Entrepreneurship Exam 2

1938: FD&C Act

Make drugs prove safety NOT EFFICACY YET

2007: FDA Amendments Act

Reauthorize PDUFA [Prescription Drug User Fee Act]

Authority to require REMS [Risk Evaluation and Mitigation Strategies]

Expanded clinical trials for Pediatrics

Had authority to charge fees for approving drugs

Limited FDA advisory members with conflicts of interest

2009: ARRA [American Recovery & Reinvestment Act]

Health Information Technology for Economic and Clinical Health (HITECH) Act

“Meaningful Use” of Electronic Health Records

• Used in meaningful manner (e-prescribing)

• Electronically exchange health information

• Use technology to submit clinical quality metrics

2010: ACA [Patient Protection & Affordable Care Act]

Overall: make it for all patients to get healthcare if you have insurance or not

Improve pharmacist’s ability to complete MTM [med therapy management] services

• “Providers of MTM”

Physician Payments Sunshine Act

Signed by President Barack Obama

2010: Safe & Secure Drug Disposal Act

DEA

Amended the Controlled Substances Act

Rules for patients & LTC facility disposal of unused controlled substances

Allows transfer of unused substances from user to authorized collector

Voluntary drug take-back events

2011: Reducing Prescription Drug Shortages Executive Order

Requires FDA to broaden reporting of possible drug shortages

Expedite reviews to avoid existing/potential shortages

Communicate evidence of stockpiling or exorbitant prices to DOJ

Signed by President Barack Obama

2012: FDA Safety & Innovation Act

Reauthorizes PDUFA

Amends FD&C Act from prescriptions & devices to include generics & biosimilars

Hospitals may repackage drugs if distributing within the health-system

Addresses drug shortages

• Life supporting, life sustaining, or prevents/treats debilitating disease

• Discontinuation of manufacturing

• Notify DHHS [Department of Health/Human Services] at least 6 mo prior

2013: DQSA [Drug Quality & Security Act]

Contains Drug Supply Change Security Act

Adds new section to FD&C

• Compounding facilities voluntarily register as “outsourcing facility”

Report to Secretary Q6 months and undergo FDA inspection

Product tracing requirements

Protect against counterfeit, stolen, contaminated, etc.

FDA: Food and Drug Administration

Approves new drugs to be sold in the US

Processes New Drug Applications (NDA)

Regulates package inserts

Regulates advertising of drugs

Issues recalls

AHRQ: Agency for Healthcare Research & Quality

Make health care safer, high quality, more accessible, equitable, & affordable

Works with Department of Health & Human Services [HHS] and other partners

Created the Consumer Assessment of Healthcare Providers & Systems [CAHPS]

Health services research arm of the United States

Established guidelines.gov [National Guidelines Clearinghouse]

NCQA: National Committee for Quality Assurance

Seal of approval = exceptional management, high-quality care, and service

Meet more than 60 standards, over 40 areas

Primary agency for accrediting Managed Care Organizations

Audits health plan data; provides metrics to employers

HEDIS [Healthcare Effectiveness Data & Information Set) used by > 90% of plans

TJC: The Joint Commission

National Patient Safety Goals + Sentinel Events

Former: Joint Commission on Accreditation of Healthcare Organizations [JCAHO]

A nonprofit founded by American Medical Association & College of Surgeons

Detailed survey & visit process-oriented, but increasingly outcome-based review

No accreditation could jeopardize funding from federal agencies like CMS

• [Centers for Medicare & Medicaid Services]

Requires tracking of performance improvement data

Antimicrobial Stewardship

Make sure patient on right agent, at right time, on right dose, for right duration

Implement services to ensure appropriate antibiotic use

Educate as to when antibiotics are NOT needed

Goal of Antomicrobial Stewardship

Control Costs

Combat Resistance

Improve Clinical Outcomes

The Joint Commission [TJC] - Regulatory Standards

Inpatient programs must address CDC’s Core Elements:

Leadership, Commitment, Accountability, Drug Expertise, Action, Tracking, Reporting, Education

The Joint Commission [TJC] - National Patient Safety Goals [NPSG]

Purpose: Improve patient safety

-use medicines safely [labeling meds & scanning properly], critical lab values, surgery, hand hygiene

The Joint Commission [TJC] - Sentinel Events

“Patient safety event [wrong organ] that reaches a patient and results in death, permanent harm, or severe temporary harm.”

• have to document + if TJC made aware, you got 45 days to report

CDC [Center of Disease Control] QI [Quality Improvement ] Measures

New Opioid Rx’s + Long-Term Opioid Therapy

• % of pt taking >50 MME/d & taking >90 MME/d

CMS [Center for Medicare & Medicaid Services]

Star Rating Systems on Medicare Advantage to Part D plans

Continued Quality Improvement [CQI]

systematic process of identifying, describing, and analyzing strengths and problems and then testing, implementing, learning from, and revising solutions

Model for Improvement - PDSA

Plan → Do → Study → Act

How Is Quality Measured?

Structure → Process -. Outcomes [ECHO] → Patient Experience

ECHO in Outcomes

Economic, Clinical, Humanistic, Outcomes

ISMP [Institute for Safe Medication Practices]

Error-Prone Abbreviations, High-Alert Med List, Do Not Crush List

Operating Revenue

Total cash inflow from your primary income-generating activity or activities

Operating Expenses

Costs incurred through regular business operations

Operating Margin

“Return on Sales”

measurement of how many dollars of profit a company earns per dollar of sales after paying operating expenses

Payer Mix

Proportion hospital payments received from different payers.

Diagnosis Related Group [DRG]

Patient classification relating the type of patients a hospital treats to the costs incurred by the hospital

Case Mix Index

average diagnosis related group (DRG) relative weight for that hospital

valuable to any organization expecting resources (including reimbursement for care costs) through CMC

Factors Impacting CMI

patient comorbidities, length of patient stay, DOCumentation specificity

Self-Pay

CMS requires disclosure of “discounted cash prices.”

Operating Revenue & Expenses

___ on the pharmacy budget equals the amount billed to patients for medications

• Pharmacy budget has 1 of the highest supply cost - personnel cost ratios

• 75% of total expenses attributed to drug supply costs

Break Even Point

where you are not earning a profit or operating at a loss

Break Even Sales Formula

__ = Fixed Expenses / Contribution Margin

Contribution Margin = monthly sales - variable expenses / monthly sales

Medication Interchanges

Simplifies inventory costs and choices

Makes treatments more affordable

GPO [Group Purchasing Organization]

Entity that negotiates discounted prices on medications and other products by aggregating their purchasing power

WAC [Whole Acquisition Cost]

Price paid by wholesalers from the manufacturers

“List Price”

340B

Federal program that requires manufacturers to sell outpatient drugs at a disconnected price