340B Helps the Needy Every Day

As we prepare for the 21st MDRP Summit, which will include a full day workshop on the 340B drug discount program, it’s worth taking a look at the current state of 340B and the role it plays to help vulnerable and low-income Americans get access to vital healthcare services.

Twenty seven million Americans remain uninsured, according to new numbers from the Centers for Disease Control. Among those under 65 with private insurance, 40 percent are enrolled in high-deductible plans. That’s an increase of 15 percent since 2010.

The result is that safety-net providers are seeing more patients who either lack insurance altogether or who cannot pay the deductibles their policies require. 340B hospitals treat these patients regardless. But treating the poor and underinsured is staggeringly expensive. 340B facilities provide 60 percent of all uncompensated care despite the fact that they represent only about one third of all hospitals. That figure comes to nearly $25 billion annually.

Safety-net hospitals care for nearly twice the number of low-come patients as other providers and more than two times the number of disabled, African American, Hispanic and Native Americans. Add to this the fact that 340B disproportionate share hospitals are more likely to provide money-losing services such as labor and delivery, HIV/AIDS care and trauma centers and the picture becomes crystal clear.

The 340B law is structured so that hospitals access savings by providing discounted drugs to all patients, including those with insurance. Congress wrote the law this way, and that’s how it’s been implemented since the beginning of the program more than twenty years ago. In addition to the documented evidence that 340B hospitals provide more uncompensated care and treat more low income patients, hospitals report using their drug discount savings in numerous ways that meet the program's purpose – enabling providers to stretch dollars so they can serve more patients and improve care.

340B makes it possible for Boston Medical Center to increase the number of Naloxone opioid overdose rescue kits dispensed. In Richmond, Va., 340B enables Virginia Commonwealth University Health System to operate primary care clinics and coordinate services for uninsured individuals. MetroHealth System in Cleveland, Ohio uses program savings to provide free and low-cost oncology care, as well as reduced prices on insulin and rescue inhalers.

The program saves lives. Jack Custalow of Richmond, VA, received treatment for a defective heart valve. Tammy Willette of Greensburg, IN, faced aggressive breast cancer with no insurance. Dorian-Gray Alexander couldn’t afford his HIV medications.

340B has been a highly successful partnership that results in better care for the underserved in America. Safety-net providers treat all patients who walk in the door.

The 340B program is essential to continuing that mission.

The author:

Maureen Testoni, Senior Vice President and General Counsel at Safety Net Hospitals for Pharmaceutical Access. 

Election 2016: What Each Candidate Could Mean for Pharma

Every four years we are inundated with non-stop coverage of the presidential election, with both sides vying contentiously for control of the White House as well as Congress. Thankfully, each election year also brings us the Summer Olympics, which offer a brief but much-needed respite from the talking heads and partisan bickering. For two short weeks, Americans come together to support the heroes who motivate and inspire us all, before returning to the ones who polarize and divide us. It’s easy for all of us to rally behind Michael Phelps and Simone Biles, sharing in their successes and taking pride in the honor they bring to our country. However, reaching a consensus on Trump and Clinton is a different story.

After the Olympics are over and the kids are back in school, Government Pricing professionals will convene in Chicago once again for IIR’s 21st Annual Summit on the Medicaid Drug Rebate Program (MDRP). We will all come with our own opinions and political convictions, but we will also be wondering how our day-to-day responsibilities will be impacted by the election. Although we at Government Pricing Specialists (GPS) don’t have a crystal ball, we can compare and contrast the candidates’ platforms, and how they could change the face of GP. Here are their positions on a few GP-related issues:

The Patient Protection and Affordable Care Act (ACA)

• Clinton – Per her website, Clinton would “Defend and expand the Affordable Care Act, which covers 20 million people.”

• Trump – Per Trump’s website, “On day one of the Trump Administration, we will ask Congress to immediately deliver a full repeal of Obamacare.”

• Potential GP Impact:  

Under a Clinton presidency, if the ACA stands, the changes codified in the recent MDRP Final Rule would likely remain in effect but the “Cadillac Tax,” the excise tax on high-cost health insurance plans, would likely be repealed. 

Under a Trump presidency, the legitimacy of the Final Rule could be challenged if the ACA is repealed. However, repealing the ACA may be difficult since taking away a benefit is usually unpopular with voters. If the Republicans control both houses of Congress, it is more likely that substantial changes to the ACA would be introduced but if Democrats control the House of Representatives or the Senate, it is unlikely that we will see significant change.

Medicaid

• Clinton – Per Clinton’s website, she would “Fight for health insurance for the lowest-income Americans in every state by incentivizing states to expand Medicaid – and make enrollment through Medicaid and the Affordable Care Act easier.” 

• Trump – Trump has said that the Federal Government should provide block-grants to the states for Medicaid, that it should be entirely controlled by the states which he believes would reduce the fraud, abuse, and waste. 

• Potential GP Impact:

Under Clinton, if Medicaid enrollment increases, Medicaid sales would likely increase, as would the volume of Medicaid rebates. 

Under Trump, if federal funding is reduced, it could actually put pressure on manufacturers to provide more in terms of rebates. However, Trump believes that his plan to get more Americans working would actually reduce the need for Medicaid because more people would have access to health insurance through their employer.

Medicare

• Clinton – Per her website, Clinton would “require drug manufacturers to provide rebates for low-income Medicare enrollees that are equivalent to rebates in the Medicaid program.” She would also “Allow Medicare to negotiate drug and biologic prices… Clinton believes that we should drive the best bargain for Americans, and especially for senior citizens, by allowing Medicare to negotiate drug prices, notably for high-cost drugs with limited competition.” Clinton also supports the idea of allowing people to “buy into” Medicare if they do not meet the eligibility requirements.

• Trump – Although he does not specifically address allowing Medicare to negotiate prices on his website, at a January rally in NH Trump supported allowing Medicare to negotiate drug prices, saying, “Drugs with Medicare, they don’t bid ‘em out… They pay like this wholesale incredible number… They say like $300 billion could be saved if we bid ‘em out. We don’t do it…”

• Potential GP Impact – A proposal to create a rebate program for Medicare, similar to the MDRP, would likely take significant time to pass and be finalized (think of the 6 years we waited for the AMP Final Rule). More likely is an extension of the Medicaid rebate to prescription drugs for “dual eligibles” (participants eligible for Medicaid and Medicare), but even that may take a bit of time. A plan to allow Medicare to negotiate drug prices with manufacturers, which both candidates support, although not the GOP at large, could require manufacturers to manage Medicare contracts similar to how they manage their VA contracts.

This election may be the most interesting one in our lifetimes, at least to date. As healthcare and health insurance become a greater part of our nation’s economy, and our own budgets, these issues will continue to receive a lot of focus. Government Pricing has always been the image of that old saying, “May you live in interesting times,” but this election year has become the poster child for it!

We look forward to the MDRP Summit to hear more on the potential GP implications of the 2016 election, and to hear your questions and comments. If you have not already registered, do so today and use code XP2158MISC to get an additional $100 off of the current registration fee. GPS will be onsite and blogging for the 2nd year in a row, so we look forward to seeing you there!


Sources:
https://trumpcare.com/trumpcare-and-medicaid/
http://www.nytimes.com/2016/04/09/us/politics/donald-trump-health-care.html?_r=0 
https://www.hillaryclinton.com/issues/social-security-and-medicare/ http://www.ontheissues.org/Senate/Hillary_Clinton_Health_Care.htm http://www.nytimes.com/2016/05/11/us/politics/hillary-clinton-health-care-public-option.html 
http://www.ontheissues.org/2016/Donald_Trump_Health_Care.htm


About the Authors: 
Katie Lapins & Dana Zelig Collins, Government Pricing Specialists, LLC, 303.993.6456, K.Lapins@GP-Specialists.com. ; D.Collins@gp-specialists.com

How Community Advocacy Improves Health and Outcomes

By Rene Macapinlac

Access to primary care is important, but there are other factors outside of the doctor’s office that determine one’s health. To help its member lead healthier lives, health plans should focus on advocacy and community-based programs.

Speaking to attendees of the Medicaid Managed Care Congress in Baltimore, Carol Steckel, senior director of public policy at WellCare, emphasized how identifying community-based solutions help improve health outcomes of their members and ultimately lower overall cost of care.

At WellCare, Steckel said they examine the health and welfare in the populations they serve. Using that data, they are able to identify the gaps in the network of social services. Where needed they link their members to such services as housing assistance, employment services, food banks and education support. They also improve quality of life for residents by providing transportation for seniors and people with disabilities so that they could go to medical appointments, day programs and shop for groceries.

 

Linking members with the community and social services improves health outcomes and ultimately lowers overall cost of care.

Rene Macapinlac is the Director of Operations at ManagedCareBiz, an online resource for managed care professionals who need to stay up-to-date on industry news, analysis and commentary.

Medicaid Drug Rebate Program Summit (MDRP) 2015 Wrap Up!

• John Shakow highlighted the “hot topics” from the various presentations that were provided prior to the conference. Some of the slides he referenced included:

• From Miree Lee’s Government Pricing Basics, the numerous pharmaceutical price points, including AAC, EAC, UAC, MAC, SMAC, NADAC, AMP, FUL, BP, URA, 340B, ASP, NFAMP, and FCP. 

• Alice Leiter (Hogan Lovells) highlighted the critical components of a 340B policy that can be applied to other GP Policies.

• Steven Ruscus (Morgan Lewis) presented the only slide about biosimilars and Part B, highlighting how they will be reimbursed which is a special hybrid arrangement. This could define the next generation of reimbursement.

• Chris Cobourn (Huron) discussed the recent results/trends of a GP diagnostic survey showing many companies have insufficient resources, inconsistent documentation, and no G/L reconciliations.

• Connie Wilkinson & Alan Arville (Epstein Becker) highlighted the recent guidance regarding an the definition of an eligible patient for the 340B program.

• Bill Sarraille (Sidley Austin) went over what that he’ll be looking for if/when the Final Rule is released.

• Alice Valder Curran (Hogan Lovells) showed how manufacturers should be evaluating the Final Rule by looking at it with the thought, “Potential challenges if the Final Rule says…” Manufacturers should know that litigation is an option, but as John Shakow noted, only if you submitted a comment to the Proposed Rule, or potentially if you are part of an associated such as PhRMA that submitted comments.

• David Tawes from the OIG, discussing the future work involving Medicaid drugs and the possibility of attaching an inflation penalty to generic products.

• John Shakow’s own slide on the 340B Proposed Rule and the comments from the covered entities that an instance of overcharging should be defined as per unit, not per order.

This year’s MDRP was full of information for manufacturers and as always, there’s a lot going on in the government programs, so if you need help or are overwhelmed by all of the information, give me a call. I can help you figure out what is relevant and how to ensure you’re ready for the Final Rule! Katie Lapins, Government Pricing Specialists, LLC, 303.993.6456, K.Lapins@GP-Specialists.com.

IIR's MDRP Summit 2015 | Day 2 – External Counsel

Friday morning, IIR arranged for a session made up of group of attorneys who serve as external counsel to pharmaceutical manufacturers, focusing in part on the government healthcare programs.  This powerhouse group was moderated by Sabrina Yohai (Pfizer), and the panelists were Alice Valder Curran (Hogan Lovells), John Shakow (King & Spalding) Jeff Handwerker (Arnold & Porter), and Bill Saraille (Sidley Austin).

First, Alice walked the attendees through the legislative process for those areas that affect pharmaceutical manufacturers, explaining the differences between legislation, regulations, rules, and guidance, and also the actual contracts with the government and the preamble of rules. Sabrina emphasized the need for manufacturers to understand all of the “documents” that can affect their operations.

The panelists then discussed the questions that are most frequently being asked of them these days:
John S – bona fide service fees, and when a drug manufacturer should blend AMPs across an NDC-9;
John H – also bona fide service fees, free goods/PAP, especially in the context of a past purchase vs. a future purchase, and outcomes-based contracting;
Bill – same as the others with the comment that outcomes-based contracting is fast becoming a big issue, and the other area is ESI offers;
Alice – besides the issues previously mentioned, she also sees questions around limited distribution plans for the 340B program.

With regards to the Final Rule, what issues are most concerning to you, and what would cause you the most heartburn:

John H – the proposed change to the definition of “bundled sales” with the possibility of it being applied retroactively, and the BP exclusions that currently allow any price to a 340B entity, but the proposed rule narrows to sales under the 340B contract.
Bill – agrees with John, especially with regards to bundled sales, and the lack of compliance by the Covered Entities in the 340B Program.
Alice – potential expansion beyond three years for restatement periods and when that might be allowed, Medicaid MCO reporting, and the potential for CMS to make rules based on the ease of implementation, not always the statutory standard.
John S – agreed with the list and added the issue of how specialty pharmacies are treated within the context of retail community pharmacies.

With regards to enforcement and settlements, the panel sees the following as “HOT TOPICS”:

Bill – bona fide service fees remain a focal point as well as a shift from Best Price to AMP and ASP issues, and with regards to defending against potential investigations, the importance of documenting your methodology and assumptions.
John H - agrees with Bill and emphasized that the standard is reasonable, but the government has shifted to what you subjectively believed at the time of a submission. Documentation is the best way to demonstrate this, including advice of counsel.
Sabrina asked about how to submit assumptions and the panel agreed that it should be focused on those areas most critical to you, and when things change.
John S - ASP submissions should include reasonable assumptions.
Bill - submit early and often!
Alice - don’t assume, a prosecutor understands or interprets the statute/regulations like CMS, so make sure, you document your interpretations.
John H - US Attorney might look at how something impacts the government’s budget even if a pharmaceutical manufacturer does not consider this when making assumptions.
Sabrina - remember that being “conservative” in one program may not be conservative in another program and make sure, your internal documentation is solid.

If you were named general counsel of a major pharma tomorrow, what would you do to strengthen the GP area:

Alice – make sure, the rest of the business understands what you do and the importance of their role in GP (regulatory with product master, rebate team with BP and tracking customers.)
John S – educate company executives to understand the issues GP folks deal with (size, way commercial programs impact GP, risks of failing to fulfill the requirements.)
John H – look at documentation (policies, SOPs, assumptions) to make sure, it is sufficient for a government audit.
Bill – would add the need to audit the system setup for GPcalcs.

What’s a good way to get the conversation started with senior executives within an organization:

John S – focus on small pieces;
Alice – look at the gross-to-net impact of the programs to highlight this as a bigger piece of the business;
John H – has seen an increased focus by senior executives.

Questions form the audience were related to Texas price reporting, co-pay cards/programs, the new DOJ policy about filing criminal charges, and The First Amendment within the context of off-label promotion.

Final advice or comments from the attorneys: understand what it is others within your company do; the importance of making sure the GP team members feel valuable, especially for the women in this arena; we can be proud that we work in an industry that saves lives, and our job within these organizations is to make sure, our products are available to the most needy in a compliant manner.

As always, MDRP Summit has provided a vast amount of information and great opportunities for networking with others in the industry. If you would like more information on any of the topics that were covered this week, please contact me. As always, there’s a lot going on in the government programs, and I can help your organization figure out what is relevant, and how to ensure you’re ready for an audit! Katie Lapins, Government Pricing Specialists, LLC, 303.993.6456, K.Lapins@GP-Specialists.com.

MDRP Summit: Day 1. Morning Sessions & Keynote Address

The first day of the conference kicked off today with Edward McAdam from Fresenius Medical Care discussing current events in the pharmaceutical industry, including recent price increases that have been covered by all of the media outlets.

The keynote address was from Ezra Klein, Editor-in-Chief of Vox.com and the central theme was, “Where is healthcare going?” within the context of politics, reform, and policy. 

Mr. Klein first spoke about Zoltan Esteban who is running for President of the United States and is going around country in a bus shaped like a coffin. “He is the only candidate whose sole issue is to conquer death.” Looking at historical elections, oftentimes, topics that were important then now seem ridiculous. To Mr. Klein, that may be the case with our current situation. All of the conversations about things like immigration reform may be viewed by historians as a waste. Obamacare, one of the biggest pieces of legislation in this administration, has been experienced as a slow moving political “trauma” by both sides of the aisle. Republicans have not been able to repeal it and Democrats have lost the House over it. This law is here to stay, especially since the US Supreme Court has made rulings on issues before it, and the best anyone can do is to change it, but neither side is comfortable with it.  Unfortunately, the most recent round of healthcare reform has not focused on what’s probably most important and that’s value within the healthcare system. 

Most people today, including political candidates, agree that the focus of healthcare reform should be on controlling cost, not increasing access. To. Mr. Klein, the belief that the central concern should be about controlling cost, there is something wrong. It should be focused on providing value. Consider these 2 scenarios:

1.    The federal government passes a law that bans all healthcare. Spending drops to a negligible amount of GDP as a result, or,
2.    Researchers invent a pill that guarantees a life span of 180 years with a good quality of life, but doing so raises healthcare costs to 45% of GDP.

Virtually everyone can agree that Option 1 costs the least but the outcome is not desirable. Option 2 costs a lot more but the outcome is more preferable to society as a whole and probably to each individual. 

Instead of focusing on costs, the question should be, “Are we getting good value for our healthcare dollar spending?” Mr. Klein says no, we’re paying more to get less and the problem is in the value, not in the “abstract amount” of what we spend. In recent years, the growth in healthcare expenditures has been slowed but that’s been a result of making healthcare more expensive at the individual level through higher copays, deductibles, etc., and lowering the costs with the providers such as hospitals and drug companies and narrowing networks to enable insurance companies to be able to better negotiate rates. A tremendous amount of the focus currently is on increasing individual responsibility with regards to cost and making people more cognizant of their healthcare decisions.  These both lower cost at the government level but do nothing to improve healthcare. 

So what is good healthcare policy? The big “win” in healthcare is not dying, not getting an infection when you go to the hospital, finding a cure for Alzheimer’s. Very little spending occurs related to things such as research and cures, with more of an emphasis on treatment. Today, the most important thing in healthcare in Washington is not the care given as part of health but is the budget related to it.  This is true in other areas that include research and development – we will often not know the advancements and opportunities we missed. Viewing healthcare as a scientific issue, not a budget or social justice issue, is a different way of looking at it, and we don’t track how healthy we are and how healthy we could be. Many of the healthcare spending forecasts do not take into account the potential savings from investments in prevention and treatment. Sovaldi® is a good example. It was in the media when it first launched because of its high cost. It treats Hepatitis C and is an expensive drug but it’s cheaper than the ongoing treatment of someone with Hepatitis C. 

Chris Hatwig from Apexus, the company that handles the 340B Prime Vendor Program, next provided an overview of their services and then went through the Proposed Guidance recently issued. (See yesterday’s post for a lot more detail on this hot topic!) And next, although CMS was going to speak about recent updates, at the last minute, they were unable to make it, so Dave Tawes from the Office of Evaluation and Inspections, Office of the Inspector General, graciously stepped in and spoke about their recent initiatives and their work plan. This included information about recent Medicaid studies as well as an interesting study about the use of anti-psychotic drugs in children covered by Medicaid. In this study, 67% of the claims showed there was “quality of care” concerns, 53% poor monitoring, and other issues such as too many drugs being prescribed, the side effects, and the use of drugs not indicated for children.

Other topics included AMP reporting and a comparison of drug expenditures under Medicaid and Medicare Part D. Not surprisingly, drug costs under Medicaid are less than those under Part D. Also, the OIG reached a $12.64 million settlement with a manufacturer for misrepresenting ASP data to Medicare. 

The future work plan includes requests from Congress and HHS, mandatory OIG reviews, emerging issues such as price increases in the industry that made recent news, generic drug price increases, treatment of authorized generics, specialty drug pricing, audits of states’ collection of rebates for drugs from Medicaid MCOs, contractor oversight of covered uses for Part B drugs, and the spread for high cost drugs within the context of Part B and reimbursement.

Check back tomorrow for more updates from MDRP Summit and if you would like more information on any of these topics, please contact me. As always, there’s a lot going on in the government programs and I can help your organization figure out what is relevant and how to ensure you’re ready for an audit! Katie Lapins, Government Pricing Specialists, LLC, 303.993.6466, K.Lapins@GP-Specialists.com.

Pre-Conference Workshop | Symposium C – 340B Mega Guidance

Today’s workshop was chaired by Mike Benedict, Vice President, Apexus, who opened with fundamentals of the 340B program and an overview of Apexus’ services which was helpful for those newer to the program. Next, an overview of the key areas within the Mega Guidance was covered by Connie Wilkson and Alan Arville (Epstein Becker Green) with a bit more detail on how we got to where we are today, including the purpose of the guidance, to provide clarity and address concerns of the program by the various stakeholders. Although this guidance was originally intended to be issued as a rule, it was issued as guidance because of PhRMA’s (successful) challenge that HRSA does not have the authority to promulgate a legislative rule related to orphan drugs. The guidance has been issued in part because of ongoing criticism by the OIG, the GAO, and Congress, including the lack of consistency with 340B eligibility, duplicate discounts, patient discounts, and what is being done with the revenues realized by the covered entities (“CEs”).

Other topics from the Mega Guidance that were reviewed were the definition of a “Covered Outpatient Drug,” the procedures manufacturers should follow in the event they need to issue refunds to the CEs, the necessary standards for limited distribution plans, recertification, records retention/audits, the GPO prohibition for CEs, contract pharmacies, and the definition of an eligible patient.

Of importance with the Mega Guidance is that it is not binding but it must be considered in the event a case is before a court, recognizing that the agency has expertise in this area. 

John Shakow (King & Spalding) covered HRSA’s Proposed Rule, not the Proposed Guidance, for Ceiling Prices & Manufacturer Civil Monetary Penalties (CMPs). These topics were those that HRSA believed they still had authority to make a rule about after the determination they did not have the authority related to orphan drugs. This included two areas. The first is the determination of the 340B Ceiling Price, including penny pricing and the pricing of new drugs. HRSA continues to believe that charging $0 is unreasonable and $0.01 is reasonable and that no other viable options exist when AMP minus URA is zero or negative. Additionally, it includes the requirement for manufacturers to estimate the 340B price and retroactively refund the difference of the actual and estimated price, even if a CE does not request one.

For CMPs, the Proposed Rule imposes a penalty of up to $5,000 for each instance of “knowingly and intentionally” overcharging by manufacturers. Areas of concern for manufacturers include the requirements that manufacturers must “police” intermediaries, including wholesalers, and the prices a CE is charged for a manufacturer’s product by a third party. Also in the Proposed Rule is the change to the definition of a 340B drug as one that is at or below the ceiling price.

Comments to the Proposed Rule by CEs of interest to manufacturers included:

1.   An instance of overcharging should be based on a per unit basis, not per order basis;
2.   CMPs should be imposed on manufacturers who overcharge based on “deliberate ignorance” and “recklessness,” not just “knowing and intentional.”

While comments by manufacturers and trade associations included:

1.    HRSA lacks the statutory authority to issue ceiling prices;
2.    Penny pricing is not reasonable;
3.    New drugs should have a 340B Ceiling Price using the minimum rebate percentage (e.g., WAC minus 23.1% for S & I products);
4.    An instance of overcharging should be per ceiling price report, not per order;
5.    Refunds should take into account a “de minimis” exception and allow offsetting/netting.

In most cases, McKesson (as a wholesaler) and HDMA agreed with manufacturers in their comments.

Kathleen Black (Pfizer) spoke about manufacturer’s 340B Ceiling Price reporting requirements and then Alice Leiter (Hogan Lovells) went through a “policy and procedure compliance checklist.”  Kathleen focused on the mechanics for the calculations and reporting by manufacturers, and Alice went through the things a manufacturer should have such as a 340B policy, that includes the ceiling price calculation as well as the manufacturer’s specific policies including things such as limited distribution plans, the definition of a covered outpatient drug, new product pricing, product acquisition and divestitures, restatements, and audits of CEs. She stressed that this is especially valuable when the “right” way has not been clearly defined by the government. 

In the afternoon, the workshop focused more on the operational side with regards to manufacturers, including best practices and lessons learned from audits of CEs from Debbie Walters-Francique (Pfizer), the opportunities and challenges for manufacturers because of the potential overlap of Medicaid and the 340B program, and duplicate discounts that may occur (Lisa Norton from Lilly USA, Glen Huttar from Johnson & Johnson Health Care Systems, Jeremy Docken, from IMS Health, and Daksha Bogdon from Genentech). Besides CEs being required to prevent diversion and duplicate discounts related to their own purchases, CEs must also ensure compliance with the program requirements if they use contract pharmacies for the 340B program. For manufacturers to audit a CE, there must be reasonable cause and a manufacturer must submit an audit plan and obtain approval from the OPA. Audits have not been heavily utilized by manufacturers. So far, there have only been seven audits by manufacturers, although there have been many others conducted by the OPA. The best defense for manufacturers may be the establishment and following of policies and procedures to identify duplicate discounts and diversion when they occur.

Finally, the workshop ended with a discussion of the 340B “hot topics”, moderated by Erin Estey Hertzog (Biotechnology Industry Organization). Many of the topics covered earlier in the day were raised again with greater input and discussion from the audience. And as always with the various government programs, it was reinforced that where regulations and guidance are silent, manufacturers must and should make reasonable assumptions, and these should be well documented.

Check back tomorrow for more updates from MDRP and if you would like more information on the proposed changes to the 340B program, please reach contact me. There’s a lot going on in this program, and I can help your organization figure out what is relevant and how best to prepare! Katie Lapins, Government Pricing Specialists, LLC, 303.993.6466, K.Lapins@GP-Specialists.com.

This Week in Healthcare: 8/24 – 8/28

Top new from around the healthcare industry:

Louisiana: Planned Parenthood Sues to Keep Medicaid Payments
Planned Parenthood asked a federal judge Tuesday to stop Gov. Bobby Jindal’s administration from ending Medicaid payments to the organization’s Louisiana clinics.

More than 80% of healthcare IT leaders say their systems have been compromised
Eighty-one percent of healthcare executives say their organizations have been compromised by at least one malware, botnet or other kind of cyberattack during the past two years, according to a survey by KPMG.

Zoom Wants Health Care to Be More Like Visiting An Apple Store 
In 2006, Dave Sanders, a Portland Oregon-based M.D., co-founded a network of walk-in clinics called Zoomcare to offer exactly that. Zoomcare wasn’t exactly Uber-esque, but it was like Starbucks or Chipotle: convenient, consistent, and affordable without coming off as "cheap." After successfully expanding into Vancouver and Seattle, Zoomcare’s creators decided to take a shot at expanding this "user experience" to more than just basic preventive care.

An Inside Look at the Digital Health Care Revolution [Video]
WellnessFX Co-Founder Jim Kean discusses the digital revolution in health care. He speaks on "Market Makers."

Have a great weekend! 

Breaking News: AMP Rule Submitted to OMB for Final Review

BREAKING NEWS: AMP Final Rule has been sent to OMB and is expected to be released at the end of August - Just in time for IIR's MDRP Summit!

At the 20th Annual Medicaid Drug Rebate Program Summit, we've got you covered on all things AMP related across three days of the conference! Join us on September 30-October 2, 2015 for:

Wednesday, September 30th: The AMP Rule Full-Day Pre-Conference | Understand the Application, Implementation and Impact of the Final Rule

• • Brace Yourself: The AMP Final Rule is Here! What To Do, What Not To Do & What To Do First
• • PANEL: Deconstructing the AMP Final Rule: A Step by Step Analysis of the Key Implications of the Final Rule
• • Identify Line Extensions & Implement Alternate Rebate Formula
• • Clarification to the Re-definition of Bundled Sales & Its Implications
• • How to Categorize & Calculate the 5i's
• • Implications of the Expansion of RCP
• • Impact of the Final Rule on Class of Trade & Innovator Products
• • PANEL: Implementation: Constructing a Final Rule Application Checklist

Thursday, October 2nd:

• • CMS Pharmacy Updates from John Coster, Director, Division of Pharmacy, CMS
• • The AMP Final Rule: Operationalizing for MDRP by Alice Valder Curran, Partner, Hogan Lovells US LLP
• • Track One: Impact of AMP on Government Pricing
• • Track Two: Post AMP Panel Navigating the Regulatory Framework
• • Track Three: Financial Implications of the AMP Final Rule on GP Calculations
• • Track Four: Re-assessing GP Methodology post AMP

Friday, October 3rd:

• • Keynote Fireside Chat with External Counsel focusing on the legal implications of the AMP Final Rule and how to remain compliant
• • Townhall to answer all your AMP related questions moderated by John Shakow, Partner, King & Spalding  

Download the MDRP brochure for complete details.

Register now and save up to $300 off standard registration.
Be sure to use priority code: XP2058BLOG

Read the OMB Submission Here.

This Week in Healthcare: 7/6 - 7/10

Top news from around the healthcare industry:

California Receives Failing Grad for Health Care Cost Transparency
California was one of 45 states to receive a failing grade for health care cost transparency, according to the third annual report by the Catalyst for Payment Reform and the Health Care Incentives Improvement Institute, Modern Healthcare reports.

FDA Strengthens Heart Safety Warning on Popular Pain Relievers
Federal health regulators are bolstering warning labels on popular pain relievers to reflect new information about their risks of heart attack and stroke.

Obama's CMS Nominee Slavitt Could Face Rough Road to Confirmation
President Barack Obama has nominated Andrew Slavitt as administrator of the CMS, the position he has held on an interim basis since Marilyn Tavenner stepped down in February.

 Happy reading! Have a great weekend.

This Week in Healthcare: 6/22 - 6/26

Top news from around the healthcare industry this week:

What people are saying about the health care subsidy ruling
Here’s a look at what lawmakers and others are saying about the U.S. Supreme Court’s ruling this morning on allowing people in Ohio and other state’s to keep their health care subsidies under the Affordable Care Act.

OSHA cracks down on healthcare employers
The Occupational Safety and Health Administration announced Thursday that it would crack down on hospitals and nursing homes for workplace hazards that aren't protected by formal rules. Experts say politics have complicated efforts to formalize workplace regulations.

Healthcare IoT, Apple Watch ready to change patient care
IT consultant and IoT thinker Frank Palermo, in the second part of a two-part Q&A, says patient satisfaction is the main benefit of healthcare IoT.

Happy reading! Have a great weekend.

This Week in Healthcare: 6/8 – 6/12

Top news from around the healthcare industry this week: 

Walgreens, MDLive expand telehealth collaboration to three more states 
Walgreens has expanded its relationship with telehealth service provider MDLive, bringing remote physician access to customers in three new states and, for the first time, to PCs as well as mobile devices. Users of Walgreens mobile apps and the walgreens.com portal in Colorado, Illinois and Washington state now can consult 24/7 with board-certified MDLive physicians for $49 per encounter, the two companies announced Tuesday.

Outraged, engaged patient takes aim at paternalistic physician 
It’s hard to know how many patients out there are truly “empowered,” and I suspect it is a relatively small number, but one of the louder voices out there is Duncan Cross, a longtime engaged patient with Crohn’s disease.

Arizona hospitals, doctors avoid 5 percent Medicaid pay cut 
Arizona hospitals, doctors and other health providers will get a reprieve after the state's Medicaid program announced it will cancel a planned 5 percent payment cut because of lower-than-expected use among enrollees and a prescription-drug rebate.

One nation, under sedation: Medicare paid for nearly 40 million tranquilizer prescriptions in 2013 
In 2012, Medicare’s massive prescription drug program didn’t spend a penny on popular tranquilizers such as Valium, Xanax and Ativan. The following year, it doled out more than $377 million for the drugs. While it might appear that an epidemic of anxiety swept the nation’s Medicare enrollees, the spike actually reflects a failed policy initiative by Congress.

Game Changer: CMS’ Proposed Medicaid Managed Care Regulation 
The Centers for Medicare and Medicaid Services (CMS) released its long awaited Medicaid managed care proposed rules on May 26; the rules were published in the Federal Register on June 1 (80 Fed. Reg. 30198-31297). The last time the federal government seriously tackled Medicaid managed care was in a 2002 regulation (67 Fed. Reg. 40989, June 14), a response to the Balanced Budget Act of 1997 (Pub. L. 105-33), which itself amounted to a major new chapter in Medicaid’s relationship to what by then had become known as managed care.


Happy reading! Have a great weekend. 

Cyber Monday starts early! See details how you can save 30% on upcoming events!

To get a head start on the holiday season, as a blog reader, we’re giving you an extended chance to take advantage of our Cyber Monday sale. Register for any of the following IIR events and receive 30% off the standard rates. Mention code CYBER2014 when registering for each or any of the following:

IIR’s 12th Annual Medicare Congress 
February 3-5, 2015 in New Orleans, LA.  
Survive the toughest rate environment to date with lessons from top-notch healthcare executives.
Visit the event website.
Register here.
 
IIR’s FDA/CMS Summit for Payers 
December 11-12, 2014 in Washington, D.C.
Drive collaboration and innovation to succeed in a patient-centric environment.
Visit the event website.
Register here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid Wednesday, Nov. 26th 2014 until Monday, December 1st  2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

Health Care Insights | Weekly Round Up

Health Care Insights brings you your weekly healthcare round up*. Below you will find relevant articles on key industry topics that we thought our readers would benefit from - enjoy.

Top Stories:
 
Healthcare's Big Data Opportunity
Global healthcare is at a pivotal moment in its history, on a par with Alexander Fleming’s discovery of penicillin and Louis Pasteur’s groundbreaking work with sterilization. As the quantity of data we generate rapidly expands and we continue to develop the computational power to store it, health authorities will be able to gather more information about their patients in a single year than has been open to them in all history.

Wearable Technology And Digital Healthcare Strategies Should Shift Focus To Chronic Medical Illness

As we marvel at the gadgets that companies such as Nike, Fitbit, Jawbone and Apple have recently produced and brought to market–gadgets that can record our heart rate, calories expended, and steps taken—one can only think of how this technology could likely be used on a greater scale to help those who truly need it the most: people with chronic medical illnesses such as emphysema, diabetes, or congestive heart failure.

 FDA approves Purdue's painkiller that can reduce abuse
The U.S. Food and Drug Administration has approved a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P., the agency said on Thursday. The FDA approved the once-daily drug, Hysingla ER, with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting.

CMS Names Niall Brennan as Nation's First Chief Data Officer  
(Niall Brennan will be speaking at the FDA/CMS Summit for Payers)

On Wednesday, CMS announced Niall Brennan will become the agency's first chief data officer and will be responsible for overseeing efforts to improve data collection and transparency and leading the department's new Office of Enterprise Data and Analytics

Have a great weekend!


*Health Care Insights has no affiliation with any of the above publications. These articles are aggregated by our team based upon our audience's areas of interest.