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FDA Medicare
Modernization Act 2003
Prepared by – Anil Kumar
M. Pharm ( Pharmaceutics )
Semester – 2nd
Roll No. 1529004
CONTENTS
- FDA
- FDA Medicare Modernization Act
- Objectives
- Brief History
- Prescription Drugs benefits
- Provisions
a. Rural providers provisions
b. Physician provisions
c. other provisions
- Medicare Administration
- Advantages/benefits
FDA -
Mission of FDA –
To protect the public health –
- Against risk associated with production, distribution & sale
of food & food additives
- Human drugs and biologics
- Radiologic and medical devices
- Animal drugs and feeds
- & cosmetics.
FDA Medicare Modernization Act 2003–
Also called as – Medicare Prescription Drug, Improvement
and Modernization Act.
Objective –
- Act provide for a voluntary prescription drug benefit under
the Medicare program
- Strengthen & improve the Medicare program
- An attempt to relieve patients of some of the financial
burden of prescription drugs
Brief History –
- Introduced by representative Dennis J. Hastert – June
25, 2003
- Passed the House(assembly) – June 27, 2003
- Passed the SENATE ( deliberative assembly or
Parliament ) – July 7, 2003
- Reported by joint conference committee – November
21, 2003, agreed by House Nov. 22, agreed by Senate
Nov. 25
- Finally signed into the law by President George W.
Bush – December 8, 2003
PRESCRIPTION DRUGS BENEFITS (Medicare Part D )
–
- Mostly beneficial in prescription drugs for tax breaks
- Provide prescription coverage consisting of either certain
reductions in cost sharing
- helpful where prescriptions harder to afford
- Provide subsidies to large employers from eliminating
private prescription coverage
- Negotiating discounts with drug companies
- Electronic prescription program - Act requires the Secretary
to develop electronic prescription standards
- information on the drug being prescribed, drugs listed in
the patient’s medication history available on lower-cost
PROVISIONS –
a. For Rural providers –
- Medicare payments to certain rural providers increase.
- Many of the rural provisions benefit urban providers as
well.
Rural Hospitals - limit on rural and small urban hospitals
payments increases from 5.25% to 12%.
Critical Access Hospitals - bed limit increased from 15 to 25,
there is no restriction on the number of these beds
Rural Physicians - Rural physicians in newly established areas
receive a 5% increase in Medicare payments.
b. For physicians –
Medicare’s payments for practice expenses increased starting
in 2004.
c. Other Provisions –
Durable Medical Equipments -payment for certain items,
oxygen and oxygen equipment, wheelchairs, diabetic lancets
and testing strips, hospital beds etc. are reduced.
Initial Physical Examination - this Medicare coverage begins
on or after January 1, 2005.
Cardiovascular Screening Blood Tests - Medicare coverage
of cardiovascular screening blood tests is authorized.
Diabetes screening test, immune deficiency disease tests also
authorized.
- Gives extra $25 billion to rural hospitals.
- Adds a pretax health savings account for working people.
- Support electronic prescribing.
Medicare Administration –
Medicare Administrative Contractors ( MAC ) serving both
part A and part B.
Administration consolidated into Jurisdictions.
PART A – divided into Fifteen Jurisdictions
- contains a group of different states.
PART B – Four specialty jurisdictions i.e. A,B,C,D.
- To handle durable medical equipment
- Home/hospital health claims.
Advantage/Benefits-
- Elderly constitute only 15% of U.S. Population, but
account foe 40% of country’s drug costs.
- Retiree health plans, Medicare+Choise plans are major
sources of prescription drugs
- The benefits have been scaled up 25% medicare
beneficiaries.
- Discount drug cards available to those with Medicare
Part A/Medicare Part B
- Via drug discount programs, patients can receive
approx. 10-15% reductions in price of medications.
- Medicare beneficiaries pay 25% of all prescription drug
costs.
- Patients can choose to receive covered services &
prescription drug coverage under Medicare Advantage
Program.
- Prescription drug benefit will cost approx. $720 billion over
the next 10 years.
- change the way physicians practice medicine.
- Directly affect the physician-patient relationship
- Strengthen the relationship by removing barriers to health
care access, prescription & disease management programs.
REFERNCES –
1. American Academy of Family Physicians, Family Practice
Management 2005, March, 12(3), Page 49-52.
2. Congressional Research Service report, Medicare
Prescription Drug, Improvement and Modernization Act of
2003, Updated December 6, 2004.
3. www.fda.gov
4. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery
Systems, 9th edition, page 18.
FDA MMA 2003

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FDA MMA 2003

  • 1.
  • 2. FDA Medicare Modernization Act 2003 Prepared by – Anil Kumar M. Pharm ( Pharmaceutics ) Semester – 2nd Roll No. 1529004
  • 3. CONTENTS - FDA - FDA Medicare Modernization Act - Objectives - Brief History - Prescription Drugs benefits - Provisions a. Rural providers provisions b. Physician provisions c. other provisions - Medicare Administration - Advantages/benefits
  • 4. FDA - Mission of FDA – To protect the public health – - Against risk associated with production, distribution & sale of food & food additives - Human drugs and biologics - Radiologic and medical devices - Animal drugs and feeds - & cosmetics. FDA Medicare Modernization Act 2003– Also called as – Medicare Prescription Drug, Improvement and Modernization Act.
  • 5. Objective – - Act provide for a voluntary prescription drug benefit under the Medicare program - Strengthen & improve the Medicare program - An attempt to relieve patients of some of the financial burden of prescription drugs
  • 6. Brief History – - Introduced by representative Dennis J. Hastert – June 25, 2003 - Passed the House(assembly) – June 27, 2003 - Passed the SENATE ( deliberative assembly or Parliament ) – July 7, 2003 - Reported by joint conference committee – November 21, 2003, agreed by House Nov. 22, agreed by Senate Nov. 25 - Finally signed into the law by President George W. Bush – December 8, 2003
  • 7. PRESCRIPTION DRUGS BENEFITS (Medicare Part D ) – - Mostly beneficial in prescription drugs for tax breaks - Provide prescription coverage consisting of either certain reductions in cost sharing - helpful where prescriptions harder to afford - Provide subsidies to large employers from eliminating private prescription coverage - Negotiating discounts with drug companies - Electronic prescription program - Act requires the Secretary to develop electronic prescription standards - information on the drug being prescribed, drugs listed in the patient’s medication history available on lower-cost
  • 8. PROVISIONS – a. For Rural providers – - Medicare payments to certain rural providers increase. - Many of the rural provisions benefit urban providers as well. Rural Hospitals - limit on rural and small urban hospitals payments increases from 5.25% to 12%. Critical Access Hospitals - bed limit increased from 15 to 25, there is no restriction on the number of these beds Rural Physicians - Rural physicians in newly established areas receive a 5% increase in Medicare payments. b. For physicians – Medicare’s payments for practice expenses increased starting in 2004.
  • 9. c. Other Provisions – Durable Medical Equipments -payment for certain items, oxygen and oxygen equipment, wheelchairs, diabetic lancets and testing strips, hospital beds etc. are reduced. Initial Physical Examination - this Medicare coverage begins on or after January 1, 2005. Cardiovascular Screening Blood Tests - Medicare coverage of cardiovascular screening blood tests is authorized. Diabetes screening test, immune deficiency disease tests also authorized. - Gives extra $25 billion to rural hospitals. - Adds a pretax health savings account for working people. - Support electronic prescribing.
  • 10. Medicare Administration – Medicare Administrative Contractors ( MAC ) serving both part A and part B. Administration consolidated into Jurisdictions. PART A – divided into Fifteen Jurisdictions - contains a group of different states. PART B – Four specialty jurisdictions i.e. A,B,C,D. - To handle durable medical equipment - Home/hospital health claims.
  • 11. Advantage/Benefits- - Elderly constitute only 15% of U.S. Population, but account foe 40% of country’s drug costs. - Retiree health plans, Medicare+Choise plans are major sources of prescription drugs - The benefits have been scaled up 25% medicare beneficiaries. - Discount drug cards available to those with Medicare Part A/Medicare Part B - Via drug discount programs, patients can receive approx. 10-15% reductions in price of medications. - Medicare beneficiaries pay 25% of all prescription drug costs.
  • 12. - Patients can choose to receive covered services & prescription drug coverage under Medicare Advantage Program. - Prescription drug benefit will cost approx. $720 billion over the next 10 years. - change the way physicians practice medicine. - Directly affect the physician-patient relationship - Strengthen the relationship by removing barriers to health care access, prescription & disease management programs.
  • 13. REFERNCES – 1. American Academy of Family Physicians, Family Practice Management 2005, March, 12(3), Page 49-52. 2. Congressional Research Service report, Medicare Prescription Drug, Improvement and Modernization Act of 2003, Updated December 6, 2004. 3. www.fda.gov 4. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th edition, page 18.