Policy and Medicine

Health Care Reform: Obama Budget Down Payment on Healthcare Reform

The Health and Human Services Portion (HHS) of the Obama budget established a reserve fund of $630 billion over ten years to finance fundamental healthcare reform.

The reserve is funded equally by new revenue and by savings proposals.  If adopted, the goal is to put 

America

further down the path of health care reform

Funding Highlights:

 • Accelerates the adoption of health information technology and utilization of electronic health records.

 • Expands research comparing the effectiveness of medical treatments to give patients and physicians better information on what works best.

• Invests over $6 billion for cancer research at the National Institutes of Health as part of the Administration’s multi-year commitment to double cancer research funding.

• Strengthens the Native American health system with sustained investments in healthcare services for Native Americans and Alaskan Natives to address persistent health disparities and foster healthy Native American communities.

• Invests $330 million to increase the number of doctors, nurses, and dentists practicing in areas of the country experiencing shortages of health professionals.

• Supports families by providing additional funding for affordable, high-quality child care, expanding Early Head Start and Head Start, and creating the Nurse Home Visitation program to support first-time mothers.

• Strengthens the Medicare program by encouraging high-quality and efficient care, and improving program integrity.

• Invests over $1 billion for Food and Drug Administration food safety efforts to increase and improve inspections, domestic surveillance, laboratory capacity, and domestic response to prevent and control food-borne illness.

In this budget, the President is committing roughly $63 billion per year for healthcare reform initiatives.  The healthcare economy is currently $2.1 trillion, and his commitment in the budget represents 3% of the total healthcare budget, which is less than the predicted growth in healthcare spending.  The total budget for Medicare will expand from $386 billion (2008) to $872 billion (2019).  The President is predicting $317 billion in undefined healthcare savings over ten years.  

As the President alluded to in his speech to Congress, we will see change, including healthcare reform but more than likely it will be incremental, and in this case very incremental.

President’s 2010 Budget HHS Section

                  Full 2010 Budget

Letters from Grassley: HHS OIG – Investigate Emory

Emory University’s (Emory) Charles Nemeroff, M.D., who in December stepped down as Chairman of the Department of Psychiatry and agreed to very strict probation policy is again under fire by Senator Grassley for his bad behavior for not disclosing income earned from promotional talks.

The Senator is asking the Health and Human Services (HHS) Office of the Inspector General (OIG) to investigate Emory University over possible violations including:

1.    Possible violation of National Institutes of Health’s (NIH) Conflict of Interest Rules;

2.    Possible violations of Institutional Review Board (IRB) protocols and failure to report IRB violations to the Office of Human Subject Research Protection (OHRP);

3.    Possible violations of Federal Contracting Rules regarding commitment of time for NIH Grants; and

4.    Possible misleading information provided to NIH.

The Senator would like the OIG to begin an investigation into this matter immediately.

In addition, Senator Grassley requested the OIG to conduct a further accounting of this issue to ensure that Emory did not, either directly or indirectly, mislead the NIH about the nature of Dr. Nemeroff’s promotional talks for GlaxoSmithKline and advocacy on behalf of Paxil.

The letter included a packet of information on a promotional program from 2000.  The document looks like a standard promotional program packet with the exception of the confidentiality information.

Dr. Nemeroff is not exactly a choir boy in this exercise and perhaps the steps that Emory has taken could have been stronger.

But do these possible violations deserve the attention of an OIG investigation?  Since Emory just recently learned of the failed disclosure, they perhaps have not thought about submitting information to the various offices at NIH.  NIH was aware of the situation and rescinded a $9.3 million grant, perhaps NIH thought that was sufficient.

Whatever the situation is, Senator Grassley does not want this case to go away.  This is not the last chapter of the Nemeroff/Grassley story.

Senator Grassley:    Letter to HHS OIG

OIG Letter PsychNet Attachment 2-24-09

The Wall Street Journal Blog:  What did Emory Tell about Nemeroff’s Pharma Pay

Previous Stories:

            Letters from Grassley: Emory Surrenders

Letters from Grassley: Emory -- Release the Hounds

            Letters from Grassley: Emory Professor Caught with Hands in Cookie Jar

Health Care Reform: Obama State of Health Care – Incremental Change

“We can’t afford to put it (healthcare) on hold.”  “It’s time.”  President Obama, Speech to Congress, February 24, 2009.

With the economy on the precipice, the President in his speech to congress gave mention to health care reform plans for 2009, rather than calling for a separate package the President presented an incremental version within his budget.

“For that same reason (financial crisis), we must also address the crushing cost of health care.

This is a cost that now causes a bankruptcy in

America

every thirty seconds.  By the end of the year, it could cause 1.5 million Americans to lose their homes.  In the last eight years, premiums have grown four times faster than wages. And in each of these years, one million more Americans have lost their health insurance. It is one of the major reasons why small businesses close their doors and corporations ship jobs overseas. And it’s one of the largest and fastest-growing parts of our budget.

Given these facts, we can no longer afford to put health care reform on hold.   Already, we have done more to advance the cause of health care reform in the last thirty days than we have in the last decade. When it was days old, this Congress passed a law (SCHIP) to provide and protect health insurance for eleven million American children whose parents work full-time.

Our recovery plan will invest in electronic health records and new technology that will reduce errors, bring down costs, ensure privacy, and save lives.

It will launch a new effort to conquer a disease that has touched the life of nearly every American by seeking a cure for cancer in our time.

And it makes the largest investment ever in preventive care, because that is one of the best ways to keep our people healthy and our costs under control.

This budget builds on these reforms. It includes an historic commitment to comprehensive health care reform – a down-payment on the principle that we must have quality, affordable health care for every American.

It’s a commitment that’s paid for in part by efficiencies in our system that are long overdue. And it’s a step we must take if we hope to bring down our deficit in the years to come.

Now, there will be many different opinions and ideas about how to achieve reform, and that is why I’m bringing together businesses and workers, doctors and health care providers, Democrats and Republicans to begin work on this issue next week.

I suffer no illusions that this will be an easy process. It will be hard.

But I also know that nearly a century after Teddy Roosevelt first called for reform, the cost of our health care has weighed down our economy and the conscience of our nation long enough. So let there be no doubt: health care reform cannot wait, it must not wait, and it will not wait another year.”

This past week, the President held a fiscal responsibility summit, next week a healthcare summit.  It will be interesting to see what ideas are actually in the budget and what those changes will mean to the healthcare economy.  The one thing we can all count on with President Obama is we will see change.

 

Physician Payment Sunshine: Medtronic to Disclose Payments to Physicians

Medtronic announced today its commitment to voluntarily disclose payments to U.S. physicians.

The company will begin capturing payment data for all of its businesses on January 1, 2010 and will publicly report this information annually. 

The first disclosure will occur in March of 2011 and will address payments made to physicians during calendar year 2010. 

The company will commission an annual third-party audit to demonstrate its commitment to the accuracy of these postings, and will make a summary of the audit results public.

Medtronic will report on the company website, the amount paid in consulting fees, royalties or honoraria for physicians who receive payments of $5,000 or more per year from Medtronic.  Medtronic’s disclosure of $5,000 and above is considerably than the $100 threshold proposed by Senators Kohl and Grassley in the revised Physician Payment Sunshine Act.

Disclosure includes, consulting agreements, education and training, clinical trial design and administration, and product design and safety.

“Relationships between industry and doctors are essential to innovation, education, and training in our industry,” said Bill Hawkins, Chairman and Chief Executive Officer.  “Through greater transparency about the nature of these relationships, we will help people better understand how important they are to developing life-saving and enhancing products for patients who need them.”

Medtronic initiated a first step toward greater transparency when it launched its online Donations Registry in August 2008 (available at www.medtronic.com).

The donations registry makes public all donations given by Medtronic to

U.S.

customers or organizations affiliated with customers, including patient groups and medical societies.

This is the first device company to voluntarily disclose payments made to physicians and they join Merck, Pfizer, Eli Lilly and GlaxoSmithKline.  This is a positive step for Medtronic, and though the threshold is higher than other registries, it reflects the need for relationships between device companies and physician inventors.

Note The Wall Street Journal Health Blog on Medtronic quotes our original article on the Physician Payment Sunshine Act of 2009

CME Grant Disclosure 2008

We have compiled a list of grant disclosure reports for 2008.

At the end of 2007 only Eli Lilly reported their CME grants and charitable donations.

 In 2008 seven pharmaceutical companies have published grants/contribution reports.   

Several additional companies have stated they will be publishing their grants in the coming year.

Company	2008
Amgen	1st Quarter
	2nd Quarter
	3rd Quarter
	4th Quarter
Astra Zeneca	1st ½ of 2008
	2nd ½ of 2008
Glaxo Smith Kline	4th Quarter 08
Johnson and Johnson Companies
Jansen	1st 2nd and 3rd Quarters
Ortho McNeil	1st 2nd and 3rd Quarters
Ortho Biotech	1st 2nd and 3rd Quarters
Centocor	1st 2nd and 3rd Quarters
McNeil Pediatrics	1st  and 2nd Quarters
Ortho McNeil  Neurologics	1st 2nd and 3rd Quarters
PriCara	1st 2nd and 3rd Quarters
Scios	1st 2nd and 3rd Quarters
Tibotech	1st 2nd and 3rd Quarters
Eil Lilly	1st Quarter
	2nd Quarter
	3rd Quarter
	4th Quarter
Merck	3rd Quarter
	4th Quarter (not yet published 2-23-09)
Pfizer	1st Quarter
	2nd Quarter
	3rd Quarter
	4th Quarter

 

As more companies report their grants we will add them to this listings.

State Policy: Data Mining in Montana

Data Mining is a the practice of collecting prescriber level prescription data information, aggregating and selling that information to pharmaceutical manufactures and others for marketing or research.

The Montana State House Human Services Committee approved House Bill 394 which would ban the practice of data mining for marketing purposes on a 9-7 vote late Monday, sending it to the full House for further action.

The vote was largely along party lines with 8 democrats and one republican voting to send the bill to the full house for a vote.

Rep. Dave McAlpin, D-Missoula, the sponsor of the bill, said Tuesday that he thinks it has a good chance of passing the House this week.

"I expect to pick up more bipartisan support and pass" the bill, he said. "I think Montanans have a high standard for personal privacy that will send this bill right to the Senate."

According to one local source, this bill will not recieve a favorable reception , if it reaches the senate.

A majority in the State Senate still support free enterprise and freedom of commercial speech including data mining. 

Montana House Bill 394

            Text

            Bill Status

Sponsor: Rep David McAlpin, D

Billings Gazette: Panel Curbs Spread of Prescription Info

Health Care Reform: Clinical Trials Leaving the US

According to a report in The New England Journal of Medicine (the Journal), clinical trials are leaving the U.S. and migrating to developing countries at an alarming rate. 

·       For the 20 largest pharmaceutical companies, one-third of the trials (157 of 509) are being conducted solely outside the United States

·       Majority of study sites (13,521 of 24,206) are outside the United States

·       Sites outside the United Statesmore than doubled in 10 years

·       The proportion of trials conducted in the United States and Western Europe decreased

The Journal sites three major reasons for this dramatic shift:

Cost Savings

A pharmaceutical executive reported that a first-rate academic medical center in India charges approximately $1,500 to $2,000 per case report, less than one-tenth the cost at a second-tier center in the United States.

 Shortened Time Lines

In 2000, the cost to develop a new drug averaged $802 million, with time costs accounting for one-half of that amount.  The large pool of potential research participants and the lower cost of research in countries, such as China and India, provide opportunities to accelerate recruitment.

Regulatory Restrictions

An important force that is moving clinical trials to developing countries is the increasingly bureaucratic and expensive regulatory environment in many wealthy countries.

Regulations governing the conduct of clinical research have become more and more complex, placing a greater burden on investigators in terms of compliance, documentation, and training.

In the United States, the costs of conducting clinical trials have generally outstripped federal funding for clinical research and strained industry's site-level research budgets.

Although these regulations are well intentioned, they are generally uncoordinated and frequently have not been subjected to empirical studies to determine which elements improve the conduct of trials and which elements add cost without benefiting participants or the research mission.

Before enacting further regulations on industry governments and regulatory bodies, we need to consider the potentially devastating side effects of those regulations.  What may sound like a “good” idea, needs to be flushed out with real evidence:

A)  Is there an actual versus perceived problem?

B)  Are the proposed changes based upon empirical versus anecdotal evidence?

C)  What are the full economic consequences of regulations or rules?

D)  Is there an actual economic, societal or patient benefit to passing the legislation or nongovernmental rule?

If we continue the trend of greater regulation, this shift in clinical trials to developing countries will only accelerate and further weaken our economy. 

The New England Journal of Medicine: Ethical and Scientific implications of Globalization of Clinical Research

The Wall Street Journal: Most Clinical Trials Done Abroad

The Wall Street Journal Blog: How to Lure Clinical Trials Back to the U.S.

State Policy: Colorado Gives the Boot to Gift Ban

In a 6-1 vote against the Colorado Senate sent the opponents of physicians and industry packing.

In Colorado the state Senate Businesses Affaires and Labor Committee heard testimony until 8:00pm on Wednesday on a perhaps one of the most restrictive bill to-date affecting the pharmaceutical and device industries.

After realizing that the bill which included  a “gift ban” with a liberal definition of gifts (anything of value), along with disclosure of everything they might have forgotten to ban, would have devastate the states bourgeoning biotech industry the committee killed the bill.

Another key point was these types of bills if passed would hamper drug manufactures ability to alert physicians to important drug information.

Each year dozens of bills are filed on the state level, but fortunately most states are weary of passing bills with potentially devastating side effects like this one.

Denver Business Journal:  Drug Company marketing curbs booted

State Policy: More State Bills

Last week, we featured some key state bills that are focused on restrictions on “gifts” to physicians and pharmaceutical marketing including data mining.  Well, our “friends” at NLARX have published a list in short form of what states are considering certain types of legislation.  This does not mean that they have necessarily filed the bills as many of the states listed are in session or have they held hearings but that legislators in those states have discussed these bills with NLARX.

Data Mining and Privacy

Includes governments placing restrictions on the resale of pharmacy data to pharmaceutical marketers.

States considering measure:  Alaska, Colorado, Connecticut, District of Columbia, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Minnesota, Maine, Montana, New Hampshire, New Mexico, New York, Washington, Wisconsin, and West Virginia

Academic Detailing

State sponsored sales reps (nurses, techs or non-medical personnel) and visiting physicians on the value of prescribing generic drugs, often includes continuing medical education (CME) credit as a hook to get into offices.

States considering measure:  California, Colorado, Connecticut, Iowa, Illinois, Maryland, Minnesota, New Mexico, Texas, Washington, Wisconsin and West Virginia

Gift Bans and Disclosure Requirements

Gift bans typically mean any payment of value and include research, education, and consulting.  Disclosure means to disclose anything that is not banned.

States considering measure:  California, Colorado, District of Columbia, Iowa, Maine, Minnesota, New Mexico, Nevada, New York, Texas, Vermont, Wisconsin and West Virginia

Summary

Every year there is a lot of activity, but little actually gets passed.  But with the state budget crises of 2008-2009, every measure that is perceived to save governments money will be looked at closely.

Given their successes in Massachusetts this past year, the NLARX members are empowered to pass more state laws further restricting our industry.

NLARX Listing of State Bills

State Policy: List of State Bills Restricting Pharmaceutical and Device Marketing or Limiting Continuing Medical Education

 

Several state legislatures have filed bills affecting the pharmaceutical and device industry on addressing Continuing Medical Education (CME), and the list only promises to grow longer as states begin their legislative sessions.

Reviews of Several State Legislatures:

Colorado

House and Senate has introduced the “Prescription Drug Ethics Act,” which includes bans on all “gifts” payments and transfers of value.

Iowa

The State Assistant Majority Leader has introduced the Iowa Healthcare Coverage Partnership program, and it includes bans on payments and gifts, reporting, advertising and expenditure reporting, restricting data mining, and academic detailing.  They use the definition of CME as having more than one speaker.

The bill was assigned to the committee where the sponsor is the chairman. 

Illinois

Introduced the Prescription Drug Ethical Marketing Act and includes reporting of all payments, fees, and gifts. 

New York      

Governor Paterson’s budget includes a resolution to adopt a strict ban on “gifts” to

physicians.

Assemblymen have introduced a bill eliminating the tax exemption for direct-to

consumer advertising.  This will go over really well on Madison Avenue in New York

Texas            

Three disclosure bills, with one requiring disclosure of payments for all CME except those sponsored by a medical society.  Also, a bill has been filed that bans resale of prescription data.  Given the make-up of Texas, we give these bills a Rhode Island-sized chance of passing in this very large, conservative state.

Vermont

Their bill that includes a “gift ban” on anything of value and reporting on everything else.  With 30 of the 30 state senators as co-sponsors, this is a trouble spot.

Virginia

Data Mining Restriction.  This will go down in history as one of the quickest turn-arounds on a bill.  It was introduced on the 14^th of January, and killed in committee on February 3^rd.

Washington

Restrictions on the sale of patent identifiable data.  Actually, we do not have a problem with this except if it does not allow sale of data for marketing.

Therapeutic Substitution: allows for pharmacists to replace Medicaid prescriptions for branded drugs with non-branded generics.  As a patient, I have always been pleased to have my pharmacist or managed care company second guess my physician, they are out for me as long as I don’t cost them anything.

The four states to keep a close eye on are Colorado,Iowa,New York and Vermont.

Other states that have publicly stated they will strive for stronger restrictions but have not filed bills as of this report, include Minnesota (enhanced disclosure), West Virginia (enhanced disclosure) and Maine (adding device manufacturers to their reports).

Download Listing of State Bills 2009 2-12-09

See list of Bills and Relevant Links:

 

State	Introduced	Bill Number	Sponsor	Bill Title and Web Link	Description	Type	Status
Colorado	2/3/09	SB09-166	House: Morgan Carroll	Prescription Drug Ethics Act	Bans all gift, fee, payment, subsidy, or other economic benefit to a health care practitioner.	Payment and Gift Ban	Assigned to Business, Labor and Technology
			Senate: Sal Pace
					Requires Reporting of other payments	Payment Disclosure
Iowa	1/27/09	SF 48	Senate: Jack Hatch Assistant Majority Leader Senate	IOWA HEALTH CARE COVERAGE PARTNERSHIP PROGRAM	In addition to Healthcare Coverage it includes the kitchen sink of pharmaceutical	Payment and Gift Ban	Assigned to Committee Human Resources Sponsor is Committee Chairman
					marketing restrictions and defines CME as only multi speaker events
				Bill Book		Payment Reporting
						Advertising and Marketing Expenditures Reporting
						Restricting Data Mining
						Academic Detailing
Illinois	1/27/09	HB0332	Rep. Jack D. Franks and Fred Crespo	Prescription Drug Ethical Marketing Act	Requires  manufacturer labeler that sells prescription drugs to disclose the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing or promotional or other marketing activities  to any health care working that can prescribe drugs	Payment Disclosure	Referred to Human Services Committee
							2/4/2009
Minnesota	Not yet filed		Senator John Marty	Policy Med	Greater Disclosure Measures	Payment Reporting
					Article
						Gift Ban
New York	1/7/09	A.158	Governor Paterson	State Budget Bill (Page 54-55)	Includes Governors Recommendation for Legislation on Payment Ban and Restriction on CME talks	Payment and Gift Ban	Referred to Ways and Means
		S. 58					1/7/2009
				Section C		Restriction on CME Presentations	Amended and re-referred to Ways and Means
				Gift and Payment Ban			1/21/2009
New York	2/10/09	A05030	Sponsor: Assemblyman Brodsky	Prohibits manufacturers and distributors of prescription drugs from deducting the costs of advertising such drugs to consumers from their income taxes		DTC Advertising Tax Exemption	Referred to Ways and Means
			Co Sponsors:				2/10/2009
			Cahill, Clark, Koon, Weisenberg
Texas	11/10/08"	SB 151	Sponsor State Senator Rodney Ellis	Physician Drug Marketing	Name and Address	Payment Disclosure	Referred to Health and Human Services 2/10/09
					$25.00 bottom
				Article	Excludes Samples
				Policy Med
Texas	1/13/09	SB 296	Sponsor State Senator Royce West	Disclosure of Payments and Transfer of Value		Payment Disclosure	Referred to Committee on State Affairs 2/11/2009
				Article
				Policy Med
Texas	1/27/09	SB 553	Sponsor Lucio	Relating to the disclosure of certain economic benefits provided by manufacturers or repackagers of prescription drugs; providing penalties	Limits gifts of $75.00 or more, CME is excluded only for specialty societies (Universities, hospitals and MECC’s will have to report participants)	Payment Disclosure	No Action
							2/11/2009
Texas	2/3/09	SB 646	Sponsor Vande Putte	Relating to a study regarding the confidentiality of prescription information; providing a civil penalty	Restricts Resale of Prescription Data	Data Mining	No Action 2/11/2009
							Bill Stages
Vermont	1/30/09	S 48	Sponsor Kevin Mullen	Health; prescription drugs; marketing; gift; ban; disclosure	Defines CME as offers CME credit, features multiple presenters on scientific research, or is authorized by the sponsoring association to recommend or make policy.	Gift Ban	Referred to Committee on Finance
			Cosponsors include all 30 of the state senators			Payment Disclosure
				Policy Med
Virginia	1/14/09	HB 2452	Delegate Mark Sicles	confidentiality of prescription information		Data Mining	Referred to Health Welfare and Institutions, 1/14/09
							Stricken from the Docket 2/03/09
Washington	1/21/09	HB 1493 - 2009-10	Sponsor: Rep Jamie Pederson	Marketing Prescription Drugs	Restrictions on selling patient data that includes patient name	Resale of Patient identifiable data – Covers all data	February 13th Hearing Committee on Health and Wellness
						News Story
	2/5/09	SB 5892 - 2009-10		Relating to authorizing state purchased health care programs		Therapeutic Substitution	Referred to committee on Health and Long Term Care
				to maximize appropriate prescription drug use in a cost-effective
				manner