As drug price transparency measures proliferate across states, the National Academy of State Health Policy (NASHP) has released revised model transparency legislation featuring a common data set to reduce reporter burden and yield standardized, actionable data that will be comparable across states. The data — to be reported by manufacturers, pharmacy benefit managers (PBMs), wholesalers, and insurers — will help state policymakers understand what is driving high drug prices through a comprehensive look across the entire drug supply chain.
This 2.0 version of NASHP’s model transparency bill also contains stronger penalties for failure to report. States will have the ability to audit any data submitted, and require a reporting entity to submit a corrective action plan for reporting deficiencies. If reporting entities do not provide the required data or if the data they provided is inadequate, the model bill allows states to invoke subpoena authority.
NASHP developed the model bill and common data set in collaboration with a work group of states currently implementing or considering transparency laws and Mathematica Policy Research. Last week, Maine State Sen. Eloise Vitelli introduced legislation based on NASHP’s updated model transparency legislation. The model bill is available in a streamlined formed as enabling legislation, as well in a longer, comprehensive version that includes in-depth information detailing the reporting requirements of the minimum data set. Additional information about the legislation, including reporting thresholds and data elements that must be reported, are available in this Q&A document. In coming weeks, NASHP will also publish customized reporting templates for manufacturers, PBMs, wholesalers, and insurers.
While NASHP’s model transparency bill builds off existing transparency measures, the common data set requires the collection of additional information not otherwise publically available, including specific information about past and projected costs and revenues at the individual drug level. Some of this information may be considered proprietary, and the model bill includes language to protect it while still requiring an annual report and public hearing to share and explore findings – although in a manner that does not reveal information specific to any one reporting entity. This reporting will provide states with more information to determine what drives high prices – and how to take effective action to address them.
States interested in this model legislation will have access to NASHP’s technical assistance. Please contact Jennifer Reck for more information.
Unrelenting and unpredictable increases in prescription drug prices have spurred states to try to unlock the black box of manufacturer pricing strategies by requiring disclosure of how prices are set and how rebates are handled throughout the supply chain.
Six states already have transparency laws on their books and almost two dozen more have introduced transparency bills during the 2019 session. In 2017, Maryland enacted a first-in-the-nation law prohibiting price gouging by drug manufacturers. Though the law is tied up in legal challenges, other states have introduced related bills to curb rapid and large drug price increases.
On the heels of ongoing state actions, federal lawmakers introduced a number of similar bills in Congress this month. These bills are able to leverage enforcement mechanisms beyond those available to states. For example, Sen. Richard Durbin (IL) and Rep. Jared Golden (ME) have introduced the Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act. FLAT would require companies to report price hikes and would limit the market exclusivity period granted with a drug patent if the price of the drug goes up more than 10 percent in one year, 18 percent in two years, or 25 percent in three years. Failure to report price hikes would limit a drug’s exclusivity period further.
Sen. Ron Wyden (OR) also introduced several transparency bills. The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act requires the Health and Human Services secretary to request price justifications from manufacturers if prices increases surpass a threshold of 100 percent over one year or 300 percent over five years. Justification is also required if a drug has a more modest price increase yet falls within the top 50th percentile of Medicare or Medicaid spending. The bill allows manufacturers to forego reporting if they lower their prices.
Wyden also followed states’ leads in pursuing transparency around undisclosed rebates that pharmacy benefit managers (PBMs) negotiate with manufacturers. (Click here for a comparison of 31 PBM laws passed by 20 states.) Wyden’s Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act requires reporting by PBMs on the total amount of rebates they receive. Following an initial two years of reporting on these rebates, the law would establish a yet-to-be-determined percentage of rebates that PBMs must pass through to health plans in order to lower premiums or other consumer cost sharing.
Last October, Congressional legislation mirrored state laws when two federal bills regulating PBMs became law. Both federal laws prohibit gag clauses — once common provisions in PBM’s contracts with pharmacists that prevented them from disclosing lower-cost drug options to consumers. One bill prohibits gag clauses under Medicare Part D starting in 2020 and the other, affecting private insurance markets, went into effect immediately.
Thirty-three states had outlawed gag clauses before passage of the federal ban, another example of how state initiatives are now reflected in federal law. To track state activity to bring down drug costs, visit the National Academy for State Health Policy’s Center for State Rx Drug Pricing.
One week into the 2019 legislative season, lawmakers from 11 states have already submitted 30 bills to address the rising cost of prescription drugs.
The bills submitted to date seek to implement wholesale drug importation programs, increase pharmaceutical pricing transparency, and regulate pharmacy benefit managers (PBMs), along with other drug cost containment initiatives.
Last year, nine states introduced legislation to either study or implement wholesale drug importation, and Vermont became the first state to pass an importation bill. This year, Colorado has reintroduced a bill that would require its Department of Health Care Policy to design a wholesale importation program, and Missouri also reintroduced a bill to study importation.
Requiring transparency into dramatic price hikes to understand better prescription drug pricing is also expected to remain an area of interest for state lawmakers. In 2018, five states enacted laws that require pharmaceutical manufacturers, PBMs, and health plans to share information behind prescription drug costs and their increases. A newly proposed bill in Texas would require greater pricing transparency for essential diabetes medications, following in the footsteps of Nevada, which passed a similar measure in 2017.
One of the most popular, bipartisan drug pricing legislation passed during the last session was regulation of PBMs. More than 90 PBM bills were introduced last year with 20 states enacting 31 of them. In October, following the legislative precedent taken by dozens of states, Congress passed legislation to prevent gag clauses in PBM contracts to allow pharmacists to share pricing information with consumers. While the prohibition on gag clauses now applies throughout the country, states continue to explore innovative ways to contain costs within the drug supply chain.
During the new 2019 season, eight states have filed 16 bills focusing on PBMs. In Montana, legislation would regulate the way health insurers contract with PBMs to prevent spread pricing — a payment model that allows PBMs to profit by charging insurance plan sponsors more for a prescription than the PBM pays the dispensing pharmacy. The lack of transparency in the spread-pricing model makes it difficult for states to identify how much spread pricing contributes to their overall drug costs. Montana’s proposed legislation is designed to lower health plan premiums for consumers.
With 46 states convening their 2019 legislative sessions and 13 states already introducing bills to curb rising prescription drug costs, clearly this a top priority for many state lawmakers. This is not surprising, in 2018 state lawmakers filed more than 170 prescription drug cost containment bills, with 45 enacted.
Drug prices were frequently mentioned by state and national candidates during the 2018 midterm elections. As national attention on drug prices expands, states will continue to explore solutions to curb the rising cost of pharmaceuticals. The National Academy for State Health Policy (NASHP) will continue to track state’s prescription drug cost bills as they are introduced, enacted, and implemented. To learn more about each state’s drug cost containment bills, explore NASHP’s Legislative Tracker.
In late December, 2018, the National Academy for State Health Policy (NASHP) hosted a webinar exploring Oklahoma Medicaid agency’s use of innovative alternative payment models (APMs) through contracts negotiated with drug manufacturers, which link supplemental rebates to patient outcomes.
The webinar, Medicaid Alternative Payment Models for Prescription Drugs: Do They Add Value for States?, featured speakers from Oklahoma’s Health Care Authority, which obtained a Medicaid State Plan Amendment in June 2018 to implement the APM. Below is a summary of questions and answers about Oklahoma’s groundbreaking program taken from the webinar. A recording of the webinar and its slides are available here.
What are some examples of Oklahoma’s Medicaid APMs for prescription drugs?
Below is a chart outlining the drug, manufacturer, therapeutic class, and outcomes measured for Oklahoma’s first four APMs.
|Drug Name||Manufacturer||Therapeutic Class||Outcome Measured|
|Aripiprazole lauroxil (Aristada)||Alkermes||Long-acting, injectable antipsychotic||Patient adherence to medication|
|Oritavancin (Orbativ)||Melinta||IV antibiotic for bacterial skin infections||Net costs to the state|
|Invega Trinza and Sustenna||Janssen/Johnson & Johnson||Long-acting, injectable antipsychotic||Overall population adherence|
How much staff time is required for the negotiation and contracting processes? How can states balance the benefits of this innovation with the cost of administering the agreements?
Oklahoma received financial support from NASHP for initial analysis and staff time. As that support concludes, Oklahoma officials are currently discussing how the state can supply the staff time needed to complete the upfront work of these contracts. Officials report the Medicaid program must review utilization data to help determine if both parties are pursuing the right patient population, products, and disease states, etc. One potential source of funding for this work could be drug manufacturers. Oklahoma officials plan to discuss how this initiative could be funded sustainably with manufacturers and may build this financial risk into future agreements. Oklahoma is also considering imposing a fee on manufacturers to pay for the initial data aggregation.
Were the drugs selected in the four agreements chosen because of manufacturers’ willingness to engage in these contracts, or did Oklahoma’s Medicaid agency determine what drugs were selected?
Oklahoma wanted a variety of agreements to focus on different drugs in order to test potential APMs for other state Medicaid programs. Oklahoma found that both parties should come to the table with some ideas but expect and be open to discussion. Negotiations were most successful when manufacturers established potential parameters for an agreement before beginning contract discussions. Negotiations succeeded when both parties had an opportunity to have a trusting, but direct conversation about what product might be a good fit. Despite the need to compromise, Oklahoma was able to ensure that each contract had the potential to be beneficial and fair for both sides.
Do any of Oklahoma’s agreements use “fill rate” (the rate at which patients adhere to or fill their prescriptions) or “cure rate” (the proportion of people that are cured from a treatment) to determine value?
Fill rate is used in some of the agreements. Oklahoma is interested in cure rates as an outcome, but it is challenging to obtain accurate, timely outcomes data around cure rates. If Oklahoma officials can find reliable data that both parties can agree on, then they will likely move forward in this area.
Oklahoma has only executed financial APMs that focused on price-volume agreements (as volume increases, unit price decreases), market share, or utilization (adherence).Two of the executed contracts focused on drug adherence. Oklahoma’s first contract with Alkermes for a long-acting, injectable antipsychotic rewards increased patient adherence with a lower drug price for the state through additional rebates. Oklahoma also entered into a contract with Janssen/Johnson & Johnson for another long-action, injectable antipsychotic that focused on increased population level adherence.
Is Oklahoma Medicaid restricting the reimbursement of therapeutically-similar drugs that are not covered by the state’s APM agreements?
None of Oklahoma’s APM agreements involves “disadvantaging” or impeding access to any products not covered by the APM agreements, such as changing their status on the preferred drug list. Two of Oklahoma’s APM agreements do, however, entail removing the prior authorization requirement for the drug in question in exchange for a guarantee of overall cost neutrality (e.g., Melinta’s Orbactiv product and Eisai’s Fycompa product).
Are Oklahoma’s agreements restricted to specialty products?
No, Oklahoma’s agreements were not restricted to any particular drug product or class.
Did Oklahoma find there were high-cost, specialty drug manufacturers interested in APM opportunities?
Oklahoma officials initially approached manufacturers of high-cost, specialty drugs, but they were not interested in completing an APM agreement. Since the completion of the first four agreements, however, officials have considered an agreement where Oklahoma would pay for a very high-cost drug over a defined period of time (e.g., several years) or might pay a different rate depending on whether a person was or was not cured.
These types of manufacturers are beginning to discuss APMs, but it may be a bit early to put one of these kinds of products in the APM arena, but discussions are ongoing. From a manufacturer’s perspective, entering into specialty drug agreements can be challenging because the smaller patient pools who use these drugs make it more difficult to show a clear benefit around such measures as increased adherence or reduced hospitalizations.
When will Oklahoma see results?
Oklahoma’s APM contracts are one-year contracts and initial results will be available after mid-2019. Additional contract periods may be necessary to allow enough time to identity their financial impact.
How are Oklahoma’s APMs expected to reduce hospitalizations?
Oklahoma’s contract with the manufacturer Eisai measures reductions in hospitalizations following initiation of its epilepsy drug Fycompa. If Fycompa does not reduce hospitalizations, the state will receive money back in the form of supplemental rebates.
Oklahoma’s contract with Melinta for oritavancin (Orbativ) removes the requirement for prior authorization in return for an assurance that the state will not see a net increase in costs. Although it is a high-priced drug, oritavancin does not require hospitalization for administration like other drugs in its class, so reduced costly hospitalizations are expected.
Who is Oklahoma Medicaid’s pharmacy benefit manager?
Oklahoma’s Medicaid program is fee for service (FFS) and does not contract with a pharmacy benefits manager (PBM). The Pharmacy Management Consultants and the Oklahoma Healthcare Authority are the pharmacy benefits administrators for the Oklahoma Medicaid program. The Pharmacy Management Consultants are a division of the Oklahoma University College of Pharmacy. This structure allows for data aggregation and analysis and also gives Oklahoma the capability to research other outcomes not necessarily stated in the contractual agreements, such as unintended outcomes, additional benefits, and other health-related outcomes.
Oklahoma is advancing APMs in a FFS environment. Would these APMs work in a state with Medicaid managed care?
Oklahoma officials noted that APM agreements may be easier to achieve in their FFS environment because it allows for efficient discussions and negotiations between just one payer and one manufacturer. While Oklahoma was the only state with APMs for Medicaid prescription drugs as of December 2018, Michigan has since followed Oklahoma’s lead, receiving federal approval in November 2018 for a Medicaid State Plan Amendment to enable APMs. Michigan operates several types of managed care programs that provide health services to Medicaid beneficiaries and may soon be able to offer valuable insights into achieving APM agreements in managed care settings. The success of APMs in states with Medicaid managed care will also depend on how each state sets up with its managed care organizations (MCOs). Some states get all their data from MCOs and require them to follow one drug formulary, which would allow a state to more easily manage APMs.
Do the manufacturers Oklahoma currently contracts with have statewide services with all pharmacy outlets or do some manufacturers limit the distribution of their product? And, is this a factor when deciding whether to contract with a manufacturer?
To date, Oklahoma’s APMs have not caused changes in pharmacy outlets’ services. When there are more agreements involving specialty products, this may be more of an issue and require additional discussion, but Oklahoma officials believe it can be addressed and negotiated in their agreements.
More information on this topic is available at the University of Oklahoma’s College of Pharmacy’s presentation, Overcoming Barriers to Value-Based Contracting.
During the 2018 legislative session, 28 states passed 45 laws to curb the rising cost of prescription drugs. In addition to legislative solutions, states are taking administrative action to better manage state spending on Medicaid pharmacy benefits. Ohio, West Virginia, and Vermont offer examples of states taking innovative administrative approaches to rein in drug costs.
Ohio Medicaid Replaces Spread Pricing with More Transparency
In August, the Ohio Department of Medicaid announced it would require its five managed care plans to end contracts with pharmacy benefit managers (PBMs) that used “spread pricing.” Spread pricing is a payment model that allows PBMs to profit by charging insurance plan sponsors more for a prescription than the PBM pays the dispensing pharmacy. The lack of transparency in the spread-pricing model makes it difficult for states to identify how much spread pricing contributes to their overall drug costs.
Ohio investigated the impact of spread pricing and found it generated an 8.8 percent PBM markup on its Medicaid managed care pharmacy claims, a margin that enabled PBMs to pocket an average of $5.70 per prescription dispensed. In response, starting Jan. 1, 2019, Ohio will require managed care plans to use a transparent, pass-through payment model that requires PBMs to charge Medicaid exactly what they pay the dispensing pharmacy. To compensate PBMs under this pass-through pricing model, Medicaid managed care plans will pay PBMs an administrative fee estimated at 95 cents to $1.90 per prescription. To meet the deadline, managed care plans are working with PBMs to restructure contracts to comply with the pass-through requirement.
In contrast to Ohio’s administrative approach, Louisiana’s 2018 spread pricing law, Act 483, bans PBMs that contract with the state from retaining any revenue in excess of the amount the PBM paid to the pharmacy through spread pricing.
West Virginia Ends Use of PBMs
In 2017, West Virginia stopped using PBMs altogether after an audit revealed that public employee health plans were charged 1 percent more for prescription drug claims than PBMs were paying pharmacies. Lawmakers determined the 1 percent cost the state $10 million per year.
Instead of using PBMs to administer pharmacy benefits for state workers and Medicaid beneficiaries, West Virginia now acts as its own PBM under a fee-for-service model run by its Bureau for Medical Services’ Office of Pharmacy Services (OPS). In addition to managing the single state preferred drug list, which had previously been used across managed care plans, OPS developed a Preferred Diabetes Supply List. The state pharmacy board estimates that carving out pharmacy benefits from its Medicaid managed care program will save the state $38 million in the first year. Administrative cost savings and modifications to dispensing cost formulas helped achieve those savings.
Vermont Explores a Direct Relationship with a Wholesaler
The Department of Vermont Health Access (DHVA) released a Request for Information (RFI) in September to explore potential savings from establishing a direct relationship with a drug wholesaler. The RFI was in response to a legislative mandate in Act 193 that requires the state to identify opportunities for saving in the prescription drug supply chain. Under this model, payment for drugs would flow directly from DHVA to the wholesaler. Currently, pharmacies purchase drugs directly from wholesalers and are then reimbursed by DHVA. All publicly-funded prescription benefits in Vermont are reimbursed under a fee-for-service model, and pharmacy reimbursement rates are set by the state, not a pharmacy benefit manager. As a result, DHVA makes all payments to pharmacies directly, and not through a third party.
A direct relationship between a wholesaler and the state would allow DHVA to purchase drugs in a manner similar to the 340B Drug Pricing Program model, which may present savings opportunities. DHVA must report its findings to the Vermont legislature by Nov. 15, 2018.
Recent action, both administrative and legislative, reflects states’ growing demand for more transparent pricing and payment models. Learn more about all state action on curbing drug costs at the National Academy for State Health Policy’s Center for State Rx Drug Pricing, a warehouse of resources, including model legislation, new state laws, and legal analysis.
*Update: On Oct. 10, 2018, President Trump signed two bills designed to increase prescription drug price transparency by prohibiting gag clauses, which prevent pharmacists from disclosing lower-cost drug options to consumers. One bill prohibits gag clauses under Medicare Part D starting in 2020 and the other affects private insurance markets and goes into effect immediately.
As states take the lead implementing dozens of innovative laws to curb the rising costs of prescription drugs, the federal government is following with a recent wave of proposed bills and rule changes designed to rein in drug costs nationally.
This year, state legislatures approved an unprecedented number of measures to curb crippling drug costs, from enacting drug price transparency laws in seven states to addressing objectionable pharmacy benefit manager (PBM) business practices in 20 states. Vermont recently passed a measure enabling the state to pursue federal certification for a wholesale importation program from Canada.
The momentum and range of activity at the state level has parallel, emerging federal action — serving as a reminder of the vital role states play as incubators for innovation. The federal government has recently taken the following action:
- Following passage of Vermont’s wholesale importation law (Act 133), the US Department of Health and Human Services announced in July it would form a work group to study importation of off-patent (generic) drugs. This federal study is not expected to directly impact Vermont’s importation plan. A regulatory channel that permits the Vermont program to move forward already exists within federal law (Section 804 of the Federal Food, Drug, and Cosmetic Act). This provision requires a state to certify the safety and cost-savings of its importation program. Vermont is poised to be the first applicant for federal certification for wholesale importation and, if approved, would serve as the state model for this approach.
- On Aug. 30, 2018, a federal judge dismissed the trade group Pharmaceutical Research and Manufacturers of America’s (PhRMA) complaint against California’s drug price transparency law (SB 17). The court decided PhRMA did not provide sufficient evidence to back its claim that the law attempted to “dictate national health care policy.” The law requires all drug price hikes of 16 percent or more over a two-year period to be subject to state transparency law review. PhRMA now has 30 days to submit new evidence to back its claims. The National Academy for State Health Policy (NASHP) will report updates on court action related to this lawsuit.
- Following in the footsteps of 17 states that have passed laws banning gag clauses in PBM contracts, which prohibit pharmacists from disclosing lower-cost drug options to consumers, the US Senate last week unanimously passed a bipartisan bill to ban gag clauses that impact patients enrolled in Medicare Advantage and Medicare Part D.
- In a parallel move, last week the House Energy and Commerce’s health subcommittee also unanimously advanced their own bill banning PBM gag clauses.
- To underscore that drug prices are a bipartisan issue, in May the Trump Administration released its Blueprint to Lower Drug Costs and recently Congressional Democrats released their own Better Deal proposal that includes many drug price control measures already implemented by states, including:
- Anti-price-gouging legislation that fines manufacturers for “unconscionable” price increases, similar to what Maryland (MD 631) passed, and
- Transparency legislation, similar to what seven state legislatures have approved, which requires manufacturers to justify large price increases.
- To underscore that drug prices are a bipartisan issue, in May the Trump Administration released its Blueprint to Lower Drug Costs and recently Congressional Democrats released their own Better Deal proposal that includes many drug price control measures already implemented by states, including:
- NASHP is also tracking the recent release of a Centers for Medicare & Medicaid Services proposed rule, Regulation to Require Drug Pricing Transparency, and will publish more information about the proposal as it becomes available.
The recent federal legislation and policy proposals demonstrate that when states lead and create innovative policy on important issues such as drug prices, federal action often follows. Learn more about state action on drug prices at NASHP’s Center for State Rx Drug Pricing, a warehouse for resources such as model legislation and legal analysis.
The National Academy for State Health Policy (NASHP) has released model legislation to help states shed light on the opaque business practices of pharmacy benefit managers (PBMs). States can use the model bill to require the licensing of PBMs, ban gag clauses that prevent pharmacists from sharing lower-price drug options with consumers, and require more transparency into who profits from rebates.
This year alone, more than 80 PBM bills have been introduced in state legislatures across the country and 26 became law. NASHP developed its new PBM transparency model act in consultation with its Pharmacy Cost Work Group following a review of these recently-enacted PBM laws.
States have implemented PBM legislation in response to its current business model, which has been criticized as anti-consumer and anti-competitive.
- Formulary design that increases PBM revenue at the expense of consumers. A formulary is an insurance plan’s list of covered prescription drugs that usually includes multiple tiers with varying copays. This tier pricing, designed by PBMs, produces financial incentives to drive consumers to purchase “preferred” drugs.
- Some PBMs penalize consumers by charging them more for shopping at pharmacies that they do not have an ownership stake in.
- Some PBM contracts prevent pharmacists from providing lower-priced drug options to consumers.
- Some PBMs have reimbursement practices that are not fair to pharmacists; and
- Some PBMs may not always serve the financial interest of their health plan clients.
The PBM business model appears to have a very basic conflict of interest – the rebates that drug manufacturers pay to PBMs are based on a percentage of the drugs purchased by the PBM. The result? Higher drug prices translate into higher rebates paid to PBMs, and only a portion of those rebates are shared with the PBM’s health plan clients or consumers. While higher drug prices generate more net revenue to PBMs, higher drug prices also mean that the health plan, pharmacy, and consumer end up paying more for prescription drugs. And, those rebate negotiations all take place under the cloak of confidentiality. This lack of transparency appears to benefit drug manufacturers, allowing them to negotiate prices without any public disclosure of discounts.
In the complex structure of prescription drug markets, “payers” are not always “purchasers.” Purchasers are pharmacies, hospitals, clinics, and nursing facilities that provide drugs to patients. Payers (insurers and their PBMs) reimburse purchasers for the drugs they dispense to patients. Drug manufacturers don’t give their deepest discounts to purchasers because these discounts are not typically passed from the purchaser (the hospital, pharmacy, etc.) to the ultimate payer (the insurer or its PBM).
Rebates allow manufacturers to focus their price concessions on the payers who can help or harm a manufacturer’s drug sales. Manufacturer price concessions don’t necessarily show up at the pharmacy counter as discounts that benefit consumers. As drug costs continue to rise, consumers pay more and more for their drugs because what consumers pay is based on the cost of the drug to the pharmacy.
Transparency measures in NASHP’s model PBM bill seek to provide answers to some key questions, including:
- Who really benefits from rebates and how much do they get?
- How are rebates and price concessions used?
- Do rebates reduce insurance premiums or do they boost PBM company stock prices?
It is hard to assess the impact of a PBM’s business model on health care costs, but there is growing concern that PBMs do not really add value to health care systems and may instead be contributing to rising health care costs. This is why states, who are major purchasers of drugs through their Medicaid programs, want more transparency into what PBMs do and how they do it.
While investigating the PBM’s business model is necessary, this legislation is just one strategy for states to combat ever-rising drug prices. Drug manufacturers’ price increases are not solved by policies aimed only at PBMs or insurers. The PBM business model is simply one component of the drug supply chain’s market dysfunction – but it is not the most significant. Explore NASHP’s Center for State Rx Drug Pricing for other model legislation that can help address drug prices, including drug affordability review (rate setting), manufacturer drug price transparency, and wholesale drug importation here.