Wednesday, April 27, 2016

The Medicaid Managed Care Regulation is here!

Since the last major updates to Medicaid Managed Care regulation in 2003, Medicaid and managed care have both evolved dramatically. After years of waiting, CMS released the long-awaited final Medicaid Managed Care 'Mega-Reg' Rule. For those of you who would like to review it immediately, it is available here. As you know, this draft regulation will govern the activities of states and plans participating in the Medicaid and CHIP programs going forward. The time to plan has ended! It is “Game Time”!

IIR's Medicaid Managed Care Congress will be your first opportunity to dissect the implications of the Mega Reg and its impact on your daily operations and overall bottom line from thought leaders in the space including ACAP, Mostly Medicaid, and more.


Medicaid Managed Care Congress (MMCC 2016)
Marriott Harbor Inn
Baltimore, MD
May 18-20

MMCC’s Mega Reg Pre-Conference symposium will address and break down the rule, and analyze and interpret its effect with like-minded individuals and organizations. Key topics will include:

• Require transparency and fairness between plans and states in rate-setting
• Encourage efficient, realistic use of limited resources;
• Hold fee-for-service programs to the same standard as managed care;
• Set standards for network adequacy which reflect local conditions as they exist;
• Provide for realistic implementation timeframes for both plans and states;
• Promote the movement to value-based payment strategies; and
• Provide for comprehensive, accurate and fair quality reporting and standards.

Click here to download the full MMCC 2016 brochure

Below is a preview of the sessions in the Mega-Reg symposium:


Jennifer Babcock, Vice President for Medicaid Policy and Director of Strategic Operations Association for Community Affiliated Plans (ACAP)



Clay Farris, Senior Healthcare Executive
Mostly Medicaid


Deborah Kilstein, Vice President, Quality Management and Operational Support
Association for Community Affiliated Plans (ACAP)



Larry Heyeck, Deputy Director for Legal Services State of New Mexico


Amy Thomas, Assistant Director of Plan Support
Association for Community Affiliated Plans (ACAP)

Have a comment? Share your thoughts in the comments section or follow us on Twitter: @healthcarebiz and #MMCC16

Tuesday, April 19, 2016

Medicaid Managed Care Congress: Q/A with Carol Steckel (WellCare Health Plans)

Medicaid Managed Care Congress
With the Medicaid Managed Care Congress (MMCC 2016) right around the corner (May 18-20, 2016) we have reached out with the Q/A to one of the keynote speakers Carol Steckel, MPH Sr. Director,  Alliance Development, WellCare Health Plans, Inc.

What do you think will be the major implications of the Mega-Reg?

- Mega-Reg has the potential to strengthen the states’ ability to use managed care to promote innovative and cost effective methods of delivering quality care to Medicaid and CHIP beneficiaries.

What do you wish someone would have told you before joining Medicaid/healthcare industry?

- Navigating such a complex system can pose challenges and the system routinely and frequently changes. These challenges are offset by the knowledge that the work you are doing is improving the lives of the people we serve.  

What upcoming major trends are you excited about?

- There is great opportunity for states and managed care organizations to work together to empower people to take control of their health. I am most excited about the linkages we are developing between physical health, behavioral health, and social determinants of health.

What is the secret to success in your opinion?

- Working hard to be part of the communities where our members live helps us bring together the resources needed to serve the most vulnerable populations. Our members often face challenges in life beyond their health. By connecting them to needed social and community services, we seek to improve their ability to take control of their health by addressing their overall needs. We also strive to engage them in needed preventive health services to ensure they are getting the right care at the right time at the right place.

For MMCC, what do you hope to learn more about / who do you want to hear from?

- Providing care to vulnerable populations often involves going the extra mile to find and engage members where they live, whether that is in their homes, in a shelter or under a bridge – none of which is possible without collaboration across sectors at the local level. Learning more about the efforts of community organizations working to support the social safety net can help MCOs identify and address care gaps that may be barriers to health. 

Do you have any best practices of success stories you’d like to share? If so, please elaborate.

Medicaid Managed Care Congress presenter's logo - WellCare Health Plans- WellCare uses a coordinated care approach designed to ensure all of our members receive the unique services and supports they need to achieve and maintain the best health outcomes possible. This is based on our belief that a healthy community is one where social safety net providers and community-based organizations are thriving and supporting the needs of its citizens. We identify care gaps, which occur when the social safety net is stretched too thin. We partner with community groups to address these needs, and close the care gaps. We also work with academic partners to evaluate the programs to quantify the results in terms of cost savings, increased access to health case, and other benefits to the public health system. This approach allows us to deliver on our mission of enhancing our members’ health and quality of life and strengthening the communities we serve. 

Carol Steckel will also be presenting at the MMCC 2016 with a case study "Community advocacy, health connections model" which will cover three important questions:

- How to link a member to a community and/or social service?
- How to support the community in developing needed services?
- How to measure the impact of the program on our members?

To learn more about Carol Steckel's case study or to see who else will be presenting at the Medicaid Managed Care Congress download the brochure here

Have a comment? Share your thoughts in the comments section or follow us on Twitter: @healthcarebiz and #MMCC16

Tuesday, April 5, 2016

How Providers Can Help Increase Transparency Into Policy Plans

While doctors and dentists are on this this earth to help us live long and healthy lives, that often does little to ease the anxiety that many feel when visiting their office. In fact, increased levels of stress almost always accompany a visit to either the doctor or dentist’s office, in addition to a corresponding elevated blood pressure reading. The process can be made easier and more settling, however, when these same doctors and dentists properly educate their patents about new processes and policies being incorporated into the insurance.

Much of the anxiety that occurs when needing to go the dentist or doctor revolves around cost. Many simply do not know how, or if, they will be able to pay for any medical procedures that become necessary. They cannot understand their insurance policy, and are unsure of where to even go for help. For this reason alone, a staggering number of Americans simply stay away from the Doctor or Dentist’s office altogether until it is often too late. There are, however, certain things that insurance providers can due to help increase transparency within their policy plans.

Transparency Made Easier Under the Affordable Care Act

Transparency Made Easier Under the Affordable Care ActOne of the final rules implemented as a provision within the Affordable Care Act was a requirement that all health plans now should provide consumers with a uniform summary of coverage. This applies to those people currently enrolled in a place, as well as new applicants. This is a step in the right direction, as it now ensures that individual dental insurance is transparent and easy to understand. Benefits and provisions of coverage should be more clearly spelled out of individuals, and this will make it easier for them to determine what is and is not covered, and to what extent.

In this regard, providers can help to ease the stress and anxiety that many consumers feel over health and dental insurance related issue. In the past, it was felt that many individuals faced too many choices when dealing with insurance policies, and that they were not adequately informed as to how coverage actually works. One survey even found that people would prefer to go to the gym or even work on their taxes than take the time to read through earlier versions of health insurance policies.

The Transparency of Coverage Disclosures

Most insurance policies must now disclose any information that would enable consumers to better understand how their particular plan will reimburse the claims that are made for covered services, and whether or not a service would actually be covered under the existing policy. In essence, the following information must be disclosed in a transparent and easy to understand manner:

• Polices and Practices Related to the Payment of Claims
• Financial Disclosure to be Made on a Periodic Basis
• Data Enrollment Must be Disclosed
• Data Account For Those Who Unenroll Must Be Disclosed As Well
• Information on the number of claims that are denied in the end
• Information about rating practices
• Data related to cost-sharing and payments, particular in terms of out-of-network coverage that is available
• Data of the rights afforded to enrollees and participants under the terms of the policy

All of the information mentioned above is to be written in clear English that is geared specifically to the consumer, and should be designed for people who have limited proficiency in the language. This effectively makes it easier for individuals to understand their policy and what they should expect from the insurance provider.

While there will likely still be a great deal of anxiety associated with visits to the doctor or dentist, this will be lessened somewhat with the advent of these new policies. Knowing what is covered and how the benefits will be paid can go a long way towards not only lessening the financial burden on the individual, but also towards making the process much more streamlined and comfortable in the end.

About the author:

Greg Dastrup is a world traveler and professional writer with a passion for learning new languages. He’s spent most of his career consulting for businesses in North America. You can follow Greg here.

Friday, April 1, 2016

The Implications of the Mega-Reg on the Medicaid Managed Care Industry: 2016 & Beyond

Healthcare word cloud featuring Managed Care, Healthcare Policy, Insurance
2016 is a year of transformation for the healthcare ecosystem - over the past year we’ve seen the implementation of major ACA provisions, delivery system reforms, payment reforms, and states pursuing better value. There’s been a recent shift away from taking a budget-driven approach, and is now driven by the desire to improve quality and outcomes. The implications will be huge and will go beyond Medicaid. 

We’ve had a short Q/A with Jennifer Babcock, Vice President for Medicaid Policy and Director of Strategic Operations, Association for Community Affiliated Plans (ACAP), who will also be chairing and presenting at the Medicaid Managed Care Congress in May. 

What upcoming major trends are you excited about? 

Medicaid is undeniably undergoing a great deal of change right now, and there are many advancing trends keeping all Medicaid policy analysts on our toes. One of the most exciting, from my perspective, is efforts by Medicaid health plans to impact social determinants of health and to integrate within the health plan help for people to get jobs, housing, nutritional support, even support as they leave the criminal justice system. A substantial number of ACAP member plans are doing important work in these areas, as described in a fact sheet we produced in 2014. Efforts by health plans to impact social determinants underscore that 
our collective goal is to improve the health and well-being of people covered in Medicaid.

Secondly, I’m excited to learn about efforts by plans, states, and providers to look at improving quality of health at the population level. Again, these efforts offer a great opportunity to
improve the health of the entire nation, given how expansive a coverage program Medicaid is. 

What do you think will be the major implications of the Mega-Reg? 

If finalized the way we at ACAP hope, the Mega Reg will erase any lingering questions about the crucial role MCOs play in Medicaid, leading the way to greater emphasis on the partnership between states and plans. I hope, for example, that CMS will require transparency between states and plans in general, and in particular with regard to the rate-setting process to ensure that all rates are set and approved in a timely and comprehensible manner. Also, I would like to see CMS move toward payment and coverage models that use MCOs to promote population health. Lastly, I would like to see movement toward standardized quality measurement that allows us to learn what Medicaid pays for, not just in MMC, but FFS as well.

Do you have any best practices of success stories you’d like to share? 

My colleagues at ACAP worked with a subset of ACAP plans last year on a substance use disorder collaborative, which resulted in this toolkit, which is available publicly for other health plans to use. This toolkit provides best practices for plans working with individuals impacted with SUD, including opioid addiction. It’s an example of how effectively and quickly Medicaid MCOs can respond to a significant population health problem. We are very proud of these plans’ efforts. 

For MMCC, what do you hope to learn more about? 

I am looking forward to hearing from the real experts about quality in Medicaid managed care and Medicaid. I am anxious to gain insights about how best to coordinate and standardize the myriad quality measurement and reporting efforts so that we can get on with the business of using results to improve care for people, and to improve Medicaid overall, and CHIP as well. While it’s fascinating to see the efforts many states are making to report on the adult and pediatric core measures sets (the CMS 2015 Annual Report on the Quality of Care for Adults in Medicaid and 2015 Annual Report on the Quality of Care for Children in Medicaid and CHIP were released in February of this year), I feel strongly that we all can do more to ensure that quality of care for Medicaid and CHIP enrollees is measured, reported, and improved.

Learn about the implications of the new regulations and beyond by joining the Medicaid Managed Care Congress (MMCC) in Baltimore, MD (May 18-20, 2016.) For more information about MMCC 2016 visit the website here.

Have a comment? Share your thoughts in the comments section or
follow us on Twitter: @healthcarebiz and #MMCC16

Friday, March 18, 2016

Four Major Managed Care Industry Concerns by Jennifer Babcock (ACAP)

The managed care landscape is evolving with the elections around the corner and the Mega-Reg stipulated to release. There is a lot going on in the industry. Read about the four major concerns of the industry by Jennifer Babcock, Vice President for Medicaid Policy and Director of Strategic Operations, Association for Community Affiliated Plans (ACAP):

1.    ACAP’s member plans are very innovative and nimble Safety Net Health Plans that have demonstrated a clear dedication to their enrollees, their communities and to safety net providers. Some Safety Net Health Plans have participated in Medicaid in their states for decades. The move toward consolidation in the industry poses a threat to this commitment, so one of ACAP’s primary goals is to provide support for and create efficiencies for these plans.

2.   The continued lack of an Affordable Care Act Medicaid expansion in many states has produced a drastically inequitable coverage system with multiple negative impacts on people, providers, and states alike. I’m heartened, though, to see the efforts our members and many others are making in those states to encourage governors and state legislatures to expand.

3.   Despite progress, it is still so difficult for people to access all the services they need to thrive, including not only health services, but services addressing social determinants of health as well. Many ACAP health plan members have moved boldly into this area by providing linkages to housing, nutrition, and employment services. CMS has provided leadership in this area as well – one example is last year’s guidance related to how Medicaid programs can fund housing activities.

4.   The continued fragmentation of coverage and care complicates health care for families. Many of the families our plans serve are split between Medicaid, CHIP, Marketplace coverage, and Medicare. Certainly, plans can and do make the choice to operate in all of these programs to address overlap for families, but participation by plans in multiple programs is not a sure thing, and it is not an easy lift, particularly for Safety Net Health Plans. There aren’t always clear incentives for them to do so, which can mean that single families can have to manage two or more sources of coverage, networks, and so on. CMS’ efforts to align requirements across programs is appropriate and useful, although more work needs to be done in this area. Ultimately, enrollee families will benefit.

Jennifer Babcock, Vice President for Medicaid Policy and Director of Strategic Operations, Association for Community Affiliated Plans (ACAP)Hear more from Jennifer Babcock as she will be chairing and presenting at the Medicaid Managed Care Congress (MMCC) 2016, Baltimore, MD with the session "Dive Deep into the Implications of the Mega-Reg"

Download the brochure to see the most up-to-date agenda for the MMCC here.

Have a comment? Share your thoughts in the comments section or
follow us on Twitter: @healthcarebiz and #MMCC16

Monday, February 22, 2016

Earn a FREE pass to the IIR's MMCC 2016 in Baltimore, MD - Become a Guest Blogger!

Medicaid Managed Care Congress (MMCC ) 
May 18-20 2016
Baltimore Marriott Inner Harbor
Camden Yards, MD

Join the IIR's Medicaid Managed Care Congress 2016 (MMCC) to learn from the government officials, health plan executives and other key players of the healthcare industry who get together for an annual knowledge exchange and networking.

As a Guest Blogger, you’ll have access to the IIR’s MMCC 2016 comprehensive agenda attracting the best insights from around the world, right in Baltimore, MD in May.

We are looking for an industry expert with interest in the following topics:

• Mega Reg;
• Financial and operational success –rate setting, risk adjustments;
• Outcomes and Social determinants of Health (population Health);
• Co-ordination and integration of care – long term care, long term services and support;
• Pay for performance or value based payment strategies;
• Driving Performance at the Provider Level;
• New contract requirements, value based payment arrangements with provider networks
• Innovation Accelerator Program (super utilizers, behavioral health & physical health integration, LTSS);
• Medicaid Eligibility churn;
• Integration of physical and behavioral healthcare services;
• Transparency and rate setting;
• Risk Quarters;
• Medicaid expansion and what the future of that looks like (Exchange models);
• Mental health and substance disorder treatment;

....and who would like to learn about the current state and the future of Medicaid managed care!

The premise is to provide MMCC 2016 related blog posts (300-500 words), whitepapers, and overall light coverage of the event.

What You get is:

• FREE all-access pass to the conference (valued up to $2,695);
• Access to extensive learning activities with the top regulatory thought leaders and policy makers;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our Healthcare Insights blog with over 2000 unique visitors monthly and more than 20 healthcare LinkedIn groups.

Learn more about the IIR's Medicaid Managed Care Congress 2016 (MMCC) by visiting the website.

Interested & want to learn more about this opportunity? Please contact Ksenia Newton at 

We hope to have you join us in Baltimore, MD this May!

Subscribe to our blog or follow us on Twitter: 

@healthcarebiz and #MMCC16

Friday, January 29, 2016

Pricing of Prescription Drugs Debated

(This article "Pricing of Prescription Drugs Debated" originally appeared on the HealthLeaders website, January 18, 2016.)

By Christopher Cheney.

In the "Great Drug Pricing Debate of 2016," a semi-fictional duo goes head-to-head on whether the pricing of prescription drugs is spiraling out of control, whether price controls should be instituted, and whether drugs can be priced based on value. 

Pricing practices for prescription drugs are drawing intense scrutiny from inside and outside the healthcare industry.

Healthcare payers are apoplectic over the rising costs of prescription drugs. America's Health Insurance Plans, the trade association for healthcare payers, has been blasting pharmaceutical companies over drug pricing on a nearly daily basis.

Healthcare providers also are sounding the alarm, with the American Medical Association announcing in November that it would launch an "advocacy campaign to drive solutions and help make prescription drugs more affordable."

Drug pricing is already a hot topic in this year's presidential race, with Democratic Party contender Hillary Clinton calling for affordable drug pricing in political advertising and on her campaign's website. Her main opponent, Sen. Bernie Sanders (D, VT) has his own plan to lower prescription drug prices.

Capitation's Second Coming Debated 

To debate the issue, I have assembled a semi-fictional duo with opposing perspectives on drug-pricing trends and their impact on the healthcare industry. The debate format gives each participant about 500 words to answer a handful of questions.

Arguing in favor of the drug-pricing practices of pharmaceutical companies is Reginald Thump, wealthy Manhattan businessman and candidate for president of the United States.

Arguing against the drug-pricing practices of pharmaceutical companies is Jennifer Campbell, analyst for healthcare cost and delivery at the National Business Group on Health.

HLM: Are prescription drug prices trending at unsustainably high levels?

Thump: This country is not as great as it used to be and certainly not as great as I could make it again. Let's face it folks, the ability to innovate is one of America's greatest strengths, and it blows my mind that my opponent and others like her want to beat up on one of the most innovative sectors of our economy.

Screws Tighten on 340B Program 

If we want to focus on unsustainable healthcare costs, we should not be focusing on prescription drugs. Pharmacy-dispensed drugs account for about 10% of total healthcare spending, and the cost of those drugs pale in significance compared to the costs of ER visits and hospitalizations. Drugs keep people out of the hospital, which generates cost savings for the entire healthcare industry. That's an undeniable fact that pharma's critics want to ignore.

Campbell: The trend is unsustainable.

While drug pricing and utilization both continue to surge, drug spending will increase by 6% or more annually from now until 2022, according to the Centers for Medicare & Medicaid Services. In 2014, U.S. spending on prescription drugs hit $379 billion, a third of which can be attributed to specialty drugs.

Layering on top of this growing financial burden is that these drugs are now being formulated and targeted for chronic conditions affecting much larger patient populations, a trend that will spark continued discovery and growth of specialty drugs.

Under current law, the Food and Drug Administration grants brand-name biologic drugs a 12-year exclusivity period upon approval. Such a long exclusivity period essentially removes the benefits of price competition, resulting in higher drug prices and a failure of less-costly generic versions to reach the market—all of which will continue to endanger affordable coverage options.

When there is a lack of lower cost substitutes for these steeply priced drugs, health plans and employers alike will increasingly struggle to execute drug access and cost management strategies. More and more, we are seeing that even when efficacious, low-cost generics do exist, payment incentives are not always aligned to promote their use.

HLM: Should there be price controls or windfall-profit taxes in the pharmaceutical sector?

Thump: Price controls would harm patients. U.S. patients have more treatment options and earlier access to medications than patients in any other country on Earth.

The new hepatitis drugs, which we should be celebrating because they cure a dreaded disease, are a great example. The doomsday predictions about these drugs have not come true. All of the patients who need these drugs have gotten these drugs. The market does work.

Campbell: We support neither approach and believe, instead, that the current pricing models are unsustainable and that manufacturers and payers should come to a consensus on pricing.

One promising approach involves manufacturers taking on risk if medications don't deliver as promised and either fail to reduce downstream costs or increase them.

HLM: What is the best way to contain rising prescription drug costs?

Thump: The costs of life-saving medications are not the problem, and the health plans should look in the mirror before they start pointing fingers at pharmaceutical companies.

The way health plans craft benefit designs contributes to increased drug prices. Some health plans require doctors to use an expensive medication when there is a cheaper alternative. Other health plans have placed generic drugs in the highest tier of their drug-pricing benefit designs with brand-name medications.

Campbell: There are a number of best practices that employers follow. In conjunction with their pharmacy benefit manager and health plan provider, employers first seek to provide employees with tools and support to guide appropriate specialty medication management.

Second, [employers seek to] create a comprehensive utilization management framework, complete with prior authorization, step therapy, quantity limit, and exclusion protocols.

Third, [they] implement a custom drug formulary that is designed based on evidence of drug safety and efficacy, and promote patient access to appropriate treatments while effectively controlling costs.

Fourth, [they] promote a more dynamic relationship between patients and their physicians and pharmacists to ensure practical treatment recommendations and compliant drug utilization behavior.

And fifth, [they] focus on site-of-care strategies and the most cost-effective distribution channels, such as specialty pharmacy chains.

HLM: Can prescription drugs be priced based on value, such as how well one drug performs clinically compared to competing drugs?

Thump: Every sector of the healthcare industry is struggling with this challenge. Singling out pharma for the sector's struggle to price prescription drugs based on value is the height of hypocrisy. I'm just saying.

Campbell: In the new value-driven healthcare system, pharma companies are feeling the pressure to demonstrate real, measurable product value. Employers have long been clamoring for more alignment between purchasers and manufacturers.

Finally, we're starting to hear more chatter around this. There are multiple efforts in the United States to make drug price determinations based on value, including the Institute for Clinical and Economic Review and DrugAbacus.

HLM: Are the costs of prescription drugs taking up too large a share of patients' total cost of care?

Thump: Again, the health plans need to take their fair share of responsibility for what is happening with the price of prescription drugs. In this country, the cost of all medications has consistently accounted for about 14% of total healthcare spending.

Patients are enduring higher out-of-pocket costs for their medications because of the way health plans are crafting benefit designs, including high deductibles. The prescription-drug share of the healthcare spend has been consistent, but the patient share of the healthcare spending burden is going up because of the way health plans are changing their benefit designs.

Campbell: The simple answer is yes, although the question is not quite that simple. As one of our forward-thinking employer members has pointed out, we need to understand the downstream costs associated with medications such as medical side effects in addition to the "value add" of the drug. 

However, in general, on a per-member, per-month basis, "specialty drugs" are having an impact on patients' total cost of care. In general, increasing drug costs are driving higher costs to health plans as well as to members, both on the medical and pharmacy side.

The better question might be, "how has specialty pharmacy had an impact on the member's total medication cost share over the course of the last year or so?" To which one member responded, "It's going up, and with no end in sight."

By Christopher Cheney, the senior finance editor at HealthLeaders Media.

Contributor Biography: Christopher Cheney has been a professional journalist for 20 years. He currently works as senior finance editor at Danvers, Massachusetts-based HealthLeaders Media. Prior to joining the staff at HLM, he worked in multiple roles at several newspapers in New England, including the Boston Herald, Cape Cod Times and Concord Monitor. Cheney began his career in healthcare research administration at Children's Hospital Boston. He holds three university degrees, including a master's degree in journalism from Boston University. Cheney is a native of the Red Sox side of Connecticut and lives in New Hampshire with his wife, Jennifer.

Thursday, December 17, 2015

The AMP Final Rule is out of OMB - Prepare for CMS' final Regulations

Have you heard? The OMB has completed their review of the AMP Final Rule and CMS is expected to publish the final regulations soon. As the industry prepares for its impact, IIR’s all-new MDRP AMP Final Rule Digital Week 4-day digital event will provide you with the best coverage of the AMP Final Rule and its many implications.

Join us on January 25-28, 2016 and hear experts from Celgene, Fresenius Kabi, Pfizer, King & Spalding, NACDS and more, as they dissect the rule, covering some of the expected topic areas to be affected:

• Default Rule
• Alternative AMP Calculation for 5i drugs
• 90/10 Rule for Determination of “Not Generally Dispensed”
• Line Extension/New Drug Formulation Rebate Calculation
• Treatment of Authorized Generics
• Specialty Pharmacies, Home Infusion Pharmacies, and Home Health Providers
• Inclusion of US Territories
• Definition of Bundled Sale
• Definition of Bona Fide Service Fee and More!

The best part is that you won’t need to leave the office to attend as this event will be available live and on-demand, streaming to wherever you’re sitting. (It means you SAVE on hotel and travel costs too and we all know how critical that is!)

Subscribe and stay tuned as we add more experts and content to the program, and we get more details in on CMS' final regulations.

Plus! For the first time ever, we're offering special pricing per organization site! Don't miss out, use code P2068LINK to secure your spot now.

Thursday, November 19, 2015

Earn a complimentary pass to IIR's FDA/CMS Summit in Washington, DC - Become a Guest Blogger!

FDA/CMS Summit and co-located Regulatory Information Management Summit (RIM)
December 14 - 15 2015
Washington, DC

Join the biopharma FDA/CMS Summit that facilitates direct dialogue between biopharma executives, investors and FDA/CMS regulators to explain complex regulatory and reimbursement policy.

As a Guest Blogger, you’ll have access to the IIR’s FDA/CMS Summit and RIM's comprehensive agenda attracting the best insights from around the world, right in Washington, DC in December.

We are looking for an industry expert with interest in the following topics:
• Healthcare policy and regulations;
• Breakthrough Therapies;
• Patient-focused drug development programs;
• Drug pricing;
• Medicare & Medicaid;
• Drug reimbursement models...

....and who would like to learn about the current and future trends in Healthcare Regulation!

The premise is to provide FDA/CMS Summit and co-located RIM related blog posts (never more than 300 words), whitepapers, and overall light coverage of the event.

What You get is:
• FREE all-access pass to the conference (valued up to $2,195);
• Access to extensive learning activities with the top regulatory thought leaders and policy makers;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our blog with over 2000 unique visitors monthly and more than 20 healthcare LinkedIn groups.

Learn more about the IIR's FDA/CMS Summit by visiting the website.

Interested & want to learn more about this opportunity? Please contact Alexandria Pump at 

We hope to have you join us in Washington, DC this December!

Subscribe to our blog or follow us on Twitter: 

@healthcarebiz and #FDACMS15

Wednesday, October 7, 2015

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,