Services for Attorneys: Laws and Regulations

PARTIAL LIST OF FEDERAL LAWS AND REGULATIONS APPLICABLE TO THE HEALTHCARE INDUSTRY

Medicare
Title XVIII of the Social Security Act (“SSA”), 42 U.S.C. § 1395 et seq., 42 C.F.R. §§ 405.201 – 498.103


Medicaid
SSA Title XIX, 42 U.S.C. § 1396 et seq.; 42 C.F.R. §§ 430.0 – 456.725


Medicare/Medicaid Anti-Fraud and Abuse statutes and regulations
SSA §§ 1128, 1128A, 1128B; 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b
Anti-Kickback Law – SSA §1128B(b), 42 U.S.C. § 1320a-7b(b)
Stark Law – SSA § 1877, 42 U.S.C. § 1395nn, 42 C.F.R. §§ 411.350 – 411.389
False Claims Act – 31 U.S.C. §§ 3729-3731
Civil monetary penalties – 42 C.F.R. §§ 1003.100 – 1003.135
Exclusions – 42 C.F.R. §§ 1001.101 – 1001.305
Safe Harbors – 42 C.F.R. § 1001.952
Healthcare Integrity Protection Data Bank – SSA § 1128E, 42 U.S.C. §1320a-7e, 45 C.F.R. §§ 61.1 – 61.16


Medicare appeals

• Reimbursement of institutional healthcare providers (PRRB) – SSA § 1878, 42 U.S.C. § 1395oo
• Hospital geographic classification (MGCRB) – SSA § 1886(d)(10), 42 U.S.C. § 1395ww(d)(10); 42 C.F.R. §§ 412.230 – 412.280
• Reimbursement of physicians and suppliers – 42 C.F.R. §§ 405.801 – 405.877
• Beneficiary’s entitlement to benefits – SSA § 1869, 42 U.S.C. § 1395ff , 42 C.F.R. §§ 405.801 – 405.877
• Provider status determinations – 42 C.F.R. §§ 498.1 – 492.103
• Civil appeals arising out of federal Fraud & Abuse enforcement – 42 C.F.R. §§ 402.1 – 402.115 and 1005.1 – 1005.23 (Civil Monetary Penalties), 1005.1 – 1005.23 (Exclusions),
• National and local coverage determinations, 42 C.F.R. §§ 426.100 – 426.587

Medicare and Medicaid Managed Care Regulations
42 C.F.R. §§ 417.1 – 417.940, 422.1 – 422.760
42 C.F.R. §§ 438.1 – 438.812


Medicare as Secondary Payor
SSA § 1862(b); 42 U.S.C. § 1395y(b)
42 C.F.R. §§ 411.20 – 411.206, 417.528, 422.108, 423.462


Medicare/Medicaid qualification to participate in the programs as a:

• Hospital – 42 C.F.R. §§ 482.1 – 482.66
• Critical access hospital – 42 C.F.R. §§ 485.601 – 485.647
• Nursing facility – 42 C.F.R. §§ 483.1 – 483.75
• Home health agency – 42 C.F.R. §§ 484.1 – 484.55
• Hospice – 42 C.F.R. §§ 418.50 – 418.205
• Ambulatory surgical center – 42 C.F.R. §§ 416.1 – 416.49
• Federally qualified health center (FQHC) – 42 C.F.R. §§ 405.2430 – 405.2452
• Rural health center (RHC) – 42 C.F.R. §§ 405.2411 – 405.2417
• Comprehensive Outpatient Rehabilitation Facility (CORF) – 42 C.F.R. §§ 485.50 – 485.74
• Provider-based entity – 42 C.F.R. § 413.65
• Health maintenance organization (HMO) – 42 C.F.R. §§ 417.400 – 417.520
• Medicare Advantage plan – 42 C.F.R. §§ 422.4, 422.50 – 422.270

Medicare/Medicaid payment of:

• Hospital – 42 C.F.R. §§ 412.1 – 412.632 (inpatient PPS), 419.1 – 419.70 (outpatient PPS), 413.122 – 413.123 (outpatient fee schedules), 412.300 – 412.352 (capital-related costs), 412.106, 412.320 (DSH), 412.105, 412.321 (IME), 413.75 – 413.32 (GME), 412.108 (Medicare dependent small, rural hospital), 413.70 (CAH), 413.74 (foreign hospital)
• Nursing facility – 42 C.F.R. §§ 413.330 – 413.355
• Home health agency – 42 C.F.R. §§ 413.25, 484.200 – 484.265
• Hospice – 42 C.F.R. §§ 418.301 – 418.405
• Ambulatory surgical center – 42 C.F.R. §§ 416.120 – 416.200
• Ambulance and air ambulance services – 42 C.F.R. §§ 414.601 – 414.625
• Federally qualified health center (FQHC) – 42 C.F.R. §§ 405.2430 – 405.2470
• Rural health center (RHC) – 42 C.F.R. §§ 405.2430 – 405.2470
• Health maintenance organization (HMO) – 42 C.F.R. §§ 417.524 – 417.598
• Medicare Advantage plan – 42 C.F.R. §§ 422.250 – 422.270, 422.300 – 422.324

Medicare Prescription Drug Benefit

• Plan sponsors – 42 C.F.R. §§ 423.500 – 423.423.516
• Coverage determinations, grievances and appeals – 42 C.F.R. §§ 423.560 – 423.638
• Contract appeals – 42 C.F.R. §§ 423.641 – 423.669
• Sanctions – 42 C.F.R. §§ 423.750 – 423.760
• Coordination with state pharmaceutical assistance programs – 42 C.F.R. § 423.464

Laws and Regulations Governing Clinical Research Activities
Protection of human subjects – 45 C.F.R. §§ 46.1 – 46.409, 46.103, 690.101 – 690.124; 21 C.F.R. §§ 50.1 – 50.56, 56.101 – 56.124
Scientific misconduct – 42 C.F.R. §§ 50.101 – 50.105; 45 C.F.R. §§ 689.1 – 689.10
Animal welfare – 7 U.S.C. § 2143; 9 C.F.R. §§ 2.30, 2.31, 2.32 – 2.38
HIPAA privacy in clinical research - 45 C.F.R §§ 164.512(i), 164.514(e)
Preventing conflict of interest – 42 C.F.R. §§ 50.601 – 50.607
DHHS grants – 45 C.F.R. §§ 74.1 – 74.91
Departmental Grants Appeals Board – 45 C.F.R. §§ 16.1 – 16.23
Nonprocurement debarment and suspension – 45 C.F.R. §§ 76.1 – 76.1020, 92.35


Laws and Regulations Affecting Hospital-Physician Relationships
Health Care Quality Improvement Act – 42 U.S.C. § 11101 et seq.
National Practitioner Data Bank – 45 C.F.R. § 60.1 – 60.14



PARTIAL LIST OF PENNSYLVANIA LAWS AND REGULATIONS APPLICABLE TO THE HEALTHCARE INDUSTRY

Medical Care Availability and Reduction of Error (MCARE) Act – 40 P.S. § 1303.101 et seq.

Licensure of hospitals, nursing homes, home health agencies, hospices, ambulatory surgical facilities, and freestanding radiation oncology facilities – 35 P.S. §§ 448.802a, 448.806, 448.811, 448.814, 448.816, 448.817.

Licensure of:

• Continuing care retirement communities – 40 P.S. § 3201 et seq.
• Dentists – 63 P.S. §§ 123.1, 129
• Mental health institutions -- 62 P.S. §§ 1001, 1002, 1026
• Personal care homes (assisted living) – 62 P.S. §§ 1001, 1002, 1026, 1057.1-1057.3
• Pharmacies – 63 P.S. §§ 390-4, 390-8
• Physicians – 63 P.S. §§ 422.9, 422.10, 422.41(allopathic physicians); 63 P.S. § 271.3, 271.11, 271. 15 (ostepathic physicians)
• Psychologists – 63 P.S. §§ 1203, 1208

Managed care – 40 P.S. § 1551 et seq. (HMOs), 40 P.S. § 764a (PPOs);

Medicaid fraud – 62 P.S. §§ 1406, 1407, 1408

Mental Health Procedures Act – 50 P.S. §§ 7101 et seq.

Reporting of professional misconduct – 35 P.S. § 448.806a