Bipartisan Group of Senators Form Working Group to Address Medicare Physician Payment System

Posted by Steve Alder

A bipartisan group of senators has formed a Medicare payment reform working group which is working on new legislation that will bring long-term reforms to physician payments under Medicare. The new legislation will ensure that healthcare providers receive fair compensation for the services they provide.

For many years, physicians have complained that they are not fairly compensated for providing services under Medicare. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) made significant strides toward a value-based payment system from a system that paid on quantity, and it aimed to provide physicians with a stable payment system; however, MACRA has not achieved its goals and further action is required to address the reimbursement challenges that come with a system that aligns payment incentives with patient outcomes.

U.S. Sens. Catherine Cortez Masto, (D-NV); Marsha Blackburn, (R-TN); John Barrasso, (R-WY); Debbie Stabenow, (D-MI); Mark Warner, (D-VA); and Minority Whip John Thune, (R-SD) formed the group with the primary goal of investigating and proposing long-term reforms to the physician fee schedule (PFS) and updating MACRA. “As the health care system has evolved since the inception of the Medicare program, the physician payment system has failed to keep pace with the actual cost of care and the improvements in new services and technologies,” explained the Senators. “We believe Congress must make changes to the current Medicare physician payment system to ensure financial stability for providers, improve patient outcomes, promote access to quality care, and incentivize the utilization of emerging health care technology.”

One of the first steps will be to reach out to stakeholders to obtain their feedback on the current problems and potential solutions. The feedback collected will inform the development of policies that will address Medicare physician payment for the long term, increase compensation for physicians who provide services under Medicare, and improve the quality of care for patients.

Action needs to be taken. A 3.4% Medicare payment rate cut took effect on January 1, 2024, on top of a 2% payment reduction in 2023, and the Medicare Economic Index (MEI) was 3.8% last year and 4.6% this year, which is the highest level it has been this century. The American Hospital Association (AHA) recently highlighted that there has been an inflation-adjusted 30% decline in Medicare reimbursement rates since 2001 and the payment freeze will not end until 2026, while the cost of keeping practices open is continuing to soar. “Physicians always put patients first. It is time for our political leaders to prioritize our nation’s physician workforce by correcting the flaws in a Medicare system that unfairly penalizes doctors for the care they provide,” said the AHA. “We can, and must, do better.”

The post Bipartisan Group of Senators Form Working Group to Address Medicare Physician Payment System appeared first on HIPAA Journal.

FDA Issues Guidance on Reporting the Amount of Listed Drugs and Biological Products Under the FD&C Act

Posted by Steve Alder

The U.S. Food and Drug Administration (FDA) has issued draft guidance to help registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.

In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 (COVID–19). One of the requirements of the CARES Act was to enhance the FDA’s ability to identify, prevent, and mitigate potential drug shortages by improving visibility into drug supply chains.

The CARES Act updated the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require persons who register with the FDA under section 510 of the FD&C Act, including repackers and relabelers, to submit annual reports to the FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

“With earlier awareness of persistent or emerging supply chain challenges, FDA is better informed and able to take more targeted and timely actions to promote stronger supply chains and reduce drug shortage risks,” explained the FDA.

The guidance document – Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act – describes the process that should be used for submitting reports on listed drugs and clarifies who is required to submit reports, what the reports must include, and the timing of reports. While reports are a legal requirement under the FD&C Act, the guidance does not establish legally enforceable responsibilities, instead, it details the FDA’s current thinking and includes best practices that should be followed.

The post FDA Issues Guidance on Reporting the Amount of Listed Drugs and Biological Products Under the FD&C Act appeared first on HIPAA Journal.

What are the OSHA Regulations for Hospitals?

Posted by Steve Alder

The OSHA regulations for hospitals consist of all applicable common workplace safety and health standards and any that apply to the nature of services provided by the hospital or its operations. For example:

Common Workplace Safety and Health Standards may include:

  • 1910.22 General Requirements
  • 1910.25 Stairways
  • 1910.35 Means of Egress
  • 1910.38 Emergency Action Plan

Specific Healthcare Safety and Health Standards may include:

  • 1910.1096 Ionization Radiation
  • 1910.1030 Bloodborne Pathogens
  • 1910 Subpart I Personal Protective Equipment
  • 1910 Subpart Z Toxic and Hazardous Substances

Healthcare Operations Safety and Health Standards may include:

  • 1910.95 Noise Exposure
  • 1910.303 General Electrical Requirements
  • 1910 Subpart J General Environmental Controls
  • 1910 Subpart O Machinery and Machine Guarding

In addition, the OSHA regulations for hospitals include all applicable administrative and recordkeeping standards promulgated by the Occupational Safety and Health Administration or state OSHA Plan.

Which OSHA Regulations for Hospital are Applicable?

The challenge of OSHA compliance for hospitals is working out which OSHA regulations are applicable. For example, there will be more threats to safety and health attributable to workplace violence in hospitals with ER departments than there will be in maternity hospitals.

With regards to healthcare operations, hospitals with inhouse laundry facilities will have to be more conscious of the OSHA regulations for hospitals relating to heat stress and machine guarding than hospitals that outsource laundry services or that only provide out-patient facilities.

How OSHA’s E-Tool for Healthcare can Help

To help determine which OSHA regulations for hospitals are applicable, the Administration has created an online e-tool that covers fourteen focus points of hospital activities. It is important to be aware that the hazards, requirements, and controls discussed in each module may not be the only hazards, requirements, or controls applicable to each focus point.

OSHA reminds employers and safety officers using the e-tool it is necessary to conduct a thorough worksite hazard analysis to determine the full range of hazards to which members of the workforce are exposed and the full range of controls to protect members of the workforce from those hazards. In this respect, the CDC’s “Pocket Guide to Chemical Hazards” can also be a valuable resource.

Complying with the OSHA General Duty Clause

The OSHA General Duty clause requires that, in addition to complying with hazard-specific standards, employers must provide a work environment “free from recognized hazards that are causing or are likely to cause death or serious physical harm.” Workplace violence is a recognized hazard in the healthcare industry and as such, employers have the responsibility via the Act to abate the hazard.

Complying with the OSHA General Duty clause can also be a challenge for hospitals due to the issue of work-related Musculoskeletal Disorders (MSDs) caused by manually lifting, moving, and repositioning patients. MSDs are also covered by the OSHA General Duty clause, and OSHA has published guidance on preventing MSDs in the workplace to help avoid injuries of this type.

Complying with OSHA Recordkeeping Requirements

With the exception of partially exempt outpatient care centers, most healthcare organizations have to comply with OSHA recordkeeping requirements. These apply to all recordable work-related injuries and illnesses suffered by employed members of the workforce, and fatalities, amputations, hospitalizations, or eye loss injuries affecting any member of the workforce.

Some OSHA regulations for hospitals have special recordkeeping requirements. For example, when recording needlestick and sharps injuries (OSHA standard §1904.8), employers must not enter the employee’s name on the OSHA 300 log. There are also privacy requirements for other types of injury recordkeeping. These can be found in OSHA standard §1904.29(b)(6) through §1904.29(b)(9).

Complying with OSHA Training Requirements

The OSHA training requirements vary by standard. Some standards (i.e., the “Personal Protective Equipment” standard) require that employees are trained in how to use the equipment the first time it is provided for them. Other standards (i.e., the “Bloodborne Pathogens” standard) require annual training. Note: annual training on some standards may be required by other agencies. For example, annual emergency action plan training is a condition of participation in Medicare.

Like the HIPAA training requirements, all members of the workforce will require general safety and health training (i.e., cleaning up spills safely), while some members of the workforce will require further OSHA training specific to their roles (i.e., using ethylene oxide safely). Similarly, healthcare organizations need to train all members of the workforce on the meaning of hazard warning signs, but only some on permissible exposure limits for the hazards they are exposed to.

Penalties for Non-Compliance with the OSHA Regulations for Hospitals

Unlike HIPAA, in which penalties are most often issued for violations attributable to willful neglect, OSHA issues financial penalties when employers “should have known” about the OSHA compliance requirements. In the year to September 2023, OSHA issued financial penalties for non-compliance with the following OSHA regulations for hospitals:

  • The bloodborne pathogen standard
  • The hazard communication standard
  • The respiratory protection standard
  • The control of hazardous energy standard
  • OSHA’s form filling requirements
  • The formaldehyde standard
  • OSHA’s general requirements
  • The asbestos standard
  • The wiring methods, components, and equipment standard.
  • The exit route standard (maintenance, safeguards, and features)

The failure to train employees is a common factor in OSHA enforcement action. In 2013, the Atlanta Health Careers Institute in Georgia was fined $62,000 for violations of the bloodborne pathogen standard, with $60,000 of the total being attributable to the employer failing to train workforce members on the hazards and precautions.

Previously, the New York Hospital of Queens was fined $112,500 for violations of the formaldehyde standard – a large part of which was attributable to the failure of the hospital to provide employees with appropriate training – while in the last year, two hospitals have been fined for just the failure to provide training to members of the workforce.

Help to Comply with OSHA Healthcare Regulations

If you have a responsibility for safety and health in a hospital, and you are not sure about which regulations apply to your organization, you can get help from multiple sources. You can download our OSHA compliance checklist, seek advice from an OSHA compliance expert, or contact OSHA directly on 800-321-6742 (OSHA). In some circumstances, you may qualify for a free on-site OSHA consultation or a grant towards developing a workplace training program.

Related Content

OSHA and HIPAA compliance

How does OSHA Enforce its Standards?

What Does OSHA Mean?

OSHA Safety Walkthrough List

Why is OSHA Necessary?

The post What are the OSHA Regulations for Hospitals? appeared first on HIPAA Journal.