Don’t Ignore the Steady Drumbeat of Drug Importation Part 2

Back in April 2019 we published an article through Specialty Pharmacy Times titled “Don’t Ignore the Steady Drumbeat of Drug Importation?” Click here to read the article

However; we have been noticing lately that there is a lot more chatter on importation, especially from the Administration. It seems as though some state administration officials are moving forward with the idea of providing imported medications for their citizens. Besides the state ideas discussed in the article above, states like Maine, Colorado, Vermont, Michigan, New Hampshire and Florida are all currently debating what an importation program would look like in their states. 

This is all a result of increased discussions initiated by the President who has mentioned the goal of lowering drug prices several times since he took office. The President has been a supporter of importing prescription drugs from Canada, namely following Florida’s importation model that was recently enacted by the state’s legislature.

While there are many solutions to lowering drug prices, importation has been a policy that has supporters on both sides of the aisle. However; there are still questions of safety as well as whether importation will have the cooperation of stakeholders such as drug manufacturers, the supply chain, and the Canadian government.  

While it can be argued that importation may not gain too much momentum with the end of the year quickly approaching and the elections starting to heat up in 2020, we still don’t expect importation to go away. If you are a stakeholder and are interested in learning what either your legal or policy options are contact us at Lanton Law by clicking here.

Lanton Law's Webinar With WellSky Now Available

Our recently recorded webinar with WellSky titled “What home care policies to watch for the rest of 2019” is now available at https://info.wellsky.com/LP-Emerging-SPRX-and-IV-Policies.html Below is a description of the webinar:

Unlike anything we have experienced before, the backend of the legislative calendar year is proving to be louder than ever. While Capitol Hill is embroiled in contentious topics, issues that are more important to home infusion and specialty pharmacy industries are impacted, and slowly working their way through the system. The webinar discussed the following:

DIR and possible policy solutions

• Latest drug price and how these will impact specialty and home infusion stakeholders

• Patient co-payments and biosimilars

• The Home Health Payment Rule

New Lanton Law Webinar on December 4th with the American College of Apothecaries (ACA)

We have a new webinar on December 4, 2019 via the American College of Apothecaries (ACA) on CBD.

Cannabidiol (CBD) products are flooding the market at an alarming rate. Many consumer stakeholders are excited about this new product line, while providers such as pharmacies, natural health food stores, and other retailers are casting a watchful eye; torn between developing market strategies to meet demand while also watching for state and federal regulatory oversight. This webinar will discuss the various aspects of CBD regulations and market trends to give stakeholders a better understanding of the CBD environment for patient and market opportunities.

Register at: https://ce.ppsinc.org/index.cfm?pg=semwebCatalog&panel=showLive&seminarid=10631

What's Next for DIR Policy?

We have a new article in the American College of Apothecaries (ACA) titled “What’s Next for DIR Policy?” We will be having a new white paper on the subject coming out soon. In the meantime, this link will take you to the article in the ACA Fall Magazine 2019. https://acainfo.org/wp-content/uploads/flipbook/22/mobile/index.html#p=9

The Specialty Pharmacist's Role in Educating Patients about Biosimilars and Biologics

Ron Lanton III, Esq. of Lanton Law discusses with Specialty Pharmacy Times the specialty pharmacist's role in educating patients about biosimilars and biologics. https://www.pharmacytimes.com/news/the-specialty-pharmacists-role-in-educating-patients-about-biosimilars-and-biologics

Specialty pharmacies really can help the patient in getting the education out about biologics and biosimilar products in a number of different ways. First of all, the specialty pharmacy is very educated about what products are out on the market, and they’re in close communication with the physician. It’s also going to depend on the formulary and whether or not the pharmacy benefit manager or the carrier is actually going to carry the drug on the particular formulary. So I think if it does, I mean, obviously they don’t know everything about the patient’s formulary but they can find out that information and then see whether or not that’s good for the patient to take, as far as cost and outcomes-wise. So I think that with the specialty pharmacist being positioned in the center of everything, it’s a great position to be in for them to say, ‘Look, this is coming down. This is something I think that can help you, and let’s try and see if we can lower your costs and improve your outcome.’

New Administration Rules Seek Healthcare Cost Transparency

With the release of the Administration’s American Patient’s First Blueprint in May 2018, price transparency was shown to be a centerpiece of the Administration’s governing agenda. Last week, the Administration released two rules, each at different points of the rulemaking process. 

The first is a final rule effective 1/1/21 targeting hospitals that will require them to display their negotiated rate to patients. The second is a proposed rule which according to CMS  “includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping.” The proposal has a 60 day comment period. At this point in time there is no anticipated effective date.  

Pricing transparency continues to be a re-emerging theme that shows no signs of slowing down. If you need strategic advice or lobbying where price transparency is concerned, contact us at Lanton Strategies. If you need legal advice with regulatory or compliance concerns, contact us at Lanton Law.

New PBM Legislation Advances in Congress

Congresswoman Amy Spanberger (D-VA) has sponsored H.R. 2115 titled “Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act.” This is important for healthcare stakeholders, as this proposed legislation requires greater transparency for discounts provided by manufacturers. This bill also proposes to include real-time benefit information as part of a prescription drug plan’s electronic prescription program under Medicare. 

Below are a few of the bill’s highlights: 

“In order to allow the comparison of PBMs’ ability to negotiate rebates, discounts, direct and indirect remuneration fees, administrative fees, and price concessions and the amount of such rebates, discounts, direct and indirect remuneration fees, administrative fees, and price concessions that are passed through to plan sponsors, beginning January 1, 2020, the Secretary shall make available on the Internet website of the Department of Health and Human Services the information with respect to the second preceding calendar year provided to the Secretary on generic dispensing rates (as described in paragraph (1) of subsection (b)) and information provided to the Secretary under paragraphs (2) and (3) of such subsection that, as determined by the Secretary, is with respect to each PBM.”

Not later than January 1, 2021, the program shall implement real-time benefit tools that are capable of integrating with a prescribing health care professional’s electronic prescribing or electronic health record system for the transmission of formulary and benefit information in real time to prescribing health care professionals. With respect to a covered part D drug, such tools shall be capable of transmitting such information specific to an individual enrolled in a prescription drug plan. Such information shall include the following:

(I) A list of any clinically-appropriate alternatives to such drug included in the formulary of such plan.

(II) Cost-sharing information for such drug and such alternatives, including a description of any variance in cost sharing based on the pharmacy dispensing such drug or such alternatives.

(III) Information relating to whether such drug is included in the formulary of such plan and any prior authorization or other utilization management requirements applicable to such drug and such alternatives so included.

Conclusion:

Efforts to advocate for stronger PBM transparency has picked up in the last few years but this legislation which was voted 403-0 is telling. Usually this time of the year has Congress winding down its legislative agenda in preparation for the upcoming election. While I don’t expect to see too much legislation that is politically charged passing by year end, I do foresee either something on drug pricing or PBM transparency; if not both passing before we head into 2020. This Act is currently in the U.S. Senate. 

If you have additional questions about lobbying or need strategic advice on developing state or federal policies, contact Lanton Strategies or our sister company Lanton Law for regulatory compliance and legal issues.

The Specialty Pharmacist's Role in Educating Patients about Biosimilars and Biologics

Ron Lanton III, Esq., discusses the specialty pharmacist's role in educating patients about biosimilars and biologics on the following link: https://www.pharmacytimes.com/news/the-specialty-pharmacists-role-in-educating-patients-about-biosimilars-and-biologics

Below is the text of the interview.

Specialty pharmacies really can help the patient in getting the education out about biologics and biosimilar products in a number of different ways. First of all, the specialty pharmacy is very educated about what products are out on the market, and they’re in close communication with the physician. It’s also going to depend on the formulary and whether or not the pharmacy benefit manager or the carrier is actually going to carry the drug on the particular formulary. So I think if it does, I mean, obviously they don’t know everything about the patient’s formulary but they can find out that information and then see whether or not that’s good for the patient to take, as far as cost and outcomes-wise. So I think that with the specialty pharmacist being positioned in the center of everything, it’s a great position to be in for them to say, ‘Look, this is coming down. This is something I think that can help you, and let’s try and see if we can lower your costs and improve your outcome.’

The Challenges to Launching Biosimilars

Check out Ron Lanton’s interview with Specialty Pharmacy Times on “The Challenges to Launching Biosimilars” https://www.pharmacytimes.com/news/challenges-to-launching-biosimilars

Below we have provided the text from the interview as well:

Ron Lanton III, Esq.: Well, there are a few challenges to launching biosimilars after approved. One I can think of is litigation. So there’s been constant litigation between the biologic and the biosimilar to make sure that there is some kind of market exclusivity. So that’s the first thing. The second thing is that the biosimilars are actually fighting the patent thicket, so the biologic or innovator product is throwing up a lot of patents to keep the biosimilar off of the market, so you’re having a fight about that. I think education—so physicians, patients, they’re not really knowing too much about biosimilars and what some of these biological products are and kind of use them interchangeably because they don’t know about either/or. So I think a little bit more education is key, and I know that the FDA has been trying to put out a lot of policies recently to get more utilization out of this to drive down the cost of medication.

Is the Insulin Price Reduction Act the Right Answer to High Insulin Prices?

I have a new article in The Centers for Biosimilars titled Is the Insulin Price Reduction Act the Right Answer to High Insulin Prices? You can find the article by clicking on the following link: https://www.centerforbiosimilars.com/contributor/ron-lanton-III-esq/2019/10/is-the-insulin-price-reduction-act-the-right-answer-to-high-insulin-prices

If you cannot access the link above, I have put the text of the article below.

At this point in the legislative calendar, it is time to take a look at what may have a likely shot at passing Congress before the 2020 election season gets underway. With the contentious debate on drug pricing that has occurred during the last several months, insulin pricing is still garnering plenty of attention.

This summer saw the unveiling of bipartisan legislation aimed to deliver a policy solution to rising insulin prices. Titled the Insulin Price Reduction Act, otherwise known as S.2199, the proposed legislation sponsored by Senators Tom Carper, D-Delaware; Jeanne Shaheen, D-New Hampshire; Susan Collins, R-Maine; and Kevin Cramer, R-North Dakota, seeks to hold payers, manufacturers, and pharmacy benefit managers accountable for insulin price increases.

According to Senator Carper’s press release, the bill would create a new insulin pricing model “where the use of rebates would be restricted for any insulin product for which the manufacturer reduces the list price back to a level no higher than the price of the product in 2006. For the most popular insulins, this would result in more than a [75%] decrease in prices compared to what we can expect to see in 2020. These rebate restrictions would apply in Medicare Part D and the private insurance market. Private insurance plans would also be required to waive the deductible for insulin products that met the list price reduction criteria. To keep these rebate exemptions and deductible waivers in future years, the manufacturer would have to limit any list price increase to no more than medical inflation.”

The bill does have support from industry stakeholders. This bill has been endorsed by the JDRF, the American Diabetes Association (ADA) and the Congressional Diabetes Caucus, and the need for insulin access is there. According to the ADA, “Between 2002 and 2013, the average price of insulin nearly tripled. For more than 7.4 million Americans, including all individuals with type 1 diabetes, insulin is a life-sustaining medication for which there is no substitute.”

While having stakeholder support is important, it is not the only factor that determines whether this bill advances. There are several bills in Congress proposing similar solutions to insulin pricing, on top of FDA’s interest in lowering insulin prices via the development of biosimilar and interchangeable insulin products. Not to mention the fact that the US Department of the Treasury has implemented guidance aimed at making chronic medication access easier for beneficiaries with High Deductible Health Plans that include Health Savings Accounts.

While the bill is bipartisan, it would help if more senators from both sides signed on to show broadening support. However, with the looming election season, it remains questionable whether both sides can agree on if the Insulin Price Reduction Act is the right vehicle to lower insulin prices.

Specialty Pharmacy Times Interviews Ron Lanton on the Prescription Drug Price Relief Act

Watch Ron Lanton’s video with Specialty Pharmacy Times, as the Times gets his viewpoints on the pending Prescription Drug Price Relief Act.
https://www.pharmacytimes.com/news/prescription-drug-price-relief-act-of-2019

Here is the text of the interview:

The Prescription Drug Price Relief Act, that’s an interesting bill. Right now, it’s pending in Congress. It’s in the Senate HELP committee—the Health, Education, Labor, and Pensions Committee, otherwise known as Senate HELP. It’s sponsored by Bernie Sanders. And I’ve never seen this type of a bill before because what it does is it takes the IPI—the International Pricing Index—and it makes it a little bit more succinct. So the administration earlier had a blueprint where it talked about taking a drug and actually benchmarking it against 16 other countries, and this particular bill benchmarks the drug against 5 different countries. So it makes it a little smaller and more manageable to figure out how is the reimbursement going to be. What is interesting about this bill is that it has a couple of elements in it really aimed at drug pricing control and trying to get more generics and biosimilars out into the marketplace and, again, spelling out that IPI. What is interesting, though, is that it has 6 co-sponsors to it, and 5 of them are actually running for president, so I don’t think I’ve ever seen anything like this before. I’m not really sure if this is a bill to make a statement on, as the debates go, to maybe shape a future platform, or whether this is something that they’re going to continue to push. But if they do, they’re running out of legislative calendar time so that’s something to be mindful of.