October 23, 2014 MHA Capitol Advocacy Center 110 W. Michigan Ave. Ste. 1200 Lansing, MI 48933 Phone: (517) 703-8601 Fax: (517) 703-8620 www.mha.org www.hospitalsact.org Learning Session on Compounding 2 Pharmacy Laws Available Online Waiver Available for DEA Rule on Disposal of Controlled Substances 2 Pending State Legislation 3 Hospitals-ACT 3 Health PAC 4 Regulatory 4 MHA Legislative Policy Panel 4 Advocacy Briefing Your Vote is Vital to Michigan’s Healthcare Future Election Day is Nov. 4, and Michigan’s healthcare future depends upon the involvement of Michigan hospitals, patients and communities in the general election. This year, Michigan voters will elect one U.S. senator, all 14 U.S. House of Representative seats, the governor, the attorney general, the secretary of state, all 38 Michigan Senate seats, all 110 Michigan House of Representative seats, and three of the seven Michigan Supreme Court justices. In the 2010 gubernatorial election, only 44 percent of Michigan’s registered voters participated in the general election. In the last two weeks leading up to the election, the active involvement of healthcare leaders will help elect healthcare champions, which are candidates who will best support healthcare in Lansing and Washington, DC. Your vote can make a significant difference to the future of healthcare in Michigan, so please be sure to make your voice heard. For more information about the election, visit http://www.mha.org/mha/ elections.htm. Remaining 2014 Michigan Health Endowment Fund Listening Tour Dates Set The Board of Directors of the Michigan Health Endowment Fund is conducting a listening tour to gain a better understanding of the health issues confronting Michigan children and seniors. Several sessions have been completed, and the final three tour dates and locations have been set. The sessions will be held Oct. 14 at the Grand Traverse Resort & Spa, Acme (near Traverse City); Oct. 20 at the UAW-GM Center for Human Resources, Detroit; and Nov. 21 at the Salvation Army Kroc Community Center, Grand Rapids. Registration and driving directions are available online. The listening tour is an opportunity for participants to respond to questions about health concerns in their community, the barriers preventing people from achieving good health, and approaches that are working well to improve the health and well-being of children and older adults, as required by the endowment fund’s statutory authorization. Requests for funding are not being accepted at this time and, based on conversations at previous sessions, comments that focus on a broad set of recommendations are well received; specific funding suggestions for narrowly designed interventions were viewed as too limited. http://www.mha.org/mha/public_site/advocacy/documents/abriefing.pdf OCTOBER 23, 2014 PAGE Learning Session on Compounding Pharmacy Laws Available Online The MHA recently held a federal and state compounding pharmacy laws learning session to summarize Public Act (PA) 280 of 2014, which contains amendments to the pharmacy licensure and drug control provisions of the Michigan Public Health Code. Kathleen Reed, an attorney with the Dykema law firm who specializes in healthcare law, presented key compliance issues in state and federal law that took effect Sept. 30. Members who were unable to participate in the learning session can view it online or review MHA Advisory Bulletin #1341 that details the changes set forth in PA 280. PA 280 was enacted in response to the New England Compounding Center’s criminal activity that caused the disastrous outbreak of fungal meningitis in 2012. The act creates a definition of compounding pharmacies and establishes new limits on compounding activities and requirements for recordkeeping related to compounds. The MHA and its members worked closely with the attorney general’s office and bill sponsors to ensure no unnecessary burden was placed on hospital pharmacists, since hospitals differ greatly from stand-alone compounding pharmacies. This law applies to preparation of intravenous drug solutions and impacts nearly every Michigan hospital. Waiver Available for DEA Rule on Disposal of Controlled Substances The U.S. Department of Justice’s Drug Enforcement Administration (DEA) final rule on disposal of controlled substances took effect, with potentially adverse consequences for hospital employees and patient care. The American Hospital Association (AHA) alerted its members that certain provisions of the rule are incompatible with established employee and patient safety protocols. In addition, the final rule includes new, unrealistic record-keeping requirements that will compel hospitals to reassign and retrain employees and, possibly, hire additional staff members. In a letter to the DEA, the AHA and other national hospital organizations asked the agency to delay enforcement of these provisions to allow time for providers to comply with the arduous requirements. Suggesting there may be more practical ways to meet the DEA’s objectives, the organizations asked the agency to meet with hospitals as soon as possible to discuss “practical solutions to these issues that can both accomplish the laudable goals in the law and effectively addresses (sic) the employee and patient safety concerns as well as those related to excessive costs and disruption.” Meanwhile, hospitals that cannot currently comply with the new regulations may submit a written request specifying that it is for a waiver of the provisions in the Sept. 9, 2014, Final Rule on Disposal of Controlled Substances that took effect Oct. 9 and are applicable to the hospital’s disposal of controlled substances. The AHA suggests the following wording when requesting the waiver: [Hospital] is requesting a waiver of the Methods of Destruction under 21 CFR sec. 1317.90 requiring that the destruction meet the "non-retrievable" standard. [Hospital] is not equipped to comply with this new standard and [Hospital's] current procedures for destruction and disposal are compliant with longstanding federal, state and local requirements. [Hospital] also seeks a waiver of the "on-site destruction" requirement requiring two employees to handle or observe handling and witness the destruction. 21 CFR 1317.95(d). This requirement is impractical for hospitals given DEA's narrow definition of "employees." It is also unnecessary given that [Hospital] has previously and will continue to utilize appropriate personnel and individuals associated with the hospital to perform these tasks. The request should be mailed to Joseph Rannazzisi, deputy assistant administrator, Drug Enforcement Administration, Office of Diversion Control/OD, 8701 Morrissette Drive, Springfield, VA 22152. http://www.mha.org/mha/public_site/advocacy/documents/abriefing.pdf 2 OCTOBER 23, 2014 PAGE Pending State Legislation No-Fault Insurance (SB 251) Establishes a $50,000 Personal Injury Protection benefit for auto insurance coverage Status: Senate Insurance MHA POSITION: OPPOSE Health Exchange Navigators (SB 324/HB 4576) Licensing and regulation for navigators who will assist citizens with the healthcare exchange established by the Conscientious Objector Legislation Affordable Care Act (SB 136) allow health care payers, health Status: House Health Policy facilities and health providers to decline or pay MHA POSITION: SUPPORT CONCEPT for certain health care services that violate ethical, moral or religious principles, or Low-cost Auto Insurance beliefs. (SB 326) Allows households having a gross Status: Senate Floor annual income equal to 300% of the federal MHA POSITION: OPPOSE poverty guidelines to apply for low-cost automobile insurance. This insurance does not Advanced Practice Registered Nurses provide benefits that are provided under the (SB 2) Eliminates provisions regarding the Michigan policy of no-fault insurance capping specialty certification of nurse midwives and the coverage at $50,000. nurse practitioners and, instead, provide for Status: Senate Insurance the licensure of advanced practice registered MHA POSITION: OPPOSE nurses (APRNs), including certified nurse midwives, certified nurse practitioners and certified clinical nurse specialists Status: House Health Policy MHA POSITION: NO POSITION CRNA Supervision Requirement (SB 180) Adds “administration of anesthesia” by certified registered nurse anesthetists (CRNAs) to the practice of nursing to allow CRNAs to practice without direct physician supervision Status: Senate Health Policy MHA POSITION: SUPPORT Concealed Weapons Exemption Repeal (SB 213) Eliminates list of specified premises on which a person licensed to carry a concealed weapon may not carry Status: Senate Natural Resources, Environment and Great Lakes MHA POSITION: NEUTRAL Medical Malpractice (HB 4354) Health care professional or health facility is not liable in emergency treatment rendered in a hospital Status: House Judiciary MHA POSITION: NEUTRAL Auto No-Fault (HB 4612) Drastically decreases coverage in Michigan’s Auto No-Fault Insurance and Nurse Staffing Ratios (SB 228/HB 4311) Requires development of an dissolves the Michigan Catastrophic Claims Association acuity system and staffing plan for nurses Status: House Floor Status: Senate Health Policy MHA POSITION: OPPOSE MHA POSITION: OPPOSE Senior Opt-out of Auto No-Fault (HB 4959) Allows seniors on Medicare to opt out of purchasing Personal Injury Protection (PIP) as part of their auto insurance Status: House Insurance MHA POSITION: OPPOSE Health Care Professional ID Cards (HB 4524) Requires all health care professionals to wear identification cards when providing direct patient care Status: House Health Policy MHA POSITION: OPPOSE Respiratory Therapist Licensure Repeal (SB 514) Repeal the licensure of Respiratory Therapists Status: Senate Regulatory Reform MHA POSITION: TBD Create a Michigan Patient Care Board (SB 568) Consolidate regulations and oversight of physicians of medicine and osteopathic, physician assistants and advanced practice registered nurses Status: Senate Health Policy MHA POSITION: NEUTRAL Hospital Chargemaster Transparency (SB 627/HB 5094) Requires hospitals to post charge description master on their website Status: Senate Health Policy MHA POSITION: SUPPORT CONCEPT Auto No-Fault Fraud Authority (SB 647) Expands the automobile insurance placement facility to include automobile insurance fraud Status: Senate Insurance MHA POSITION: SUPPORT E-cigarette Sales to Minors (HB 5393) Prohibit sales of e-cigarettes or other devices that provide vaporized nicotine to minors and also require the products to be sold in child-proof containers Status: House Regulatory Reform MHA POSITION: SUPPORT Hospitals–ACT Hospitals Advocating Care Together (Hospitals-ACT) is a grassroots initiative dedicated to helping MHA members achieve public policies that protect access to affordable health care for all Michigan residents. Hospitals-ACT brings together hospital employees, trustees and volunteers to deliver advocacy messages to state lawmakers, Gov. Snyder and the media. These voices - the voices of lawmakers’ constituents - truly complement and enforce the MHA’s overall advocacy efforts. To learn more, please visit the Web site at www.hospitalsact.org. http://www.mha.org/mha/public_site/advocacy/documents/abriefing.pdf 3 OCTOBER 23, 2014 PAGE leaders must recognize the crucial role that community hospitals play in the future well-being of The 2014 Health PAC fundraising this state. Funding from the Health PAC campaign had another successful year, yet assists the MHA and members in again reaching an all-time high of more developing relationships and sharing than $375,000. Elected officials and state information with key legislators. The MHA 4 Health PAC Board strongly encourages those hospitals/health systems that have not met or exceeded their organizational goals to take the necessary steps to complete their fundraising campaigns. Members with questions should contact Stacy Dowdy at the MHA. Regulatory Update: Certificate of Need Certificate of Need is a state regulatory program intended to balance cost, quality and access issues and ensure that only needed services and facilities are developed in Michigan. The 11-member, governor-appointed state Certificate of Need (CON) Commission meets quarterly to review standards that regulate covered health care services, beds, new construction and renovation. Proposed standards receive a public hearing, and then if approved by the CON Commission, are forwarded to the legislature and executive branch for final approval before taking effect. The Michigan Health & Hospital Association supports the Certificate of Need law as a means of maintaining access and preserving high-quality care in the community hospital setting, while restraining the proliferation of unnecessary facilities and services. The Commission met last on Sept. 25, 2014 and action items included approval of new county designations to reflect recent federal census changes, consideration of proposed language to amend the standards governing nursing homes and hospital long-term-care units largely supported by the industry, and review of proposed amendments to the hospital bed standards that would clarify the definition of a hospital campus to include the grounds within 250 yards of the facility. A public hearing has been scheduled for Oct. 23rd to obtain comments on the draft language for both standards. Written comments may be submitted electronically to the CON Commission through 5 pm on Oct. 30th. The commission also called for bylaws changes to allow for more flexibility in the appointment of experts on Standard Advisory Committees and set an Oct. 15 date to begin receiving public comments on standards slated for review in 2015. Information about the criteria and deadlines for seeking an appointment to a Standard Advisory Committee, as well as information about proposed standards, upcoming CON Commission meetings, public comment deadlines, agendas, workgroups, CON application forms, and lists of approved and disapproved applications can be accessed via the state’s CON website at www.michigan.gov/con. The next CON Commission meeting is Dec. 11, 2014. MHA Advocacy Staff David Finkbeiner Senior Vice President, Advocacy (517) 703-8604 ▪ [email protected] Laura Appel Senior Vice President, Strategic Affairs (517) 703-8606 ▪ [email protected] Amy Barkholz General Counsel (517) 886-8224 ▪ [email protected] Stacy Dowdy Manager, Grassroots Advocacy & Health PAC (517) 703-8648 ▪ [email protected] Paige Fults Manager, Advocacy (517) 703-8616 ▪ [email protected] Chris Mitchell Vice President, Advocacy (517) 703-8622 ▪ [email protected] Stephanie Yager Executive Assistant (517) 703-8629 ▪ [email protected] MHA Legislative Policy Panel The MHA Legislative Policy Panel (LPP) reviews emerging health care legislation in a timely and efficient manner and recommends an appropriate association response to the MHA Board of Trustees. In addition, the LPP is active in identifying new legislative initiatives for the association to champion. Peter Karadjoff, President of Providence Park Hospital will served as chairperson of the LPP during the 2014-2015 program year. Vice chairperson will be Diane Postler-Slattery, President & CEO of MidMichigan Health. The next meeting of the program year will be held Dec. 11, 2014 at the MHA Capitol Advocacy Center, 110 W. Michigan Ave., Ste. 1200, Lansing. For more information about the meetings, please contact Chris Mitchell at (517) 703-8622 or [email protected]. http://www.mha.org/mha/public_site/advocacy/documents/abriefing.pdf
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