With the 2020 political season quickly approaching, healthcare and life sciences industry stakeholders have started showing interest in forming Political Action Committees (PACs).
A Political Action Committee or (PAC) is organized for the purpose of raising and spending money to either help candidates elected or defeated. These organizations represent industrial or ideological interests and are regulated under either state or federal campaign finance laws depending on the PAC’s usage.
PACs continue to be influential under the right guidance. Stakeholders that are more aggressive in advancing their political agendas have found that the use of PACs are effective in getting their respective messages out. Frier Levitt Government Affairs helps organizations create PACs and provides ongoing consultation regarding compliance, policy recommendations, and other strategic suggestions to help organizations achieve their respective goals.
The Massachusetts Health Policy Commission has released its analysis of state PBM activity titled, Cracking Open the Black Box of Pharmacy Benefit Managers. Notably, the report concludes the need for additional PBM oversight and scrutinized the practice of PBM spread pricing.
According to the report, PBM spread pricing practices appear to be increasing in Massachusetts: “…this practice covered 22% of PBM compensation in 2014, but rose to 54% in 2016. This practice, often used as a means of payment for PBM services instead of administrative fees, may have significant impacts on public insurance programs, employer health plans, and consumers. Additionally, the media has reported growing concerns from pharmacists about low reimbursement rates from PBMs in Massachusetts and other states. PBM payments to pharmacies are sometimes even below the pharmacy’s acquisition costs of the drugs, which can affect the financial viability of pharmacies and potentially impact access to care. Yet the extent to which PBMs profit from this practice, and on which drugs, remains largely hidden from payers and the public.”
Additionally, the Commission cited, “As part of the fiscal year 2020 state budget strategy on MassHealth drug prices, the Baker-Polito administration proposed a new requirement for PBMs to be transparent about their pricing and to limit PBM margins under contracts with MCOs and accountable care organizations (ACOs), which the administration projects will save $10 million. To advance transparency, MassHealth recently released a bulletin directing MCOs and MassHealth Accountable Care Partnership Plans to obtain and submit to MassHealth drug-specific data from their PBMs including payments to dispensing pharmacies and rebate and administrative payment data.”
Based on recent activities and discussions with Massachusetts, additional PBM policies are forthcoming. Frier Levitt Government Affairs’ (FLGA) forecasting and monitoring services help keep healthcare and life sciences stakeholders “in the know” regarding pending policy and marketplace changes. Forecasting and monitoring helps stakeholders make better strategic decisions so that they no longer just “reacting” to outside changes. Contact FLGA today for forecasting and monitoring services tailored for you and your organization.
Frier Levitt Government Affairs (FLGA) works with different individuals within the healthcare and life sciences sectors to provide relevant and up-to-date content for your immediate needs. This includes producing industry-leading white papers to circulate among the industry and content creation for websites, newsletters, and publications. FLGA also creates content specific to your organization for “leave behind” packets to help policymakers understand your issues. FLGA has extensive experience in tailoring content to specific audiences to help showcase products, services, or industry.
Types of content include, but are not limited to:
• White papers for state or national organizations
• Informative content regarding recent state or national policy trends to send to your membership
• “Leave behind” packets detailing your issues for meetings with legislators
Contact FLGA today to learn content options to meet your needs.
New York State Senator James Skoufis, Chair of the Senate Committee on Investigations & Government Operations, in coordination with Senator Gustavo Rivera, Chair of the Senate Committee on Health, has released the Final Investigative Report: Pharmacy Benefit Managers in New York. The report comes after the Committee opened an investigation into the practices of Pharmacy Benefit Managers (PBMs) in New York State in January 2019.
Some key findings of the report include:
• One of the key mechanisms by which PBMs generate revenue is through spread pricing
• The lack of transparency and oversight of PBMs has created an environment in which PBMs are able to engage in self-dealing to the detriment of consumers across New York State
• New York State must take immediate action to regulate the practices of spread pricing, MAC appeals, mail order operations, and reimbursements
• The New York State Comptroller should perform a full audit of all dollars paid to PBMs via spread pricing
Legislative recommendations provided by the report include:
• Regulate the practices of spread pricing in all pharmacy benefit contracts
• Enhance the transparency of MAC appeals
• Require the licensing and registration of PBMs to enhance accountability and oversight by instituting a fiduciary duty for their clients
• Prohibit PBMs from mandating that patients use specialty and mail order pharmacies
• Providing for the adequate and transparent reimbursements for pharmacies
• Require PBMs to pass-through all discounts or rebates received from drug manufacturers to its Medicaid managed care clients
This is definitely not the last time New York, or any other state, will develop policies to help regulate abusive PBM practices. Frier Levitt Government Affairs (FLGA) is constantly monitoring new state PBM policies and working with pharmacy stakeholders nationwide to have their voices heard. Contact FLGA today to learn more about getting involved.
Over the last week, three states- Alabama, Illinois and Louisiana- sent legislation to their respective Governor’s to sign aimed at fighting back against Pharmacy Benefit Managers (PBMs). Highlights of the pending legislative bills include:
Effective January 1, 2020, a PBM must be licensed by the Commissioner. The legislation also prohibits gag clauses. Furthermore, a health plan may not include a provision that requires an enrollee to make a payment for a prescription drug at the point of sale in an amount that exceeds the lessor of:
1. the contracted co-payment amount; or
2. the amount an individual would pay for a prescription if that individual were paying with cash.
This bill states that a contract between a health insurer and PBM must:
1. Require the PBM to update maximum allowable cost pricing information and maintain a process that will eliminate drugs from maximum allowable cost lists or modify drug prices to remain consistent with changes in pricing data
2. Prohibit the PBM from limiting a pharmacist’s ability to disclose the availability of a more affordable alternative drug
3. Prohibit the PBM from requiring an insured to make a payment for a prescription drug in an amount that exceeds the lesser of the applicable cost-sharing amount or the retail price of the drug
• Prohibits PBM spread pricing unless the PBM provides written notice consisting of spread pricing transparency to the insurer
• Provides the Board of Pharmacy with PBM oversight
• Requires PBM licensure
• Strengthens maximum allowable costs (MAC) requirements
• Creates a PBM monitoring advisory council
• Prohibits unfair or deceptive trade practices by PBMs including prohibits them from patient steering to a PBM owned pharmacy without disclosure and prohibits penalizing beneficiaries or inducing them to use a pharmacy that is PBM owned
• Prohibits retroactive denials or reductions in pharmacy claims that have already been approved by the PBM
This legislation provides a model for other states on ways to combat abusive PBM tactics.
Frier Levitt Government Affairs (FLGA) monitors new legislative developments for pharmacy stakeholders and provides tools to help keep them “in the know.” Contact FLGA today to learn more about new legislative developments and for help preparing legislation that will get you back on track to attaining a level playing field for your respective state(s).
Proposed regulations are something that are underutilized by healthcare and life sciences supply chain entities. While legislation captures all the excitement with lobbying and either amending or passing new laws, when it comes to healthcare, the gaps legislation oftentimes leaves open-ended are left to an agency to do the details of filling in the gaps. For example, specifics on reimbursement or licensing changes are usually done by the likes of CMS, FDA, HRSA or state departments of insurance.
Changes are done via rulemaking, which are found in the federal or state register. Through proposed rules, agencies give stakeholders an opportunity to comment on a rule change, which starts a certain timed process.
Participation in agency rulemakings are key because these rules affect the finer points of your operation. Additionally, not knowing about a change in these critical rules can oftentimes result in adverse action from an agency like a fine or a warning letter if your compliance is not up to date.
Frier Levitt Government Affairs (FLGA) guides healthcare and life sciences stakeholders through the regulatory comment process. FLGA looks at your business model, monitors for proposals that will impact you, and counsels you on strategic next steps. Additionally, healthcare and life sciences stakeholders will get the benefit of working with boutique healthcare law firm Frier Levitt, LLC, who will help ensure that your company stays compliant with any news rules that are promulgated.
FLGA offers a hybrid service flexible with an organization’s changing needs. We monitor and forecast regulatory issues of importance in a concise, easy to understand and time friendly format. Our monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.
With regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact Frier Levitt Government Affairs today to get “in the know” and finally be prepared for regulatory changes ahead.
Senators Alexander (R-TN) and Murray (D-WA) of the U.S. Senate Health, Education, Labor and Pensions Committee, have introduced the introduced the Lower Health Care Cost Act as their proposal to decrease health care costs. This large piece of legislation will address issues such as surprise medical billing, prescription drug prices, and vaccine hesitancy.
The bill addresses patent protections to open markets to generic medications. In addition, the bill tackles PBM business practices by requiring PBM transparency through mandated quarterly reports from PBMs regarding fees, costs, and rebate information, as well as limits their spread pricing practices.
Senator Alexander has stated his desire for the bill to get to the Senate floor by July 2019.
With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive.
Frier Levitt Government Affairs (FLGA) offers a hybrid service flexible with an organization’s changing needs. FLGA monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.
Contact FLGA today to get “in the know” and start preparing for the changes ahead.
A coalition of over 40 state attorneys general and Puerto Rico have filed a federal lawsuit in Connecticut against several of the largest generic drug manufacturers as the coalition alleges the defendants conspired to manipulate prices for more than 100 prescription drugs that target chronic disease states such as HIV, diabetes, oncology and arthritis.
According to the lawsuit, the AGs reference how the generic pharmaceutical industry has a “fair share” agreement where they have “operated pursuant to an understanding among generic manufacturers not to compete with each other and to instead settle” for a fair share. “Rather than enter a particular generic drug market by competing on price in order to gain market share, competitors in the generic drug industry would systematically and routinely communicate with one another directly, divvy up customers to create an artificial equilibrium in the market, and then maintain anticompetitively high prices.” In alleging industry discussion, negotiation and collusion among the industry over the years, the suit goes into describing Teva and other co-conspirators involvement.
Additionally, the AGs allege in the suit that, “At the zenith of this collusive activity involving Teva, during a 19-month period beginning in July 2013 and continuing through January 2015, Teva significantly raised prices on approximately 112 different generic drugs. Of those 112 different drugs, Teva colluded with its “High Quality” competitors on at least 86 of them (the others were largely in markets where Teva was exclusive). The size of the price increases varied, but a number of them were well over 1,000%.”
What is interesting about this case is that this is the second one in three years that has been filed in this investigation. The first lawsuit was filed in 2016 in the U.S. District Court for the Eastern District of Pennsylvania. According to the suit, “the defendant and co-conspirators knowingly entered into and engaged in a combination and conspiracy with other persons and entities engaged in the production and sale of generic pharmaceutical products, including doxycycline hyclate, the primary purpose of which was to allocate customers, rig bids, and fix and maintain prices of doxycycline hyclate sold in the United States. The combination and conspiracy engaged in by the defendant and co-conspirators was in unreasonable restraint of interstate and foreign trade and commerce in violation of Section 1 of the Sherman Act (15 U.S.C. § 1).” That case is still ongoing as two former manufacturer executives have entered into their respective settlement agreements and are cooperating with the investigating AGs.
In addition to the aforementioned lawsuit, Congress has been active on generic drug pricing. While the Senate Finance Committee has been holding a series of hearings with Pharmacy Benefit Managers (PBMs) and manufacturers, this March the House Energy and Commerce Committee held a hearing titled, “Lowering the Cost of Prescription Drugs: Reducing Barrier to Market Competition,” where several bills were heard whose objectives where to essentially create a more consumer friendly generic marketplace.
The issue of drug price is not going away anytime soon. Frier Levitt Government Affairs (FLGA) is uniquely positioned in being a hybrid company that gives you a complete perspective. FLGA educates manufacturers and other life sciences stakeholders on legal developments, tracks and consults on state and federal policymaking, and keeps them informed on marketplace changes. If you are a manufacturer or life sciences stakeholder looking to learn more about your competitors, how your market is going to look over the next few years, or whether you can take advantage of either a law or a rule where your product is concerned, contact FLGA to learn about the options available.
Many healthcare and life sciences industry stakeholders often wish they knew about pending laws before they are enacted, why a new regulation was drafted the way it was, or why they are being asked about information from a supply chain partner on an issue they knew nothing about. Not being “in the know” raises the risk of being unprepared for an emerging law or regulation and can also hurt a business’ bottom line.
Frier Levitt Government Affairs (FLGA) offers a hybrid service flexible with an organization’s changing needs. FLGA monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.
With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact Frier Levitt Government Affairs today to get “in the know” and finally be prepared for the changes ahead.
On May 17, 2019, CMS announced a delay in its final national coverage determination for Chimeric Antigen Receptor (CAR) T-cell therapy. Using a patient’s own immune system to attack cancer cells, CAR T-cell therapy has been getting more and more recognition as the potential next step for oncology over the last year.
According to CMS’s announcement, CAR T-cell therapy is a precision cancer treatment wherein each treatment dose is individually manufactured for the patient using their own T-cells, a type of white blood cell known as a lymphocyte. CAR T-cell therapy is a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers. Treatment protocols vary, but may be summarized in five steps:
1. lymphocyte harvesting from the patient with cancer;
2. creation of cancer-targeting lymphocytes in vitro using various immune modulators;
3. selection of lymphocytes with reactivity to cancer antigens using enzyme-linked immuno-assay;
4. depletion of the patient’s remaining lymphocytes using immunosuppressive agents;
5. transfusion of the cancer-targeting lymphocytes back into the patient with cancer-this transfusion represents one treatment.
Frier Levitt Government Affairs (FLGA) has been monitoring developments in this sector since early 2018 and continues to follow the latest news.
FLGA’s forecasting and monitoring services help keep healthcare and life sciences stakeholders “in the know” regarding pending policy and marketplace changes. Forecasting and monitoring helps stakeholders make better strategic decisions so that they no longer just “reacting” to outside changes. Contact FLGA today for tailored forecasting and monitoring services for you and your organization.
