Thursday, August 20, 2015

State Programs and Government Pricing

Guest Author: Katie Lapins
 
Keeping track of all of the reporting requirements associated with Government Pricing can be daunting. Is your product a brand, authorized generic, generic, injectable or otherwise administered in a clinic or doctor’s office? Not only are these important questions that dictate what reporting must be done on a monthly, quarterly, and/or annual basis, but manufacturers must also comply with various state reporting requirements, currently New Mexico (Q3 only), Vermont (Quarterly) and Texas (Monthly and Quarterly). Here’s a review of the current state reporting requirements:

New Mexico originally required quarterly reporting but this has changed to just the third quarter of each year, due by January 15 of the following year. New Mexico requires the following information for all Covered Outpatient Drugs from all manufacturers:
  • - Quarterly Average Manufacturer Price (“AMP”),
  • - Greatest wholesaler prompt pay discount percentage,
  • - Lowest indirect price through a New Mexico wholesaler, and
  • - Lowest prices to wholesalers, Pharmacy Benefits Managers and any other New Mexico entity that purchases directly from the manufacturer without the use of a wholesaler.

Vermont requires quarterly reporting within 30 days of the quarter end (January 30, May 1, August 1, and November 1). AMP and BP, if applicable, must be reported for each Covered Outpatient Drug. Additionally, manufacturers must report the undiscounted price paid by Vermont wholesalers for product received in Vermont during the quarter (the Vermont WAC). Vermont also requests that each manufacturer provide the methodology utilized to perform the calculations. For manufacturers, it may be worth including a note as to the confidentiality and proprietary nature of their methodology that is submitted.

Texas has two different reporting requirements. The first is simply that manufacturers must submit AMP on a quarterly basis. The second requirement is due by the 10th day of each month and must include the following information:

  • - Direct Price to Chain Pharmacy
  • - Direct Price to Long Term Care (“LTC”) Pharmacy
  • - Direct Price to Pharmacy
  • - Price to Wholesaler/Distributor

In the event a manufacturer reports a price range for these price points, they must also report a weighted average, based on unit sales. Texas also has requested that manufacturers submit pricing data for eligible pharmacies in Texas only. Last year, at IIR’s MDRP Summit, a Texas representative announced that this reporting requirement would most likely be going away and just this month, the Texas Health & Human Services Commission (“TX HHSC”) Vendor Drug Program announced that they will propose the following changes to the reporting requirement:

  1. - If a manufacturer wants to place its products on the Texas Code Index, they would be required to submit AMP, AWP, Direct Price to LTC Pharmacy, Direct Price to Pharmacy, and Price to Wholesaler/Distributor
  2. - No future prices would need to be submitted unless requested from the TX HHSC and at that point, the manufacturer would have 10 days to provide the information

Remember, these changes are proposed and as of today, pharmaceutical manufacturers should still be reporting to Texas the required data outlined above.

Also of note is New York’s EPIC and Pennsylvania’s PACE Programs. They also require quarterly submissions that contain the same information as your DDR submission.

And speaking of states, MDRP is the perfect time to bring your documentation to resolve any outstanding disputes with representatives from the following states who will be attending: Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Mississippi, Montana, Nevada, North Carolina, Oregon, Utah, Virginia, Wisconsin, and Wyoming.

If you need more information on the various state requirements or assistance in handling a dispute, please feel free to reach out to me. Katie Lapins, Government Pricing Specialists, LLC, 303.993.6466, K.Lapins@GP-Specialists.com. I look forward to seeing you in Chicago at MDRP!


Katie Lapins
Katie Lapins has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for 15 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, assisted manufacturers with voluntary disclosures/restatements, led audits and assessments, calculated and submitted statutory pricing requirements (AMP, BP, ASP, Non-FAMP, PHS and TRICARE), processed Medicaid/ SPAP/ Supplemental invoices, validated PHS eligibility, handled Class of Trade projects with over 100K entities, and created training for onsite and web-based instruction for 2 – 200 employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management.




Thursday, August 13, 2015

Last Chance! Save $500 off MDRP Registration | Rates Increase Friday, 8/14


As you probably already heard, the highly anticipated AMP Final Rule has been submitted to OMB and the proposed rule is expected to be released at the end of August—Just in time for IIR's MDRP Summit!

MDRP 2015 is a platform to impact the Final Rule during the comment period and directly influence its outcome. Connect with 550+ MDRP executives and 100+ industry experts to dissect the proposed rule and submit feedback to CMS. Get a head start on your compliance operations for the impending Final Rule implementation.

How will MDRP facilitate the industry comments to CMS? Click here to see all the AMP related content we have throughout all three days of the conference. For full session and speaker details, download the brochure.

If you are planning on joining us in Chicago on September 30-October 2, 2015, now is the time to register! Not only is this Friday the last chance for you to save on registration, but the Chicago Marriott Downtown Magnificent Mile hotel is also nearly sold out! Reserve you hotel room here.

PLUS! Get 340B Updates directly from HRSA on October 1st during the main conference from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA, and during the full-day 340B Mega Guidance Compliance pre-conference summit on September 30th.

This Friday, August 14th is your last chance to SAVE up to $300 off the standard rate. Be sure to use priority code: XP2058BLOG. After Friday, rates will go up! Register here.

We look forward to meeting you in Chicago this September!





Thursday, August 6, 2015

Update on 340B Rules

Guest Author: Katie Lapins

The long-awaited “Mega” Rule related to the 340B Program may soon be released. In the past, the 340B Program has been primarily administered without formal regulations, establishing the rules that govern the 340B program primarily through policy releases, informal guidance, and FAQs. However, when the Patient Protection and Affordable Care Act (ACA) / Health Care and Education Reconciliation Act (HCERA) was passed, Health Resources and Services Administration (HRSA) was mandated to specifically address certain topics that require clarity or further guidance.

Before any rule can be published, it is submitted to the Office of Management and Budget (OMB) who must first clear it which normally takes about 90 days. The “Mega” Rule was submitted in June, making its release in September likely. Although rules can be held up at OMB for months, or longer, most experts do not expect that to happen with this one. So what are a few of the “hot topics” in the 340B Program?

Orphan Drug Rule
You may remember that HRSA had previously submitted a Proposed Rule regarding Orphan Drugs to the OMB but withdrew it in November 2014 after a court ruled that HRSA had overstepped its authority 1. This rule was later reissued as “interpretive,” PhRMA has challenged it (again), and we still are waiting for a ruling from the courts. This case has been important as the court’s decision implies that an agency must have the specific authority from Congress to issue rules that change those items established through statute. However, this interpretive guidance could ultimately be the foundation for enforcement against manufacturers, creating a conundrum for them since that would mean HRSA’s interpretation would have the same impact as a rule. The next court decision in this matter could clarify this situation, making the procedures of HRSA as important as the content in this case.

The “Mega” Rule
Earlier this year, HRSA issued a Proposed Rule regarding the calculation of 340B ceiling prices and CMPs and public comments are due within 60 days (August 17, 2015). So what’s left for the 340B Program and why is there still a pending “Mega” Rule? Many people believe it will contain components related to the 340B Program that remain vague and require clarity for all stakeholders, including:

1. Definition of a 340B patient
2. Hospital eligibility requirements, including off-site facilities
3. Contract pharmacy arrangements
4. Price reporting/transparency
5. Duplicate discounts and procedures for manufacturer refunds

Many of these topics are related to the overall intent, and potentially unintended outcomes, of the program. In recent years, the growth of the program has been rapid for a few reasons; many hospitals have acquired other facilities that are 340B eligible and also, as of March 2010, covered entities can use multiple contract pharmacies. As this growth has occurred, questions have arisen regarding the intent of the program and the profits of various stakeholders. Congress has issued letters to some of the stakeholders and held special hearings, and the General Accounting Office and Office of the Inspector General have also raised concerns about the program’s integrity. Even without diversion or duplicate discounts, the ability to purchase drugs at deeply discounted prices and administer them to patients who may have health insurance provides a large “spread” or profit to the covered entity. The retail outlets serving as contract pharmacies also have the potential to see significant revenue from this role, beyond what was originally imagined. HRSA’s mission is to, “improve[e] access to health care by strengthening the health care workforce, building healthy communities and achieving health equity.”2. At issue to many is if the way the 340B Program is currently functioning follows the intent of the program.

The “Mega” Rule will be issued as a Proposed Rule, allowing 60 days for comments from stakeholders. It’s important that manufacturers read the entire document and involve the appropriate personnel and departments to determine the potential impact on their own company’s operations and ultimately, their bottom line. This will include not only the legal and policy areas but also the procedural and administrative ones, as well.

Clearly, the 340B Program continues to be one of great change and important considerations must be weighed by all of its stakeholders. The 20th MDRP Summit by IIR is filled with 340B-related topics and includes a full day workshop on this important topic. Hear from colleagues, attorneys, and government officials who have expertise in the 340B Program to find out about the implications for your organization of these impending changes. Download the agenda to see a complete topic list.



Katie Lapins
Katie Lapins has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for 15 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, assisted manufacturers with voluntary disclosures/restatements, led audits and assessments, calculated and submitted statutory pricing requirements (AMP, BP, ASP, Non-FAMP, PHS and TRICARE), processed Medicaid/ SPAP/ Supplemental invoices, validated PHS eligibility, handled Class of Trade projects with over 100K entities, and created training for onsite and web-based instruction for 2 – 200 employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management.


1 - In brief, HRSA’s Orphan Drug Proposed Rule said that the free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals purchasing orphan-designated drugs are entitled to purchase those drugs at the 340B ceiling price when they are used for an indication other than the orphan indication.

2 - http://www.hrsa.gov/about/index.html





Wednesday, August 5, 2015

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.




Thursday, July 16, 2015

340B Changes Are Coming - Are You Prepared?

With the completed review of HRSA's latest Proposed Rule: "340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations" by the White House Office of Management and Budget (OMB) and the long-awaited proposed "Mega" Guidance under review and slated to come out later this year, are you prepared for the compliance requirements brought on by these policy and procedure changes?

At the 20th Annual Medicaid Drug Rebate Program Summit, we've got an entire day dedicated to just 340B. Join us during the pre-conference day on Wednesday, September 30th to get key 340B compliance information, with sessions on:
  • • Key Highlights and Updates on HRSA, OPA 2015 Rulemaking
  • • Getting it Right: 340B Policy & Procedure Compliance Checklist
  • • Panel: Navigating the 340B Drug Pricing Program Database
  • • Ensuring Compliance & Conducting Monitoring and Internal Auditing
  • • Panel: 340B Hot Topics
  • • And More!

PLUS! Get 340B Updates directly from HRSA on Thursday, October 1st during the main conference from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA.

This full-day summit is part of the Platinum Pass, which gives you access to the full three days of the MDRP Summit - the best value! Register now and save up to $300 off standard registration. Be sure to use priority code: XP2058BLOG

See you in Chicago this September!




Tuesday, July 14, 2015

Is Medicaid Extension Really Feasible?

The following excerpt is from a Podcast recorded by the MDRP Summit with Grace-Marie Turner, President of the Galen Institute last June. Access the complete MP3 and Transcript here.

Is Medicaid extension really feasible?

Grace-Marie: I just think that it’s going to be very difficult to convince those other states that have resisted so far because more and more evidence is coming down to show that expanding Medicaid as a traditional program as it is currently structured is real harmful to people. And it’s really harmful to the most vulnerable citizens who are on Medicaid today. If people have many chronic conditions, many of them have no place else to go. They are basically not insurable in the private marketplace. If they are under 100 or 138% of poverty, Medicaid really is their only option. As a result, you wind up with more people competing for the same limited number of doctors who will see Medicaid patients and making it even more difficult for people on Medicaid today to find a doctor to see them.

I had a father write to me recently who has a daughter who is on Medicaid – many chronic conditions and in a wheelchair. He said: “It takes me sometimes six weeks to get an appointment with her urologist”. He said: “Do they even think about how much more difficult it’s going to be to get an appointment with the urologist if there are a million more people competing for those same appointments?” So, we must fix it so that it allows the safety net to be intact for the most vulnerable people and give those who have the option to get private coverage to do so, so that they are not competing.

And then finally, I think that the states who want to expand the program need to guarantee that providers will be paid enough that they will be able to see a Medicaid patient. In some states like New Mexico that have a very high match rate, Medicaid pays at very close to Medicare rates. In other states, a doctor may be paid $5 or $7 for an office visit – not even enough to begin to cover expenses. Doctors want to take care of these patients, but they can only keep so many and keep the lights on and pay their own bills. So, we’ve got to be able to pay providers more and that’s the kind of leverage that I think that the states would be able to have if they were not so constrained by an avalanche of federal rules and all the “Mother May I?” waiver requests that they have to get to make any changes to their plan.

If they had more flexibility, then they could make sure that patients on the program today could actually find a doctor to see them and also make sure that those who may be in an expansion population have the option of coverage that looks more like the private insurance and the private marketplace so that it’s a track and a platform to private coverage rather than the cliff that Medicaid is today – either in or out. If you make $1 too much money then you’re out of Medicaid or $1 less and you’re in. It needs to be a smoother ramp to private coverage and there are a lot of ideas to do that, including giving people the option of basically taking their Medicaid allotment as a voucher to buy into private coverage. There are a lot of ideas out there to improve this program, but we need to remember that we’re doing it for the most vulnerable citizens who are on the program today, who have no place else to go, competing for a limited number of appointments with a shrinking number of doctors to actually get appointments.

We can do so much better and I think you’re going to see many more governors actually demanding those kinds of changes and that kind of flexibility in exchange for any expansion.


Join us at the 2015 MDRP Summit for complete coverage on all things pricing, rebates, contracting and collaboration. Register now and save $300 when you use the code: XP2058BLOG





Friday, July 10, 2015

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.




Thursday, July 2, 2015

Celebrate July 4th with 30% Off to MDRP 2015!


Take advantage of this special July 4th offer and save 30% to MDRP! Register with code XP2058SAVE30 to activate your 30% discount off the standard rates to IIR’s 20th Annual Medicaid Drug Rebate Programs Summit taking place September 30-October 2nd, 2015 in Chicago, IL. Visit the website for full details.

This limited-time offer expires on Monday, July 6th | Register here.

The 20th Annual Medicaid Drug Rebate Programs Summit continues to be the authoritative gathering for everything pricing, rebates, contracting, and collaboration. You’ll get unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them. Collaborate with your peers to benchmark best industry practices and navigate regulatory hurdles, minimize wasted resources and optimize finances.

Don't miss out on getting essential regulatory updates from CMS, HRSA, OIG, VA and more!

Activate your 30% savings now with code XP2058SAVE30! Offer expires 7/6

Qualifications, rules and regulations: 
Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 30% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from July 2 – July 6, 2015. All registrations are subject to IIR approval.




Friday, June 26, 2015

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.




Wednesday, June 24, 2015

Prepare for VA Contract Negotiations at MDRP 2015 | Last Chance to Save $500 is Friday

Last Chance to save up to $400 to MDRP 2015 is THIS Friday, 6/26. PLUS! Take an additional $100 off when you use the code XP2058BLOG | $500 in total savings! Register now.

Your successful compliance with the VA's contractual and statutory requirements can spell the difference between profitable partnerships and drawn-out audits.

At the 20th Annual Medicaid Drug Rebate Program Summit, join us during the Pre-Conference event titled, "Pharmaceutical VA Contracting and Compliance Summit." This half-day summit is ideal for pharmaceutical and biotech manufacturers looking to comprehensively tackle the challenges of designing and complying with the complex - but highly lucrative - contracts in this sector.

You will touch upon key steps necessary to ensure you are ready for 2015 and beyond. Below are just a few session highlights:

• The Ins and Outs of a VA Audit: Comprehensive Overview of the Review Process
• Restating non-Federal Average Manufacturing Prices (NFAMP) and VA Federal Ceiling Prices (FCP)
• Panel Discussion: Prepare for Contract Negotiations


This half-day summit is part of the Platinum Pass, which gives you access to the full three days of the Medicaid Drug Rebate Program Summit - the best value! Registration rates go up after this Friday, June 26th. Save up to $500 off standard registration, be sure to use priority code XP2058BLOG | Register here.

Ensure you have the most comprehensive educational experience over three days with unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs. Reserve your seat today at the most comprehensive MDRP event to date!

See you in Chicago!