Advocacy with the Administration
The AMA continues to advocate for changes to decrease the regulatory burden on physicians. Recently, the AMA was instrumental in securing significant regulatory improvements.
AMA comments including Legal Memorandum outlining CMS Authority to remove Drug Costs from SGR Calculations; Proposed Rule: Payment Policies Under the Physician Fee Schedule for CY 2013, September 4, 2012
Looking ahead to 2013, the AMA along with specialty and state medical societies sought action from the Centers for Medicare and Medicaid Services (CMS) to address medicine's serious concerns about an onslaught of overlapping regulations that affect physicians. Programs with overlapping timelines include the penalties under the electronic prescribing program, physician quality reporting system (PQRS) and electronic health record incentive programs, the value-based modifier, as well as the transition to ICD-10. The physician community is especially concerned about the back-dating of penalty programs such that performance in 2013 determines penalties for 2015, for example, and the lack of alignment in the requirements for the various programs.
Additionally, in a March 30 letter to CMS, the AMA voiced physician concerns regarding CMS' policy on observation care and requested a policy review and new policy development. This policy has created significant confusion and tremendous, unanticipated financial burden for Medicare patients. The AMA supports rescinding the three-day stay policy, as well as counting observation care toward the three-day inpatient stay requirement for as long as this requirement remains in place.
The AMA is committed to addressing and advocating for solutions to the ongoing problems in the claims management revenue cycle that contribute to increased complexity and expense.
The AMA is urging the Federal Trade Commission (FTC) and the Department of Justice (DOJ) to shift the focus on current physician antitrust policy to remove obstacles that prevent physicians from forming clinically integrated networks that can jointly negotiate with health plans for the purposes of participating in quality improvement programs and HIT initiatives. The AMA is also urging the DOJ to increase its oversight of health insurer consolidation.
Statement to the U.S. Senate Judiciary Committee, Subcommittee on Antitrust, Competition Policy, and Consumer Rights given by Henry S. Allen, Jr. Esq. on Consolidation in the Pennsylvania Health Insurance Industry: The Right Prescription? July 31, 2008
The purpose of CER is to enhance physician clinical decision-making and foster the delivery of patient-centered care. Most current research on medical treatments compares the benefits of a specific treatment to no treatment, but little information is available to physicians to help them determine if new treatments outperform existing options.
Physicians today have access to a wide array of medical information. However, there remains far too little rigorous evidence available about which treatments work best for which patients. The AMA strongly supports increased federal funding of comparative effectiveness research (CER). Though there are a broad array of areas where CER would bring benefits, the health care community must strategically target support for CER where it will significantly improve health care value by enhancing physician clinical judgment, foster the delivery of patient-centered care, and produce substantial benefit to the health care system as a whole.
The Drug Enforcement Administration (DEA) registration number system was implemented as a way to successfully track controlled substances from the time they are manufactured until the time they are dispensed to the patient. The AMA strongly opposes the use of the DEA number for purposes other than its original intent.
The AMA provided recommendations to the Food and Drug Administration's (FDA) Drug Shortages Task Force on its Strategic Plan in a March 14, 2013 letter. In its letter, the AMA highlighted physician concern and frustration with ongoing shortages, particularly of sterile injectables. In addition, AMA indicated its support of the concept of developing a qualified manufacturing partner program; and strongly supported targeted notification to physician medical specialty organizations.
e-Prescribing for Controlled Substances
On March 31, 2010 the DEA published an interim final rule (IFR) permitting physicians to prescribe controlled substances electronically as of June 1, 2010. The IFR specifies the rules that physicians and other health care providers must follow in order to e-prescribe controlled substances. The AMA together with several medical specialty societies commented on the DEA's proposed rule in 2008 and the IFR in 2010. While the DEA made a number of positive changes in the final rule, there are still a number of e-prescribing requirements specific to controlled substances that physicians must comply with. E-prescribing for controlled substances remains optional for physicians. For those physicians who would like to prescribe controlled substances electronically, the DEA requires what is known as a "two-factor authentication." Authentication is information (e.g., PINs, passwords, biometrics) that is used to verify a person’s identity for security purposes. According to the IFR, when e-prescribing controlled substances, physicians must use two out of three factors: something you know (e.g., passwords), something you have (e.g., hard token stored separately from the computer being accessed like a USB device or smart card), or something you are (e.g., biometrics such as a fingerprint or iris scan). While the effective date is June 1, before physicians can prescribe controlled substances electronically, vendors must make their e-prescribing applications compliant with the IFR requirements and undergo a third-party audit before changes to physician's software can be made. In addition, physicians must undergo a verification process (either in person or remotely) with a federally approved entity in order to receive authorization to e-prescribe controlled substances. Also, please check with your vendor to ensure that their system is compliant with the DEA requirements and check if your State law allows you to e-prescribe controlled substances.
Prescribing in Long-Term Care Settings
Tip Sheet for Practicing Clinicians: Prescribing Controlled Substances in Long-Term Care
Congress requires the DEA's Office of Drug Diversion Control to be self-funded. Therefore, DEA registration fees support this office. However, DEA fees are disproportionately high for physician prescribers compared to others like manufacturers and distributors, something the AMA has vigorously opposed. The three-year cost for a physician DEA registration is $551 which also represents a steep increase over prior practitioners registration feeds. Furthermore, the DEA requires physicians to obtain a DEA number for each state where they prescribe adding potentially more costs for physicians.
On December 23, 2010, CMS published an Advanced Notice of Proposed Rulemaking on the Emergency Medical Treatment and Labor Act (EMTALA). That ANPRM indicated that CMS was reconsidering its current policy which provides that: 1) a hospital’s EMTALA obligation ends upon the admission of a patient as an inpatient, and 2) EMTALA does not apply to the transfer of an inpatient to a hospital with specialized capabilities.
The AMA submitted comments in response to the ANPRM that strongly objected to the extension of EMTALA to the inpatient setting or to the transfer of an inpatient to a hospital with specialized capabilities. The AMA reasoned that physicians are already bound by a host of legal and ethical obligations to provide necessary patient care, and take those obligations seriously. Further, the AMA asserted that EMTALA obligations often result in over-utilization of physician resources, uncompensated care, and administrative hurdles.
On February 2, 2011, CMS published a Request for Comment in which CMS states that it is maintaining its current policy that EMTALA does not extend to inpatients or to the transfer of inpatients to hospitals with specialized capabilities. CMS says that it will continue to monitor whether it may be appropriate in the future to reconsider the inapplicability of EMTALA to the transfer of inpatients to hospitals with specialized capabilities, and invites comment on that issue. The AMA commented in support of CMS' decision not to extend EMTALA.
AMA urges that FDA modify risk reduction plans
The AMA wrote Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, to express concern about the manner in which FDA has been implementing the Risk Evaluation and Mitigation Strategies (REMS) provisions of a 2007 law and recommend improvements. The AMA believes that REMS should support physician decision-making and help promote safe prescribing without erecting barriers to delivery of appropriate care. The FDA has not required manufacturers to obtain input from practicing physicians on “elements to assure safe use” when such elements are included in REMS; however, nor has it outlined methods to assess the impact of REMS on patient access to needed drugs. In its letter, the AMA recommended that the FDA: require this type of consultation with specialty societies and practicing physicians; ensure that manufacturers evaluate the impact of REMS on patient access and clinical practice; provide for review of proposed REMS by the FDA Advisory Committees; and reduce the administrative burdens associated with REMS. In response to the concerns expressed by AMA and other stakeholders, the FDA convened a public meeting on July 27-28, 2010, and reopened the comment period on its draft guidance on REMS. Dr. Sandra Fryhofer of the AMA Council on Science and Public Health represented the AMA at the public meeting.
FDA Plans for Opioids
Last year the FDA announced an initiative to work with manufacturers of extended-release and high-potency opioids to develop a Risk Evaluation and Mitigation Strategy or REMS. In meetings, testimony at public hearings, and comment letters, AMA has urged the agency to: ensure that the REMS does nothing to impair patient access to needed pain medications; seek a REMS focused primarily on educating physicians and patients; provide positive incentives rather than penalties; allow substantial opportunities for physician involvement in designing the educational programs; avoid restricted distribution; and work to prevent unintended consequences such as an increase in use of immediate-release opioids that are not included in the REMS or undertreatment of pain.
The AMA is working to ensure that fraud and abuse laws and enforcement do not unduly burden honest physicians.
Health information technology (Health IT) encompasses a wide range of products and systems, including software, hardware and infrastructure, that are used to support the collection, storage and exchange of patient data throughout the clinical practice of medicine. Health Information Technology (Health IT) is a term that encompasses a huge range of products and systems. There are many public and private initiatives currently promoting and developing effective Health IT.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prompted new Federal regulations which require physicians to ensure they are protecting the privacy and security of patients' medical information and using a standard format when submitting electronic transactions, such as submitting claims to payers.
Payers who conduct business electronically need to be aware of two significant changes concerning standard transactions and code sets. On January 16, 2009, the Department of Health and Human Services (HHS) announced two new compliance deadlines.
Effective April 1, 2011, CMS expects home health agencies and hospices have fully established internal processes to comply with the face-to-face encounter requirements mandated by the Affordable Care Act (ACA) for purposes of certification of a patient’s eligibility for Medicare home health services and of recertification for Medicare hospice services. Section 6407 of ACA established a face-to-face encounter requirement for certification of eligibility for Medicare home health services, by requiring the certifying physician to document that he or she, or a non-physician practitioner working with the physician, has seen the patient. The encounter must occur within the 90 days prior to the start of care, or within the 30 days after the start of care. Documentation of such an encounter must be present on certifications for patients with starts of care on or after January 1, 2011. CMS had originally proposed a much short time frame for when the encounter had to occur, however, due to AMA advocacy, CMS extended the timeframe. Similarly, section 3131(b) of ACA requires a hospice physician or nurse practitioner to have a face-to-face encounter with a hospice patient prior to the patient’s 180th-day recertification, and each subsequent recertification. The encounter must occur no more than 30 calendar days prior to the start of the hospice patient’s third benefit period. The provision applies to recertifications on and after January 1, 2011.
The original compliance date for these new requirements was originally scheduled for January 1, 2011. However, the AMA expressed significant concerns to CMS that since this new policy was only finalized on November 29, 2010, that it did not leave an adequate amount of time to educate physicians on this change. CMS therefore extended the compliance date to April 1, 2011. While the AMA believes that even more time is necessary to educate physicians, CMS has elected not to extend the compliance date any further.
AMA Correspondence on Face-to-Face Encounters
December 23, 2010 Letter to CMS on the Face-to-Face Encounter Requirements
The AMA is concerned about the negative impacts on patients and physicians resulting from retroactive changes to hospital admission status and increased placement in observation care. To alleviate these problems, the AMA is advocating for rescission of the three-day inpatient stay requirement for patient coverage of skilled nursing facility (SNF) care, increased transparency of commercial black-box edit software and physician decision-making regarding admission status; and for physicians to be held harmless from audits related to admission status.
The Affordable Care Act (ACA) significantly expands those covered by Medicaid. As a result of the new law and the 2012 decision by the US Supreme Court on the constitutionality of the ACA, states can decide whether to expand their Medicaid programs to cover all non-Medicare eligible individuals under 65 years of age with incomes up to 133% of the federal poverty level (FPL) based on modified gross income. Through this change, Medicaid is expected to cover an additional 16 million people beginning in 2014.
As a result of AMA Advocacy, in September, 2009, President Obama directed the HHS Agency for Healthcare Research and Quality (AHRQ) to implement a $25 million state-based demonstration project on Medical Liability Reform and Patient Safety. The demonstrations will help states and health care systems to test models that meet four goals:
- Put patient safety first and work to reduce preventable injuries;
- Foster better communication between doctors and patients;
- Ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits; and
- Reduce liability premiums
The first grant program is funding for one-year planning grants to create plans for development, implementation and evaluation of approaches that focus on medical liability reform and patient safety. These are one-year grants for up to $300,000 each. The second program is funding for three-year demonstration projects to allow States and health systems who are ready to go to develop, implement, and evaluate medical liability models that focus on patient safety and reform the medical liability system. These are three-year grants for up to $3 million dollars each.
State medical associations are not eligible to apply for grants on their own directly. Those eligible to apply are states and "health systems". Medical associations can be a "component" of a health system if in coalition with them. Criteria listed to qualify address both patient safety and MLR reform and are drafted broadly. The language does not limit the type of reforms that may be considered—applicants will have wide discretion and flexibility in designing their patient safety and medical liability innovations that meet specified criteria (i.e., health courts, early offer programs, and administrative-type programs may all be considered if they meet the patient safety and medical liability objectives.)
The grant application period opens December 27th and will close January 27th. Funding decisions will be made within four months.
Both grant announcements are available at the following links:
- Medical Liability Reform and Patient Safety Planning Grants (R21)
- Medical Liability Reform and Patient Safety Demonstration Projects (R18)
An Advisory Subcommittee has been established to advise AHRQ on the review criteria in the announcement or clarify additional issues for applicants. William Hazel, MD, an AMA Trustee and an orthopedic surgeon, serves on the Subcommittee.
The AMA is working to fixed the flawed Sustainable Growth Rate formula and prevent the looming 21% physician Medicare cuts.
As a result of a provision in the Medicare Modernization Act of 2003 (MMA), the Centers for Medicare and Medicaid Services (CMS) has been charged with significantly altering the way they award contracts to carriers and fiscal intermediaries. Understand how this will impact your process and what you need to know about this transition.
The Medicare enrollment process is a critical area of the program as it serves as the gateway into the program. Before physicians can bill Medicare they must submit an enrollment application to their Medicare contractor and have it successfully processed. Learn about the latest changes to the process and how to get your application processed successfully.
In 2005 the AMA lead the passage of the Patient Safety and Quality Improvement Act (Public Law 109-41 109th Congress). The AMA will continue to lead physicians' efforts to measurably improve patient safety by working to ensure the law's implementation and to advance other measures, including voluntary reporting systems with strong confidentiality protections.
On November 21, 2008, HHS issued the final rule that establishes the authorities, processes, and requirements for implementing the Patient Safety and Quality Improvement Act of 2005 (the Patient Safety Act). The final rule captures the intent of the Patient Safety Act; to create a voluntary reporting program through which health care providers can share information relating to patient safety events with patient safety organizations (PSOs) on a privileged and confidential basis in order to improve patient safety and the quality of care. The final rule reiterates that this voluntary program is not federally funded but sets forth the framework by which health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, for the collection and analysis of patient safety events. The final rule indicates that the Agency for Healthcare Research and Quality (AHRQ) will implement and oversee the process for certification and listing of PSOs and that the Office of Civil Rights (OCR) will investigate and enforce compliance with the confidentiality requirements.
April 11, 2008, AMA comments submitted to the Agency for Healthcare Research and Quality (AHRQ) on the proposed rule for implementing the Patient Safety law that establishes a federal framework for physicians, hospitals, and other health care professionals and entities to voluntarily report patient safety work product to patient safety organizations (PSOs) on a privileged and confidential basis. Read the letter
The U.S. Government Accountability Office (GAO) on September 23 announced the appointment of 19 members to the Board of Governors of the new Patient-Centered Outcomes Research Institute (PCORI). Established by the Affordable Care Act (ACA), the PCORI is being set up as a nonprofit organization to fund research projects on the comparative effectiveness of various patient diagnostic, treatment and disease prevention methods. To read more about PCORI, please visit www.pcori.org.
On September 1, 2011 the AMA along with 26 medical specialty organizations responded to PCORI's call for comment on its proposed working definition of "patient centered outcomes research." The letter also includes 2011-2012 Comparative Effectiveness Research priority recommendations.
The Physician Payments Sunshine Act, which was part of the Affordable Care Act (ACA), requires manufacturers of drugs, medical devices, and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.
On November 29, 2010 CMS finalized a requirement in the 2011 Physician Fee Schedule Final Rule which required physicians to sign every lab requisition. However, the AMA, together with numerous other stakeholders including the laboratory industry, strongly opposed this requirement due to significant interruptions in workflow and access to patient care which would result if this requirement were to be retained. CMS initially elected to delay the compliance date for the requirement from January 1, 2011 to April 1, 2011 in order to give physicians, labs and others sufficient time to comply. However, following significant outreach to CMS concerning the impact this requirement would have, CMS has decided to indefinitely postpone the requirement that physicians sign every lab requisition. CMS is expected to propose removing this requirement in future rulemaking.
AMA Correspondence on Lab Requisitions
August 29, 2011 AMA letter to CMS applauding retraction of policy requiring signature on lab requisitions
The AMA is actively involved in discussing and engaging the Administration and Congress regarding implementation of various quality measurement and improvement programs and activities.
Congress created the recovery audit contractors (RAC) program to help the Centers for Medicare and Medicaid Services (CMS) identify improper payments made by Medicare. The RAC contractors are private entities that are retained by the government to identify overpayments or under payments made to physicians and other healthcare providers, as well as, to recoup overpayments or return underpayments. The RAC was created by Congress first as a demonstration program and was subsequently expanded as a permanent, nationwide program.
The AMA remains deeply opposed to the bounty hunter-like program. During the initial stages of the demonstration program, CMS only rewarded the RACs for locating overpayments. However, thanks to significant AMA advocacy CMS also began rewarding these contractors for locating underpayments as an improper payment could also have resulted in a physician being underpaid. Several other changes were made to the expanded program as a result of AMA advocacy but the program remains a burden for physicians.
In 2010, the AMA successfully urged Congress to pass legislation, the "Red Flag Program Clarification Act of 2010," which limits the type of "creditor" that must comply with the Red Flags Rule. In February 2013, the AMA issued comments in response to the FTC's interim final rule that amends the Red Flags regulation to make it consistent with the Clarification Act.