Pharmaceutical Industry

With Portal Plagued by Problems, AMA, MMS and Others Urge Sunshine Act Delay

Posted in Pharmaceutical Industry, Regulation, sunshine act on August 5th, 2014 by MMS – Comments Off on With Portal Plagued by Problems, AMA, MMS and Others Urge Sunshine Act Delay

penThe American Medical Association, Massachusetts Medical Society, and 110 other state and specialty medical societies today asked the federal government to delay the public release of information about payments and other transfers of value to physicians from the pharmaceutical and medical device industries.

In a joint letter to Marilyn Tavenner (.pdf), administrator of the Centers for Medicare and Medicaid Services, the groups said that because of an “overly complex” registration process and a condensed time frame, it is “effectively impossible” for physicians to review and dispute reports by the August 27, 2014 deadline.

The reports are scheduled to be released to the public by Sept. 30, 2014. The letter recommends a release date of March 31, 2015. “This process must be streamlined and physicians must be given adequate time to review and dispute their reports,” the letter states.

The reports are mandated by the Physician Payments Sunshine Act, which was enacted in 2010. The report this year will cover activities from Aug. 1 to Dec. 31, 2013.

The joint letter also asked the CMS to:

  • Explicitly direct industry manufacturers to label as “disputed” any unresolved disputes between physicians and industry, even after the physician’s appeal is rejected by the manufacturer. CMS has no plans to mediate physician-industry disputes, even though physicians are already reporting significant errors in the data.
  • Exempt manufacturers from reporting about funding for continuing education activities when the manufacturer does not know the name of program faculty and other participants before the event. Current regulations require reports if industry learns of the identities before or after the event. “Our organizations are concerned that this would have a significant chilling impact on CE [continuing education], which runs contrary to the public interest,” the letter states.
  • Exempt medical textbooks, journal article supplements and reprints from public reporting. The letter states that these publications “represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients.”

Debate on Prescription Drug Bill Resolved; Goes to Governor for Signature

Posted in Drug Abuse, e-prescribing, Pharmaceutical Industry, Regulation on August 9th, 2012 by MMS Communications – 1 Comment

The Massachusetts House and Senate today resolved the debate over a proposed prescription drug monitoring bill intended to increase scrutiny of the way prescriptions are handled. The bill now goes to Governor Patrick for his signature.

According to State House News Service, the bill would limit the number of doctors who overprescribe medications that may be abused or illegally sold and would increase participation in the state’s Prescription Monitoring Program (PMP) by prescribers – a tactic that can be used to identify patients who might be engaged in “doctor shopping”  to gain drugs.

The compromise bill contains provisions that the MMS had advocated for: automatic enrollment in the Prescription Monitoring Program and a required check of the database only for new patients.  MMS had argued that automatic enrollment would increase registrations, currently numbering only 1,800 out of 40,000 some prescribers in the state, and that mandatory use of the system would negatively affect long-standing physician-patient relationships.

Under the bill, participation in the PMP by those who prescribe controlled substances would be mandatory, but enrollment becomes automatic upon license renewal – a provision that the Medical Society said would reduce administrative burdens on physicians and avoid a cumbersome process of paper applications. The bill also says prescribers would only be required to consult the PMP for new patients, and dropped a requirement that physicians check the database before prescribing painkillers to a patient for the first time –a condition the MMS had opposed, saying that any law should allow prescribers to use their professional judgment in treating a patient.

Among the bill’s other provisions as reported by the News Service: Medicaid patients who fill 11 prescriptions from four doctors or at four different pharmacies within 90 days would be put on a watch list; pharmacies would be prohibited from filling prescriptions for narcotics unless written by a doctor licensed and registered in-state, or in one of the five contiguous states to Massachusetts and Maine; a ban on the drug called “bath salts;” pharmacies and drug manufacturers must report thefts to local or state police and the Drug Enforcement Agency; prescriptions for controlled substances would have to be written by doctors on “secure,” tamper-proof prescription pads already required for Medicare and Medicaid patient; pharmacies will be required to sell drug lockboxes, but they will only have to advertise them near registers; the Department of Public Health will provide patient information on the dangers of Class II and Class III drugs; and a working group of physicians will be tapped to write a “best practices” guide for prescribing opioids.


MMS Ethics Forum: Partners’ Conflict of Interest Policy is an Evolving Process

Posted in Annual Meeting 2010, Ethics Forum, Pharmaceutical Industry on May 14th, 2010 by MMS – Comments Off on MMS Ethics Forum: Partners’ Conflict of Interest Policy is an Evolving Process

_MG_4418Calling relations between industry and academic medicine “essential to our mission of translating scientific advances into improved health care,” Eugene Braunwald, M.D., explained the latest conflict-of-interest (COI) policies at Partners Healthcare System at Thursday’s MMS Ethics Forum.

Dr. Braunwald is a world-renowned cardiologist, Harvard professor, and faculty dean for academic programs at Partners.

Here’s a summary of several Partners COI guidelines. Those who willfully violate them receive warnings and then face dismissal for further lapses, Dr. Braunwald said.

  • All gifts to Partners physicians are prohibited, including meals, unless the meals occur in the course of non-marketing business activities
  • Free drug samples will be distributed to patients through a centralized outlet. Physicians will not be permitted to keep drug samples received from industry reps
  • All visits by industry representatives must be preceded by a written invitation specifying the purpose and duration of the visit
  • Partners is developing a process to monitor financial interests held by physicians in companies that make products the physician prescribes or uses in clinical practice
  • In any industry-sponsored educational program or fellowship, there must be more than one sponsor, and no single sponsor can contribute more than 70 percent of the funding
  • All Partners faculty are barred from participating in industry-sponsored “speakers’ bureaus” and from “ghostwriting” for industry
  • “Institutional officials” at Partners (e.g., presidents, senior VPs, and department chairs) may not receive more than $5,000 a day for work with an outside board of directors that does business with Partners and they may have no equity stake in such companies.

Dr. Braunwald noted that these policies represent a “series of compromises” that were often “challenging to reach consensus on.”

Asked by the outgoing MMS President, Mario Motta, M.D., whether the tightened rules were hurting efforts to recruit physicians and researchers, Dr. Braunwald said, “Yes, but most all academic centers are changing their COI rules.” He did concede that he’s heard “some grouching” from Partners faculty about the changes.

MMS Members Comment

Listen to Dr. Braunwald’s lecture (1:16:31)

Obama’s Health Care Budget: New Spending, New Cuts and Tax Hikes

Posted in Health Policy, Health Reform, Pharmaceutical Industry on February 28th, 2009 by MMS – Comments Off on Obama’s Health Care Budget: New Spending, New Cuts and Tax Hikes

The Obama administration’s budget plan this week features the creation of $635 billion “reserve fund” to pay for changes in the country’s health care system. It includes roughly equal measures of spending cuts and tax increases.

Based on various news summaries and other reports, here’s what Obama proposed. The estimated value of spending, cuts and tax increases come from the Obama administration.

New Spending

  • Eliminate scheduled payment cuts to physicians. A 21% cut is
    scheduled for 2010; 40% over the next decade.
  • Spend $330 million to address the shortage of health care
    providers in certain areas. This includes loan repayment programs for doctors, nurses
    and dentists who practice in under-served areas. Also, there is assistance for
    nursing schools.
  • Increase cancer research spending at the NIH by $400 million
    to $6 billion.
  • Spend $211 million at the HHS for research into autism, as
    well as for screening, public awareness and support services for autism
  • Spend $12 billion in quality incentives to hospitals: $12
    billion over 10 years

Spending Cuts

  • Eliminate the 14% worth of higher payments that Medicare
    Advantage plans now get from the federal government and require them to submit
    to competitive bidding. Savings: $177 billion over 10 years. Medicare Advantage
    plans cover about 23% of Medicare beneficiaries.
  • Set up a "regulatory pathway" to approve generic
    versions of biologic drugs developed by biotechnology companies. Savings: $9.2 billion over 10 years.
  • Require drug makers to provide bigger discounts to Medicaid.
    Savings: $19.5 billion over 10 years
  • Bundle Medicare payments for hospital and post-hospital care,
    to be split by physicians and hospitals. Savings: $17.8 billion over 10 years
  • Cut payments for hospitals for preventable readmissions.
    $8.4 billion over 10 years.
  • Reduce payments to home health agencies by $37 billion over
    10 years.
  • Use radiology benefit managers in Medicare. Savings: $260
    million over 10 years
  • Total value of spending cuts: $316 billion

Tax increases

  • Increase top tax bracket to 39.6% (currently 35%)
  • Limit deductions for mortgage interest and charitable
    donations by taxpayers in the top two tax brackets to 28%.
  • Increase premiums for Medicare prescription drugs plans for
    high-earning taxpayers ($8 billion over 10 years)
  • Allow tax cuts for upper income taxpayers to phase out in
  • Block phase out of the estate tax
  • Total value of tax increases: $318 billion

What do you think? What's realistic, and what's not?

Worth a read: Understanding Physician-Pharmaceutical Industry Interactions

Posted in Pharmaceutical Industry on May 10th, 2007 by MMS – Comments Off on Worth a read: Understanding Physician-Pharmaceutical Industry Interactions

Much has been written about the relationships between the drug industry and physicians.  Headlines blare: "Doctors reap millions for anemia drugs;" "Pills for Patients, Payday for Docs;" "Posing as pals, drug reps sway doctors’ choices." To some, even within our own physician ranks, it appears an insidious relationship exists. Press reports would have you believe most doctors are checking patients with their right hand and looking for a hand-out with their left. Some may; most do not.

Understanding Physician-Pharmaceutical Industry Interactions
, a new book for which I had the honor of writing the forward, is long overdue. Written by a young physician, Shaili Jain, M.D., a General Adult Psychiatrist in Milwaukee, Wisconsin, it focuses on a critically important topic for all health professionals who prescribe medicines.

These interactions continue to generate heated debate in academic and public arenas, yet sadly, research shows that physicians and physicians in training remain ignorant of the core issues and poorly trained to face the sophisticated industry promotion which has become ubiquitous in medical environments. This book aims to address this gap in education by providing a single concise resource that explains the essential elements.

Business ethics and medical ethics are different. What Big Pharma, as a business, considers normal, the medical profession considers unethical. But the principles I learned in medical school many years ago — prescribe as few medicines as possible, but when doing, use medicines that are therapeutically effective, safe, and cost the least — hold true today. Yet to curtail the rising cost of health care, everyone must become cost conscious, especially for medicines. No other service or product is purchased so blindly.

The achievements in medicine during the 20th century were spectacular. Vaccines have saved millions of lives and prevented countless suffering. More medicines and discoveries are in progress. To continue that advance, the pharmaceutical industry and the medical professional must work in synergy. The relationship must be completely devoid of conflict of self-interest and greed. And the relationship between the prescriber and drug manufacturer must not be self-serving for either. It is – and should be — all about the patient and the betterment of the health of the world’s population. 

Leonard J. Morse, M.D., Commissioner of Public Health, City of Worcester, Past Member and Chair, Council on Ethical and Judicial Affairs, American Medical Association; Past President, Massachusetts Medical Society