As we have noted over the past few weeks, many health care groups and organizations have been submitting comments on the proposed regulations that would implement Section 6002 of the Patient Protection and Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
As reported by MassDevice.com, almost 100 groups last week submitted comments expressing their concern about the proposed regulations and the impact they will have on practicing physicians. These groups, including the American Medical Association (AMA) and the Society for Vascular Surgery pushed back against the current format of the Sunshine Act, “warning that the rule doesn’t do enough to protect the reputations of physicians in case of a dispute.”
These groups urged the Centers for Medicare and Medicaid (CMS) to make changes to the provision, which requires drug and device manufacturers to begin reporting gifts or payments worth more than $10. The reporting will begin at a time determined once CMS publishes the final rule. The result, a searchable database containing the names and addresses of each recipient and the details of the payments, will be made publicly available sometime in 2013.
The act also mandates stiff penalties for companies that fail to comply. Companies found to inadvertently omit reports could ring up civil fines of between $1,000 and $10,000 “for each payment or other transfer of value or ownership or investment interest not reported,” according to the act. Companies found to knowingly skirt the reporting rules could be slapped with fines of $10,000 to $100,000. The total amount of fines can’t exceed $1 million, or 0.1 percent of total annual revenues, in a single year.
While AMA and other health groups supported the intention of the act, “they warned that physicians need better safeguards and pathways to challenge payments.” The proposed rule excludes CMS from involvement in any disputes between manufacturers and physicians, a hands-off approach that has industry groups worried. Instead, CMS noted that it would basically put an asterisk (*) next to a doctors name for the specific payment, indicating that the physician or teaching hospital had challenged the payment. Not many other details were provided or proposals indicating a formal or administrative grievance process to challenge such mistakes.
“False, misleading, and inaccurate information could be publicly posted on a government website while denying physicians basic due process rights to challenge such information,” according to the letter, signed by groups including the American College of Cardiology, the American Assn. of Orthopedic Surgeons and the Society of Thoracic Surgeons.
The groups urged rule-makers to establish an independent arbiter to mediate disagreements and provide physicians with an avenue to dispute entries in the public database with a written response in the interest of protecting a physician’s good name.
“A few disputes between a manufacturer and a handful of physicians are unlikely to ruin a manufacturer/GPO’s standing or even subject the manufacturer/GPO to civil money penalties,” the groups wrote. “In contrast, physicians may have their careers and professional reputations damaged as a result of one disputed report, and physicians may incur significant expenses to resolve a dispute with a manufacturer/GPO.”
“We strongly urge CMS to re-structure the process the agency has outlined,” the health groups wrote. “The proposed rule opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate, or misleading reporting and suffer significant damages including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood.”
The full list of co-signers of the letter includes:
American Medical Assn.
Aerospace Medical Assn.
American Academy of Dermatology Assn.
American Academy of Family Physicians
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Physical Medicine and Rehabilitation
American Assn. of Clinical Endocrinologists
American Assn. of Clinical Urologists
American Assn. of Neurological Surgeons
American Assn. of Neuromuscular and Electrodiagnostic Medicine
American Assn. of Orthopaedic Surgeons
American College of Cardiology
American College of Chest Physicians
American College of Emergency Physicians
American College of Mohs Surgery
American College of Osteopathic Family Physicians
American College of Osteopathic
American College of Osteopathic Surgeons
American College of Phlebology
American College Radiology
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Gastroenterological Assn.
American Medical Group Assn.
American Osteopathic Academy of Orthopedics
American Osteopathic Assn.
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Pediatric Nephrology
American Society for Radiation Oncology
American Society of Cataract and Refractive Surgery
American Society of Echocardiography
American Society of Hematology
American Society of Nuclear Cardiology
American Society of Plastic Surgeons
American Thoracic Society
American Urogynecologic Society
American Urological Assn.
College of American Pathologists
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council of Allergy, Asthma and Immunology
Medical Group Management Assn.
Renal Physicians Assn.
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Gynecologic Oncology
The Endocrine Society
The Society of Thoracic Surgeons
Medical Assn. of the State of Alabama
Alaska State Medical Assn.
Arkansas Medical Society
California Medical Assn.
Connecticut State Medical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Assn. Inc
Hawaii Medical Assn.
Idaho Medical Assn.
Illinois State Medical Society
Iowa Medical Society
Kansas Medical Society
Kentucky Medical Assn.
Louisiana State Medical Society
Maine Medical Assn.
MedChi, The Maryland State Medical Society
Massachusetts Medical Society
Michigan State Medical Society
Minnesota Medical Assn.
Mississippi State Medical Assn.
Missouri State Medical Assn.
Montana Medical Assn.
Nebraska Medical Assn.
Nevada State Medical Assn.
New Hampshire Medical Society
Medical Society of New Jersey
New Mexico Medical Society
Medical Society of the State of New York
North Carolina Medical Society
North Dakota Medical Assn.
Ohio State Medical Assn.
Oregon Medical Assn.
Pennsylvania Medical Society
Rhode Island Medical Society
South Dakota State Medical Assn.
Tennessee Medical Assn.
Texas Medical Assn.
Utah Medical Assn.
Vermont Medical Society
Medical Society of Virginia
West Virginia State Medical Assn.
Wyoming Medical Society