Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 438

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 438
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 Physician Payments Sunshine Act within the ACA requires that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, physicians, and teaching hospitals and to report annually certain ownership and investment interests held by physicians, certain other healthcare professionals, and their immediate family members. •Similar federal, state and foreign fraud and abuse laws and regulations may apply to sales or marketing arrangements and claims involving healthcare items or services. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant federal government compliance guidance, and require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. •State laws that require the registration or licensure of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws. The scope and enforcement of each of these laws may be uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies have long scrutinized interactions between pharmaceutical manufacturers and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Increasing Efforts to Cap or Reduce Prices of or Reimbursements for Drugs The costs of new drugs with patent protection (and substantial price increases for drugs whose patent protection expired) in the U.S. has drawn attention from across the political spectrum, resulting in various proposals to cap or reduce drug prices. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. On August 16, 2022 the Inflation Reduction Act of 2022 was passed, which among other things, allows for CMS to negotiate prices for certain single -sourcedrugs and biologics reimbursed under Medicare Part B and Part D, beginning with ten high -costdrugs paid for by Medicare Part D starting in 2026, followed by up to15 Part D drugs in 2027, up to 15 Part