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Healthcare Reform - Pharmacy Benefits (Medicaid, Medicare Advantage and Medicare Part D)

The PPACA and HERA - are expected to have some Impact on pharmacy plans as well. Most changes are targeted at Medicaid and Medicare, though.

Transparency Related Regulations 
MA-PDs, PDPs and plans participating in health exchanges will be expected to additionally report on a few additional parameters -
1. Mail order / retail prescription volume ratios, as well as generic dispensing rates.
2. Rebates and discounts, as well as the percentage of the rebates / discounts passed through to the plan sponsor
3. Spread Pricing Percentages (difference between what health plans paid for the prescriptions vs what the PBM pays its suppliers)
This will translate into additional federal and state oversight of PBM businesses. Parameters such as mail order vs retail, generic dispensing rates etc., should be part of standard reporting for most PBMs and should n't mean much. But disclosure related to rebate pass throughs and spread pricing percentages are likely to cause a lot of discomfort to PBMs - since traditionally this has been the core business models of PBMs - aggregate demand and negotiate for bulk discounts. But over the last 4 - 5 years, a lot of hue and cry has been raised with regard to the need for more transparency in the PBM business,and regard rebate pass through in particular. This initiative is clearly aimed at addressing this concern.

Medicaid Related Regulations 
For Medicaid, Pharmaceutical Manufacturers contract directly with HHS to obtain medicaid coverage for their prescription drugs and pay rebates to the HHS. The rebates would be either 15.1% of the AMP (manufacturer reported average manufacturer price) and Manufacturer best price (lowest price per unit for any buyer for that manufacturer) - for branded drugs and 11% for generics currently. Every quarter pricing data is provided to HHS by the manufacturers. The HHS then calculates the rebate amounts based on the actual drug utilization data. This rebate amount is normally shared between the federal government and the states. The healthcare reform act proposes an increase in minimum rebates on branded drugs to 23.1% (from 15.1%) and on generics to 13% (from 11%). Federal government will retain a higher percentage of the rebates. In addition, Medcaid MCOs will be eligible for Sec 340B (healthcare pricing act) which was previously open only to state medicaid programs and some non profits. Also some drugs previously not included in the benefits have been included (Benzodiapenes, Barbiturates and smoking cessation drugs).
As far as pharmacy plans are concerned, this may have a minimal impact or low impact, mostly administrative in nature.

Medicare Advantage Prescription Plans and Medicare Part D impact 
Reduction of the Donut Hole Gap 
Currently, Part D members hit a coverage gap (commonly referred to as the 'Donut Hole') - once their drug costs have gone beyond a specified threshold. The members are responsible for 100% of their drug costs in this range, till they hit the amount when catastrophic coverage kicks in. In 2010, patients who hit the donut hole will be eligible for a refund of $250. Starting 2011, the donut hole will be subsidized for branded drugs by pharma manufacturers to the extent of 50%, the remaining 50% is to be paid by patients through 2012. Starting 2013, medicare pays an increasing percentage of the patients 50% till it levels off in 2020 at 25%. So in 2020, the cost sharing for the donut hole would be 50-25-25 (pharma - patients - medicare). For generic drugs, medicare contribution to donut hole will begin with 7% in 2010, till it levels off at 75% in 2010. The idea behind this - is clearly to eliminate the donut hole. In addition, the threshold for catastrophic coverage will also be reduced to decrease the impact of the donut hole.
pharmacy plans are not likely to be impacted to a large extent by this regulation, except for changes in their plan administration and claim processing set ups.

Increase in Drug Coverage 
Given that the drug coverage in part D is described as "all drugs covered in medicaid", Part D will now have to include coverage for Benzodiapenes and barbiturates (used for treatment of epilepsy, cancer, or a chronic mental disorder).
From a Pharmacy Plans Perspective, This may have a slight upward effect on premium costs, due to increase in coverage.

Additional Formulary Requirements 
Plans will need to include all available drugs in their formulary for classes / categories identified by the secretary (protected classes).
This particular regulation has the potential to drive up drug costs for prescription plans and in turn, the premiums, if a large number of classes / categories are designated as protected by the secretary of the HHS.

Simplification of Annual Beneficiary Election Period 
Open enrolment period for MAs are eliminated and beneficiaries can return to their Traditional and Part D plan within the first 45 days of the year if they want to. Also the annual co ordinated election period for Part C and D plans has been increased by 1 month. This is likely to lead to administrative simplification.

Improved complaints systems, Uniform Exceptions (Forms) and Appeals Process
This regulation is likely to lead to administrative simplification for Pharmacy Plans.

RDS - Removal of Tax Deductibility
The RDS is a subsidy offered by the CMS - which provides payments to the extent of 28% to retiree drug plans offered by employers and unions.The RDS amount currently is tax deductible. As of 2010, RDS impacts 4000 plan sponsors and 7 million members.  The healthcare reform act proposes to remove the tax deductibility from 2013. The cost to large corporate sponsors is expected to be high - AT&T has estimated the cost to be $1Bn and Verizon - $970 mn. The plans will need to start booking the financial impact as of 2010, due to changes in tax deductibility.  Plans may also experience additional administrative costs as sponsors may consider migrating to other retiree plans, if found financially better or may decide to stop offering retiree benefits altogether.

High Income Premiums increased for Part D 
There is no direct impact on Prescription Plans

Low Income Benchmark Calculation Change and 'De Minimis' rule 
This is targetted at Part D plans - to reduced frequent changes in enrolment for beneficiaries. Impact of medicare Part C will be removed from the calculations of medicare part D low income subsidies. This is done because, Part C premiums are generally lower, since they can apply the rebates of part A and B to the Part C premiums (11% to reduction of premiums. An additional 5% can be applied to increase of benefits - but that shouldn't impact the premiums). This may mean lower administrative costs for prescription plans, higher subsidies - but in some regions where there is a high rate of medicare advantage enrolments, there could be some uncertainty for the plans.

Authority to Deny Bids
The secretary will be enpowered to deny bids which may proposed increased cost sharing or decreased coverage. Since this restricts the ability of plans to tweak with cost share or coverage to keep premium costs lower, this may result in increases in premiums cost - but this may be very low impact.

Additionally there are some areas which may have a tangential impact on PBM operations -

  1. Sunshine act provisions for disclosure of any potential for conflict of interests between physician and physician groups, GPOs , Pharmaceutical manufacturers as well as medical devices companies, 
  2. Reporting for samples of prescription drugs provided to physicians as part of marketing 
  3. Enabling the FDA to authorize generics for biologicals / specialty drugs, with the definition of a new approval pathway for the same
Related Posts By Me:
Impact of Healthcare Reform on Health Insurance Industry - http://healthreflect.blogspot.com/2010/02/hi_13.html




This post first appeared on Through The Looking Glass...., please read the originial post: here

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Healthcare Reform - Pharmacy Benefits (Medicaid, Medicare Advantage and Medicare Part D)

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