal lawsuit removes the off-label restriction for Medicare beneficiaries living in the Southern District of New York (Manhattan, Bronx, Westchester, Putnam, Rockland, Orange, Dutchess, and Sullivan counties). Layzer v. Leavitt, 07 Civ. 11339 (March 7, 2011).
29 For a partial list of excluded drugs indicating whether Medicaid and/or EPIC will cover them, see CIDNY, Part D Excluded Drugs by Type and Payer in New York, at
http://www.cidny.org/content/cidnyweb/Files/PART_D_EXCLUDED_DRUGS_I
N_NEW_YORK.doc (January 2006).
30 Pub.L.111-148, the Patient Protection and Affordable Care Act of 2010 (PPACA) Section 2502.
31 For more information on Part B versus Part D coverage issues, see
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/BvsDCoverag
eIssues.pdf (February 10, 2006) and
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/BvsDCoverag
e_07.27.05.pdf (July 27, 2005)
32 CMS, Prescription Drug Benefit Manual, Chapter 5: Benefits and Beneficiary Protections, 30. See note 15.
33 42 U.S.C. § 1395w-102(b)(4)(C) 34 See note 14.
35 Id.
36 42 C.F.R. § 423.120 37 42 C.F.R. § 423.120(a)(10)
38 42 C.F.R. § 423.120(a)(5); CMS, Long-Term Care (LTC) Convenient Access Standard Statement, at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/LTCCoverLet
ter11.08.05.pdf, (November 8, 2005); CMS, Long Term Care Guidance, at
http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/LTCGuidance .pdf, (March 16, 2005). 39 42 C.F.R. § 423.120(a)(9) 40 42 C.F.R. § 423.773(c); 20 C.F.R. § 418.3105 41 42 C.F.R. § 423.773(c)(2) 42 42 C.F.R. § 423.773(c)(1)
43 42 C.F.R. § 423.773(c)(1)(ii). In New York, all those who qualify for SSI will also qualify for Medicaid, and thus qualify for “full extra help.” This provision is just for those states with more restrictive eligibility criteria for Medicaid.
44 42 C.F.R. § 423.772(d); 42 C.F.R. § 423.773(c)(1)(i)
45 42 C.F.R. § 423.773(c)(i)(iii); SSA POMS SI § 01715.005A.5, at
http://policy.ssa.gov/poms.nsf/lnx/0501715005 (November 15, 2001). See New
York State Dep’t of Health website at http://tinyurl.com/W393P. 46 42 C.F.R. § 423.773(c)(i)(iii); SSA POMS SI § 01715.005A.6, at
http://policy.ssa.gov/poms.nsf/lnx/0501715005 (November 15, 2001). See New
York State Dep’t of Health website at http://tinyurl.com/W393P.
47 42 C.F.R. § 423.773(c)(i)(iii). See New York State Dep’t of Health website at
http://tinyurl.com/W393P.
48 See note 2. 49 See note 47.
50 NYS Dep’t of Health, Form DOH-4238, available at
http://www.health.state.ny.us/health_care/medicaid/program/update/savingspro gram/msapp.pdf, (June 2008). 51 SSA POMS § HI 030, at https://secure.ssa.gov/apps10/poms.nsf/subchapterlist!openview&restricttocateg ory=06030. 52 POMS § HI 03001.010C (September 9, 2008)
53 “However, if a subsidy application is filed outside of an enrollment period the subsidy award will not be effective until Part D coverage is obtained.” SSA POMS § HI 03001.015D (November 08, 2005)
54 SSA POMS § HI 03020.055 (January25, 2008)
55 http://www.ssa.gov/i1020/
56 You must contact SSA at 1-800-772-1213 to request a paper Extra Help
application. You must mail this application to: Social Security Administration / Wilkes-Barre Data Operations Center / P.O. Box 1020 / Wilkes-Barre, PA 18767- 9910. 57 Pub. Law 110-275. 58 42 C.F.R. § 423.773(b)(1); SSA POMS § HI 03001.020, at http:/policy.ssa.gov/poms.nsf/links/0603001020 (October 29, 2009). 59 42 C.F.R. § 423.773(b)(2); SSA POMS § HI 03030.025, at http:/policy.ssa.gov/poms.nsf/links/0603030025 (October 30, 2009). 60 See note 58. 61 See note 59. 62 42 C.F.R. § 423.773(d); SSA POMS § HI 03001.020, at http:/policy.ssa.gov/poms.nsf/links/0603001020 (October 29, 2009). 63 42 C.F.R. § 423.773(d)(2); SSA POMS § HI 03030.025, at http:/policy.ssa.gov/poms.nsf/links/0603030025 (October 30, 2009). 64 See note 62.
65 See note 63.
66 Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), § 113. See also Center for Medicare Advocacy, Important New Medicare Law
Provisions: a Beneficiary's Perspective (Part 2), available at
http://www.medicareadvocacy.org/Reform_08_08.14.MIPPAKeyProvisions2.htm
(September 29, 2009).
67 Applicants can opt out by checking the box at question 15 on page 5 of the Extra Help application. See draft of new application, available at
http://tinyurl.com/YAEN8ZA.
68 The explanation of the Extra Help to MSP deeming process was based on the minutes of the August, September, and October meetings of the New York State Medicare Savings Program Coalition, chaired by the Medicare Rights Center.
See http://www.medicarerights.org/about-mrc/medicare_savings_coalition.php.
69 42 C.F.R. § 423.780(a) 70 See note 3.
71 2012 Benchmark premium for New York from CMS, Regional Rates and Benchmarks 2012, at
https://www.cms.gov/MedicareAdvtgSpecRateStats/Downloads/RegionalRatesB
enchmarks2012.pdf, (August 3, 2011).
72 42 C.F.R. § 423.780(b); Federal Register, Vol. 70, No. 18, pgs. 4384-4385 73 42 C.F.R. § 423.780(d) 74 Adapted from 42 C.F.R. § 423.780(d) 75 42 C.F.R. § 423.782(a)(1) 76 42 C.F.R. § 423.782(b)(1) 77 42 C.F.R. § 423.782(a)(2) 78 42 C.F.R. § 423.782(a)(2)(ii) 79 42 C.F.R. §§ 423.782(a)(2)(iii)(A)-(B), 423.782(b)(2) 80 42 C.F.R. § 423.782(a)(2)(iii)(B) 81 42 C.F.R. § 423.782(a)(3)
82 CMS, Prescription Drug Benefit Manual, Chapter 5: Benefits and Beneficiary Protections, 30.4. See note 15.
83 42 C.F.R. § 423.782(b)(3)
84 CMS, Loss of Deemed (Extra Help) Status Letter, Publication No. 11198, at
http://www.cms.hhs.gov/LimitedIncomeandResources/downloads/11198.pdf (August 2009). 85 20 CFR § 418.3125(b); SSA POMS § HI 03050.011, at http://policy.ssa.gov/poms.nsf/lnx/0603050011 (September 9, 2008). 86 20 CFR § 418.3120(b) 87 20 CFR § 418.3123(a), (b)
88 20 CFR § 418.3123(c), (d)
89 SSA POMS § HI 03050.005B.1 (February 27, 2006)
90 20 CFR § 418.3120(b)(2); SSA POMS § HI 03050.005B.2 (February 27, 2006) 91 20 CFR § 418.3510
92 20 CFR § 418.3515
93 (1) Kate is a dual eligible. She is auto-enrolled in the “full” extra help. It does not matter how much her spend down is, since she meets it with home care. (2) Henry is in the Medicare Savings Program so is deemed eligible for the “full”
extra help and does not have to apply.
(3) Natalie and Jack -- Since their income is well over 150% FPL for a couple, they will not qualify for extra help.
(4) Ralph’s monthly income ($1,250/mo.) is between 135% and 140% FPL, which makes him income-eligible for Partial Extra Help. His assets are below the asset limit of $12,510. Thus, he is eligible for Partial Extra Help (with a 75% premium subsidy), and must apply to SSA.
94 42 C.F.R. §§ 423.38(a)(3), 407.14; CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.1, at
http://www.cms.hhs.gov/MedicarePresDrugEligEnrol/Downloads/2009PDPenrol
lmentguidance.pdf (July 16, 2008); CMS, Medicare Managed Care Manual,
Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.2, at
http://www.cms.hhs.gov/MedicareMangCareEligEnrol/Downloads/2009MAenro
llmentguidance.pdf (July 16, 2008).
95 42 C.F.R. § 423.38(b)(2); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.1 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.1 (see note 94).
96 For Medicare Advantage plans, it is called a “Special Election Period,” and the same criteria apply. 42 C.F.R. § 422.62(b); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4 (see note 94).
97 42 C.F.R. § 423.38(c)(1); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.5 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4(9) (see note 94).
98 42 C.F.R. §§ 423.38(c)(4), (c)(8)(ii); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.2, 20.3.8(7) (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4(5), 30.4.4(12) (see note 94).
99 42 C.F.R. § 423.38(c)(6); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.4 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.3 (see note 94).
100 42 C.F.R. § 423.38(c)(7); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.1 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.1 (see note 94).
101 42 C.F.R. § 423.38(c)(8)(i); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.3 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.2 (see note 94).
102 42 C.F.R. § 423.38(c)(8)(ii); CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.8 (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4 (see note 94).
103 CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.8(1) (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4(1) (see note 94).
104 CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.8(5) (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4(5) (see note 94).
105 CMS, Prescription Drug Benefit Manual, Chapter 3: Eligibility, Enrollment and Disenrollment, 20.3.8(9) (see note 94); CMS, Medicare Managed Care Manual, Chapter 2: Medicare Advantage Enrollment and Disenrollment, 30.4.4(11) (see note 94).
106 CMS, New Exceptional Circumstance Special Enrollment Period Based on Incorrect or Misleading Information, at http://tinyurl.com/2BFSB6 (July 18, 2007) 107 42 C.F.R. § 423.46
108 42 C.F.R. §§ 423.46(a), 423.56(a)
109 42 CFR 423.56(c), (d), and (f)(3). CMS, Prescription Drug Benefit Manual, Chapter 4: Creditable Coverage Period Determinations/Late Enrollment Penalty,
http://www.cms.hhs.gov/MedicarePresDrugEligEnrol/Downloads/CCLEP2007G
uidance.pdf, (June 27, 2006).
110 42 CFR 423.46
111 EPIC, Sample letter to members informing them that EPIC is no longer creditable coverage, available at
http://nyhealth.gov/health_care/epic/docs/non_creditable_coverage_20120101.pdf. 112 CMS, Qualifying Covered Retirees, at
http://www.cms.hhs.gov/EmployerRetireeDrugSubsid/Downloads/20080530%20
Retiree%20Issues%20Guidance_final.pdf, (May 30, 2008).
113 The penalty amount is calculated as “1 percent of the base beneficiary premium (computed under paragraph (c) of this section),” which provides that “[t]he base
beneficiary premium for a Part D plan for a month is equal to [a complicated formula].” 42 C.F.R. §§ 423.286(d)(3)(i)(B), 423.286(c)
“The premium that would otherwise applyis increased by at least 1% of the base beneficiary premium (which is set by CMS and published each year) for each month without creditable coverage. This penalty may apply for as long as the individual remains enrolled in Part D. The individual’s higher premium charge will be recalculated each year, because the base beneficiary premium changes annually.” CMS, Disclosure of Creditable Coverage to Medicare Part D Eligible Individuals Guidance, 4, at
http://www.cms.hhs.gov/CreditableCoverage/Downloads/Updated_Guidance_0
2_15_07.pdf, (February 15, 2007).
114 CMS, Annual Release of Part D National Average Bid Amount and other Part C & D Bid Information, available at http://tinyurl.com/3TWDE66 (August 3, 2011). 115 Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), Pub.
Law 110-275, § 114; Center for Medicare Advocacy, Important New Medicare Law Provisions: A Beneficiary’s Perspective (Part 1), at
http://medicareadvocacy.org/Reform_08_08.07.MIPPAKeyProvisions.htm
(August 7, 2008).
116 CMS, 2012 Reassignment of Low-Income Subsidy Beneficiaries in PDPs, available at http://www.centerforbenefits.org/downloads/CMS-Memo-LIS-
Reassignment-2012.pdf (September 1, 2011); CMS, Tip Sheet: Reassignment, Pub.
No. 11221-P, available at http://www.cms.gov/partnerships/downloads/11221-
P.pdf (September 2010).
117 See note 71. 118 See note 114.
119 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 3303; CMS, Announcement of Calendar Year (CY) 2011 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter, available at
http://www.cms.gov/MedicareAdvtgSpecRateStats/Downloads/Announcement2
011.pdf (April 5, 2010).
120 CMS, 2011 Reassignment of Low-Income Subsidy Beneficiaries in Terminating Medicare Advantage (MA) Plans, available at
http://www.medicarerights.org/pdf/MA-reassign-guidance-8-13-2010-FINAL.pdf
(August 13, 2010).
121 CMS, Guide to LIS Beneficiary Mailings from CMS, Social Security and Plans, available at
http://www.cms.hhs.gov/LimitedIncomeandResources/Downloads/2010Mailings .pdf (September 21, 2010).
122 New York State Dep’t of Health, New York State EPIC Program: 2010 Part D Prescription Drug Plan Re-Assignments, available at
123 Beginning June, 2004, NYS began enrolling SSI-only Medicaid recipients in Medicare Part A and B by enrolling them in the Medicare Savings Program for both A & B. Usually people just join the MSP for Part B. Enrollment of SSI-only recipients into Medicare has increased from only 1,272 statewide in Jan. 2002 to 104,861 in Dec. 2004. (NYS DOH Dual Eligible Statistics, Robert Borrelli, on file with Selfhelp).
124 New York State Dep’t of Health, Elderly Pharmaceutical Insurance Coverage (EPIC) Program, at http://www.health.state.ny.us/nysdoh/epic/faq.htm (June 2008).
125 See note 29.
126 A State Pharmaceutical Assistance Program (SPAP) is a state program that does not receive any federal funding that provides or supplements prescription drug coverage or benefits on behalf of financially or medically needy individuals. Costs paid by a certified SPAP count toward the beneficiary’s TrOOP costs, helping them meet the catastrophic coverage threshold. An SPAP may not contract with or steer members to any particular plan. 42 USCA § 1395w-133(b);
http://tinyurl.com/3DBR8B. EPIC is the only SPAP in New York State.
127 See sample notice of non-creditable coverage at http://tinyurl.com/34UNQJ.
128 http://tinyurl.com/2Q3F9Z
129 42 CFR 423.578(b) 130 42 CFR 423.578(b)(1)(i)
131 This rule is not in the statute, it is only in the final regulation 132 42 CFR 423.578(b)(4)