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Prescription: Washington

May Provide Useful Data, But Not Downward Pressure on Prices
Congressional deliberations over several competing bills on drug-price transparency may generate some useful data but are unlikely to have any effect on prices.
Stephen Barlas
Will “All of Us” provide clues on the origins of various illnesses? Congress hopes that analyzing the medical and biological data of millions of people will boost precision medicine and help predict outcomes.
Stephen Barlas
Several drug-price “remedy” bills are floating around Congress, with most being described as a “first step.” So why is no one referring to that step as significant?
Stephen Barlas
Reverse Payments Crimped, Patent Thickets Untouched
How easy is it for generics to enter the market? It could be easier with legislation that opens up the field for generic competitors, but it is unlikely that such a bill will ever be introduced.
Stephen Barlas
The current rebate “safe harbor” encourages drug manufacturers to inflate list prices. The HHS’s newly proposed rule threatens to eliminate this safe harbor but offers two new ones instead.
Stephen Barlas
What role, if any, do group purchasing organizations play in drug shortages?
Stephen Barlas

Will the new opioid abuse bill prove more effective than its predecessor? A plethora of provisions will have little impact on pharmacists and pharmaceuticals.

Stephen Barlas
Controversial Issues Included, Some Excluded

President Trump’s American Patients First plan to reduce drug prices has some innovative aspects but might face political roadblocks.

Stephan Barlas
Outsourcing Facilities Can Be Co-Located With 503A Pharmacies

FDA guidance on outsourcing facilities and 503A pharmacies

Stephen Barlas
Has the DEA Been Fast and Flexible Enough?

Hospitals search for IV opioids

Stephen Barlas
Upcoming Guidance Documents Will Spell Out What and How to Submit

Upcoming Guidance Documents Will Spell Out What and How to Submit

Stephen Barlas
Price-Lowering Ideas Generated, Some Already in Motion

White House report on drug prices is a detailed road map

Stephen Barlas

CMS consideration of rebate overhaul elicits strong opinions

Stephen Barlas

NIH starts to spend billions in Cures drug research money

Stephen Barlas

CMS considering pharmacy counter discounts for Part D drugs in the future

Stephen Barlas
Door Opens to More Step Therapy And Indication-Based Formularies

As the door opens to more step therapy and indication-based formularies, P&T committees must walk a fine line between managing treatment costs and providing access to critical drugs.

Stephen Barlas
P&T Committees Can Receive Data Beyond the Drug Label

P&T committees may soon have access to more than drug-label information as HHS considers implementing a safe harbor for value-based contracts between drug manufacturers and health insurers.

Stephen Barlas
P&T Committees Can Receive Data Beyond the Drug Label

The FDA has made it easier for P&T committees to make formulary coverage decisions by expanding the health care economics information that drug manufacturers can provide to them.

Stephen Barlas

CMS finalizes drastic 340B reimbursement cut for 2018

Stephen Barlas

Hospitals press FCC to expand health care on the airwaves

Stephen Barlas
Industry Seeking Clarification of Terms and Requirements

FDA delays drug-tracking pilot programs

Stephen Barlas

A significant change in tiering exceptions policy for Part D is coming in 2018

Stephen Barlas

Drug companies breathe easier as PDUFA VI heads for approval

Stephen Barlas
Is It an About–Face From the FDA on Off-Label Promotion?

Drug companies worry about new FDA “totality of evidence” standard

Stephen Barlas

FDA pleases no one with final guidance on biological and biosimilar naming

Stephen Barlas
New FDA and GAO Reports Highlight Continuing Issues

New FDA and GAO reports highlight compounding issues

Stephen Barlas
But Moving Away from Clinical Trials Worries Some

21st Century Cures bill may lead to faster drug/device approvals

Stephen Barlas

Over-the-counter products in line for user fee program

Stephen Barlas

Medicare allows add-on payments to hospitals for some new products

Stephen Barlas
But Democrats Could Run at Least One Off the Rails

Off-label drug bills are back on track but could run off the rails

Stephen Barlas
Roadblocks Remain to Quieting Drug Pricing Controversies

Plan to settle 340B disputes is itself the focus of a dispute

Stephen Barlas
Bill Provision Sides With Brand-Name Companies Over USP

Congress set to tackle biosimilar naming debate

Stephen Barlas
Rules Severely Limit Distribution

Recent FDA compounding guidances raise hackles

Stephen Barlas
Drug Access and Formulary Construction Still Unguided

HHS walks a middle ground in final nondiscrimination rule

Stephen Barlas
Program Seeks to Reduce Use of Expensive Biologics

CMS Medicare Part B reimbursement plan panned

Stephen Barlas
States May Jump Into the Void

CMS stands pat on exchange formulary standards

Stephen Barlas
Changes to NAIC Model Act Would Restrict Formularies, Too

Tighter P&T committee rules proposed for NAIC model act.

Stephen Barlas
Agency Tries to Expand List of Useable “Bulk Drug Substances”

Confusion, ire follow FDA interim policy on compounding.

Stephen Barlas
They Push in Opposite Ways on Eligibility, Discounts, and More

340B guidance upsets both hospitals and drug makers.

Stephen Barlas

Medicare names plans for Part D MTM demo

Stephen Barlas
Can the FDA Do More to Encourage Their Development?

Can the FDA do more to encourage orphan drug development?

Stephen Barlas
Potential Law Would Clarify When Brand-Name Manufacturers Must Supply Drug Samples

Generic companies press for REMS relief with Senate bill

Stephen Barlas

FDA deluged with opinions on biosimilar naming plans.

Stephen Barlas
No “Give” on Drug Pricing, Cost Shifting, and Other Concerns

The Centers for Medicare and Medicaid Service’s final ACO rule offers little for pharmacists.

Stephen Barlas
Changes to Medical Loss Ratio, Network Adequacy Disputed

CMS Medicaid plan ignores major drug-access issues.

Stephen Barlas
New Labeling Is Possible; Pre-Market Testing Seems Unlikely

FDA may step up enforcement for homeopathic products.

Stephen Barlas
A Website Would Replace Paper Package Inserts

Pharmacist access to prescribing information may change.

Stephen Barlas
Proof Needed of “Independent” Members’ Independence

Seeking proof of P&T committee members’ independence

Stephen Barlas
Accreditors Look Closely at Some Practices but Not at Others

Medicare oversight of hospital compounding is questioned.

Stephen Barlas
Sandoz’s Filgrastim Faces Naming and Court Hurdles

As first biosimilar approval nears, key questions remain.

Stephen Barlas
An Accurate Accounting of Those GPO Rebates Is at Issue

GAO eyes group purchasing organization hospital rebates.

Stephen Barlas
Medicare Is Finally Offering More Flexibility for MTM Programs

Pharmacists are the focus of drug adherence pilot program.

Stephen Barlas
Confusion as Deadline Passes: Paper, Digital, or Web Portal?

Pharmacies wrestle with the FDA’s new drug-tracing rule.

Stephen Barlas
The Definitions of “Distribution” and “Inordinate” Stir Concern

The FDA’s plan for interstate compounding jars hospitals.

Stephen Barlas
But Restrictions Imposed by the DEA Are a Disincentive
Hospitals can collect leftover narcotics—but will they?
Stephen Barlas

In a new 340B controversy, OPA rebuffs a court ruling

Stephen Barlas
QHPs Must Respond Within 24 Hours to “Expedited” Requests
HHS adjusts its formulary “exception” policy for 2015.
Stephen Barlas
Congressional and Patient-Group Opposition to Other, More Controversial Part D Reforms Sank the Plan
Medicare ditches medication therapy management changes
Stephen Barlas

FDA starts light-touch inspections for some imports.

Stephen Barlas
The Impacts on Pharmacy Workload and Prescription Drug Abuse Are at Issue
DEA’s hydrocodone combination plan divides pharmacists.
Stephen Barlas
Office of Pharmacy Affairs Promises Regulatory Response
Investigators question 340B contract pharmacy programs.
Stephen Barlas
FDA Proposal Seeks to Improve Early Warning System
Drug makers and hospitals spar over shortage reporting.
Stephen Barlas
American Hospital Association Wants New Concessions

Hospitals gain a year to meet stage 2 meaningful use rules.

Stephen Barlas
Is the Bar Being Set Too High, or Too Low?

FDA draft guidance on 503B compounding widely faulted

Stephen Barlas
However, the Agency’s Requirements Are Still Unclear

The FDA has accepted its first biosimilar application.

Stephen Barlas
Pharmacists want the FDA to standardize REMS programs.
Stephen Barlas
Drug Companies Push to Rein in 340B Discount Drugs
Drug companies push to rein in 340B discount drugs.
Stephen Barlas
Senate Bill’s Exemption of Hospital Pharmacies Stirs Debate
A Senate bill that exempts hospital compounding pharmacies from some rules is stirring debate.
Stephen Barlas
Hospital Pharmacies Will Need to Read 2D Bar Codes
Congress finally addresses track-and-trace technology.
Stephen Barlas
New medicare Part D rules and possible cuts to hospitals
Stephen Barlas
More Scrutiny for Hospital Pharmacies
FDA pushes plans for drug compounding
Stephen Barlas
Health Plans and PBMs Block Broader Drug Access For Patients and Businesses

Patients and small businesses might not be able to obtain some brand-name drugs when the new health exchanges are in place.

Stephen Barlas
Accessing Formularies in Health Plans Is a Major Problem
The DHS pushes to expand e-prescribing. Pharmacy groups push back.
Stephen Barlas
Technical Complexities of Labels Could Compromise Utility
A proposed FDA rule on unique device identification could complicate billing and bar-coding procedures for hospitals.
Stephen Barlas
Facilities Able to Scan Unique Device Identifiers Will Benefit
New FDA rules on medical devices shouldn’t be a burden for hospitals that can scan unique device identifiers.
Stephen Barlas
Modest Changes Walk Narrow Political Line
Stricter labeling requirements for ER and LA opioids might not be enough.
Stephen Barlas
Pharmacies and Their Vendors Worry About Quality
More FDA regulation of HIT looms large.
Stephen Barlas
How Directly Will They Be Affected?
Pharmacists will need to become well versed in the FDA’s REMS for opioids.
Stephen Barlas
Act Omits Key Provisions Sought by Pharmacy Groups
The FDA’s PDUFA reauthorization bill passes but omits significant safety provisions.
Stephen Barlas
Drug companies may be required to report shortages sooner, but the FDA legislation still lacks power.
Stephen Barlas
Differentiating ‘Scientific Exchange’ From ‘Promotion’ Is Complicated
Stephen Barlas
Federal Funding Levels Remain Uncertain
Stephen Barlas
Action Should Spur Faster FDA Approvals
Stephen Barlas
Acceptance or Rejection by Stakeholders Will Influence Congress
Stephen Barlas
Republicans Say Requirements for Incentives Are Set Too Low
Hospitals will need to add more pharmacy data into their electronic records systems to meet “Stage 2” CMS criteria.
Stephen Barlas
Payment Would Be for Transitional Care After Hospital Discharge

A new Medicare “G” code for transitional care may help to reduce the number of hospital readmissions.

Stephen Barlas
Why Hospitals Are Paying Exorbitant Drug Prices
Hospitals are paying exorbitant prices for drugs because of an insidious “gray market” pipeline.
Stephen Barlas
Who Is Asking for the Information Anyway?
Stephen Barlas
Slow Review Time and Safety Are at Issue
Stephen Barlas
Senate Bill Might Help … or Not
Stephen Barlas
Will the FDA Quickly Define an Abbreviated Pathway for Biosimilars?
Stephen Barlas
Hospital Payments Will Depend on Performance in Fiscal Year 2013
Stephen Barlas
Medicare to Define Which Professionals Can Join in 2012
Stephen Barlas
Pharmacists to Play a Secondary Role in New Physician–Hospital Organizations
Stephen Barlas
California Pharmacists Initiate Lawsuits
Stephen Barlas
But They Are Not Yet Recovering Overhead Costs for Expensive Drugs
Stephen Barlas