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SRI SAI COLLEGEOF PHARMACY

FDA Medicare Modernization Act 2003

Prepared by – Anil KumarM. Pharm ( Pharmaceutics )

Semester – 2ndRoll 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 bedsRural 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.gov4. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery

Systems, 9th edition, page 18.

THAT’S ALL